8

Hepatitis B Vaccine

INTRODUCTION

Hepatitis B virus (HBV) is a 42-nm spherical particle that replicates primarily in the liver of infected individuals (Mast and Ward, 2008). In infected persons, the virus can be found in most bodily fluids, with the highest infectious concentration in the serum and with transmittable levels also found in semen and saliva (Alter et al., 1977; Bancroft et al., 1977; CDC, 2006; Scott et al., 1980). The virus is very hardy and can live on surfaces for more than 7 days (CDC, 2006). Among adults, the primary modes of transmission are sexual intercourse with persons with chronic lifelong infection (carriers) and percutaneous exposure to the virus due to intravenous drug usage or occupational exposures to needles and other sharp objects (CDC, 2006). In the United States, exposure in children 5 years old and under is generally limited (Shapiro, 1993). Infection is associated with perinatal exposure to maternal blood or exposure to infected blood or saliva within the immediate environment (Shapiro, 1993).

HBV-infected individuals are often asymptomatic. Clinical symptoms of acute HBV infection are more likely in older individuals than in younger individuals (McMahon et al., 1985). When manifested, symptoms may include fever, fatigue, nausea, vomiting, and abdominal pain before progressing to clay-colored stools, dark urine, and jaundice indicating increased liver involvement and cholestasis—the accumulation of bile in the liver (CDC, 2006; Mast and Ward, 2008). Extrahepatic manifestations of hepatitis B can include arthritis, urticaria, vasculitis, and glomerulonephritis (Mast and Ward, 2008). Symptomatic infection generally presents within



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8 Hepatitis B Vaccine INTRODUCTION Hepatitis B virus (HBV) is a 42-nm spherical particle that replicates primarily in the liver of infected individuals (Mast and Ward, 2008). In infected persons, the virus can be found in most bodily fluids, with the high- est infectious concentration in the serum and with transmittable levels also found in semen and saliva (Alter et al., 1977; Bancroft et al., 1977; CDC, 2006; Scott et al., 1980). The virus is very hardy and can live on surfaces for more than 7 days (CDC, 2006). Among adults, the primary modes of transmission are sexual intercourse with persons with chronic lifelong infec- tion (carriers) and percutaneous exposure to the virus due to intravenous drug usage or occupational exposures to needles and other sharp objects (CDC, 2006). In the United States, exposure in children 5 years old and under is generally limited (Shapiro, 1993). Infection is associated with peri- natal exposure to maternal blood or exposure to infected blood or saliva within the immediate environment (Shapiro, 1993). HBV-infected individuals are often asymptomatic. Clinical symptoms of acute HBV infection are more likely in older individuals than in younger individuals (McMahon et al., 1985). When manifested, symptoms may include fever, fatigue, nausea, vomiting, and abdominal pain before pro- gressing to clay-colored stools, dark urine, and jaundice indicating in- creased liver involvement and cholestasis—the accumulation of bile in the liver (CDC, 2006; Mast and Ward, 2008). Extrahepatic manifestations of hepatitis B can include arthritis, urticaria, vasculitis, and glomerulonephritis (Mast and Ward, 2008). Symptomatic infection generally presents within 435

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436 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY the first 6 months of exposure averaging 90 days from exposure to jaun- dice and 60 days to abnormal serum alanine aminotransferase (ALT) levels indicating liver injury (Krugman et al., 1979). Approximately 95 percent of all hepatitis B infections among other- wise healthy adults resolve without sequelae, and the recovered individual possesses lifelong immunity to HBV infection (CDC, 2006). In the other 5 percent, chronic infection develops (CDC, 2006). Chronic HBV infection may lead to liver cirrhosis, liver failure, hepatocellular carcinoma, or death (Mast and Ward, 2008). These outcomes are thought to be the result of the constant activity of the immune system and not a direct consequence of damage caused by the virus itself (Ganem and Prince, 2004). The likeli- hood of chronic hepatitis B disease is inversely related to the age of the individual at the time of HBV infection (Beasley et al., 1983; Edmunds et al., 1993). Among infants perinatally infected with HBV, 80–90 percent develop chronic disease; among children infected postnatally through 5 years of age, 30 percent; and among adults, fewer than 5 percent (Hyams, 1995). The risk of chronic disease may be higher in the immunocompro- mised and diabetics dependent on finger-stick monitoring devices (CDC, 2006; Polish et al., 1992). HBV transmission through blood and blood products was first evi- denced in 1883 after an outbreak of hepatitis among shipyard workers following smallpox vaccination in Bremen, Germany (Mast and Ward, 2008). In 1965, Blumberg and Alter (Blumberg and Alter, 1965) discovered the Australia antigen (Au), which was later determined to be hepatitis B surface antigen (HBsAg) (Prince, 1968). Research performed in the early 1970s showed that HBV could be heat-inactivated and that inoculation with inactivated serum provided resistance to or modification of the virus (Krugman, 1974; Krugman and Giles, 1973). In the early 1980s, several groups developed preliminary HBV vaccines (Coutinho et al., 1983; McLean et al., 1983; Purcell and Gerin, 1975). The vaccines consisted of inactivated, alum-adsorbed, 22-nm HBsAg particles recovered and purified from individuals with chronic hepatitis B infection (Coutinho et al., 1983; McLean et al., 1983; Purcell and Gerin, 1975). With the development of DNA recombinant technologies and the ability to obtain HBsAg from other sources such as Saccharomyces cerevisiae (baker’s yeast), DNA recombinant vaccines replaced plasma-derived vaccines in the United States (Mast and Ward, 2008). In 1991, the Centers for Disease Control and Prevention (CDC) and the American Academy of Pediatrics recommended HBV vaccination for all infants and adults (CDC, 1991). Currently, hepatitis B vaccines are available in single- and multiantigen formulations (CDC, 2005). The two single-antigen vaccines are Recom- bivax HB (Merck & Co., Inc.) and Engerix-B (GlaxoSmithKline Biologi- cals) (CDC, 2005). Of the three licensed combination vaccines, Comvax (Merck) and Pediarix (GlaxoSmithKline) are used for infant and child

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437 HEPATITIS B VACCINE vaccination, while Twinrix (GlaxoSmithKline) is used for adult vaccina- tion (CDC, 2005). Comvax is a bivalent vaccine designed to prevent Hae- mophilus influenzae type B infection in addition to hepatitis B and contains Haemophilus influenzae type B capsular polysaccharide polyribosylribitol phosphate affixed to Neisseria meningitides outer-membrane protein com- plex and HBsAg from recombinant yeast cultures (CDC, 2005). Pediarix contains recombinant HBsAg, diphtheria and tetanus toxoids and acel- lular pertussis adsorbed (DTaP), and inactivated poliovirus (CDC, 2005). Twinrix is designed to prevent hepatitis A and B, and contains recombinant HBsAg and inactivated hepatitis A virus (CDC, 2005). The Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians recommend the HBV vaccine in a series of three doses: at birth, between 1 and 2 months, and between 6 and 18 months (CDC, 1991; Mast and Ward, 2008). In unvaccinated adolescents and adults, the CDC recommends three doses of the vaccine with the first and second dose 1 month apart and the third dose 6 months after the initial dose (CDC, 1991). The three-dose series results in protective concentrations of HBsAg antibodies in more than 95 percent of healthy infants, children, and adolescents and in greater than 90 percent of healthy adults aged up to 40 years (Mast and Ward, 2008). In adults older than 40 years, immunogenicity drops below 90 percent (Mast and Ward, 2008). The hepatitis B vaccine has a preexposure efficacy of 80–100 percent, and if given in conjunction with hepatitis B immune globulin, the vaccine is 85–95 percent effective in preventing chronic infec- tion post-HBV exposure (Mast and Ward, 2008). Following vaccination, HBV immunity appears to be lifelong, and booster doses of the vaccine are not routinely recommended (Mast and Ward, 2008). In 2009, 92 percent of U.S. children aged 19–35 months completed all three recommended doses of hepatitis B vaccine (CDC, 2010). ENCEPHALITIS AND ENCEPHALOPATHY Epidemiologic Evidence No studies were identified in the literature for the committee to evalu- ate the risk of encephalitis or encephalopathy after the administration of hepatitis B vaccine. Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between hepatitis B vaccine and encephalitis or encephalopathy.

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438 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Mechanistic Evidence The committee identified three publications reporting encephalitis or encephalopathy after administration of a hepatitis B vaccine. The publica- tions did not provide evidence beyond temporality (Deisenhammer et al., 1994; Manna et al., 1996; Yang et al., 2006). The publications did not contribute to the weight of mechanistic of evidence. Weight of Mechanistic Evidence The committee assesses the mechanistic evidence regarding an as- sociation between hepatitis B vaccine and encephalitis or encepha- lopathy as lacking. Causality Conclusion Conclusion 8.1: The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and encephalitis. Conclusion 8.2: The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and encephalopathy. SEIZURES Epidemiologic Evidence The committee reviewed four studies to evaluate the risk of seizures after the administration of hepatitis B vaccine. Two studies (Dobson et al., 1995; Niu et al., 1996) were not considered in the weight of epidemiologic evidence because they provided data from passive surveillance systems and lacked unvaccinated comparison populations. One controlled study (Zipp et al., 1999) had very serious methodological limitations that precluded its inclusion in this assessment. The study by Zipp et al. (1999) was a letter to the editor judged by the committee to have insufficient methodological detail. The one remaining controlled study (Lewis et al., 2001) contributed to the weight of epidemiologic evidence and is described below. Lewis et al. (2001) conducted a cohort study in children enrolled in the San Francisco Medical Center of Northern California Kaiser Permanente. Patients born from November 1991 through April 1994 were included in the study; premature and low-birth-weight infants, and infants with diagno- ses (e.g., sepsis, congenital infection, hematologic disorder, cardiac disease, neurologic disease, and lung disease) that made vaccination less likely in the opinion of the authors were excluded. A total of 5,655 patients met the in-

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439 HEPATITIS B VACCINE clusion criteria and were included in the analysis. Computerized databases provided information on hepatitis B vaccinations and hospital, outpatient, or emergency department visits for seizures. An event was considered a seizure if one of the following diagnoses were listed in the medical record: seizure or infantile spasm, seizure, seizure in newborn, and epilepsy. In the primary analysis, patients who received hepatitis B vaccine within 21 days of birth were classified as vaccinated (3,302 cases). In the secondary analy- sis, patients who received hepatitis B vaccine on the day of birth or the day after birth were classified as vaccinated (2,718 cases). The study did not specify the timing from vaccination to seizure. The relative risk of seizure following administration of hepatitis B within 21 days of birth was 0.18 (95% CI, 0.02–1.6) and following administration of hepatitis B on the day of birth or day after birth was 0.22 (95% CI, 0.02–2.19). The authors con- cluded that hepatitis B vaccination does not increase the risk of seizure in children, but noted the analysis had limited power to assess this association. Weight of Epidemiologic Evidence The committee has limited confidence in the epidemiologic evi- dence based on one study that lacked validity and precision to assess an association between hepatitis B vaccine and seizures. Mechanistic Evidence The committee identified six publications reporting seizures after ad- ministration of a hepatitis B vaccine. The publications did not provide evidence beyond temporality, some too long or too short based on the pos- sible mechanisms involved (Battaglia and Valiani, 1992; de Carvalho and Shoenfeld, 2008; Hartman, 1990; Kaygusuz et al., 2002; Planchamp et al., 2009; Yang et al., 2006). In addition, Planchamp et al. (2009) reported the concomitant administration of vaccines, making it difficult to determine which, if any, vaccine could have been the precipitating event. The publica- tions did not contribute to the weight of mechanistic evidence. Weight of Mechanistic Evidence The symptoms described in the publications referenced above are con- sistent with those leading to a diagnosis of seizure. In some instances fever may contribute to the development of seizures; however, the publications did not provide evidence linking this mechanism to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as- sociation between hepatitis B vaccine and seizures as lacking.

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440 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Causality Conclusion Conclusion 8.3: The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and seizures. ACUTE DISSEMINATED ENCEPHALOMYELITIS Epidemiologic Evidence No studies were identified in the literature for the committee to evalu- ate the risk of acute disseminated encephalomyelitis (ADEM) after the administration of hepatitis B vaccine. Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between hepatitis B vaccine and ADEM. Mechanistic Evidence The committee identified eight publications describing the development of ADEM after the administration of hepatitis B vaccine. Six publications did not report evidence of causality beyond a temporal relationship be- tween vaccination and the development of ADEM (Brinar and Poser, 2008; Cabrera-Gomez et al., 2002; Geier and Geier, 2004; Herroelen et al., 1991; Rogalewski et al., 2007; Voigt et al., 2001). In addition, Rogalewski et al. (2007) reported the concomitant administration of vaccines making it dif- ficult to determine which vaccine, if any, could have been the precipitating event. These publications did not contribute to the weight of mechanistic evidence. Described below are two publications reporting clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence. Konstantinou et al. (2001) reported a 39-year-old woman presenting with complete right homonymous hemianopia and severe dyslexia 4 weeks after receiving the second dose of hepatitis B vaccine. Brain MRI revealed a lesion occupying the left occipital lobe and extending into the splenium of corpus callosum. T1-weighted sequences of the lesion displayed hypoin- tense signal while T2-weighted sequences displayed hyperintense signal. The lesion was enhanced on postgadolinium T1-weighted sequences and demonstrated mass effect and obliteration of adjacent sulci. Histological examination and immunoperoxidase staining of a biopsy of the lesion were consistent with demyelinating disease. Improvement in the condition was noted after surgery. Eleven days after the third dose of hepatitis B vaccine the patient developed left hemiparesis and acute progressive deterioration

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441 HEPATITIS B VACCINE of vision. Brain MRIs after the second and third vaccine doses revealed large lesions occupying the left occipital lobe and right parieto-occipital re- gion, respectively. The lesions displayed hypointense signals on T2-weighted MRIs. Histologic examination and immunoperoxidase staining were con- sistent with demyelinating disease. Testing for oligoclonal IgG bands in the cerebrospinal fluid (CSF) and examination for intrathecal hepatitis B surface antibodies were not performed after the third dose of vaccine. Improvement of the condition was noted after treatment with dexametha- sone. Brain MRIs performed at follow-up visits 1 year and 2.5 years after the onset of the initial episode showed almost complete resolution of the previous findings. Tourbah et al. (1999) reported a 31-year-old man (patient 5 in the ar- ticle) with vertigo and paresthesia in hands and legs 2 weeks after the first injection of hepatitis B vaccine. The symptoms resolved in 10 days. The patient presented with asthenia, vertigo, paresthesia, and left hemihypoes- thesia after the second dose of a hepatitis B vaccine. The symptoms resolved in 10 days. The symptoms reappeared 7 days after receiving a booster dose of hepatitis B vaccine. A brain MRI after the first dose showed multiple T2-weighted high-intensity signals. An MRI after the third dose showed high signal lesions T2-weighted images involving arcuate fibers of both hemispheres, periventricular and subcortical white matter, corpus callosum and cerebellar white matter, and cortex. Weight of Mechanistic Evidence The two publications described above, when considered together, pre- sented clinical evidence suggestive but not sufficient for the committee to conclude the vaccine may be a contributing cause of ADEM after vac- cination against hepatitis B. The mechanistic evidence contributing to the analysis includes a clinical picture consistent with ADEM, and recurrence of symptoms after revaccination with hepatitis B vaccine where new white matter disease was associated with each revaccination. In the publications described above all of the patients recovered with steroids. In addition, a brain biopsy performed by Konstantinou et al. (2001) showed demyelin- ation. Furthermore, Konstantinou et al. (2001) did not observe oligoclonal bands in the CSF. Neither publication reported the development of antibod- ies to HBsAg. Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms of ADEM; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an asso- ciation between hepatitis B vaccine and ADEM as low-intermediate based on two cases.

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442 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Causality Conclusion Conclusion 8.4: The evidence is inadequate to accept or reject a causal relationship between hepatitis B vaccine and ADEM. TRANSVERSE MYELITIS Epidemiologic Evidence No studies were identified in the literature for the committee to evalu- ate the risk of transverse myelitis after the administration of hepatitis B vaccine. Weight of Epidemiologic Evidence The epidemiologic evidence is insufficient or absent to assess an association between hepatitis B vaccine and transverse myelitis. Mechanistic Evidence The committee identified seven publications reporting transverse myeli- tis after the administration of hepatitis B vaccine. Six publications did not provide evidence beyond temporality, some too long or too short based on the possible mechanisms involved (Fonseca et al., 2003; Iniguez et al., 2000; Karaali-Savrun et al., 2001; Mahassin et al., 1993; Renard et al., 1999; Senejoux et al., 1996). Long latencies between vaccine administration and development of symptoms make it impossible to rule out other possible causes. These publications did not contribute to the weight of mechanistic evidence. Described below is one publication that reported clinical, diagnostic, or experimental evidence that contributed to the weight of mechanistic evidence. Tartaglino and colleagues (1995) described a 40-year-old man present- ing with lower extremity numbness and difficulty walking 2 weeks after receiving the first dose of hepatitis B vaccine. One month after receiving the second dose of hepatitis B vaccine the patient had difficulty walking, and the sensory disturbance ascended to the nipple level. A swollen edematous cord extending from C-3 to T-9 was revealed via T1-weighted and T2- weighted spin-echo pulse sequences. Weight of Mechanistic Evidence The publication described above did not present evidence sufficient for the committee to conclude the vaccine may be a contributing cause of

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443 HEPATITIS B VACCINE transverse myelitis after vaccination against hepatitis B. The timing of the rechallenge appears to be a second episode, but the 1-month time frame between the two episodes is not sufficient to determine if the symptoms represent one or two episodes. A patient must return to baseline or be stable for at least 6 weeks before a new episode is recorded. Furthermore, no immunology indicating an enhancement of a proinflammatory response linked to the vaccine is presented. Autoantibodies, T cells, and molecular mimicry may contribute to the symptoms of transverse myelitis; however, the publications did not provide evidence linking these mechanisms to hepatitis B vaccine. The committee assesses the mechanistic evidence regarding an as- sociation between hepatitis B vaccine and transverse myelitis as weak based on one case. Causality Conclusion Conclusion 8.5: The evidence is inadequate to accept or reject a causal relation between hepatitis B vaccine and transverse myelitis. OPTIC NEURITIS Epidemiologic Evidence The committee reviewed three studies to evaluate the risk of optic neuritis in adults after the administration of hepatitis B vaccine. One study (Geier and Geier, 2005) was not considered in the weight of epidemiologic evidence because it provided data from a passive surveillance system and lacked an unvaccinated comparison population. The two remaining controlled studies (DeStefano et al., 2003; Payne et al., 2006) were included in the weight of epidemiologic evidence and are described below. DeStefano et al. (2003) conducted a case-control study to evaluate the association between hepatitis B vaccination and optic neuritis using data from three health maintenance organizations (HMOs) participating in the Vaccine Safety Datalink (VSD). The optic neuritis analysis included 108 cases and 228 controls. The cases had a documented physician’s diagnosis from 1995 through 1999, and were matched to controls from the HMO on date of birth (within 1 year) and sex. The authors evaluated the date of disease onset using data described in the medical record or reported in the telephone interview. The immunization status was obtained from vaccination records, medical records, and telephone interviews. The study had high rates of self-reported vaccinations from outside the HMO system (51 percent of cases and 50 percent of controls) that could not be verified,

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444 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY which may have biased the results. The odds ratio for ever vaccinated with hepatitis B before optic neuritis diagnosis was 1.2 (95% CI, 0.5–3.1). The authors concluded that hepatitis B vaccination does not appear to be as- sociated with an increased risk of optic neuritis in adults. Payne et al. (2006) used the Defense Medical Surveillance System (DMSS) to conduct a case-control study among U.S. military personnel. The study included 1,131 cases with a first diagnosis of optic neuritis from 1998 through 2003, and 3,393 controls. The cases and controls were matched on sex, military service (e.g., active or reserve), and deployment within 18 weeks of diagnosis date. The vaccination status and date of first symptom of optic neuritis were obtained from the DMSS and reviewed by a neuro-opthalmologist. About 3 percent of the cases (37 patients) and controls (118 patients) received hepatitis B vaccine within the 18-week risk period, which suggested that possible confounders related to the decision to vaccinate were present. Although the authors considered three exposure times—6, 12, and 18 weeks after vaccination—only the odds ratio for optic neuritis diagnosis within 18 weeks of hepatitis B vaccination was given (OR, 1.02; 95% CI, 0.68–1.54). The authors noted without present- ing results that similar conclusions were obtained using 6- and 12-month exposure times. The authors concluded that vaccination against hepatitis B does not appear to increase the risk of optic neuritis in adults. Weight of Epidemiologic Evidence Two case-control studies evaluating the risk of optic neuritis in adults after hepatitis B vaccination were included in the committee’s review of the epidemiologic evidence. Neither of these studies found a significantly increased risk of optic neuritis after hepatitis B vaccination. Hepatitis B vaccination was infrequent in both cases and controls, raising the possibil- ity that selection bias could affect reported associations. See Table 8-1 for a summary of the studies that contributed to the weight of epidemiologic evidence. The committee has limited confidence in the epidemiologic evi- dence, based on two studies that lacked validity and precision to assess an association between hepatitis B vaccine and optic neuritis in adults. Mechanistic Evidence The committee identified six publications reporting optic neuritis after the administration of hepatitis B vaccine. The publications did not provide evidence beyond temporality (Albitar et al., 1997; Erguven et al., 2009;

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TABLE 8-1 Studies Included in the Weight of Epidemiologic Evidence for Hepatitis B Vaccine and Optic Neuritis Operationally Primary Effect Size Heterogeneous Limitations Defined Study Defined Study Study Sample Estimatea (95% CI or p Subgroups at (Negligible Citation Outcome Setting Population Design Size value) Higher Riskb or Serious)c DeStefano Date of optic Three Case 108 OR for optic neuritis None Serious Ages < 18, 18–40, et al. neuritis onset HMOs control patients onset any time after described > 40 years (2003) from medical participating with optic hepatitis B vaccination: Cases had optic records or in the VSD neuritis 1.2 (95% CI, 0.5–3.1) neuritis diagnosed telephone by a physician from 228 interviews 1995 through 1999 controls Payne Date of first Defense U.S. military Case 1,131 OR for optic neuritis None Serious et al. symptom of Medical control patients onset within 18 weeks of described personnel ages ≥ 18 (2006) optic neuritis Surveillance years with optic hepatitis B vaccination: listed in System neuritis 1.02 (95% CI, 0.68–1.54) Cases had optic system and neuritis diagnosed 3,393 reviewed by a physician from controls by neuro- 1998 through 2003 opthalmologist a The committee assumed statistical significance below the conventional 0.05 level unless otherwise stated by the authors. b The risk/effect estimate for the subgroup/alternate definition of exposure or outcome differs significantly (e.g., is heterogeneous with nonoverlap- ping 95% confidence intervals) compared with the risk/effect estimate reported for the primary group/definition. c Studies designated as serious had more methodological limitations than those designated as negligible. Studies assessed as having very serious limitations were not considered in the weight of epidemiologic evidence. 445

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494 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY REFERENCES Adverse Drug Reactions Advisory Committee. 1996. Hepatitis B vaccines—musculoskeletal reactions. Australian Adverse Drug Reactions Bulletin 15(2). Agmon-Levin, N., Y. Zafrir, Z. Paz, T. Shilton, G. Zandman-Goddard, and Y. Shoenfeld. 2009. Ten cases of systemic lupus erythematosus related to hepatitis B vaccine. Lupus 18(13):1192-1197. Aherne, P., and M. Collins. 1995. Psoriatic arthropathy. Irish Medical Journal 88(2):72. Albitar, S., B. Bourgeon, R. Genin, M. Fen-Chong, P. N’Guyen, M. O. Serveaux, H. Atchia, and D. Schohn. 1997. Bilateral retrobulbar optic neuritis with hepatitis B vaccination. Nephrology Dialysis Transplantation 12(10):2169-2170. Aletaha, D., T. Neogi, A. J. Silman, J. Funovits, D. T. Felson, C. O. Bingham, 3rd, N. S. Birnbaum, G. R. Burmester, V. P. Bykerk, M. D. Cohen, B. Combe, K. H. Costenbader, M. Dougados, P. Emery, G. Ferraccioli, J. M. Hazes, K. Hobbs, T. W. Huizinga, A. Kavanaugh, J. Kay, T. K. Kvien, T. Laing, P. Mease, H. A. Menard, L. W. Moreland, R. L. Naden, T. Pincus, J. S. Smolen, E. Stanislawska-Biernat, D. Symmons, P. P. Tak, K. S. Upchurch, J. Vencovsky, F. Wolfe, and G. Hawker. 2010. 2010 rheumatoid arthritis classification criteria: An American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis and Rheumatism 62(9):2569-2581. Allen, M. B., P. Cockwell, and R. L. Page. 1993. Pulmonary and cutaneous vasculitis following hepatitis B vaccination. Thorax 48(5):580-581. Alter, H. J., R. H. Purcell, J. L. Gerin, W. T. London, P. M. Kaplan, V. J. McAuliffe, J. Wagner, and P. V. Holland. 1977. Transmission of hepatitis B to chimpanzees by hepatitis B sur- face antigen-positive saliva and semen. Infection and Immunity 16(3):928-933. Ascherio, A., S. M. Zhang, M. A. Hernan, M. J. Olek, P. M. Coplan, K. Brodovicz, and A. M. Walker. 2001. Hepatitis B vaccination and the risk of multiple sclerosis. New England Journal of Medicine 344(5):327-332. Ball, R., M. M. Braun, G. T. Mootrey, S. Ellenberg, S. Rastogi, C. Krueger, R. Wise, M. Niu, D. Davis, F. Varricchio, P. Perucci, T. DuVernoy, R. Chen, P. Haber, V. Pool, W. Wattigney, T. Strine, R. Pless, V. Caserta, and G. Evans. 2001. Safety data on meningococcal poly- saccharide vaccine from the Vaccine Adverse Event Reporting System. Clinical Infectious Diseases 32(9):1273-1280. Bancroft, W. H., R. M. Scott, W. T. Watson, and J. J. Karwacki. 1977. Transmission of hepati- tis B virus to gibbons by exposure to human saliva containing hepatitis B surface antigen. Journal of Infectious Diseases 135(1):79-85. Battaglia, A., and R. Valiani. 1992. Description of case of seizure following anti-hepatitis B immunization [in Italian]. Rassegna di Medicina Sperimentale 39(7-9):119-122. Beasley, R. P., L. Y. Hwang, G. C. Y. Lee, C. C. Lan, C. H. Roan, F. Y. Huang, and C. L. Chen. 1983. Prevention of perinatally transmitted hepatitis B virus infections with hepatitis B immune globulin and hepatitis B vaccine. Lancet 2(8359):1099-1102. Begier, E. M., C. A. Langford, M. C. Sneller, R. P. Wise, R. Ball, and V. W. Group. 2004. Polyarteritis nodosa reports to the Vaccine Adverse Event Reporting System (VAERS): Implications for assessment of suspected vaccine-provoked vasculitis. Journal of Rheu- matology 31(11):2181-2188. Bellut, A., E. Laveine, W. Kaise, I. Vivard-Wallee, J. L. Schmutz, and A. Barbaud. 2001. Cuta- neous manifestations due to vaccines; Prospective study in Lorraine (France) [in French]. Nouvelles Dermatologiques 20(3):152-155. Beretta, L., M. Caronni, M. Vanoli, and R. Scorza. 2001. Churg-Strauss vasculitis with brain involvement following hepatitis B vaccination. Clinical and Experimental Rheumatology 19(6):757.

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495 HEPATITIS B VACCINE Biasi, D., A. Carletto, P. Caramaschi, A. Frigo, M. L. Pacor, D. Bezzi, and L. M. Bambara. 1994. Rheumatic manifestations following hepatitis B vaccination. Two case reports [in Italian]. Recenti Progressi in Medicina 85(9):438-440. Biasi, D., G. De Sandre, L. M. Bambara, A. Carletto, P. Caramaschi, G. Zanoni, and G. Tridente. 1993. A new case of reactive arthritis after hepatitis B vaccination. Clinical and Experimental Rheumatology 11(2):215. Blumberg, B. S., and H. J. Alter. 1965. A “new” antigen in leukemia sera. Journal of the American Medical Association 191(7):541-546. Bohlke, K., R. L. Davis, S. M. Marcy, M. M. Braun, F. DeStefano, S. B. Black, J. P. Mullooly, and R. S. Thompson. 2003. Risk of anaphylaxis after vaccination of children and ado- lescents. Pediatrics 112(4):815-820. Bourgeais, A. M., M. X. Dore, A. Croue, C. Leclech, and J. L. Verret. 2003. Cutaneous poly- arteritis nodosa following hepatitis B vaccination [in French]. Annales de Dermatologie et de Venereologie 130(2 Pt 1):205-207. Bracci, M., and A. Zoppini. 1997. Polyarthritis associated with hepatitis B vaccination. British Journal of Rheumatology 36(2):300-301. Brinar, V. V., and C. M. Poser. 2008. Disseminated encephalomyelitis in adults. Clinical Neu- rology and Neurosurgery 110(9):913-918. Bui-Quang, D., E. Thomas, M. Riols, P. Levillain, D. Picaud, A. Sechet, M. Baron, and C. Verove. 1998. Cutaneous vasculitis after hepatitis B vaccination with recombinant vac- cine in a renal transplant recipient [in French]. Presse Medicale 27(26):1321-1323. Cabrera-Gomez, J. A., N. Echazabal-Santana, L. Garcia Gonzalez, A. M. Ramos Cedeno, M. O. Rodriguez Roque, O. Lopez Hernandez, J. A. Cabrera Nunez, J. Gonzalez De La Nuez, and L. Tellez. 2002. A severe episode in a patient with recurrent disseminated acute encephalitis due to vaccination against hepatitis B. For or against vaccination? [in Spanish]. Revista de Neurologia 34(4):358-363. Cacoub, P., and B. Terrier. 2009. Hepatitis B-related autoimmune manifestations. Rheumatic Diseases Clinics of North America 35(1):125-137. Caillard, J. F., C. Bastard, and P. Czernichow. 1985. Side effects of hepatitis B vaccination (a study in 1047 subjects at the CHR of Rouen) [in French]. LARC Medical 5(3):129-132. Casals, J. L., and M. A. Vasquez. 1999. Arthritis after hepatitis B vaccination [in Spanish]. Anales de Medicina Interna 16(11):601-602. Cathebras, P., O. Cartry, M. H. Lafage-Proust, A. Lauwers, S. Acquart, T. Thomas, and H. Rousset. 1996. Arthritis, hypercalcemia, and lytic bone lesions after hepatitis B vaccina- tion. Journal of Rheumatology 23(3):558-560. CDC (Centers for Disease Control and Prevention). 1991. Hepatitis B virus: A comprehen- sive strategy for eliminating transmission in the United States through universal child- hood vaccination: Recommendations of the immunization practices advisory committee (ACIP). Morbidity & Mortality Weekly Report 40(RR-13):1-19. CDC. 2005. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States—recommendations of the Advisory Committee on Im- munization Practices (ACIP). Part 1: Immunization of infants, children, and adolescents. Morbidity & Mortality Weekly Report 54(RR16, Suppl. S):1-16, 17-23, 25-31. CDC. 2006. A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States—recommendations of the Advisory Committee on Immunization Practices (ACIP). Part II: Immunization of adults. Morbidity & Mortality Weekly Report 55(RR16, Suppl. S):1-16, 17-33. CDC. 2010. National, state, and local area vaccination coverage among children aged 19-35 months—United States, 2009. Morbidity & Mortality Weekly Report 59(36):1171-1177. Chave, T., C. Neal, and R. Camp. 2003. Henoch-Schonlein purpura following hepatitis B vaccination. Journal of Dermatological Treatment 14(3):179-181.

OCR for page 435
496 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Cherian, M. P., K. A. Al-Kanani, S. S. Al Qahtani, H. Yesurathinam, A. A. Mathew, V. S. Thomas, A. M. Mathew, and M. A. Abduljabbar. 2010. The rising incidence of type 1 diabetes mellitus and the role of environmental factors—three decade experience in a primary care health center in Saudi Arabia. Journal of Pediatric Endocrinology and Metabolism 23(7):685-695. Christau, B., and P. Helin. 1987. Reactive arthritis following vaccination against hepatitis B [in Danish]. Ugeskrift for Laeger 149(28). Cockwell, P., M. B. Allen, and R. Page. 1990. Vasculitis related to hepatitis B vaccine. British Medical Journal 301(6763):1281. Confavreux, C., S. Suissa, P. Saddier, V. Bourdes, and S. Vukusic. 2001. Vaccinations and the risk of relapse in multiple sclerosis. New England Journal of Medicine 344(5):319-326. Cooper, G. S., M. A. Dooley, E. L. Treadwell, E. W. St. Clair, and G. S. Gilkeson. 2002. Risk factors for development of systemic lupus erythematosus: Allergies, infections, and family history. Journal of Clinical Epidemiology 55(10):982-989. Coutinho, R. A., N. Lelie, P. Albrechtvanlent, E. E. Reerinkbrongers, L. Stoutjesdijk, P. Dees, J. Nivard, J. Huisman, and H. W. Reesink. 1983. Efficacy of a heat inactivated hepatitis B vaccine in male-homosexuals: Outcome of a placebo controlled double-blind trial. British Medical Journal 286(6374):1305-1308. Creange, A., G. Temam, and J. P. Lefaucheur. 1999. Lumbosacral acute demyelinating poly- neuropathy following hepatitis B vaccination. Autoimmunity 30(3):143-146. de Carvalho, J. F., R. M. R. Pereira, and Y. Shoenfeld. 2008. Systemic polyarteritis nodosa following hepatitis B vaccination. European Journal of Internal Medicine 19(8):575-578. de Carvalho, J. F., and Y. Shoenfeld. 2008. Status epilepticus and lymphocytic pneumonitis following hepatitis B vaccination. European Journal of Internal Medicine 19(5):383-385. De Keyser, F., J. M. Naeyaert, P. Hindryckx, D. Elewaut, P. Verplancke, I. Peene, M. Praet, and E. Veys. 2000. Immune-mediated pathology following hepatitis B vaccination. Two cases of polyarteritis nodosa and one case of pityriasis rosea-like drug eruption. Clinical and Experimental Rheumatology 18(1):81-85. Deisenhammer, F., P. Pohl, S. Bosch, and C. Schmidauer. 1994. Acute cerebellar ataxia after immunisation with recombinant hepatitis B vaccine. Acta Neurologica Scandinavica 89(6):462-463. Delbrel, X., J. Fach, D. Neau, M. Le Bras, and M. Longy Boursier. 1998. Lupus flare-up after hepatitis B vaccination [in French]. Presse Medicale 27(6):260. DeStefano, F., J. P. Mullooly, C. A. Okoro, R. T. Chen, S. M. Marcy, J. I. Ward, C. M. Vadheim, S. B. Black, H. R. Shinefield, R. L. Davis, and K. Bohlke. 2001. Childhood vaccinations, vaccination timing, and risk of type 1 diabetes mellitus. Pediatrics 108(6):E112. DeStefano, F., T. Verstraeten, L. A. Jackson, C. A. Okoro, P. Benson, S. B. Black, H. R. Shinefield, J. P. Mullooly, W. Likosky, and R. T. Chen. 2003. Vaccinations and risk of central nervous system demyelinating diseases in adults. Archives of Neurology 60(4):504-509. DeStefano, F., E. S. Weintraub, and R. T. Chen. 2005. Recombinant hepatitis B vaccine and the risk of multiple sclerosis: A prospective study. Neurology 64(7):1317-1318. DiMiceli, L., V. Pool, J. M. Kelso, S. V. Shadomy, and J. Iskander. 2006. Vaccination of yeast sensitive individuals: Review of safety data in the US Vaccine Adverse Event Reporting System (VAERS). Vaccine 24(6):703-707. Dobson, S., D. Scheifele, and A. Bell. 1995. Assessment of a universal, school-based hepatitis B vaccination program. Journal of the American Medical Association 274(15):1209-1213. Drucker, Y., R. A. Prayson, A. Bagg, and L. H. Calabrese. 1997. Lymphocytic vasculitis pre- senting as diffuse subcutaneous edema after hepatitis B virus vaccine. Journal of Clinical Rheumatology 3(3):158-161. Duclos, P. 1992. Adverse events after hepatitis B vaccination. Canadian Medical Association Journal 147(7):1023-1026.

OCR for page 435
497 HEPATITIS B VACCINE Edmunds, W. J., G. F. Medley, D. J. Nokes, A. J. Hall, and H. C. Whittle. 1993. The influ- ence of age on the development of the hepatitis B carrier state. Proceedings of the Royal Society of London Series B-Biological Sciences 253(1337):197-201. Elkayam, O., M. Yaron, and D. Caspi. 2002. Safety and efficacy of vaccination against hepatitis B in patients with rheumatoid arthritis. Annals of the Rheumatic Diseases 61(7):623-625. Erguven, M., S. Guven, U. Akyuz, O. Bilgic, and F. Laloglu. 2009. Optic neuritis following hepatitis B vaccination in a 9-year-old girl. Journal of the Chinese Medical Association 72(11):594-597. Ferrazzi, V., C. Jorgensen, and J. Sany. 1997. Inflammatory joint disease after immunizations. A report of two cases. Revue du Rhumatisme. English Edition 64(4):227-232. Finielz, P., L. F. Lam-Kam-Sang, and J. Guiserix. 1998. Systemic lupus erythematosus and thrombocytopenic purpura in two members of the same family following hepatitis B vaccine. Nephrology Dialysis Transplantation 13(9):2420-2421. Fisher, M. A., S. A. Eklund, S. A. James, and X. Lin. 2001. Adverse events associated with hepatitis B vaccine in U.S. children less than six years of age, 1993 and 1994. Annals of Epidemiology 11(1):13-21. Fonseca, L. F., T. R. Noce, M. L. Teixeira, A. L. Teixeira, Jr., and M. A. Lana-Peixoto. 2003. Early-onset acute transverse myelitis following hepatitis B vaccination and respiratory infection: Case report. Arquivos de Neuro-Psiquiatria 61(2A):265-268. Fourrier, A., B. Begaud, A. Alperovitch, M. H. Verdier-Taillefer, E. Touze, N. Decker, and J. L. Imbs. 2001. Hepatitis B vaccine and first episodes of central nervous system demyelinat- ing disorders: A comparison between reported and expected number of cases. British Journal of Clinical Pharmacology 51(5):489-490. Ganem, D., and A. M. Prince. 2004. Mechanisms of disease: Hepatitis B virus infection— natural history and clinical consequences. New England Journal of Medicine 350(11): 1118-1129. Geier, D. A., and M. R. Geier. 2002a. Hepatitis B vaccination and arthritic adverse reactions: A followup analysis of the Vaccine Adverse Events Reporting System (VAERS) database. Clinical and Experimental Rheumatology 20(1):119. Geier, D. A., and M. R. Geier. 2002b. A one year followup of chronic arthritis follow- ing rubella and hepatitis B vaccination based upon analysis of the Vaccine Adverse Events Reporting System (VAERS) database. Clinical and Experimental Rheumatology 20(6):767-771. Geier, D. A., and M. R. Geier. 2005. A case-control study of serious autoimmune adverse events following hepatitis B immunization. Autoimmunity 38(4):295-301. Geier, M. R., and D. A. Geier. 2000. Arthritic reactions following hepatitis B vaccination: An analysis of the Vaccine Adverse Events Reporting System (VAERS) data from 1990 through 1997. Clinical and Experimental Rheumatology 18(6):789-790. Geier, M. R., and D. A. Geier. 2002c. Hepatitis B vaccination safety. Annals of Pharmaco- therapy 36(3):370-374. Geier, M. R., and D. A. Geier. 2004. A case-series of adverse events, positive re-challenge of symptoms, and events in identical twins following hepatitis B vaccination: Analysis of the Vaccine Adverse Event Reporting System (VAERS) database and literature review. Clini- cal and Experimental Rheumatology 22(6):749-755. Goolsby, P. L. 1989. Erythema-nodosum after Recombivax-HB hepatitis B vaccine. New England Journal of Medicine 321(17):1198-1199. Grasland, A., F. Le Maitre, J. Pouchot, P. Hazera, C. Bazin, and P. Vinceneux. 1998. Adult Still’s disease after hepatitis A and B vaccination? [in French]. Revue de Medecine Interne 19(2):134-136.

OCR for page 435
498 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Grezard, P., M. Chefai, V. Philippot, H. Perrot, and M. Faisant. 1996. Cutaneous lupus erythematosus and buccal aphthosis following hepatitis B vaccination in a 6 year-old boy [in French]. Annales de Dermatologie et de Venereologie 123(10):657-659. Gross, K., C. Combe, K. Kruger, and M. Schattenkirchner. 1995. Arthritis after hepatitis B vaccination. Report of three cases. Scandinavian Journal of Rheumatology 24(1):50-52. Guiserix, J. 1996. Systemic lupus erythematosus following hepatitis B vaccine. Nephron 74(2):441. Hamard, H., P. Hamard, P. Gohier, B. Roussat, D. Doummar, and M. T. Iba-Zizen. 2000. Idio- pathic acute optic neuropathies in children [in French]. Bulletin de l’Academie Nationale de Medecine 184(7):1511-1521. Hartman, S. 1990. Convulsion associated with fever following hepatitis B vaccination. Journal of Paediatrics and Child Health 26(1):65. Hassan, W., and R. Oldham. 1994. Reiter’s syndrome and reactive arthritis in health care workers after vaccination. British Medical Journal 309(6947):94. Hernan, M. A., S. S. Jick, M. J. Olek, and H. Jick. 2004. Recombinant hepatitis B vaccine and the risk of multiple sclerosis: A prospective study. Neurology 63(5):838-842. Herroelen, L., J. de Keyser, and G. Ebinger. 1991. Central-nervous-system demyelination after immunisation with recombinant hepatitis B vaccine. Lancet 338(8776):1174-1175. Hocine, M. N., C. P. Farrington, E. Touze, H. J. Whitaker, A. Fourrier, T. Moreau, and P. Tubert-Bitter. 2007. Hepatitis B vaccination and first central nervous system demyelinat- ing events: Reanalysis of a case-control study using the self-controlled case series method. Vaccine 25(31):5938-5943. Hyams, K. C. 1995. Risks of chronicity following acute hepatitis B virus-infection: A review. Clinical Infectious Diseases 20(4):992-1000. Iniguez, C., J. A. Mauri, P. Larrode, J. Lopez del Val, I. Jerico, and F. Morales. 2000. Acute transverse myelitis secondary to hepatitis B vaccination [in Spanish]. Revista de Neuro- logia 31(5):430-432. Jacobi, D., F. Maillot, C. Hommet, S. Arsene, J. P. Cottier, F. Lamisse, and L. Guillevin. 2005. P-ANCA cranial pachymeningitis: A case report. Clinical Rheumatology 24(2):174-177. Journe, F., F. Deschamps, and M. L. Germain. 1995. Vascularitis and vaccination against hepatitis B [in French]. Archives des Maladies Professionnelles et de Medecine du Travail 56(1):48. Kakar, A., and P. K. Sethi. 1997. Guillain Barré syndrome associated with hepatitis B vaccina- tion. Indian Journal of Pediatrics 64(5):710-712. Karaali-Savrun, F., A. Altintas, S. Saip, and A. Siva. 2001. Hepatitis B vaccine related-myelitis? European Journal of Neurology 8(6):711-715. Kaygusuz, S., A. K. Erdemoglu, and I. Koksal. 2002. Afebrile convulsion in an adult af- ter recombinant hepatitis B vaccination. Scandinavian Journal of Infectious Diseases 34(4):314-315. Kerleau, J. M., H. Levesque, G. Lair, F. Lecomte, O. Carrara, and H. Courtois. 1997. Is hepa- titis B vaccination a new cause of necrotizing vasculitis? [in French]. Revue de Medecine Interne 18(6):491-492. Khamaisi, M., Y. Shoenfeld, and H. Orbach. 2004. Guillain-Barré syndrome following hepa- titis B vaccination. Clinical and Experimental Rheumatology 22(6):767-770. Konstantinou, D., C. Paschalis, T. Maraziotis, P. Dimopoulos, H. Bassaris, and A. Skoutelis. 2001. Two episodes of leukoencephalitis associated with recombinant hepatitis B vac- cination in a single patient. Clinical Infectious Diseases 33(10):1772-1773. Koziel, M. J., and C. L. Thio. 2010. Hepatitis B virus and hepatitis delta virus. In Mandell, Douglas, and Bennett’s principles and practice of infectious diseases. 7th ed. 2 vols. Vol. 2, edited by G. L. Mandell, J. E. Bennett, and R. Dolin. Philadelphia, PA: Churchill Livingstone Elsevier. Pp. 2059-2086.

OCR for page 435
499 HEPATITIS B VACCINE Krugman, S. 1974. Viral-hepatitis and hepatitis B antigen—recent advances. Postgraduate Medical Journal 50(584):327-333. Krugman, S., and J. P. Giles. 1973. Viral-hepatitis, type B (MS-2-strain)—further observations on natural-history and prevention. New England Journal of Medicine 288(15):755-760. Krugman, S., L. R. Overby, I. K. Mushahwar, C. M. Ling, G. G. Frosner, and F. Deinhardt. 1979. Viral-hepatitis, type-B—studies on natural-history and prevention reexamined. New England Journal of Medicine 300(3):101-106. Le Goff, P., P. Fauquert, P. Youinou, and S. Hoang. 1988. Periarteritis nodosa following im- munization against hepatitis B [in French]. Presse Medicale 17(34):1763. Le Goff, P., P. Fauquert, P. Youinou, and S. Hoang. 1991. Periarteritis nodosa (PAN) following vaccine against hepatitis B [in French]. Rhumatologie 43(3):79. Le Hello, C., P. Cohen, M. G. Bousser, P. Letellier, and L. Guillevin. 1999. Suspected hepatitis B vaccination related vasculitis. Journal of Rheumatology 26(1):191-194. Lewis, E., H. R. Shinefield, B. A. Woodruff, S. B. Black, F. Destefano, R. T. Chen, and R. Ensor. 2001. Safety of neonatal hepatitis B vaccine administration. Pediatric Infectious Disease Journal 20(11):1049-1054. Llobat Estelles, T., M. J. Benlloch Muncharaz, L. Santos Serrano, J. M. Paricio Talayero, J. Martin Ruano, and M. Grieco Burucua. 1995. Hepatitis B vaccine associated with erythema nodosum. A case report [in Spanish]. Anales Espanoles de Pediatria 42(2):149. Lunn, E. R., B. J. Hoggarth, and W. J. Cook. 2000. Prolonged hepatitis B surface antigenemia after vaccination. Pediatrics 105(6):E81. Mahassin, F., J. P. Algayres, J. Valmary, H. Bili, G. Coutant, D. Bequet, and J. P. Daly. 1993. Acute myelitis following hepatitis B vaccination [in French]. Presse Medicale 22(40):1997-1998. Maillefert, J. F., P. Farge, M. P. Gazet-Maillefert, and C. Tavernier. 1997. Mental nerve neu- ropathy as a result of hepatitis B vaccination. Oral Surgery, Oral Medicine, Oral Pathol- ogy, Oral Radiology, & Endodontics 83(6):663-664. Maillefert, J. F., J. Sibilia, E. Toussirot, E. Vignon, J. P. Eschard, B. Lorcerie, R. Juvin, N. Parchin-Geneste, C. Piroth, D. Wendling, J. L. Kuntz, C. Tavernier, and P. Gaudin. 1999. Rheumatic disorders developed after hepatitis B vaccination. Rheumatology 38(10): 978-983. Maillefert, J. F., C. Tavernier, J. Sibilia, and E. Vignon. 2000. Exacerbation of systemic lupus erythematosus after hepatitis B vaccination: Comment on the article by Battafarano et al. and the letter by Senecal et al. Arthritis and Rheumatism 43(2):468-469. Mamoux, V., and C. Dumont. 1994. Systemic lupus erythematosus and vaccination against hepatitis B virus [in French]. Archives de Pediatrie 1(3):307-308. Manna, R., A. De Santis, A. Oliviero, A. Carnevale, S. Caputo, M. Pahor, A. Laudisio, and G. Gasbarrini. 1996. Leukoencephalitis after recombinant hepatitis B vaccine. Journal of Hepatology 24(6):764-765. Masse, I., and M. C. Descoffres. 1998. Hypersensitivity vasculitis after hepatitis B vaccination [in French]. Presse Medicale 27(20):965-966. Mast, E. E., and J. W. Ward. 2008. Chapter 13. Hepatitis B vaccines. In Vaccines, edited by S. A. Plotkin, W. A. Orenstein, and P. A. Offit. Philadelphia, PA: Saunders/Elsevier. Mathieu, E., O. Fain, and A. Krivitzky. 1996. Cryoglobulinemia after hepatitis B vaccination. New England Journal of Medicine 335(5):355. McLean, A. A., M. R. Hilleman, W. J. McAleer, and E. B. Buynak. 1983. Summary of world- wide clinical-experience with H-B-Vax (B, MSD). Journal of Infection 7(Suppl. 1):95-104. McMahon, B. J., W. L. M. Alward, D. B. Hall, W. L. Heyward, T. R. Bender, D. P. Francis, and J. E. Maynard. 1985. Acute hepatitis B virus-infection: Relation of age to the clinical expression of disease and subsequent development of the carrier state. Journal of Infec- tious Diseases 151(4):599-603.

OCR for page 435
500 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Mikaeloff, Y., G. Caridade, S. Assi, M. Tardieu, and S. Suissa. 2007a. Hepatitis B vaccine and risk of relapse after a first childhood episode of CNS inflammatory demyelination. Brain 130(4):1105-1110. Mikaeloff, Y., G. Caridade, M. Rossier, S. Suissa, and M. Tardieu. 2007b. Hepatitis B vac- cination and the risk of childhood-onset multiple sclerosis. Archives of Pediatrics & Adolescent Medicine 161(12):1176-1182. Mikaeloff, Y., G. Caridade, S. Suissa, and M. Tardieu. 2009. Hepatitis B vaccine and the risk of CNS inflammatory demyelination in childhood. Neurology 72(10):873-880. Miron, D., D. Fink, and P. J. Hashkes. 2003. Kawasaki disease in an infant following immuni- sation with hepatitis B vaccine. Clinical Rheumatology 22(6):461-463. Niu, M. T., D. M. Davis, and S. Ellenberg. 1996. Recombinant hepatitis B vaccination of neonates and infants: Emerging safety data from the Vaccine Adverse Event Reporting System. Pediatric Infectious Disease Journal 15(9):771-776. Payne, D. C., C. E. Rose, J. Kerrison, A. Aranas, S. Duderstadt, and M. M. McNeil. 2006. Anthrax vaccination and risk of optic neuritis in the United States military, 1998-2003. Archives of Neurology 63(6):871-875. Peng, M. M., and H. Jick. 2004. A population-based study of the incidence, cause, and severity of anaphylaxis in the United Kingdom. Archives of Internal Medicine 164(3):317-319. Pirmohamed, M., and P. Winstanley. 1997. Hepatitis B vaccine and neurotoxicity. Postgradu- ate Medical Journal 73(861):462-463. Planchamp, F., K. A. Nguyen, T. Vial, S. Nasri, E. Javouhey, Y. Gillet, B. Ranchin, F. Villard, D. Floret, P. Cochat, F. Gueyffier, and B. Kassai. 2009. Active drug monitoring of adverse drug reactions in pediatric emergency department [in French]. Archives de Pediatrie 16(2):106-111. Poirriez, J. 2004. A preliminary experiment of absorption of antinuclear antibodies by the hepatitis B vaccine components, in a case of neurolupus. Vaccine 22(23-24):3166-3168. Polish, L. B., C. N. Shapiro, F. Bauer, P. Klotz, P. Ginier, R. R. Roberto, H. S. Margolis, and M. J. Alter. 1992. Nosocomial transmission of hepatitis B virus association with the use of spring-loaded fingerstick device. New England Journal of Medicine 326(11):721-725. Pope, J. E., A. Stevens, W. Howson, and D. A. Bell. 1998. The development of rheumatoid arthritis after recombinant hepatitis B vaccination. Journal of Rheumatology 25(9): 1687-1693. Prince, A. M. 1968. An antigen detected in the blood during the incubation period of serum hepatitis. Proceedings of the National Academy of Sciences of the United States of America 60(3):814-821. Pritchard, J., R. Mukherjee, and R. A. C. Hughes. 2002. Risk of relapse of Guillain-Barré syndrome or chronic inflammatory demyelinating polyradiculoneuropathy following im- munization. Journal of Neurology, Neurosurgery, and Psychiatry 73(3):348-349. Purcell, R. H., and J. L. Gerin. 1975. Hepatitis B subunit vaccine: Preliminary report of safety and efficacy tests in chimpanzees. American Journal of the Medical Sciences 270(2):395-399. Ramagopalan, S. V., W. Valdar, D. A. Dyment, G. C. Deluca, I. M. Yee, G. Giovannoni, G. C. Ebers, and A. D. Sadovnick. 2009. Association of infectious mononucleosis with multiple sclerosis. Neuroepidemiology 32(4):257-262. Renard, J. L., J. S. Guillamo, J. M. Ramirez, H. Taillia, D. Felten, and Y. Buisson. 1999. Acute cervical transverse myelitis after anti-hepatitis B vaccination: Time course of anti-HBs antibodies [in French]. Presse Medicale 28(24):1290-1292. Rogalewski, A., J. Kraus, M. Hasselblatt, C. Kraemer, and W. R. Schabitz. 2007. Improvement of advanced postvaccinal demyelinating encephalitis due to plasmapheresis. Neuropsy- chiatric Disease and Treatment 3(6):987-991.

OCR for page 435
501 HEPATITIS B VACCINE Rogerson, S. J., and F. J. Nye. 1990. Hepatitis B vaccine associated with erythema nodosum and polyarthritis. British Medical Journal 301(6747):345. Roussat, B., P. Gohier, D. Doummar, M. T. Iba-Zizen, V. Barbat, D. Jarry, E. A. Cabanis, H. Hamard, and J. P. Nordmann. 2001. Acute optic neuritis in children: Clinical fea- tures and treatment. A study of 20 cases (28 eyes) [in French]. Journal Francais d Ophtalmologie 24(1):36-44. Saadoun, D., P. Cacoub, D. Mahoux, A. Sbai, and J. C. Piette. 2001. Vasculitis compli- cating vaccination: A report of three cases [in French]. Revue de Medecine Interne 22(2):172-176. Sadovnick, A. D., and D. W. Scheifele. 2000. School-based hepatitis B vaccination programme and adolescent multiple sclerosis. Lancet 355(9203):549-550. Sahlberg, A. S., K. Granfors, and M. A. Penttinen. 2009. HLA-b27 and host-pathogen interac- tion. Advances in Experimental Medicine and Biology 649:235-244. Santoro, D., M. Stella, G. Montalto, and S. Castellino. 2007. Lupus nephritis after hepatitis B vaccination: An uncommon complication. Clinical Nephrology 67(1):61-63. Schessl, J., B. Luther, J. Kirschner, G. Mauff, and R. Korinthenberg. 2006. Infections and vac- cinations preceding childhood Guillain-Barré syndrome: A prospective study. European Journal of Pediatrics 165(9):605-612. Scott, R. M., R. Snitbhan, W. H. Bancroft, H. J. Alter, and M. Tinpalapong. 1980. Experimen- tal transmission of hepatitis B virus by semen and saliva. Journal of Infectious Diseases 142(1):67-71. Sebag, O., G. Bolla, B. Bebin, and F. Sebag. 1998. Exacerbation of chronic juvenile arthritis induced by hepatitis B vaccination [in French]. Archives de Pediatrie 5(9):1046. Senecal, J. L., C. Bertrand, and F. Coutlee. 1999. Severe exacerbation of systemic lupus erythematosus after hepatitis B vaccination and importance of pneumococcal vaccination in patients with autosplenectomy: Comment on the article by Battafarano et al. Arthritis & Rheumatism 42(6):1307-1308. Senejoux, A., D. Roulot, C. Belin, L. Tsakiris, J. Rautureau, and T. Coste. 1996. Acute myelitis after immunization against hepatitis B with recombinant vaccine [in French]. Gastroenterologie Clinique et Biologique 20(4):401-402. Seti, N. K., R. Reddi, I. Anand, and P. K. Sethi. 2002. Gulliane Barré syndrome following vaccination with hepatitis B vaccine. Journal of the Association of Physicians of India 50:989. Shapiro, C. N. 1993. Epidemiology of hepatitis B. Pediatric Infectious Disease Journal 12(5): 433-437. Sieper, J. 2001. Pathogenesis of reactive arthritis. Current Rheumatology Reports 3(5):412-418. Sikora, A., H. Brozik, D. Chlebna-Sokol, D. Kardas-Sobantka, M. Biernacka, E. Smolewska, and E. Polakowska. 2000. Vaccination against virus hepatitis B in children with con- nective tissue diseases part I. Safety of vaccination against hepatitis type B in children with chronic juvenile arthritis and other connective tissue diseases [in Polish]. Przeglad Pediatryczny 30(4):292-297. Sinsawaiwong, S., and P. Thampanitchawong. 2000. Guillain-Barré syndrome following re- combinant hepatitis B vaccine and literature review. Journal of the Medical Association of Thailand 83(9):1124-1126. Souayah, N., A. Nasar, M. F. K. Suri, and A. I. Qureshi. 2007. Guillain-Barré syndrome after vaccination in United States a report from the CDC/FDA Vaccine Adverse Event Report- ing System. Vaccine 25(29):5253-5255. Souayah, N., A. Nasar, M. F. K. Suri, and A. I. Qureshi. 2009. Guillain-Barré syndrome after vaccination in United States: Data from the Centers for Disease Control and Prevention/ Food and Drug Administration Vaccine Adverse Event Reporting System (1990-2005). Journal of Clinical Neuromuscular Disease 11(1):1-6.

OCR for page 435
502 ADVERSE EFFECTS OF VACCINES: EVIDENCE AND CAUSALITY Soubeyrand, B., F. Boisnard, M. Bruel, H. Debois, D. Delattre, A. Gauthier, S. Soum, and C. Thebault. 2000. Central nervous system demyelinating disease following hepatitis B vac- cination with GenHevac B. Review of ten years of spontaneous notifications (1989-1998) [in French]. Presse Medicale 29(14):775-780. Soubrier, M., J. J. Dubost, C. Bielsa, J. M. Ristori, and J. L. Bussiere. 1997. Erosive polyar- thritis triggered by vaccination against hepatitis B [in French]. Presse Medicale 26(2):75. Stewart, O., B. Chang, and J. Bradbury. 1999. Simultaneous administration of hepatitis B and polio vaccines associated with bilateral optic neuritis. British Journal of Ophthalmology 83(10):1200-1201. Tartaglino, L. M., T. Heiman-Patterson, D. P. Friedman, and A. E. Flanders. 1995. MR imaging in a case of postvaccination myelitis. American Journal of Neuroradiology 16(3):581-582. Terney, D., S. Beniczky, P. Barsi, I. Kondakor, J. Perenyi, A. Faludi, M. Szapper, and L. Vecsei. 2006. Multiple sclerosis after hepatitis B vaccination in a 16-year-old patient. Chinese Medical Journal 119(1):77-79. Thivolet, C., B. Vialettes, C. Boitard, and J. Bringer. 1999. No evidence that anti hepati- tis B vaccine causes insulin dependent diabetes [in French]. Diabetes and Metabolism 25(5):441-445. Toivanen, A., and P. Toivanen. 2000. Reactive arthritis. Current Opinion in Rheumatology 12(4):300-305. Tourbah, A., O. Gout, R. Liblau, O. Lyon-Caen, C. Bougniot, M. T. Iba-Zizen, and E. A. Cabanis. 1999. Encephalitis after hepatitis B vaccination: Recurrent disseminated en- cephalitis or MS? Neurology 53(2):396-401. Touze, E., A. Fourrier, C. Rue-Fenouche, V. Ronde-Oustau, I. Jeantaud, B. Begaud, and A. Alperovitch. 2002. Hepatitis B vaccination and first central nervous system demyelinating event: A case-control study. Neuroepidemiology 21(4):180-186. Touze, E., O. Gout, M. H. Verdier-Taillefer, O. Lyon-Caen, and A. Alperovitch. 2000. First episode of central nervous system demyelination and hepatitis B vaccination: A pilot case control study [in French]. Revue Neurologique 156(3):242-246. Treves, R., L. Lacoste, D. Bontoux, E. Pitrou, P. Bertin, and C. Bonnet. 1997. Erosive nodular rheumatoid arthritis triggered by hepatitis B vaccination [in French]. Presse Medicale 26(14):670. Tsai, J. F., H. S. Margolis, J. E. Jeng, M. S. Ho, W. Y. Chang, M. Y. Hsieh, Z. Y. Lin, and J. H. Tsai. 1998. Immunoglobulin- and hepatitis B surface antigen-specific circulating immune complexes in chronic hepatitis B virus infection. Clinical Immunology and Im- munopathology 86(3):246-251. Tudela, P., S. Marti, and J. Bonal. 1992. Systemic lupus erythematosus and vaccination against hepatitis B. Nephron 62(2):236. Tuohy, P. G. 1989. Guillain-Barré syndrome following immunisation with synthetic hepatitis B vaccine. New Zealand Medical Journal 102(863):114-115. Vanoli, M., D. Gambini, and R. Scorza. 1998. A case of Churg-Strauss vasculitis after hepatitis B vaccination. Annals of the Rheumatic Diseases 57(4):256-257. Vautier, G., and J. E. Carty. 1994. Acute sero-positive rheumatoid arthritis occurring after hepatitis vaccination. British Journal of Rheumatology 33(10):991. Ventura, F., H. Antunes, C. Brito, F. Pardal, T. Pereira, and A. P. Vieira. 2009. Cutaneous polyarteritis nodosa in a child following hepatitis B vaccination. European Journal of Dermatology 19(4):400-401. Verstraeten, T., D. Descamps, M. P. David, T. Zahaf, K. Hardt, P. Izurieta, G. Dubin, and T. Breuer. 2008. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine 26(51):6630-6638.

OCR for page 435
503 HEPATITIS B VACCINE Vital, C., A. Vital, G. Gbikpi-Benissan, M. Longy-Boursier, M. T. Climas, Y. Castaing, M. H. Canron, M. Le Bras, and K. Petry. 2002. Postvaccinal inflammatory neuropathy: Periph- eral nerve biopsy in 3 cases. Journal of the Peripheral Nervous System 7(3):163-167. Voigt, U., U. Baum, W. Behrendt, S. Hegemann, C. Terborg, and J. Strobel. 2001. Neuritis of the optic nerve after vaccinations against hepatitis A, hepatitis B and yellow fever [in German]. Klinische Monatsblatter fur Augenheilkunde 218(10):688-690. Wu, Z., H. Wu, and Q. Wang. 1999. A case-control study on Guillain-Barré syndrome in children of north China [in Chinese]. Zhonghua Yufang Yixue Zazhi 33(5):279-281. Yang, Y., S. Sujan, F. Sun, Y. Zhang, Y. Jiang, J. Song, J. Qin, and X. Wu. 2006. Acute metabolic crisis induced by vaccination in seven Chinese patients. Pediatric Neurology 35(2):114-118. Zaas, A., P. Scheel, A. Venbrux, and D. B. Hellmann. 2001. Large artery vasculitis following recombinant hepatitis B vaccination: 2 cases. Journal of Rheumatology 28(5):1116-1120. Zipp, F., J. G. Weil, and K. M. Einhaupl. 1999. No increase in demyelinating diseases after hepatitis B vaccination. Nature Medicine 5(9):964-965.

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