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Index
A
Acellular antigens, 11, 18, 20, 28, 30, 129, 446
Adenovirus, 29, 33
Adjuvants, 34–35, 372–377, 430
animal models, 373–374, 375, 376
defined, 372
diabetes, 388
Helicobacter pylori, 365–366
hepatitis C virus, 336
Histoplasma capsulatum, 358
mycobacterium tuberculosis, 352–353
papillomaviruses, 340
Administration of vaccines, see Delivery of vaccines
Adolescents, see Children
Adults, 23, 47–50, 100, 111, 112
chlamydia, 149
dengue virus, 345–346
Epstein-Barr virus, 7, 88, 177
hepatitis B, 18
hepatitis C, 189
herpes simplex virus, 196
influenza virus, 21, 224
papillomaviruses, 213
pneumonococcal vaccines, 21
polio, 24
streptococus, group B, 6, 305–306, 307, 309
Streptococcus pneumoniae, 314
see also Elderly persons; Men; Women
African Americans, 50
Age factors, 4, 435
Coccidiodes immitis, 160, 359
cost-effectiveness model, analytic approach, 60, 66, 68–69, 80–83, 84
cost-effectiveness model, detailed review, 93, 95, 98–100, 101–103, 105
diabetes mellitus, 233
ethical issues, 112
Helicobacter pylori, 181, 182
herpes simplex virus, 197
Histoplasma capsulatum, 207, 208
influenza virus, 225–226
melanoma, 239
multiple sclerosis, 245
mycobacterium tuberculosis, 252, 253
parainfluenza virus, 275
quality-adjusted life years, 58, 66, 68–69, 80–82, 84, 80–83, 84, 95, 98–99
respiratory syncytial virus, 279, 280, 281
rheumatoid arthritis, 285, 286
streptococcus, group A, 299
streptococcus, group B, 305, 306
Streptococcus pneumoniae 313, 314
see also Adults; Children; Elderly persons; Infants
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Aggregation
ethical issues, 117–118, 119
quality-adjusted life years, 2, 56
AIDS, see Human immunodeficiency virus
American Academy of Pediatrics, 45, 126
American College Health Association, 49
Americans with Disabilities Act, 112–113
Animal models, 419, 423, 425, 426–427, 436
adjuvants, 373–374, 375, 376
antigen delivery, 378–379, 380
autoimmune diseases, 386–387, 388–395, 399–403, 404–407
chlamydia, 349, 350–351
cholera, 376
Coccidiodes immitis, 357, 358–359
costimulation 408
diabetes, 386–387, 388–395
DNA vaccines, 382–383
Epstein-Barr virus, 333–334
gonorrhea, 368–369, 371
Helicobacter pylori, 365–366
hepatitis C virus, 335, 336, 337, 338
herpes simplex virus, 328–329
Histoplasma capsulatum 357–358
papillomaviruses, 340–341
programmed T-cell death, 397
streptococcus, group A, 361–362, 363
Antigens, 18, 20, 26–27, 28, 29, 30, 31, 35, 40, 377–381, 412, 417, 420–424, 432
acellular, 11, 18, 20, 28, 30, 129, 446
autoimmune disease, 35–38
chlamydia, 350–351
Coccidiodes immitis, 358–359
dengue virus, 346
diabetes, 387–388
DNA vaccines, 381–386
gonorrhea, 368–371
Helicobacter pylori, 367
hepatitis B virus, 378
hepatitis C virus, 337
Helicobacter pylori, 364
Histoplasma capsulatum 358
influenza virus, 223
multiple sclerosis, 399, 400
polio, 24
programmed T-cell death, 37, 395–399, 409, 410–411
streptococcus, group A, 360
see also B cells; T cells
Apoptosis, 37, 395–399, 409, 410–411
Attenuated live viruses, 19, 20, 379
herpes simplex virus, 328–329
mycobacterium tuberculosis, 352
polio, 24–25
Attitudes
physicians, 47
public complacency and fear, 9, 46, 73–74, 130
vaccine acceptance, 11, 20
Autoimmune diseases, 1, 12, 35–38, 45, 380, 399–407
animal models, 386–387, 388–395, 399–403, 404–407
antigens, 35–38
diabetes mellitus, 6, 35, 37, 37, 54, 67, 87, 90, 233–238, 386–389, 391, 392, 393–395, 403
cancer therapy, 427–429, 431
multiple sclerosis, 6, 35, 54, 87, 245–249, 397, 399–400
programmed T-cell death, 397–399
rheumatoid arthritis, 6, 35, 54, 67, 87, 285–290, 403
T cells, 35–38, 233, 245, 389–391, 392–395, 399–406 (passim)
B
Barriers to research and development, 11, 13, 90, 130–131
see also Litigation; Market forces
B cells, 28, 32, 35, 380, 381, 436
adjuvants, 372, 376
autoimmune disease, 36, 37
diabetes, 387, 391
Epstein-Barr virus, 330, 332, 334
Helicobacter pylori, 364
streptococcus, group A, 362
see also Mucosal immunity
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Biotechnology, 26, 30, 33–34, 90, 379, 381–386
attenuated live viruses, 19, 20, 24–25, 328–329, 352, 379
Epstein-Barr virus, 332–333, 334
hepatitis B virus, 18, 379
hepatitis C virus, 337
herpes simplex virus, 327–328
Histoplasma capsulatum 358
hybridoma, 30
monoclonal antibodies, 29–30
mycobacterium tuberculosis, 355
papillomaviruses, 339–340
risk capital, 125
Salmonella, 31–32
see also DNA; Genomes; RNA
Bordetella pertussis, 11, 18, 19, 20, 28, 30, 46
Borrelia burgdorferi, 7, 44, 54, 88, 91, 100, 143–148
Burkitt’s lymphoma, 330, 331, 332, 333
C
Canada, 49, 62, 66, 68, 96, 99
Cancer, 1, 12, 185, 189, 190, 194, 213–219, 381, 411, 415–433
autoimmune therapy, 427–429, 431
Epstein-Barr virus, 330–333
melanoma, 6, 54, 88, 89–90, 239–243, 421
papillomaviruses, 338–342
Caribbean region, 343
Centers for Disease Control and Prevention, 14, 28, 50, 100, 125, 126
Central nervous system, 67, 399–403
herpes simplex virus, 196–200 (passim), 202, 204, 328
multiple sclerosis, 6, 35, 54, 87, 245–249, 397, 399–400
see also Neisseria meningitidis
Children, 7, 8–9, 45–47, 60, 69, 72, 80–82, 91, 99, 100, 101, 111, 130, 377
American Academy of Pediatrics, 45, 126
CDC recommendations, 28
chlamydia, 6, 88, 157
combination vaccines, 9, 18, 38, 46–47, 75, 130
contraceptive vaccines, health effects, 76
cytomegalovirus, 6, 90, 167
dengue virus, 343, 345
Epstein-Barr virus, 7, 88, 177, 179, 330–331, 333
gonorrhea, 6, 88
Helicobacter pylori, 181
herpes simplex virus, 6, 88, 196, 203, 329
influenza virus, 223–224
liability issues, 128–129
meningitis, 267
National Childhood Vaccine Injury Act, 20–21, 128–129, 258
papillomaviruses, 6, 88, 219, 342
pregnant, 51
polio, 24
record-keeping, 46, 47, 49
respiratory syncytial virus, 88, 279, 280, 281
rotavirus, 291–292
school entry immunizations, 7, 8–9, 20, 49, 90, 130
Shigella, 295
streptococcus, group A, 299, 363
streptococcus, group B, 6, 93, 310, 311–312
Streptococcus pneumoniae 313, 314, 315
Vaccines for Children Program, 47, 131
see also Infants
Children’s Vaccine Initiative, 127–128
China, 334
Chlamydia, 6, 54, 67, 88, 89–90, 97, 149–158, 347–351, 368
Cholera, see Vibrio cholerae
Clinical trials, 9, 19, 70, 105, 126, 406, 417, 424, 430–431, 436
djuvants, 373, 374
AIDS, 373, 379
Bordetella pertussis, 30
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Coccidiodes immitis, 7, 19
dengue virus, 345–346
diabetes, 387
Epstein-Barr virus, 329, 333
funding, 125
gonorrhea, 371
herpes simplex virus, 327
mycobacterium tuberculosis, 352, 353–354, 355
papillomaviruses, 342
programmed T-cell death, 397–398
respiratory syncytial virus, 6, 19
streptococcus, group A, 362, 363
Cloning, 26, 36
Coccidiodes immitis, 7, 19, 44, 54, 88, 90, 91, 159–164, 356–359
Cognitive impairments, 62, 64–65
Combination vaccines, 9, 18, 38, 46–47, 75, 130, 436
elicobacter pylori, 364, 366–367
herpes simplex virus, 327
Computer technology
committee’s model, application of, 13, 95
Internet, IOM, 4, 323
physician reminders, 48
Confidentiality, 47
Conjugate vaccines
Haemophilus influenzae, 11
varicella-zoster virus, 11, 18
Cost and cost-effectiveness analysis, general, 2–3, 11, 12, 17, 20, 435–436, 437
age factors, analytic approach of model, 60, 66, 68–69, 80–83, 84
age factors, detailed review of model, 93, 95, 98–100, 101–103, 105
aggregation, 2, 56, 117–118, 119
children, 46
combination vaccines, 47
death rates, analytic approach of model, 61–62, 66, 68, 78–79, 80–83, 86
death rates, detailed characterization of model, 95, 97–98, 100, 103–104
defined, 56
discounting, 18, 60–61, 68–69, 74, 80, 83, 85–86, 97–98, 99, 101–103, 105–107, 114–115
ethical issues, 3–4, 58, 75, 109–122, 128, 129
licensure possibilities, scope of study at hand, 39, 40, 43
licensure process, 19–20, 54–55, 58;
see also Time factors
life expectancy, analytic approach of model, 57, 66, 68, 76, 120
life expectancy, detailed characterization of model, 95–96, 98, 99, 101–102, 103, 104, 106–107
mathematical formulae, 94–97, 99, 101–106 (passim)
model, analytical approach, 53–92
model, detailed description, 93–108
morbidity/morbidity scenarios, analytic approach of model, 61–66, 67, 68, 69, 71, 76, 78–79, 80–85
morbidity/morbidity scenarios, detailed characterization of model, 95, 96, 97, 98, 108
opportunity costs, 74, 115–116, 130
polio, 25–26
pregnant women, 22
ranking of vaccines covered, 5–8
reasons for, 57
sensitivity analysis, 3, 57
specific diseases/pathogens/vaccines,
lists of, 54–55, 87–91
review for each, 143–433;
see also diseases/pathogens/vaccines found in lists
utilization of vaccines, analytic approach of model, 72–73, 75, 76, 79, 80, 86, 88, 89, 91
utilization of vaccines, detailed characterization of model, 95, 107–108
see also Death rates; Efficacy of vaccines; Morbidity scenarios; Quality-adjusted life years
Contraceptive vaccines, 75–76
Costimulation, 372, 373, 375, 389, 398, 399, 400, 401, 402, 407–412, 419
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Court cases, see Liability issues;
Litigation
Cuba, 343
Cystic fibrosis, 33, 42
Cytokines, 27, 374, 409–411, 415, 429–433
autoimmune disease, 36, 38, 389–392, 404–405
chlamydia, 348–349
dengue virus, 344
gonorrhea, 371
Interleukin, 27, 38, 348–349, 372, 373, 374, 388, 389, 390–394, 396, 402–403, 405–406, 409, 410, 411–412, 420, 424, 430, 432
Cytomegalovirus (CMV), 6, 19, 20, 22, 54, 87, 89, 90, 165–171
D
Death rates, 377
as assessment criterion, 27
model, analytic approach, 61–62, 66, 68, 78–79, 80–83, 86
model, detailed characterization, 95, 97–98, 100, 103–104
chlamydia, 149
Coccidiodes immitis, 159, 160, 162
dengue virus, 343
gonorrhea, 257
Helicobacter pylori, 181, 182
herpes simplex virus, 198
Histoplasma capsulatum, 207, 208
influenza virus, 225–226
malaria, 43
melanoma, 239
meningitis, 267, 268
mycobacterium tuberculosis, 252, 253, 351
parainfluenza virus, 273
polio, 24
papillomaviruses, 215
respiratory syncytial virus, 279, 281, 283
rheumatoid arthritis, 287
rotavirus, 291
streptococcus, group B, 305, 307, 309
Streptococcus pneumoniae 313, 321
see also Life expectancy; Quality-adjusted life years
Dengue hemorrhagic fever, 342–347
Dental caries, 44–45
Delivery of vaccines, 130
adults, 47–50
antigens, various, 377–381
children, 45–47
DNA vaccines, 381–386
intranasal immunization
mycobacterium tuberculosis, 354
polio, 25–26
pregnant women, 50–51
see also Noninjection routes; Utilization of vaccines; Vaccine schedules
Demographic factors, 58
see also Age factors; Immigrants; Men; Race/ethnicity; Regional factors; Travelers; Urban areas; Women
Dengue hemorrhagic fever, 8
Department of Health and Human Services, 20–21
Centers for Disease Control and Prevention, 14, 28, 50, 100
Food and Drug Administration, 14, 125, 126, 362, 367, 373, 374;
see also Licensure, vaccines
Health Care Financing Administration, 71, 106
see also National Institutes of Health; specific institutes
Developing countries, 1, 17, 127–128, 173, 355, 360
Diabetes mellitus, 6, 35, 37, 54, 67, 87, 90, 233–238, 386–389, 391, 392, 393–395, 403
Diptheria, 20, 28, 30, 46, 49
Disabilities, 63–66, 68, 78–79, 86, 89, 97–98
cognitive impairments, 62, 64–65
emotional impairments, 64–65
ethical factors, 111, 112–113, 114–115
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mobility impairments, 24, 25, 64, 126–127
sensory impairments, 62, 64, 64, 67, 236
Disability-adjusted life years, 63, 66, 111, 112
Discounting, 18, 60–61, 68–69, 74, 80, 83, 85–86, 97–98, 99, 101–103, 105–107
ethical issues, 114–115
quality-adjusted life years, 18, 60–61, 68–69, 114–115
time factors, 68–69, 86, 101
Disease burden, 7–8, 11, 12, 43–45, 86, 89, 126, 127, 129
cost-effectiveness analyses, specific diseases, 24–25, 42–43, 143–437 (passim);
see also specific pathogens
ethical issues, 109, 117–118, 121
malaria, 42–43
polio, 24–25
waterborne pathogens, 42
workshop summaries, specific diseases, 326–433 (passim)
see also Death rates; Disabilities; Epidemiology; Incidence; Morbidity
Disease scenarios, see Death rates; Incidence; Morbidity scenarios; Prevalence;
Diseases of Importance in Developing Countries, 1, 11
Diseases of Importance in the United States, 1, 11, 17
DNA, 33, 34, 90, 381–386, 418, 420, 421, 422
antigen delivery, 380, 395
chlamydia, 348
Coccidiodes immitis, 358–359
dengue virus, 346
Epstein-Barr virus, 330, 331
hepatitis B virus, 379
hepatitis C virus, 335, 336, 337
HIV, 382–383
papillomaviruses, 6, 54, 88, 213–221, 338–342, 384, 433
transfection, 32, 34
tuberculosis, 383–384
see also Genomes
Drug resistance, 131, 380
gonorrhea, 368
malaria, 43
mycobacterium tuberculosis, 252, 253–254, 351
E
E-coli, see Escherichia coli
Economic factors, 9
market forces, 9, 19, 125–126
see also Cost and cost-effectiveness analysis; Funding
Efficacy of vaccines, 32, 71–72, 79, 80, 94, 95, 107–108
Borrelia burgdorferi, 145, 147
chlamydia, 157
Coccidiodes immitis, 163, 164
cytomegalovirus, 170
diabetes mellitus, 237, 238
DNA vaccines, general, 384
enterotoxigenic E. coli, 174, 176
Epstein-Barr virus, 179, 180
gonorrhea, 264, 265
Helicobacter pylori, 186–187
hepatitis C virus, 193
herpes simplex virus, 203, 204, 328, 329
Histoplasma capsulatum, 209, 210
influenza virus, 229, 230
melanoma, 242
meningitis, 271, 272
multiple sclerosis, 248
mycobacterium tuberculosis, 254, 255, 256, 351–352, 355
papillomaviruses, 219, 220
parainfluenza virus, 276
respiratory syncytial virus, 282, 283
rheumatoid arthritis, 289
rotavirus, 292–293
Shigella, 296–297
streptococcus, group A, 303–304
streptococcus, group B, 310–312
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Streptococcus pneumoniae 320–321
see also Clinical trials; Quality-adjusted life years
Elderly persons, 23, 47–48, 49, 80–82, 100, 112
Helicobacter pylori, 181
influenza, 48, 223–224
Medicare, 4, 49–50
parainfluenza, 6, 273, 275
rheumatoid arthritis, 285
respiratory syncytial virus, 279
streptococcus, group B, 6, 7, 47–48, 310
Streptococcus pneumoniae 313, 314, 316–317, 319–321
ELISA, see Enzyme-linked immunosorbent assays
Emotional impairments, 64–65
Emergency departments, 49
Enterococci, 42
Enterotoxigenic E. coli, see Escherichia coli
Enzyme-linked immunosorbent assays, 341, 342
Epidemiology, 12, 17, 26, 44, 435
dengue virus, 343
hepatitis C virus, 334–335
poliomyelitis, 23–26, 91–92
see also Death rates; Incidence; Morbidity; Morbidity scenarios; Prevalence
Epstein-Barr virus, 7, 54, 67, 88, 177–180, 329–334
Equations, see Mathematical formulae
Escherichia coli, 7, 54, 67, 88, 91, 173–176, 361, 365–366, 374, 379
Ethical issues, 3–4, 109–122, 128, 129
aggregation, 117–118, 119
committee membership, 14
confidentiality, 47
contraceptive vaccines, 75
incidence of disease, 117, 118
pregnant women, 22
quality-adjusted life years, 3–4, 58, 111, 112, 113, 114–115, 120–121, 129–130
transplants, 120–121, 122
worst-off/sickest persons, 119–120
see also Quality of life
Europe, 347, 367, 377
Expanded Programme on Immunization, 127–128
Expert judgment, 3, 12
committee membership, 14, 17
list of, 437–442
morbidity scenarios, 97
survey instrument, 435–437
F
Fairness, see Ethical issues
Federal Advisory Committee on Immunization Practices, 45
Fertility, 62, 65, 151, 155, 259, 264
contraceptive vaccines, 75–76
Food and Drug Administration, 14, 125, 126, 362, 367, 373, 374
see also Licensure, vaccines
Foreign countries, 1, 5, 8, 11, 17, 39, 42–43, 59, 110
dengue virus, 343
polio, 25
pregnant women, 21
see also Developing countries; Immigrants; Travelers; specific countries
Formulae, see Mathematical formulae
Funding, 8, 19, 123–126, 436
National Childhood Vaccine Injury Act, 20–21
G
Gender factors, see Men; Women
Genetics, 233
Epstein-Barr virus, 330–332
Helicobacter pylori, 364–365
papillomaviruses, 339–340
see Biotechnology; DNA; Genomes; RNA
Genomes, 32, 395
Epstein-Barr virus, 330–331, 333–334
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hepatitis C virus, 335
herpes simplex virus, 327, 328
influenza, 223
Geographic factors, see Developing countries; Foreign countries; Regional factors; Urban areas
Glycopolymers, 374
Glycoprotein vaccines, 19, 20, 33, 223, 327, 336, 380, 382–383
Gonorrhea, see Neisseria gonorrhea
Group A streptococcus, 6, 43, 54, 67, 88, 299–304, 359–363
Group B streptococcus, 6, 19, 20, 54, 67, 87, 88, 89, 90, 129, 305–312
adolescent girls, 93
pregnant women, 7, 21, 22, 23, 93
Guillain-Barré syndrome, 21
H
Haemophilus influenzae (Hib), 11, 18, 19, 23, 28, 46–47, 114, 126
Health Care Financing Administration, 71, 106
Health care workers
hepatitis B, 18
hepatitis C virus, 337
see also Nurses; Physicians
Health departments, 46, 49
varicella-zoster virus, 18
Health insurance, 131
children, 47, 90
incentives to, 9
performance measures, 7
Health utility index (HUI), 62–68 (passim), 76, 96, 97, 98–99, 102
Borrelia burgdorferi, 143, 145, 146
chlamydia, 150, 151–152
Coccidiodes immitis, 161, 162
cytomegalovirus, 165–166, 167
diabetes mellitus, 234
enterotoxigenic E. coli, 173
Epstein-Barr virus, 177, 178
ethical issues, 117, 119
gonorrhea, 257, 258
Helicobacter pylori, 181, 182, 183
hepatitis C virus, 191
herpes simplex virus, 196, 200
Histoplasma capsulatum, 208
influenza virus, 227
melanoma, 239
meningitis, 267–268
multiple sclerosis, 246
mycobacterium tuberculosis, 252, 254
papillomaviruses, 214, 215–216
respiratory syncytial virus, 279
rheumatoid arthritis, 286
streptococcus, group A, 300, 301
streptococcus, group B, 305
Streptococcus pneumoniae 313
Heat shock proteins, 353
Helicobacter felis, 30
Helicobacter pylori, 6, 54, 67, 88, 181–188, 363–367
Hepatitis A virus, 11, 18, 19, 334, 337
Hepatitis B virus, 11, 18, 19, 28, 30, 44–44, 47–48, 114, 334, 337, 378, 379, 412–415
Hepatitis C virus, 6, 54, 88, 189–194, 334–338, 433
Herpes simplex virus, 6, 19, 22, 54, 67, 88, 195–205, 326–329, 384
Herpesvirus (Epstein-Barr), see Epstein-Barr virus
Hispanics, 50
Histoplasma capsulatum 7, 44, 54, 67, 89, 91, 207–212, 356–359
Historical perspectives, 123–124
childhood immunizations, 46
hepatitis, 334
IOM studies, 1, 2, 11, 17, 123–124
litigation, 20–23
malaria, 42–43
quality-adjusted life years, 2, 56
polio, 23–26, 91–92
syphilis, 41
vaccine development, 12
Hodgkin’s disease, 330, 331
Hospitals and hospitalization, 4, 48–49, 67, 106
cost-effectiveness, general, 59, 71
chlamydia, 153–156
Coccidiodes immitis, 161, 162
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cytomegalovirus, 166, 167, 168–169
gonorrhea, 257–263 (passim)
Helicobacter pylori, 184–185
hepatitis C virus, 190, 192
herpes simplex virus, 202–203
Histoplasma capsulatum, 209, 211
influenza virus, 224, 227
melanoma, 240, 241
meningitis, 268, 269, 270
multiple sclerosis, 246, 247
mycobacterium tuberculosis, 252, 254, 255
nosocomial infections, 9, 18, 41, 42, 131
papillomaviruses, 214
parainfluenza virus, 274, 275
respiratory syncytial virus, 20, 281, 282
rheumatoid arthritis, 286, 288
streptococcus, group A, 301–302
streptococcus, group B, 306, 307, 308, 309
Streptococcus pneumoniae 318–320
HUI, see Health utility index
Human immunodeficiency virus, 2, 13–14, 22, 32, 42, 43, 44, 112, 119–120, 159–160, 165, 195, 330, 368, 373, 377, 379, 380, 382–383, 386
Human papillomaviruses, see Papillomaviruses
Humoral immunity, 41
adjuvants, 373
Coccidiodes immitis, 357
hepatitis C virus, 337
Histoplasma capsulatum 357
see also B cells; Mucosal immunity; T cells
Hybridoma, 30, 401–402, 404–405
I
Iceland, 378
Immigrants
Borrelia burgdorferi, 7, 88, 145
Coccidiodes immitis, 7, 88, 159, 161, 163
Histoplasma capsulatum, 7, 89, 207, 209
Immune system, general, 26–30, 377
Coccidiodes immitis, 358–359
chlamydia, 349–351
dengue virus, 345–346
gonorrhea, 368–369
hepatitis C virus, 336
herpes simplex virus, 327, 329
Histoplasma capsulatum 357–358
mycobacterium tuberculosis, 352–353
papillomaviruses, 339
pregnant women, 22–23
streptococcus, group A, 363
see also Adjuvants; Antigens; Autoimmune diseases; B cells; Macrophages; Mucosal immunity; Peptide therapy; T cells
Immunoglobin, 27, 28, 29–30, 32, 33, 378, 379–380, 408, 426
Epstein-Barr virus, 334
Helicobacter pylori, 364, 366
streptococcus, group A, 362
transplacental transport, 22–23
Impairments, see Disabilities; Morbidity
Incidence, 3, 435
Bordetella pertussis, 143, 144
chlamydia, 149–152, 347
Coccidiodes immitis, 159, 160, 162, 356–357
cost-effectiveness model, analytic approach, 58, 68, 80–84 (passim), 87, 89
cost-effectiveness model, detailed review, 100
cytomegalovirus, 165–166
dengue virus, 343
diabetes mellitus, 233
enterotoxigenic E. coli, 173
Epstein-Barr virus, 177, 329–330
ethical issues, 117, 118
gonorrhea, 257, 367–368
Helicobacter pylori, 181, 182, 183, 363
hepatitis C virus, 189, 191, 334
herpes simplex virus, 196, 197, 326
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Histoplasma capsulatum 207, 208, 356–357
influenza virus, 224, 225, 227
melanoma, 239, 240
meningitis, 267, 268
multiple sclerosis, 245
mycobacterium tuberculosis, 252, 253, 351
papillomaviruses, 213, 338
parainfluenza virus, 6, 273
polio, 24–25
respiratory syncytial virus, 279, 280
rheumatoid arthritis, 285
rotavirus, 291
Shigella, 295
streptococcus, group A, 299, 300, 360
streptococcus, group B, 305, 306
Streptococcus pneumoniae 313, 314
see also Death rates
Infants, 8–9, 23, 45–47, 60, 69, 84, 100, 101
Borrelia burgdorferi, 7, 88, 145
chlamydia, 152, 153, 156, 347–348
Coccidiodes immitis, 7, 88, 161, 163
cytomegalovirus, 165–166, 168, 170
enterotoxigenic E. coli, 7, 88, 173
Haemophilus influenzae, 11, 114
Helicobacter pylori, 88
hepatitis B virus, 18, 114
herpes simplex virus, 6, 88, 199, 201, 326, 327–328
Histoplasma capsulatum 7, 89, 209
meningitis, 7, 23, 89, 267
parainfluenza virus, 6, 273, 275
respiratory syncytial virus, 6, 19, 279, 280, 281, 282
rotavirus, 6, 88, 291–292
Shigella, 7, 89, 295, 296, 297
streptococcus, group A, 6, 88, 303
streptococcus, group B, 20, 23, 88, 305, 307, 308
Streptococcus pneumoniae 314
tuberculosis, 91
varicella-zoster virus, 18
see also Pregnant women
Infertility, see Fertility
Inflammatory response, 35, 36, 37, 385, 390, 397, 398, 411–412, 422, 423, 428
adenoviruses, 33
central nervous system, 399, 401, 402, 403
disbetes, 233, 386, 387
gastric, 363, 264
heat shock protein, 351
macrophage activation, 372, 373
multiple sclerosis, 245
pelvic inflammatory disease (PID), 150, 153, 257, 348
peptides, 403, 404, 405, 406
rheumatoid arthritis, 285
Influenza virus, 6, 11, 19, 22, 30, 34, 48–50, 54, 59–60, 67, 87, 89, 223–231, 382, 386
litigation, 21
see also Parainfluenza virus
Insert baculovirus system, 30
Insulin-dependent diabetes mellitus, see Diabetes mellitus,
Insurance, see Health insurance
Interferon, 351, 357, 373, 387, 388, 392, 393, 409
Interleukin, 27, 38, 348–349, 372, 373, 374, 388, 389, 390–394, 396, 402–403, 405–406, 409, 410, 411–412, 420, 424, 430, 432
International perspectives, see Foreign countries
Internet, IOM, 4, 323
Intranasal delivery, 9, 28, 29–30, 33, 34, 37, 47, 130, 355, 358, 361–362, 366, 378, 380
J
Japan, hepatitis C virus, 334
L
Legislation, general
pregnant women, 7
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school entry immunizations, 7, 8–9, 20, 49, 90, 130
Legislation, specific
Americans with Disabilities Act, 112–113
National Childhood Vaccine Injury Act, 20–21, 128–129, 258
Less-developed countries, see Developing countries
Liability issues, 19, 128–129
see also Litigation
Licensure, vaccines, 1, 4, 5, 11, 18–19, 39, 43, 89–91, 436
Borrelia burgdorferi, 145
chlamydia, 157
Coccidiodes immitis, 20
cytomegalovirus, 20, 167
diabetes mellitus, 234, 237
enterotoxigenic E. coli, 174
Epstein-Barr virus, 179
funding issues, 8
gonorrhea, 6, 20, 264, 265
Helicobacter pylori, 185
hepatitis A, 18
hepatitis B, 18
hepatitis C, 190
herpes simplex virus, 201
Histoplasma capsulatum, 209
influenza virus, 228
length of process, general, 19–20, 54–55, 58, 60–61, 79, 80–82, 90, 95, 108, 121, 437
melanoma, 240
meningitis, 271
multiple sclerosis, 246
mycobacterium tuberculosis, 253
papillomaviruses, 219
parainfluenza virus, 20, 276
polio, 25, 126–127
respiratory syncytial virus, 20, 280
rheumatoid arthritis, 287, 289
rotavirus, 18, 292
Shigella, 296, 297
streptococcus, group A, 302
streptococcus, group B, 20, 306–309
Streptococcus pneumoniae 317, 321
therapeutic vaccines, general, 45
varicella-zoster virus, 18
see also Animal models; Clinical trials; Time factors
Life expectancy, general
cost-effectiveness model, analytic approach, 57, 66, 68, 76, 120
cost-effectiveness model, detailed characterization, 95–96, 98, 99, 101–102, 103, 104, 106–107
ethical issues, 112, 113, 120
see also Quality-adjusted life years
Litigation, 8, 20–23, 127, 128–129
pregnant women, 21–23
streptococcus, group B, 6
see also Liability issues
Local government, see Health departments
Lymphocytes, see B cells; T cells
M
Macrophages, 27, 28, 246, 353, 357, 372, 373, 374, 375, 377, 378, 392, 393, 399, 401, 402–403, 409, 430, 432
Major histocompatibility complex (MHC), 26–27, 32–37 (passim), 344, 350, 358, 373, 381, 390, 399–400, 404, 406, 407, 410–422 (passim), 430, 432, 433
Malaria, 8, 42–43
March of Dimes, 24
Market forces, 9, 19, 125–126
Mathematical formulae, 94–97, 99, 101–106 (passim)
Measles, 20, 28, 49, 131, 386
Medicaid, 118
Medicare, 4, 49–50
Melanoma, 6, 54, 88, 89–90, 239–243, 421
Men, 68, 97, 98–99
chlamydia, 97, 149–153 (passim), 155–156, 347
gonorrhea, 257, 258, 260, 263, 264–265
herpes simplex virus, 326
papillomaviruses, 214, 216, 218–219
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Meningitis, see Neisseria meningitidis
Microspheres, 378–379, 380
Migration, see Immigrants
Military personnel, 330, 356
Minority groups, see Race/ethnicity
Mobility impairments, 64
polio, 24, 25, 126–127
onoclonal antibodies, 29–30
herpes simplex virus, 327
Mononucleosis, see Epstein-Barr virus
Monophosphoric lipid-A, 373
Morbidity, 61–66, 67, 68, 78–79, 108
as assessment criterion, 27, 39, 80–82, 95, 96
health utility index, general, 62–68 (passim), 76, 96, 97, 98–99, 102
scenarios, see Morbidity scenarios; specific diseases listed under Health utility index
chlamydia, 347–348
Coccidiodes immitis, 356
dengue virus, 342–343
Epstein-Barr virus, 330
gonorrhea, 368
hepatitis C virus, 334
Helicobacter pylori, 363–364
Histoplasma capsulatum 356
malaria, 43
papillomavirus, 338–339
streptococcus, group A, 359–360
see also Disabilities; Quality-adjusted life years
Morbidity scenarios, 69, 71, 78, 80–85, 95, 96, 97, 98
Bordetella pertussis, 143–144, 146
chlamydia, 150, 151–152
Coccidiodes immitis, 162
cytomegalovirus, 165–166, 167
diabetes mellitus, 234
enterotoxigenic E. coli, 173
Epstein-Barr virus, 177
gonorrhea, 257, 259
Helicobacter pylori, 182–183, 363–364
hepatitis C virus, 190, 191
herpes simplex virus, 196, 198–199
Histoplasma capsulatum, 208, 210
influenza virus, 224, 227
melanoma, 239–240, 241
meningitis, 267–269
multiple sclerosis, 246
mycobacterium tuberculosis, 252, 254
papillomaviruses, 214, 215–216
parainfluenza virus, 273, 274
respiratory syncytial virus, 279, 281
rheumatoid arthritis, 285–286, 287
rotavirus, 291
Shigella, 295
streptococcus, group A, 299–300
streptococcus, group B, 305–306, 307
Streptococcus pneumoniae 313, 315–317
see also Health utility index
Mortality, see Death rates
Mucosal immunity, 27, 28–30, 32, 33, 47
adjuvants, 374–375, 376
antigen delivery, 377, 378, 380
autoimmune disease, 35, 37
chlamydia, 348
Epstein-Barr virus, 333
Helicobacter pylori, 365
papillomaviruses, 338–339, 341
streptococcus, group A, 362
see also B cells; Intranasal delivery
Multiple sclerosis, 6, 35, 54, 87, 245–249, 397, 399–400
Mumps, 20, 28, 49
Mycobacterium tuberculosis, 6, 54, 88, 89–90, 91, 100, 251–256, 351–355, 383–384, 386
N
Nasal delivery, see Intranasal delivery
National Cancer Institute, 339–341
National Center for Health Statistics, 14
National Childhood Vaccine Injury Act, 20–21, 128–129
National Foundation for Infantile Paralysis-March of Dimes, 24
National Health Interview Survey, 50
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National Institute of Allergy and Infectious Diseases, 17, 18, 110, 124–125, 126
National Institute of Child Health and Development, 125
National Institute of Occupational Safety and Health, 356–357
National Institutes of Health
hepatitis C virus, 334, 336
HIV research, 13–14
papillomaviruses, 339–341
study at hand, methodology, 14, 110
National Vaccine Injury Compensation Program, 20–21, 128–129
Neisseria gonorrhea, 6, 20, 54, 67, 88, 100, 257–265, 367–372
Neisseria meningitidis, 7, 19, 23, 54, 66, 67, 89, 200, 251, 267–272
streptococcus, group B, 20, 23, 88, 305, 307, 308–309
Streptococcus pneumoniae 313–320 (passim)
Neonates, see Infants;
Pregnant women
New Vaccine Development: Establishing Priorities, 1, 11, 17
Noninjection routes, vaccines, 9, 25, 29, 31–34, 47
diabetes, 387–388
intranasal administration, 9, 28, 29–30, 33, 34, 37, 47, 130, 355, 358, 361–362, 366, 378, 380
oral administration, 9, 28, 29, 31–32, 37, 130, 378, 380
polio, 20, 25–26, 28–29, 32
tuberculosis, 354, 355
particulate vaccines, 30–34
rotavirus, 20–29
Nosocomial infections, 9, 18, 41, 42, 131
Nurses, 49, 255
O
Occupational health, see Health care workers
Older persons, see Elderly persons
Ontario Health Survey, 96
Opportunity costs, 74, 115–116, 130
Oral administration, 9, 28, 29, 31–32, 37, 130, 378, 380
diabetes, 387–388
Helicobacter pylori, 366
mycobacterium tuberculosis, 354, 355
polio vaccine, 20, 25–26, 28–29, 32
Organ transplants, see Transplants (organs)
P
Pain, 62, 65, 260–261
Pan-American Health Organization, 25
Panel on Cost-Effectiveness in Health and Medicine, 56, 85
Papillomaviruses, 6, 54, 88, 213–221, 338–342, 384, 433
Parainfluenza virus, 6, 19, 20, 54, 88, 273–277
Particulate vaccines, 30–34
Pasteur Institute, 340
Peptide therapy, 26–27, 33, 35–36, 37, 358, 395, 396, 410, 411, 412–432 (passim)
adjuvants, 373, 374, 375
autoimmune diseases, 399–401, 403–407
chlamydia, 350
dengue virus, 344
Epstein-Barr virus, 333, 334
gonorrhea, 369, 370
hepatitis B virus, 412–415
multiple sclerosis, 399, 300
streptococcus, group A, 362
Pertussis acellular vaccine, 11, 18, 20, 28, 30, 129
Physicians, 17, 47–48
Borrelia burgdorferi, 145
chlamydia, 153–156
Coccidiodes immitis, 161, 162
cytomegalovirus, 166, 168–169
diabetes mellitus, 234, 235–236
enterotoxigenic E. coli, 174
Epstein-Barr virus, 178, 179
gonorrhea, 260–264 (passim)
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Helicobacter pylori, 184
hepatitis C virus, 192
herpes simplex virus, 202–203
Histoplasma capsulatum, 211
influenza virus, 228
melanoma, 240, 241
meningitis, 270
multiple sclerosis, 246, 247
mycobacterium tuberculosis, 252, 255
papillomaviruses, 214, 215, 217–219
parainfluenza virus, 274, 275
respiratory syncytial virus, 282
rheumatoid arthritis, 286, 288
Shigella, 295–296, 297
streptococcus, group A, 302
streptococcus, group B, 306, 308, 309
Streptococcus pneumoniae 318–320
varicella-zoster virus, 18
Poliomyelitis, 20, 23–26, 28–29, 32, 91–92
Poverty
ethical issues, 115–116, 118
Medicaid, 118
see also Developing countries
Pregnant women, 7, 21–23, 50–51, 69, 91, 101, 128–129
chlymadia, 154, 347–348
contraceptive vaccines, 75–76
fertility, 62, 65, 151, 155, 259, 264
gonorrhea, 259, 368
hepatitis C virus, 334
herpes simplex virus, 326–327
meningitis, 22
parainfluenza, 88
streptococcus, group B, 20, 90, 93, 306, 307, 309, 310–311
Streptococcus pneumoniae 22
tetanus toxoids, 23
time of delivery, 20, 23, 51
various pathogens, 22
Prevalence
cost-effectiveness model, analytic approach, 68
cost-effectiveness model, detailed description, 100
see also Incidence
Privacy, see Confidentiality
Private sector, 8, 19, 105, 125, 436
market forces, 9, 19, 125–126
papillomaviruses, 342
streptococcus, group B, 6
see also Health insurance; Litigation
Pseudomonas aeruginosa, 42, 44, 128
Psychological factors, see Attitudes; Cognitive impairments; Emotional impairments
Psychomotor impairments, see Mobility impairments
Puberty, see Children
Public Health Service, 56
Public opinion, see Attitudes
Q
Quality-adjusted life years, 2, 57, 58, 61–69, 76–89, 95–99 102–104, 106, 107–108
age and, 58, 66, 68–69, 80–82, 84, 80–83, 84, 95, 98–99
aggregation, 2, 56
average population health states, 66, 68
definitional issues, 2, 56, 58, 61–62, 86, 95
disability-adjusted life years, 63, 66, 111, 112
discounting, 18, 60–61, 68–69, 114–115
ethical issues, 3–4, 58, 111, 112, 113, 114–115, 120–121, 129–130
mathematical formulae, 95, 96, 99
see also Life expectancy
Quality-adjusted life years, specific vaccines
Borrelia burgdorferi, 147
chlamydia, 157, 158
Coccidiodes immitis, 163–164
cytomegalovirus, 167, 170–171
diabetes mellitus, 237, 238
Enterotoxigenic E. coli, 174, 176
Epstein-Barr virus, 179–180
gonorrhea, 264–265
Helicobacter pylori, 186–187
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hepatitis C virus, 193–194
herpes simplex virus, 204
Histoplasma capsulatum, 210, 211
influenza virus, 229–230
melanoma, 241, 242–243
meningitis, 271, 272
multiple sclerosis, 248, 249
mycobacterium tuberculosis, 254, 256
papillomaviruses, 220
parainfluenza virus, 276, 277
ranking of vaccines covered, 5–7
respiratory syncytial virus, 282–283
rheumatoid arthritis, 289
rotavirus, 293
Shigella, 296, 297
streptococcus, group A, 301, 303, 304
streptococcus, group B, 307, 310–312
Streptococcus pneumoniae 315, 320—321
Quality of life, general, 15
Quality of Well-Being Scale, 63, 66
R
Race/ethnicity, 50
syphilis, 41
see also specific racial/ethnic groups
Receptor-centered regulation, 22, 26, 29, 30–31, 36, 37–38, 407, 418, 426
chlamydia, 349, 350
dengue virus, 343–344
gonorrhea, 369, 370–371
hepatitis B virus, 412–413
streptococcus, group A, 360
virus-like particles, 30–31
Record-keeping, 46, 47, 49
Regional factors, 7, 44, 71, 88, 89, 91, 93, 105, 128
Borrelia burgdorferi, 144, 145
chlamydia, 347
Coccidiodes immitis, 159
dengue virus, 343
gonorrhea, 257, 367–368
Histoplasma capsulatum 207, 209, 356–357
mycobacterium tuberculosis, 352, 355
see also Developing countries; Foreign countries; Immigrants
Respiratory syncytial virus, 6, 19, 20, 22, 23, 43, 54, 88, 90, 279–284
Rheumatoid arthritis, 6, 35, 54, 67, 87, 285–290, 403
RNA
dengue virus, 342–347
diabetes, 388
Epstein-Barr virus, 330
gonorrhea, 368
hepatitis C virus, 335, 336
Rotavirus, 6, 11, 18, 19, 22, 28–29, 54, 88, 291–294
Rubella, 20, 28
S
Salmonella, 31–32
Schedules, see Vaccination schedules
School entry immunizations, 7, 8–9, 20, 49, 90, 130
Sensitivity analysis, 3, 57
Sensory impairments, 62, 64, 64, 67, 236
Sex differences, see Men; Women
Sexually transmitted diseases, 7
chlamydia, 6, 54, 67, 88, 89–90, 149–158, 347–351, 368
hepatitis C virus, 334–335
herpes simplex virus, 6, 19, 22, 54, 67, 88, 195–205, 326–329, 384
gonorrhea, 6, 20, 54, 67, 88, 100, 257–265, 367–372
human immunodeficiency virus, 2, 13–14, 22, 32, 42, 43, 44, 112, 119–120, 159–160, 165, 195, 330, 368, 373, 377, 379, 380, 382–383, 386
papillomaviruses, 6, 54, 88, 213–221, 338–342, 384, 433
syphilis, 41
Shigella, 7, 43, 54, 100, 295–297, 379
Socioeconomic status, see Poverty; Race/ethnicity
Southeast Asia, 339, 343
Staphylococcus aureus, 42
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State public health programs, see Health departments
Streptococcus, see Group A streptococcus; Group B streptococcus; Streptococcus mutans; Streptococcus pneumoniae
Streptococcus mutans, 44–45
Streptococcus pneumoniae 6, 21, 43, 47–48, 49, 54, 60, 88, 89, 313–322
Syncytial virus, see Respiratory syncytial virus
Syphilis, 41
T
Target populations, see Age factors; Immigrants; Men; Race/ethnicity; Women
T cells, 26–35, 408–409, 410, 415–433 (passim), 436
adjuvants, 372–373, 374, 376
antigen-induced programmed cell death, 37, 395–399, 409, 410–411
autoimmune disease, 35–38, 233, 245, 389–391, 392–395, 399–406 (passim)
chlamydia, 348–349, 350
cholera, 375
Coccidiodes immitis, 357
dengue virus, 344–345, 346, 347
diabetes mellitus, 233, 387–389, 391, 392, 393–395
Epstein-Barr virus, 330, 331, 332, 333
DNA vaccines, 378, 380, 381, 382, 383, 385
Helicobacter pylori, 364
hepatitis B virus, 412, 413–415
hepatitis C virus, 335, 337–338
herpes simplex virus, 329
Histoplasma capsulatum 357
mycobacterium tuberculosis, 353–355
papillomaviruses, 342
Tetanus, 20, 23, 28, 30, 46, 49
Time factors, 68–69, 79, 86
Bordetella pertussis, 145
chlamydia, 156
Coccidiodes immitis, 161
cytomegalovirus, 167
development/licensure process, 19–20, 54–55, 58, 60–61, 79, 80–82, 90, 95, 108, 121, 437
diabetes mellitus, 234, 237
enterotoxigenic E. coli, 174
Epstein-Barr virus, 179
gonorrhea, 264
Helicobacter pylori, 185
hepatitis C, 190
herpes simplex virus, 201
Histoplasma capsulatum, 209
influenza virus, 228
melanoma, 240
meningitis, 271
multiple sclerosis, 246, 248, 249
mycobacterium tuberculosis, 252, 254
papillomaviruses, 219, 220
parainfluenza virus, 276, 277
respiratory syncytial virus, 280, 282–283
rheumatoid arthritis, 287, 289
rotavirus, 292, 293
Shigella, 296, 297
streptococcus, group A, 302, 304
streptococcus, group B, 306, 311
Streptococcus pneumoniae 317, 321
discounting, 68–69, 86, 101
licensure possibilities, scope of study at hand, 39, 40, 43
patient time costs, 74
patterns of vaccine use, 60, 93–94
pregnant women, 20, 23, 51
Tobacco, 379–380
Tourists, see Travelers
Transfection, 32, 34, 416, 418, 423–424
Transplants (organs), 391
cytomegalovirus, 165, 169
Epstein-Barr virus, 330
ethical issues, 120–121, 122
hepatitis C virus, 334
Travelers, 105
E. coli, 7, 88, 173, 174
malaria, 42–43
Shigella, 7, 89, 295, 296, 297
Treponema pallidum, 41
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Tuberculosis, see Mycobacterium tuberculosis
Tyler’s murine encephalomyelitis, 399
Typhoid, 29, 30, 47
U
Urban areas
influenza, 50
syphilis, 41
Utilization of vaccines, 9, 39, 45, 130
Borrelia burgdorferi, 147
chlamydia, 157
Coccidiodes immitis, 163, 164
complacency and fear, 9, 46, 73–74 [ALL]
cost-effectiveness model, analytic approach, 72–73, 75, 76, 79, 80, 86, 88, 89, 91
cost-effectiveness model, detailed review, 95, 107–108
cytomegalovirus, 170
diabetes mellitus, 237, 238
E. coli, 174, 176
Epstein-Barr virus, 179, 180
gonorrhea, 264, 265
streptococcus, group B, 6
Helicobacter pylori, 186–187
hepatitis C virus, 193, 194
herpes simplex virus, 204
Histoplasma capsulatum, 210
influenza virus, 229, 230
melanoma, 242, 243
meningitis, 271, 272
multiple sclerosis, 248, 249
mycobacterium tuberculosis, 253–254, 255, 256
papillomaviruses, 219, 220
parainfluenza virus, 276, 277
respiratory syncytial virus, 281, 282, 283
rheumatoid arthritis, 289
rotavirus, 292–293
school entry immunizations, 7, 8–9, 20, 49, 90, 130
Shigella, 296–297
specific vaccines, various, 53
streptococcus, group A, 303–304
streptococcus, group B, 310–312
Streptococcus pneumoniae 320–321
see also Attitudes; Barriers to research and development; Delivery of vaccines
V
Vaccine Injury Compensation Program, 20–21, 128–129
Vaccine schedules, 45–46, 431–432
Borrelia burgdorferi, 145, 147
chlamydia, 157
Coccidiodes immitis, 163
cytomegalovirus, 170
diabetes mellitus, 237
enterotoxigenic E. coli, 174
Epstein-Barr virus, 179
gonorrhea, 264
Helicobacter pylori, 186
hepatitis C virus, 193, 336
herpes simplex virus, 203, 329
Histoplasma capsulatum, 209
influenza virus, 229
melanoma, 242
meningitis, 271
multiple sclerosis, 248
mycobacterium tuberculosis, 254
papillomaviruses, 219
parainfluenza virus, 276
respiratory syncytial virus, 282
rheumatoid arthritis, 289
rotavirus, 292
Shigella, 296
streptococcus, group A, 303
streptococcus, group B, 310
Streptococcus pneumoniae 320
Vaccines for Children Program, 47, 131
Varicella-zoster virus, 11, 18, 19, 28
Vector-borne pathogens, 8, 42–43, 342–347
Vibrio cholerae, 30, 31, 35, 374, 375–376, 378
Virus-like particulates, 30–34
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Visting Nurse Assocations, 49
W
Waterborne pathogens, general, 42
World Bank, 63
World Health Organization, 21, 25, 63
Women, 68, 98–99
chlymadia, 97, 149, 150–152, 153, 154
contraceptive vaccines, 75–76
fertility, 62, 65, 151, 155, 259, 264
gonorrhea, 257, 258, 259–265
papillomaviruses, 214, 215, 217, 338–342
respiratory syncytial virus, 6, 280, 281
streptococcus, group B, 6, 88, 309, 307, 310
syphilis, 41
see also Pregnant women
World Wide Web, see Internet
Representative terms from entire chapter:
herpes simplex
