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A newborn infant is at risk of perinatal HBV infection if its mother is either a chronic HBsAg carrier or if she has an acute HBV infection near the time of delivery. Infants with the highest incidence of perinatal HBV infection are those whose mothers are members of high-risk groups (e.g., immigrants from endemic areas, medical personnel, and drug addicts).

Others who are considered at high risk of HBV infection are family contacts of HBsAg carriers and the residents and staff of some institutions (e.g., prisons and schools for the mentally retarded). Travelers in endemic areas may be at risk of HBV infection if they have intimate contact with the local population or receive indigenous medical care (a possible source of parenteral exposure).

Because of the difficulty in identifying and reaching some of those in groups at risk of hepatitis B (homosexual men, IV drug users, heterosexual contacts of infectious people), and because a substantial portion of patients with hepatitis B do not fit into any identifiable group, it may be necessary to administer HBV vaccine to all children to effectively control this disease. Should the safety record of current (or new) vaccines continue to be good and should the price of vaccine decrease, universal vaccination could be re-evaluated.

Suitability for Vaccine Control

The current hepatitis B vaccine has been available commercially since June of 1982, but its acceptance by the targeted high-risk populations has been disappointing (Hilleman et al., 1982; McAuliffe et al., 1982). In addition to the cost of immunization, barriers to vaccine use have been the general reluctance of adults to use any vaccine; inaccurate perceptions of the risk of HBV infection and the significance of hepatitis and its sequelae; and the fear of side effects. The latter was aggravated by the recent appearance of acquired immune deficiency syndrome (AIDS) and the concern that it might be caused by a blood-transmissible agent present in plasma-derived vaccines. Although this fear has proved unwarranted (Stevens, 1983), many who need protection are not yet convinced and have not taken the vaccine.

This is unfortunate because no satisfactory treatment exists for an established acute or chronic HBV infection. Approaches to control other than immunization, such as standard hygiene measures, use of disposable medical equipment, and screening of blood donors for HBsAg, reduce the risk of exposure but do not provide complete protection. Passive immunization with hepatitis B immune globulin (HBIG) is only partially effective as a means of post-exposure prophylaxis (Seeff, 1982).

The plasma-derived hepatitis B vaccine (composed of purified HBsAg 20 nanometer particles adsorbed onto an alum adjuvant) has minimal side effects and is at least 90 percent effective in preventing HBV infection and providing subtype cross-protection in healthy adults (Coutinho et al., 1983; Desmyter et al., 1983; Francis et al., 1982; Guesry et al., 1982; Szmuness et al., 1980, 1982). In combination



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