Long-Term Immunogenicity and Efficacy of Hepatitis B Vaccine in Homosexual Men

To study the duration of antibody persistence and protection provided by the hepatitis B vaccine, we followed 773 homosexual men for five years after completion of vaccination. Among the 635 participants in whom antibody levels above 9.9 sample ratio units (SRU) developed after vaccination, 15 percent lost antibody altogether, and in another 27 percent, antibody levels declined below 10 SRU within five years. The extent of the maximal antibody response strongly predicted the persistence of protective antibody. Hepatitis B infection occurred in 55 men; 8 of these infections were clinically important (characterized by the presence of the hepatitis B surface antigen and elevation of liver-enzyme levels), and two of the patients became hepatitis B virus carriers. The long-term risk of hepatitis B infection was inversely related to the maximal antibody response to vaccine. Most severe infections occurred among those who responded poorly or had no response to the vaccination. The risk of late infection with hepatitis B in those with an initially adequate vaccine response increased markedly when antibody levels decreased below 10 SRU, but only 1 of 34 late infections resulted in viremia and liver inflammation. A second series of vaccinations induced a moderate antibody response in 50 percent of the subjects who initially had no response or a poor response; however, the persistence of antibody was poor. Both antibody loss and the risk of severe disease should be considered when booster-dose strategies for the hepatitis B vaccine are being designed. (N Engl J Med 1986; 315:209–14.) CONTROLLED studies have shown that plasma-derived hepatitis B vaccines are highly effective in providing protection against hepatitis B virus (HBV) infection. 1 2 3 4 5 6 Protective antibodies (antibody levels above 9.9 sample ratio units [SRU] by radioimmunoassay) develop in 80 to 97 percent of normal adults who receive the recommended vaccine series. The efficacy of the vaccine in the prevention of viremic HBV infection, with or without elevation of liver-enzyme levels, is 85 to 95 percent, and protection is virtually complete for up to two years in those who respond to the vaccine. Although some HBV infections have occurred in persons who responded to . . .