Safety and efficacy of hepatitis B vaccine in hospital personnel.
Clinical trials of the hepatitis B vaccine developed in Japan were performed by the phase I, phase II and phase III studies. It was found that this vaccine did not only contained HBV itself but also other pathogens. It was ascertained to be adequately safe, since no major side effect was induced. After inoculation of the vaccine 3 times into 195 hospital employees, an HBs antibody seroconversion rate of 91.8% (97.0% in females and 86.3% in males) was obtained. In recipients aged more than 50 years, the rate was significantly lower. Although 8.2% of the recipients were non-responders to the vaccination, there was no significant correlation between the strength of the HBs antibody response and the lymphocyte subsets in the peripheral blood. It was observed, however, that among the non-responders, the incidence of low OKT4+/OKT8+ cell ratios tended to be somewhat increased. In follow-up studies of the antibody, majority of subjects, in whom the antibody level at 1 month after the 3 inoculations was below 50 RIA units, demonstrated negative conversion within 1 or 2 years. Namely, their value were reduced to below the minimal protective antibody value for prophylaxis of HBV infection.
D000328:Adult; D002986:Clinical Trials as Topic; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006510:Hepatitis B Antibodies / Q000096:biosynthesis; D006801:Humans; D008214:Lymphocytes / Q000145:classification; D008297:Male; D008875:Middle Aged; D010564:Personnel, Hospital; D012449:Safety; D013997:Time Factors; D014761:Viral Hepatitis Vaccines / Q000009:adverse effects / Q000627:therapeutic use*
D006510:Hepatitis B Antibodies; D014761:Viral Hepatitis Vaccines