Key words:hepatitis B vaccine,anti-hbs,cellular immunity,side effect

Transcription

1 Key words:hepatitis B vaccine,anti-hbs,cellular immunity,side effect

2 Table 1 Age and sex of the vaccinees given H-B-VAX male and female vaccinees given H-B-VAX. Fig.1 Comparison of anti-hbs development in

3 Fig.2 Antibody responses(ria)in the vaccinees given H-B-VAX two or three doses. Two doses Fig.3 Comparison of anti-hbs development in the vaccinees given H-B-VAX two or three doses. Table 2 Incidence of local and systemic reactions in the vaccinees during a five-day period following vaccination with H-B-VAX.

4 Table 3 Immunological evaluations of the vaccinees at 3 M and 9 M after the first vaccination. The control group consisted of normal,unvaccinated subjects.

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6 Med. Sci., 270: , ) Data on file, Merck Sharp & Dohme Research Laboratoires. 11) Maupas, P., et al.: Efficacy of hepatitis B vaccine in prevention of early HBsAg carrier state in children. Lancet, 1: , Feb. 7, ) Szmuness, W., et al.: Passive-active immunization against hepatitis B: Immunogenicity studies in adult Americans. Lancet, 1: 575 7) Stevens, C.E., et al.: Hepatitis B vaccine, immune responses in hemodialysis patients. Lancet, 2: , Dec. 6, ) Szmuness, W., et al.: Hepatitis vaccine, demonstration of efficacy in a controlled clinical trial in a high risk population. N. Engl. J. Med., 303: , Oct. 9, ) Purcell, R.H. & Gerin, J. L.: Hepatitis B subunit vaccine, A preliminary report of safety and efficacy tests in chimpanzees. Amer. J. 1) Goldsmith, M.F.: Crossing gthreshold hof hepatitis B control awaits greater vaccine use. J. A.M.A., 251: , ) Gerety, R.J., et al.: Newly licensed hepatitis B vaccine: Known safety and unknown risks. 4) Krugman, S., et al.: Viral hepatitis, type B J. A. M. A., 249: , (MS-2 strain), studies on active immunization. 16) Stevens, C.E.: No increased incidence of J. A. M. A., 217: 41-45, AIDS in recipients of hepatitis B vaccine. N. Engl. J. Med., 308: , ) Valenzuela, P., et al.: Nucleotide sequence of the gene coding for the major protein of hepatitis 6) Hilleman, M.R., et al.: Control of hepatitis by B virus surface antigen. Nature, 280: vaccines, in gpreventive Medicine in the Coming Decade h. A.G. Beam(ed.), Merck Sharp & , ) Valenzuela, P., et al.: Synthesis and assembly Dohme International: 55-57, of hepatitis B virus surface antigen particles in yeast. Nature, 298: , ) McAleer, W.J., et al.: Human hepatitis B vaccine from recombinant yeast. Nature, 307: , ) Scolnick, E.M., et al.: Clinical evaluation in healthy adults of a hepatitis B vaccine made by recombinant DNA. J. A. M. A., 251: , 1984.

7 Clinical Results of a Hepatitis B Vaccine(H-B-VAX,Merck)in Healthy Adults in Japan Hiroyuki IWASAKI,Shunichi KATO & Mikio KIMURA Department of Pediatrics,Tokai University School of Medicine Shohei MATSUZAKI Department of Internal Medicine, Tokai University School of Medicine Efficacy and safety of a hepatitis B vaccine(h-b-vax,marck)were studied in 70 healthy medical personnels of Tokai University Hospital.The subjects received primary dosis of 20 micrograms of the vaccine with one or two boosters one and six months later. Systemic and local reactions following vaccination were monitored.serological responses were studied measuring anti-hbs titers by a radioimmunoassay.antibody titers were measured at 1,3,6 and 9 months after the primary vaccination. Seroconversion rates were 45.7% after one month, 88.6% after 3 months, 90.5% after 6 months and 95.5% after 9 months respectively. The incidence of systemic reactions such as chill,headache,fatigue,malaise and myalgia/arthralgia ranged from 1.8% to 17.8%.Temperature elevation above 37.5 Ž was not observed. Local reactions such as heat,induration,swelling and pruritus were observed in 1.2% to 21.9% of the vaccinees. Cellular immunity of the vaccinees before and after vaccinations were also evaluated.lymphocyte subpopulations (T, B),T-cell subsets(okt 3,4,8 and 4/8 ratio),and mitogenic responses(pha ConA) showed no significant changes. United Consequently,this H-B-VAX may be considered to be effcient and safe as already observed in the States.