A controlled clinical trial of the efficacy of the hepatitis B vaccine (heptavax B): A final report

Szmuness, Wolf; Stevens, Cladd E.; Zang, Edith; Harley, Edward J.; Kellner, Aaron

doi:10.1002/hep.1840010502

Cited by 425 publications

(136 citation statements)

References 13 publications

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“…Other side effects were a rash at the injection site, pruritus and temperature elevations, which were seen in a few cases only. Thus it can be concluded that the vaccine is safe and the adverse effects are similar to those after application of other vaccine preparations [22,23,27].…”

Section: Discussionmentioning

confidence: 99%

“…The studies of Szmuness et al [21,22], Maupas et al [12], Crosnier et al [2,3], and ReerinkBrongers et al [18] demonstrated the safety and efficacy of active immunization against hepatitis B in homosexuals, children in Senegal, hemodialysis unit staff and patients, and volunteers. These populations are not only at high risk as far as morbidity and mortality of the acute illness is concerned, but also because of chronic viral hepatitis, liver cirrhosis, and primary liver cell carcinomaconditions which to date cannot be treated effectively.…”

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confidence: 99%

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German experimental hepatitis B vaccine — Influence of variation of dosage schedule, sex and age differences on immunogenicity in health care workers

et al. 1986

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Summary.Of the medical staff of our hospital 217 members at high risk for hepatitis B were immunized with an experimental hepatitis B vaccine and anti-HBs titers used to study the influence of two dosage schedules, age, and sex on immunogenicity. Participants were 34 years of age (mean; range, 20-61); they were divided into two groups and vaccinated three times. Group A received 42 lag HBsAg for each vaccination. Group B received 84 lag for the first and 21 lag for the second and third vaccinations. The seroconversion rate was 32.7% after the first, 78.8% after the second, and 95.7% after the third vaccination. The participants who failed to produce anti-HBs titer (3 IU/1; n = 9) or whose anti-HBs titers were below 50 IU/1 (n= 31) were vaccinated a fourth time. Only mild side effects of injections were observed in a third of all participants, usually in the form of a sore arm.Between groups A and B there were no significant differences as far as the seroconversion rate and anti-HBs titer were concerned. Nonresponders plus low-responders accounted for 19%. Female participants produced a markedly higher anti-HBs titer than males, and the female/male ratio among non-and low-responders was 1:2; among nonresponders, 1:2.5. There was a negative correlation of the anti-HBs titer with the age of the participants. These results not only have practical consequences for revaccination policy, but also offer the opportunity to further study the genetic regulation Abbreviations: anti-HBc = antibody to hepatitis B core antigen ; anti-HBe= antibody to hepatitis B e antigen; anti-HBs =anti-body to hepatitis B surface antigen; HBsAg=hepatitis B surface antigen; IU/1 = international units per liter; MSD = Merck, Sharp, and Dohme of the immune response to a complex peptide antigen in man.

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Section: Discussionmentioning

confidence: 99%

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confidence: 99%

German experimental hepatitis B vaccine — Influence of variation of dosage schedule, sex and age differences on immunogenicity in health care workers

et al. 1986

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“…GMTs for anti-HBs levels in each age group at 1 and 12 months were 402.08 (330. 13 (16.88, 37.29) mIU/ml, respectively. Apart from the seroconversion rate at 1 month (p > 0.05), significant differences were identified of the sero-protective rate at 12 months and…”

Section: Immunogenicity-related Factorsmentioning

confidence: 95%

Optimal vaccination program for healthy adults in China

Yao

Qiu

Chen

et al. 2015

Human Vaccines & Immunotherapeutics

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These authors equally contributed to this work. Keywords: adult vaccination, anti-HBs titers, hepatitis B vaccine, immunogenicityThere is still no suitable routine hepatitis B immunization strategy for adults in China. To establish an optimal vaccination schedule for healthy adults, we investigated various schedules in healthy adults. In this randomized 5143 healthy adults received 10 mg hepatitis B vaccine at 0, 1 and 3 months(group A), 0, 1 and 6 months(group B), or 0, 1 and 12 months(group C). Blood samples were collected after 1 month and 12 months after the third dose. The geometric mean titer (GMT), seroconversion rate (levels of anti-HBs 10 mIU/mL) and high response rate (levels of antiHBs 100 mIU/mL) were assayed. In our study, 2438 healthy adults finished the full vaccination program and follow-up. The seroconversion/sero-protective rate of groups A-C at one and 12 month after administration of the third vaccine dose was 100%, 99.9% and 97.9% verse 64.9%, 75.7% and 79.0%, respectively. GMT for anti-HBs tested in group A to C within 1 or 12 month after the third vaccination was 213.16, 432.58 and 451.47 mIU/ml verse 22.07, 46.70 and 56.18 mIU/ml, respectively. There were significant differences of seroconversion/sero-protective rate and GMT among the 3 groups (p < 0.01). Given the high anti-HBs seroconversion rate and GMT in all 3 groups, a flexible schedule for Hepatitis B vaccine should be recommended to adults, but 0-1-12 schedule is a better choice.

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“…This vaccine has been widely used all over the world with considerable success. It has proved to be highly effective in preventing infection, especially in healthy individuals with a minimum of side effects [1]. Non-responsiveness to the vaccine is more prevalent in individuals with some degree of immunodeficiency, but even this problem can often be overcome by increasing the dose.…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity of yeast-derived hepatitis B vaccine from two different producers

Dahl-Hansen¹,

Siebke²,

Ss³

et al. 1990

Epidemiol. Infect.

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SUMMARYThe immunogenicity and reactogenicity of two preparations of yeast-derived hepatitis B vaccines were compared in healthy adult populations. The two groups were vaccinated in parallel, but they were not matched for age and sex. All subjects seroconverted, and 9 months after the first vaccine dose, all had anti HBs titres of at least 10 IU/l. The anti-HBs titres were higher in the group of subjects given 20 gtg vaccine antigen made by Smith Kline & RIT (GMT 2943 at 9 months) compared to those who received 10 ,tg of vaccine made by Merck, Sharp & Dohme (GMT 729 at 9 months). Adverse effects were recorded in 32'0 and 44'7 % of the participants, but these were limited to minor local and general reactions. In the present study both preparations were safe and efficient.

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A controlled clinical trial of the efficacy of the hepatitis B vaccine (heptavax B): A final report

Cited by 425 publications

References 13 publications

German experimental hepatitis B vaccine — Influence of variation of dosage schedule, sex and age differences on immunogenicity in health care workers

German experimental hepatitis B vaccine — Influence of variation of dosage schedule, sex and age differences on immunogenicity in health care workers

Optimal vaccination program for healthy adults in China

Immunogenicity of yeast-derived hepatitis B vaccine from two different producers

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