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Hepatitis B Vaccine: Demonstration of Efficacy in a Controlled Clinical Trial in a High-Risk Population in the United States
Abstract
We assessed the efficacy of an inactivated hepatitis B vaccine in a placebo-controlled, randomized, double-blind trial in 1083 homosexual men known to be at high risk for hepatitis B virus infection. The vaccine was found to be safe and the incidence of side effects was low. Within two months, 77% of the vaccinated persons had high levels of antibody against the hepatitis B surface antigen. This rate increased to 96% after the booster dose and remained essentially unchanged for the duration of the trial. For the first 18 months of follow-up, hepatitis B or subclinical infection developed in only 1.4 to 3.4% of the vaccine recipients as compared with 18 to 27% of placebo recipients (P < 0.0001). The reduction of incidence in the vaccinees was as high as 92.3%; none of the vaccinees with a detectable immune response to the vaccine had clinical hepatitis B or asymptomatic antigenemia. A significant reduction of incidence was already seen within 75 days after randomization; this observation suggests that the vaccine may be efficacious even when given after exposure.
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Citations
Cited by
Protein Therapeutics: A Summary and Pharmacological Classification
Leader, B., Baca, Q. J., & Golan, D. E. (2008) · Nature Reviews Drug Discovery · doi:10.1038/nrd2399 · Cited by 2,161
An Assessment of Clinically Useful Measures of the Consequences of Treatment
Laupacis, A., Sackett, D. L., & Roberts, R. S. (1988) · New England Journal of Medicine · doi:10.1056/nejm198806303182605 · Cited by 1,681
Risks of chronicity following acute hepatitis B virus infection: a review.
Hyams, K. C. (1995) · Clinical Infectious Diseases · doi:10.1093/clinids/20.4.992 · Cited by 521
The global impact of vaccination against hepatitis B: A historical overview
Zanetti, A. R., Van Damme, P., & Shouval, D. (2008) · Vaccine · doi:10.1016/j.vaccine.2008.09.056 · Cited by 420
Obesity as a Predictor of Poor Antibody Response to Hepatitis B Plasma Vaccine
Weber, D. J. (1985) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.1985.03360220053027 · Cited by 345
Metadata
- Authors
- Szmuness, W., Stevens, C. E., Harley, E. J., Zang, E. A., Oleszko, W. R., William, D. C., Sadovsky, R., Morrison, J. M., & Kellner, A.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 1980-10-09
- Volume
- 303
- Issue
- 15
- Pages
- 833-841
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W3144051925
- Cited by
- 1,100
- References
- 0
- FWCI
- 90.45
- Type
- journal article
- Language
- en
- Open access
- closed
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- CoChat. (2026). Citation check: Hepatitis B Vaccine: Demonstration of Efficacy in a Controlled Clinical Trial in a High-Risk Population in the United States. https://app.cochat.ai/papers/10.1056/nejm198010093031501
- The paper
- Szmuness, W., Stevens, C. E., Harley, E. J., Zang, E. A., Oleszko, W. R., William, D. C., Sadovsky, R., Morrison, J. M., & Kellner, A. (1980). Hepatitis B Vaccine: Demonstration of Efficacy in a Controlled Clinical Trial in a High-Risk Population in the United States. New England Journal of Medicine. https://doi.org/10.1056/nejm198010093031501
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
