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Hepatitis B Vaccine Clinical Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000583
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To determine the efficacy of a hepatitis vaccine in preventing hepatitis B.

Condition Intervention Phase
Hepatitis B Hepatitis, Viral, Human Liver Diseases Biological: hepatitis B vaccines Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: November 1978
Study Completion Date: June 1980
Detailed Description:

BACKGROUND:

Although most carriers of HBsAg are asymptomatic, a substantial proportion eventually develop chronic active hepatitis and cirrhosis. There is also overwhelming evidence that the hepatitis B virus is the single most important causative factor of hepatocellular carcinoma. Thus, mass immunization programs against HBV infection may ultimately affect not only the incidence of acute hepatitis B and the pool of chronic carriers but may also reduce the morbidity and mortality from chronic active hepatitis, cirrhosis, and hepatocellular carcinoma.

Krugman and his co-workers laid the groundwork for active immunization against hepatitis B in 1970 to 1973. They discovered that a 1:10 dilution of hepatitis B infective serum lost its infectivity when boiled for one minute but retained its antigenicity and prevented hepatitis B in 70 percent of vaccinated subjects. Hilleman and his colleagues at the Merck Institute of Therapeutic Research developed a more sophisticated vaccine consisting of highly purified, formalin-inactivated HBsAg particles derived from the plasma of chronic carriers of the antigen. By 1978, data were sufficient to permit testing in a clinical trial.

The first subject was inoculated in November 1978, and by October 1979, recruitment had ended. In May 1980, all trial events were reviewed and classified by an expert panel. In June 1980 the code of vaccine and placebo allocation was broken.

DESIGN NARRATIVE:

Randomized, double blind, fixed-sample. A total of 549 subjects were allocated to the vaccine group in which they were treated with highly purified formalin-inactivated virus subunits derived from the plasma of chronic carriers of hepatitis B. A total of 534 were allocated to the placebo group. Both groups received injections at 0, 1 month, and 6 months unless evidence of infection developed before the series was completed.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
Men at high risk for hepatitis B virus infection, 36 years of age or younger, no recent symptoms of hepatitis, blood specimen negative for HBsAg, anti-HBs and anti-HBe.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000583     History of Changes
Other Study ID Numbers: 303
P01HL009011-18A1 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: March 17, 2014
Last Verified: April 2012

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Diseases
Hepatitis, Viral, Human
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs