|
Hepatitis B Vaccine Clinical Trial Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Hepatitis B Vaccine Clinical Trial conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Hepatitis B Vaccine Clinical Trial Clinical research trials and Hepatitis B Vaccine Clinical Trial health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Hepatitis B Vaccine Clinical Trial. Hepatitis B Vaccine Clinical Trial Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Hepatitis B Vaccine Clinical Trial clinical trial. Human subjects often get the best healthcare possible for their Hepatitis B Vaccine Clinical Trial condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "H" Clinical Trials Conditions > Hepatitis B Vaccine Clinical Trial  Hepatitis B Vaccine Clinical Trial
Hepatitis B Vaccine Clinical Trial
For Condition: Hepatitis B,Hepatitis, Viral, Human,Liver Diseases
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To determine the efficacy of a hepatitis vaccine in preventing hepatitis B.
Details: 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:
Study Type: Interventional, Prevention, Randomized, Double-Blind, Placebo Control
Minimum Age/Maximum Age: 18 Years/36 Years
Genders: Male
Protocol Entry 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.
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 303;
Study Start Date: November 1978
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000583
Other Liver Diseases Studies:
1. Treatment of Hepatitis in Patients who are Triple-Infected with HIV, Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
2. The Tolerance of HIV-Infected Patients with Herpes Group Virus Infections to Oral Doses of FIAU
3. A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
4. Treatment of Hepatitis B Virus (HBV) Before Beginning Anti-HIV Drugs in Patients with Both HBV and HIV
5. Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin
Related Studies:
Other Liver Diseases Clinical Trials
Other Clinical Trials
Other Clinical Trials
Hepatitis B Vaccine Clinical Trial
|
|
|
|
|
|
|
|
