Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000583
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-10-27
Brief Title:
Hepatitis B Vaccine Clinical Trial
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the efficacy of a hepatitis vaccine in preventing hepatitis B
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 110 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
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 110 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P01HL009011-18A1 | NIH | None | httpsreporternihgovquickSearchP01HL009011-18A1 |