A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A
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Purpose
Immune globulin is effective about 85% of the time in preventing hepatitis A in people who have been exposed, if it is given within 14 days of exposure. Several lines of evidence suggest that hepatitis A vaccine might also be effective in this setting, and vaccine has the advantage of providing long term protection. In this study, we compare how well immune globulin and hepatitis A vaccine work in preventing clinical hepatitis A in household contacts of persons with the disease. The study's hypothesis is that the the proportion of exposed household contacts who receive hepatitis A vaccine within 14 days of exposure and develop hepatitis A disease will be similar to the proportion of exposure household contacts who receive immune globulin within 14 days of exposure and develop hepatitis A disease.
| Condition | Intervention |
|---|---|
|
Hepatitis A |
Biological: Hepatitis A vaccine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Blinded Randomized Comparative Study of Hepatitis A Vaccine and Immune Globulin for Postexposure Prophylaxis for Hepatitis A Disease |
- clincal hepatitis A disease
- 1) subclinical hepatitis A
- 2) asymptomatic hepatitis A virus infection, with hepatitis A virus viremia
| Estimated Enrollment: | 1500 |
| Study Start Date: | September 2003 |
| Estimated Study Completion Date: | May 2005 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria: Exposure to an index case of hepatitis A within 14 days of onset of illness; at least 2 years and no more than 40 years of age at time of study entry; susceptible to hepatitis A; give informed consent or have informed consent given by a responsible parent/guardian -
Exclusion Criteria: history of hepatitis A; prior receipt of hepatitis A vaccine; receipt of immune globulin within 180 days before study entry; evidence of liver disease; receipt of any live virus vaccine within 21 days prior to study entry; moderate or severe intercurrent illness or axillary temperature of 37.5 degrees or higher at time of study entry; various other medical conditions;
-
Contacts and Locations| Kazakhstan | |
| Sanitary EpidemiologyAuthority | |
| Almaty, Kazakhstan | |
| Principal Investigator: | Beth P Bell, MD, MPH | Centers for Disease Control and Prevention |
More Information
No publications provided by Centers for Disease Control and Prevention
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00139139 History of Changes |
| Other Study ID Numbers: | CDC-NCID-2643, ASPHS196421/21 |
| Study First Received: | August 29, 2005 |
| Last Updated: | August 29, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Centers for Disease Control and Prevention:
|
hepatitis A hepatitis A vaccine immune globulin |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections |
Picornaviridae Infections RNA Virus Infections Antibodies Immunoglobulins Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013