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| Sponsors and Collaborators: |
Centers for Disease Control and Prevention University of Michigan Ministry of Health, Kazakhstan |
|---|---|
| Information provided by: | Centers for Disease Control and Prevention |
| ClinicalTrials.gov Identifier: | NCT00139139 |
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: | Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Blinded Randomized Comparative Study of Hepatitis A Vaccine and Immune Globulin for Postexposure Prophylaxis for Hepatitis A Disease |
| 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;
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Contacts and Locations| Kazakhstan | |
| Sanitary EpidemiologyAuthority | |
| Almaty, Kazakhstan | |
| Principal Investigator: | Beth P Bell, MD, MPH | Centers for Disease Control and Prevention |
More Information
| Study ID Numbers: | CDC-NCID-2643, ASPHS196421/21 |
| Study First Received: | August 29, 2005 |
| Last Updated: | August 29, 2005 |
| ClinicalTrials.gov Identifier: | NCT00139139 |
| Health Authority: | United States: Federal Government |
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hepatitis A hepatitis A vaccine immune globulin |
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Virus Diseases Hepatitis Antibodies Liver Diseases Digestive System Diseases |
Picornaviridae Infections Hepatitis, Viral, Human Hepatitis A Enterovirus Infections Immunoglobulins |
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RNA Virus Infections Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
