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A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A

This study has been completed.
University of Michigan
Ministry of Health, Kazakhstan
Information provided by:
Centers for Disease Control and Prevention Identifier:
First received: August 29, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
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

Resource links provided by NLM:

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • clincal hepatitis A disease

Secondary Outcome Measures:
  • 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


Ages Eligible for Study:   2 Years to 40 Years   (Child, Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00139139

Sanitary EpidemiologyAuthority
Almaty, Kazakhstan
Sponsors and Collaborators
Centers for Disease Control and Prevention
University of Michigan
Ministry of Health, Kazakhstan
Principal Investigator: Beth P Bell, MD, MPH Centers for Disease Control and Prevention
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): 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 A
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016