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.
Sponsor:
Collaborators:
University of Michigan
Ministry of Health, Kazakhstan
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00139139
First received: August 29, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  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

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

  Eligibility

Ages Eligible for Study:   2 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00139139

Locations
Kazakhstan
Sanitary EpidemiologyAuthority
Almaty, Kazakhstan
Sponsors and Collaborators
University of Michigan
Ministry of Health, Kazakhstan
Investigators
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
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
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 April 17, 2014