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

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ClinicalTrials.gov Identifier: NCT00139139
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : August 31, 2005
Sponsor:
Collaborators:
University of Michigan
Ministry of Health, Kazakhstan
Information provided by:
Centers for Disease Control and Prevention

Brief Summary:
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 or disease Intervention/treatment Phase
Hepatitis A Biological: Hepatitis A vaccine Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Blinded Randomized Comparative Study of Hepatitis A Vaccine and Immune Globulin for Postexposure Prophylaxis for Hepatitis A Disease
Study Start Date : September 2003
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. clincal hepatitis A disease

Secondary Outcome Measures :
  1. 1) subclinical hepatitis A
  2. 2) asymptomatic hepatitis A virus infection, with hepatitis A virus viremia


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Ages Eligible for Study:   2 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
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;


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00139139


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

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
First Posted: August 31, 2005    Key Record Dates
Last Update Posted: August 31, 2005
Last Verified: August 2005

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
Vaccines
Immunoglobulins
Antibodies
gamma-Globulins
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs