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.

First Received on August 29, 2005. No Changes Posted

Sponsor:	Centers for Disease Control and Prevention
Collaborators:	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:	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:

MedlinePlus related topics: Hepatitis Hepatitis A

Drug Information available for: Immunoglobulins Hepatitis A Vaccines Globulin, Immune

U.S. FDA Resources

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;

Contacts and Locations

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

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):

Victor JC, Monto AS, Surdina TY, Suleimenova SZ, Vaughan G, Nainan OV, Favorov MO, Margolis HS, Bell BP. Hepatitis A vaccine versus immune globulin for postexposure prophylaxis. N Engl J Med. 2007 Oct 25;357(17):1685-94. Epub 2007 Oct 18.

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 February 09, 2012