Status:
COMPLETED
Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
Conditions:
HIV Infection
Hepatitis B
Eligibility:
All Genders
12-25 years
Brief Summary
This laboratory-based substudy of an effectiveness trial of two Hepatitis B vaccines in HIV-negative youths is being done to evaluate the genetic contribution to the individualized immune response.
Detailed Description
This laboratory-based substudy of ATN 024 and 025 will evaluate the genetic contribution to highly individualized immune responses to hepatitis B vaccine in individuals and confirm the correlation of ...
Eligibility Criteria
Inclusion
- Subjects currently enrolled in ATN 024 or ATN 025 are eligible for enrollment in ATN 052 beginning at or following completion of the week 28 visit.
- Subjects previously enrolled in ATN 024 or ATN 025 are eligible for enrollment in ATN 052, unless the subject was prematurely discontinued from the study prior to the first post-vaccination serology assessment which is performed at week 28.
- Current pregnancy is permitted.
- A signed informed assent/consent must be obtained from the subject.
- Written parental or guardian permission must be obtained where required by the institutional review board/ethics committee (IRB/EC).
Exclusion
- Inadequate post-vaccination serology evaluation in ATN 024 or ATN 025.
- Unable to obtain informed consent and/or parental/legal guardian permission where required by the local IRB/EC.
Key Trial Info
Start Date :
October 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT00142740
Start Date
October 1 2005
End Date
June 1 2008
Last Update
February 28 2017
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of California at San Francisco
San Franciso, California, United States, 94118
3
Children's Hospital National Medical Center
Washington D.C., District of Columbia, United States, 20010
4
University of Southern Florida College of Medicine
Tampa, Florida, United States, 33606