Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025

Completed

Conditions studied: HIV Infection, Hepatitis B

In brief

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.

Key facts

Study ID

NCT00142740

Run by

University of North Carolina, Chapel Hill

People needed

337

Starts

2005-10-01

Expected to finish

2008-06-01

Last updated by the study team

2017-02-28

Who can join

Age: 12 and older, up to 25. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• University of California at San Francisco — San Franciso, California, United States
• Children's Hospital National Medical Center — Washington D.C., District of Columbia, United States
• University of Southern Florida College of Medicine — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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