This is an exploratory, laboratory-based evaluation of cellular immune response to immunization with hepatitis B surface antigen in HIV-infected and HIV-uninfected adolescents. This is a substudy of ATN 024 and ATN 025. This substudy will compare cellular immune response in responders and nonresponders to immunization and also evaluate the relationship of these factors to the persistence of known correlates of serologic protection for the hepatitis B virus.

Condition	Intervention	Phase
Healthy subjects HIV Infection	Vaccine: Engerix B  Vaccine: Twinrix  Vaccine: Recombivax	Phase IV

Further Study Details: 

Primary Outcomes: concentrations of IFN-γ, IL-4, IL-10
Secondary Outcomes: hepatitis B antibody concentrations (IU/mL)
Expected Total Enrollment:  150

This substudy will enroll volunteers from participants of ATN 024 and ATN 025. Participants in ATN 024 are HIV-infected youths aged 12-24 years while participants in ATN 025 are HIV-uninfected youths aged 12-17 years. These youths must also be negative for HBV core antibody, HBV surface antigen, and HBV surface antibody to be eligible.

Blood will be drawn from study participants prior to immunization, 1 month after completion of primary immunization and at study exit (week 72 for ATN 024 and week 76 for ATN 025) for cytokine assays and enumeration of antibody-secreting cells. In addition, the antibody to HBV surface antigen will be determined 2 and 4 weeks after supplemental immunization in nonresponders to the primary series and at study exit.

This laboratory substudy is designed to evaluate some aspects of cellular immune response to hepatitis B vaccination that are directly related to the generation and durability of antibody response to HBV surface antigen in HIV-infected and HIV-uninfected adolescents. Cytokine production by peripheral mononuclear cells will be determined following in-vitro stimulation, and antibody-secreting cells will be enumerated.

Ages Eligible for Study:  12 Years   -   25 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Subjects that are eligible for participation in ATN 024 and ATN 025 are eligible for ATN 048. Subjects consented for ATN 024 or ATN 025 should be consented for ATN 048 at the same time. A written informed assent/consent must be obtained from the subject along with written parental/legal guardian permission as determined by the local IRB before any study-related procedures are performed.

Please refer to this study by ClinicalTrials.gov identifier  NCT00142753

Sushma Ahmad, MPH      (301) 294-3842    sushmaahmad@westat.com

California
      Childrens Hosp of Los Angeles, Los Angeles,  California,  90027,  United States; Recruiting
District of Columbia
      Children''''s Hosp Natinal Med Center, Washington,  District of Columbia,  20010,  United States; Recruiting
Louisiana
      Tulane Med Center, New Orleans,  Louisiana,  70112,  United States; Recruiting

Study chairs or principal investigators

Stephen Obaro, MBBS, PhD,  Study Chair,  ATN   

Study ID Numbers:  ATN 048
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00142753
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-06