Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
95 participants
INTERVENTIONAL
2005-08-31
2007-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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A1: ATN 024 Energix-B Standard Adult Dose
Engerix B
Standard adult dose for A1; increased adult dose for A2. Doses at Entry, Weeks 4 and 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at Week 48.
A2: ATN 024 Engerix-B Increased Adult Dose
Engerix B
Standard adult dose for A1; increased adult dose for A2. Doses at Entry, Weeks 4 and 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at Week 48.
A3: ATN 024 Twinrix Standard Adult Dose
Twinrix for ATN 024
Standard adult dosage, taken at Entry, Weeks 4 and 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at week 48.
B1: ATN 025 Recombivax
Recombivax
Dosage at entry and week 24; non-responders ((\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive 3rd dose of Recombivax during weeks 48-72.
B2: ATN 025 Twinrix
Twinrix for ATN 025
Doses at Entry and Week 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive a dose of Recombivax during week 48-72.
Interventions
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Engerix B
Standard adult dose for A1; increased adult dose for A2. Doses at Entry, Weeks 4 and 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at Week 48.
Twinrix for ATN 024
Standard adult dosage, taken at Entry, Weeks 4 and 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive Engerix-B increased adult dose at week 48.
Recombivax
Dosage at entry and week 24; non-responders ((\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive 3rd dose of Recombivax during weeks 48-72.
Twinrix for ATN 025
Doses at Entry and Week 24. Non-responders (\<10 IU/mL of antibody at week 28/4 weeks after dose #3) will receive a dose of Recombivax during week 48-72.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
12 Years
25 Years
ALL
Yes
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
National Institute of Mental Health (NIMH)
NIH
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
University of North Carolina, Chapel Hill
OTHER
Responsible Party
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Principal Investigators
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Stephen Obaro, MBBS, PhD
Role: STUDY_CHAIR
ATN
Locations
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Childrens Hosp of Los Angeles
Los Angeles, California, United States
University of California at San Francisco
San Franciso, California, United States
Children's Hosp Natinal Med Center
Washington D.C., District of Columbia, United States
Tulane Med Center
New Orleans, Louisiana, United States
Countries
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Related Links
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(Website for the Adolescent Trials Network for HIV/AIDS Interventions)
Other Identifiers
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ATN 048
Identifier Type: -
Identifier Source: org_study_id
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