Immunologic Memory (Supp. of ATN 024)
Information source: National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects; HIV Infections
Intervention: Engerix B (Biological); Twinrix for ATN 024 (Biological); Recombivax (Biological); Twinrix for ATN 025 (Biological)
Phase: Phase 4
Status: Completed
Sponsored by: National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Stephen Obaro, MBBS, PhD, Study Chair, Affiliation: ATN
Summary
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.
Clinical Details
Official title: Correlates of HBV-Specific B Cell Memory Following Vaccination in HIV-Infected Adolescents and HIV-Uninfected Adolescents: A Substudy of ATN 024 and ATN 025
Study design: Prevention, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: To measure interferon-γ (IFN-γ), interleukin -4 (IL-4), and interleukin-10 (IL-10) production in serologic responders and non-responders.To measure concentration of hepatitis B antibodies in serologic responders and non-responders. To measure concentration of antibody-secreting cells in serologic responders and non-responders.
Secondary outcome: Measure whether the profile of cytokine secretion or the number of antibody-secreting cells can be used as a predictor of anamnestic response to a supplemental vaccine dose following serologic nonresponse to a primary series of immunization.To compare the rate of loss of antibody-secreting cells after vaccination through the end of the study in each vaccine arm.
Detailed description:
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.
Eligibility
Minimum age: 12 Years.
Maximum age: 25 Years.
Gender(s): 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.
Locations and Contacts
Childrens Hosp of Los Angeles, Los Angeles, California 90027, United States
University of California at San Francisco, San Franciso, California 94118, United States
Children's Hosp Natinal Med Center, Washington, District of Columbia 20010, United States
Tulane Med Center, New Orleans, Louisiana 70112, United States
Additional Information
(Website for the Adolescent Trials Network for HIV/AIDS Interventions)
Starting date: August 2005
Ending date: November 2007
Last updated: February 29, 2008
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