Immunologic Memory (Supp. of ATN 024)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00142753
First received: August 31, 2005
Last updated: October 8, 2013
Last verified: August 2013

August 31, 2005
October 8, 2013
August 2005
November 2007   (final data collection date for primary outcome measure)
  • To measure interferon-γ (IFN-γ), interleukin -4 (IL-4), and interleukin-10 (IL-10) production in serologic responders and non-responders. [ Time Frame: Before and one month after receipt of primary series of immunization. ] [ Designated as safety issue: No ]
  • To measure concentration of hepatitis B antibodies in serologic responders and non-responders. [ Time Frame: 1, 2, and 4 weeks after supplemental vaccine dose. ] [ Designated as safety issue: No ]
  • To measure concentration of antibody-secreting cells in serologic responders and non-responders. [ Time Frame: Before and one month after receipt of primary series of immunization. ] [ Designated as safety issue: No ]
concentrations of IFN-γ, IL-4, IL-10
Complete list of historical versions of study NCT00142753 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: Prior to immunization, 1 month after primary immunization, at study exit (week 72 for ATN 024; week 76 for ATN 025); at 2 & 4 weeks after supplemental immunization in nonresponders, & at study exit for ATN 024 subjects. ] [ Designated as safety issue: No ]
  • To compare the rate of loss of antibody-secreting cells after vaccination through the end of the study in each vaccine arm. [ Time Frame: Prior to immunization, 1 month after completion of primary immunization and at study exit. ] [ Designated as safety issue: No ]
hepatitis B antibody concentrations (IU/mL)
Not Provided
Not Provided
 
Immunologic Memory (Supp. of ATN 024)
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

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
HIV Infections
  • Biological: 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.
    Other Name: There are no other names.
  • Biological: 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.
    Other Name: There are no other names.
  • Biological: 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.
    Other Name: There are no other names.
  • Biological: 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 Name: There are no other names.
  • Active Comparator: A1: ATN 024 Energix-B Standard Adult Dose
    Intervention: Biological: Engerix B
  • Experimental: A2: ATN 024 Engerix-B Increased Adult Dose
    Intervention: Biological: Engerix B
  • Active Comparator: A3: ATN 024 Twinrix Standard Adult Dose
    Intervention: Biological: Twinrix for ATN 024
  • Experimental: B1: ATN 025 Recombivax
    Intervention: Biological: Recombivax
  • Experimental: B2: ATN 025 Twinrix
    Intervention: Biological: Twinrix for ATN 025
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
95
November 2007
November 2007   (final data collection date for primary outcome measure)

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.
Both
12 Years to 25 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00142753
ATN 048
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)
  • National Institute of Mental Health (NIMH)
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study Chair: Stephen Obaro, MBBS, PhD ATN
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP