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Immunologic Memory (Supp. of ATN 024)
This study has been completed.
Sponsor:
University of North Carolina, Chapel Hill
Collaborators:
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00142753
First received: August 31, 2005
Last updated: February 27, 2017
Last verified: February 2016
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Purpose
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 |
|---|---|---|
| HIV Infections | Biological: Engerix B Biological: Twinrix for ATN 024 Biological: Recombivax Biological: Twinrix for ATN 025 | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of North Carolina, Chapel Hill:
Primary Outcome Measures:
- 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. ]
- To measure concentration of hepatitis B antibodies in serologic responders and non-responders. [ Time Frame: 1, 2, and 4 weeks after supplemental vaccine dose. ]
- 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. ]
Secondary Outcome Measures:
- 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. ]
- 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. ]
| Enrollment: | 95 |
| Study Start Date: | August 2005 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A1: ATN 024 Energix-B Standard Adult Dose |
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.
|
| Experimental: A2: ATN 024 Engerix-B Increased Adult Dose |
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.
|
| Active Comparator: A3: ATN 024 Twinrix Standard Adult Dose |
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.
|
| Experimental: B1: ATN 025 Recombivax |
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.
|
| Experimental: B2: ATN 025 Twinrix |
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.
|
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| Ages Eligible for Study: | 12 Years to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00142753
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142753
Locations
| United States, California | |
| Childrens Hosp of Los Angeles | |
| Los Angeles, California, United States, 90027 | |
| University of California at San Francisco | |
| San Franciso, California, United States, 94118 | |
| United States, District of Columbia | |
| Children's Hosp Natinal Med Center | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Louisiana | |
| Tulane Med Center | |
| New Orleans, Louisiana, United States, 70112 | |
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
| Study Chair: | Stephen Obaro, MBBS, PhD | ATN |
More Information
Additional Information:
| Responsible Party: | University of North Carolina, Chapel Hill |
| ClinicalTrials.gov Identifier: | NCT00142753 History of Changes |
| Other Study ID Numbers: |
ATN 048 |
| Study First Received: | August 31, 2005 |
| Last Updated: | February 27, 2017 |
Keywords provided by University of North Carolina, Chapel Hill:
|
Hepatitis B vaccines HIV-infected adolescents Hepatitis B infection |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |
ClinicalTrials.gov processed this record on June 23, 2017