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
1 other identifier
interventional
95
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 hiv-infections
Started Aug 2005
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFebruary 28, 2017
February 1, 2016
2.3 years
August 31, 2005
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
To measure interferon-γ (IFN-γ), interleukin -4 (IL-4), and interleukin-10 (IL-10) production in serologic responders and non-responders.
Before and one month after receipt of primary series of immunization.
To measure concentration of hepatitis B antibodies in serologic responders and non-responders.
1, 2, and 4 weeks after supplemental vaccine dose.
To measure concentration of antibody-secreting cells in serologic responders and non-responders.
Before and one month after receipt of primary series of immunization.
Secondary Outcomes (2)
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.
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.
Prior to immunization, 1 month after completion of primary immunization and at study exit.
Study Arms (5)
A1: ATN 024 Energix-B Standard Adult Dose
ACTIVE COMPARATORA2: ATN 024 Engerix-B Increased Adult Dose
EXPERIMENTALA3: ATN 024 Twinrix Standard Adult Dose
ACTIVE COMPARATORB1: ATN 025 Recombivax
EXPERIMENTALB2: ATN 025 Twinrix
EXPERIMENTALInterventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
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 D.C., District of Columbia, 20010, United States
Tulane Med Center
New Orleans, Louisiana, 70112, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Stephen Obaro, MBBS, PhD
ATN
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
August 1, 2005
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
February 28, 2017
Record last verified: 2016-02