Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025
Population Genetics and Immune Response to Hepatitis B Vaccination in Adolescents: A Substudy of ATN 024 and ATN 025
1 other identifier
observational
337
1 country
4
Brief Summary
This laboratory-based substudy of an effectiveness trial of two Hepatitis B vaccines in HIV-negative youths is being done to evaluate the genetic contribution to the individualized immune response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2005
Typical duration for all trials
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
First Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedStudy Start
First participant enrolled
October 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2008
CompletedFebruary 28, 2017
February 1, 2016
2.7 years
August 31, 2005
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To confirm the correlation of HLA-DRB1 and HLA-DQB1 alleles and haplotypes with HBV antibody concentrations and antibody decay kinetics in vaccinated adolescents.
Specimen obtained at or after the first post- vaccination serology visit.
Secondary Outcomes (3)
To determine if other genetic variations (768 single nucleotide polymorphisms (SNP) in about 50 genes) in the immune response pathways can confer additional effects on immune responses to hepatitis B vaccination.
Specimen obtained at or after the first post-vaccination serology visit.
To compare the strength of genetic and non-genetic associations with specific antibody responses following HBV vaccination.
Specimen obtained at or after the first post-vaccination serology visit.
To explore similarities and differences in genetic associations between HIV-positive and HIV-negative cohorts.
Specimen obtained at or after the first post-vaccination serology visit.
Study Arms (2)
1 - HIV Positive
Participant in parent study ATN 024, aged 12-24 years, testing HIV positive. All eligible youths must be negative for HBV core antibody, HBV surface antigen, and HBV surface antibody at the time of enrollment in to ATN 024.
2 - HIV Negative
Participant in parent study ATN 025, aged 12-24 years and testing negative for HIV infection. All eligible youths must be negative for HBV core antibody, HBV surface antigen, and HBV surface antibody at the time of enrollment in to ATN 025.
Eligibility Criteria
All subjects who are currently enrolled or have completed ATN 024 or ATN 025 are eligible for participation on this substudy with the exception of those who were discontinued from ATN 024 or ATN 025 prior to completing the first post-vaccination serology (week 28) visit. Participants in ATN 024 are HIV-infected youths aged 12 to 24 years, while participants in ATN 025 are HIV-uninfected youths aged 12 to17 years, thus participants in this substudy will be HIV-infected and uninfected youth aged 12 to 24 years. All eligible youths must be negative for HBV core antibody, HBV surface antigen, and HBV surface antibody at the time of enrollment in to the parent protocols.
You may qualify if:
- Subjects currently enrolled in ATN 024 or ATN 025 are eligible for enrollment in ATN 052 beginning at or following completion of the week 28 visit.
- Subjects previously enrolled in ATN 024 or ATN 025 are eligible for enrollment in ATN 052, unless the subject was prematurely discontinued from the study prior to the first post-vaccination serology assessment which is performed at week 28.
- Current pregnancy is permitted.
- A signed informed assent/consent must be obtained from the subject.
- Written parental or guardian permission must be obtained where required by the institutional review board/ethics committee (IRB/EC).
You may not qualify if:
- Inadequate post-vaccination serology evaluation in ATN 024 or ATN 025.
- Unable to obtain informed consent and/or parental/legal guardian permission where required by the local IRB/EC.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Children's Hospital of Los Angeles
Los Angeles, California, 90027, United States
University of California at San Francisco
San Franciso, California, 94118, United States
Children's Hospital National Medical Center
Washington D.C., District of Columbia, 20010, United States
University of Southern Florida College of Medicine
Tampa, Florida, 33606, United States
Related Links
Biospecimen
Approximately 5 ml whole blood or 5 x 106 peripheral blood mononuclear cells.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jianming Tang, Ph.D
University of Alabama at Birmingham
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2008
Study Completion
June 1, 2008
Last Updated
February 28, 2017
Record last verified: 2016-02