NCT00142740|CompletedDMC
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
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Population Genetics and Immune Response to Hepatitis B Vaccination in Adolescents: A Substudy of ATN 024 and ATN 025
Sponsor study identifier
observational
337
1 country
4
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 31, 2005
Actual (reported)September 2, 2005
Actual (reported)October 2005
Date type not reportedThis date has not been verified as actual or estimated.
June 2008
Actual (reported)June 2008
Actual (reported)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.
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.
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.
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.
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.
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
Approximately 5 ml whole blood or 5 x 106 peripheral blood mononuclear cells.
Jianming Tang, Ph.D
University of Alabama at Birmingham
337 participants (actual enrollment reported by the registry).
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
October 2005
Date type not reportedThis date has not been verified as actual or estimated.
A Comparison of Adefovir and Tenofovir for the Treatment of Lamivudine-Resistant Hepatitis B Virus in People With HIV
Entecavir Intensification for Persistent HBV Viremia in HIV-HBV Infection
Contact the study team to confirm eligibility.
Primary Completion
June 2008
Actual (reported)Study Completion
June 2008
Actual (reported)Last Updated
February 28, 2017
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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