Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025
|Study Design:||Observational Model: Case-Control
Time Perspective: Prospective
|Official Title:||Population Genetics and Immune Response to Hepatitis B Vaccination in Adolescents: A Substudy of ATN 024 and ATN 025|
- To confirm the correlation of HLA-DRB1 and HLA-DQB1 alleles and haplotypes with HBV antibody concentrations and antibody decay kinetics in vaccinated adolescents. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Specimen obtained at or after the first post-vaccination serology visit. ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||October 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
This laboratory-based substudy of ATN 024 and 025 will evaluate the genetic contribution to highly individualized immune responses to hepatitis B vaccine in individuals and confirm the correlation of specific human leukocyte antigen (HLA) alleles and haplotypes with Hepatitis B Virus (HVB) antibody concentrations and antibody decay kinetics in vaccinated adolescents. Approximately 5 ml of whole blood will be collected from study participants at the time of the week 28 visit or at any subsequent study visit or clinic visit following successful completion of the week 28 visit. Peripheral blood mononuclear cells will be obtained and QIA amp Blood kit will be used to extract high-quality genomic DNA for polymerase chain reaction-based genotyping by the PEII laboratory.
The study is expected to be available for the duration of the parent studies which is approximately 2 years. This study requires one visit that may be arranged to coincide with a study or routine clinic visit. There are no follow up visits.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142740
|United States, California|
|Children's Hospital 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 Hospital National Medical Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|University of Southern Florida College of Medicine|
|Tampa, Florida, United States, 33606|
|Study Chair:||Jianming Tang, Ph.D||University of Alabama at Birmingham|