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.
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.
Study Type
OBSERVATIONAL
Enrollment
337
Children's Hospital of Los Angeles
Los Angeles, California, United States
University of California at San Francisco
San Franciso, California, United States
Children's Hospital National Medical Center
Washington D.C., District of Columbia, United States
University of Southern Florida College of Medicine
Tampa, Florida, United States
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.
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