HIV Infection Clinical Trial
Official title:
Population Genetics and Immune Response to Hepatitis B Vaccination in Adolescents: A Substudy of ATN 024 and ATN 025
Verified date | February 2016 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 337 |
Est. completion date | June 2008 |
Est. primary completion date | June 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 25 Years |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Los Angeles | Los Angeles | California |
United States | University of California at San Francisco | San Franciso | California |
United States | University of Southern Florida College of Medicine | Tampa | Florida |
United States | Children's Hospital National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | National Institute of Mental Health (NIMH), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | ||
Secondary | 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. | ||
Secondary | 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. |
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