Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142740
• Other study ID #: ATN 052
• Status: Completed
• Phase: N/A
• First received: August 31, 2005
• Last updated: February 27, 2017
• Start date: October 2005
• Est. completion date: June 2008

Study information

• Verified date: February 2016
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• HIV Infection
• HIV Infections

Locations

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

Sponsors (4)

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)

Country where clinical trial is conducted

United States, 

Outcome

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.

External Links

•   Adolescent Trials Network for HIV/AIDS Intervention