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

February 27, 2017 updated by: University of North Carolina, Chapel Hill

Population Genetics and Immune Response to Hepatitis B Vaccination in Adolescents: A Substudy of ATN 024 and ATN 025

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

337

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital of Los Angeles
      • San Franciso, California, United States, 94118
        • University of California at San Francisco
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's Hospital National Medical Center
    • Florida
      • Tampa, Florida, United States, 33606
        • University of Southern Florida College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Specimen obtained at or after the first post- vaccination serology visit.

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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.
Specimen obtained at or after the first post-vaccination serology visit.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute on Drug Abuse (NIDA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Jianming Tang, Ph.D, University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATN 052

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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