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

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ClinicalTrials.gov Identifier: NCT00142740
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : February 28, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
HIV Infection Hepatitis B

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 Design

Study Type : Observational
Actual Enrollment : 337 participants
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
Study Start Date : October 2005
Primary Completion Date : June 2008
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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
Approximately 5 ml whole blood or 5 x 106 peripheral blood mononuclear cells.

Eligibility Criteria

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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00142740


Locations
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
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Study Chair: Jianming Tang, Ph.D University of Alabama at Birmingham
More Information

Additional Information:
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00142740     History of Changes
Other Study ID Numbers: ATN 052
First Posted: September 2, 2005    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2016

Keywords provided by University of North Carolina, Chapel Hill:
Hepatitis B vaccines
HIV-infected adolescents
Hepatitis B infection (negative)
HIV vaccine trial

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
HIV Infections
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Lentivirus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs