Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025 - Full Text View

Purpose

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	Phase
HIV Infection Hepatitis B	Phase 4


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis A Hepatitis B

U.S. FDA Resources

Further study details as provided by Westat:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]
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. ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Approximately 5 ml whole blood or 5 x 106 peripheral blood mononuclear cells.


Enrollment:	337
Study Start Date:	October 2005
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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.

Eligibility


Ages Eligible for Study:	12 Years to 25 Years (Child, Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Westat

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:

Adolescent Trials Network for HIV/AIDS Intervention This link exits the ClinicalTrials.gov site


Responsible Party:	Westat
ClinicalTrials.gov Identifier:	NCT00142740 History of Changes
Other Study ID Numbers:	ATN 052
Study First Received:	August 31, 2005
Last Updated:	February 29, 2016
Health Authority:	United States: Federal Government

Keywords provided by Westat:


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

ClinicalTrials.gov processed this record on September 23, 2016