Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025
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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.
| 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 |
- 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 ]
- 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 |
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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.
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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.
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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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00142740
| 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 | |
| Study Chair: | Jianming Tang, Ph.D | University of Alabama at Birmingham |
More Information
Additional Information:
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00142740 History of Changes |
| Other Study ID Numbers: | ATN 052 |
| Study First Received: | August 31, 2005 |
| Last Updated: | February 12, 2015 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
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Hepatitis B vaccines HIV-infected adolescents Hepatitis B infection (negative) HIV vaccine trial |
Additional relevant MeSH terms:
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Hepatitis Hepatitis B DNA Virus Infections Digestive System Diseases |
Hepadnaviridae Infections Hepatitis, Viral, Human Liver Diseases Virus Diseases |
ClinicalTrials.gov processed this record on March 03, 2015