Hepatitis B Vaccine Genetics: A Substudy of ATN 024 and ATN 025
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| ClinicalTrials.gov Identifier: NCT00142740 |
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Recruitment Status
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Completed
First Posted
: September 2, 2005
Last Update Posted
: February 28, 2017
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| Condition or disease |
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| HIV Infection Hepatitis B |
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 |
| 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 |
| Actual Primary Completion Date : | June 2008 |
| Actual Study Completion Date : | June 2008 |
| Group/Cohort |
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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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- 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. ]
- 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. ]
- 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. ]
- 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
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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 |
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.
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
| 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 |
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:
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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 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 |