Human Immune Responses Toward HIV-1 Envelope Antigens (HIVBLD)
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Purpose
The primary objectives of this study is to
- Define the envelope-specific B-cell and T-cell responses in humans who have received a St. Jude HIV-1 vaccine.
- Describe mechanisms of HIV-1 envelope processing and consequent B-cell and T-cell activities.
| Condition |
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HIV Infection |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Human Immune Responses Toward HIV-1 Envelope Antigens |
- Specific B cell and T cell responses in humans who received St Jude HIV-1 Vaccine [ Time Frame: 5 years ] [ Designated as safety issue: No ]The outcome measures will be assessed in such a way that individuals will be sampled longitudinally (every 6months) until the immune response is no longer detectable by HIV ELISA or until the 5 year study period is complete, whichever comes first. A volume of 120 ml will be collected at each visit for immune response assays (both B-cell and T-cell) and 2 ml of blood will be collected for the HIV ELISA.
- Mechanism of HIV-1 envelope processing B cell and T cell activities [ Time Frame: 5 years ] [ Designated as safety issue: No ]The outcome measures will be assessed by new developments in the field that may ultimately yield improved methods for the testing of antigen processing and B-cell and T-cell functions, in which case new assays will be adopted for use in this study. Lymphocyte samples will also support HLA testing. Samples will be used for continued B-cell and T-cell studies supportive of the 2 study objectives. The volume of blood drawn will be closely monitored and will remain below the defined criteria for minimal risk research.
Biospecimen Retention: Samples Without DNA
Maximally, there will be up to 30 draws per study participant with no more than 120 ml of blood collected at any one time and no more than 2.5 L collected for the entire study. Samples will be used for continued B-cell and T-cell studies supportive of the 2 study objectives. The volume of blood drawn will be closely monitored and will remain below the defined criteria for minimal risk research.
| Estimated Enrollment: | 63 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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Group 1
The first group will comprise individuals who have received a St. Jude HIV-1 vaccine and who have exhibited sustained immune responses
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Group 2
Groups 2 will be HIV-1-infected. The first visit of individuals in groups 2 will involve the collection of 120 ml of blood as well as a minimal blood volume required for the specified screening laboratory evaluation for each group.
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Group 3
Groups 3 will be HIV-1-uninfected. The first visit of individuals in groups 3 will involve the collection of 120 ml of blood as well as a minimal blood volume required for the specified screening laboratory evaluation for each group.
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Detailed Description:
The goal of this protocol is to understand how human lymphocytes respond to HIV-1 antigens in the context of vaccination or infection. This protocol will support understanding of the immune response by providing a source of lymphocytes and serum from selected individuals to study in laboratory based investigations. Blood samples from individuals who have received an HIV-1 vaccine, individuals who are HIV-1-infected, and individuals who are HIV-1-uninfected are requested to: (1) test previously vaccinated volunteers for HIV-1 envelope-specific B-cell and T-cell immune activities, and (2) increase understanding of how the human immune system processes and responds to HIV-1 envelope proteins.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Group 1: Previous St. Jude HIV-1 vaccine study participants will be contacted by phone by study investigators or their designees to assess interest in participation in this protocol.
Group 2: Participants will be recruited from those receiving care for their HIV infection in the Translational Trials Unit at St. Jude.
Group 3: Participants will be recruited from the Memphis community. Recruitment will occur on College and University campuses, from community groups, through word-of-mouth, and through the use of a study brochure.
Inclusion Criteria:
- Participant is greater than or equal to 18 years of age.
- Participant is in good general health.
- Participant weighs ≥ 110 pounds.
- Participant has hemoglobin > 12 gm/dL within last 12 weeks.
Group 1 (Vaccinees) only Inclusion Criteria:
- Participant has previously received one of the St. Jude HIV-1 vaccines via enrollment in prior St. Jude HIV vaccine studies.
Group 2 (HIV positive) only Inclusion Criteria:
- Participant is HIV-1 positive by medical record review.
Group 3 (HIV negative) only Inclusion Criteria:
- Participant is HIV-1 negative as determined by HIV ELISA.
Exclusion Criteria:
- Participant is unable or unwilling to give written informed consent.
- Participant is pregnant female.
Group 2 (HIV positive) only Exclusion Criteria:
- Participant is enrolled in other clinical trials that include any blood sampling such that the cumulative blood draws would exceed that established as constituting minimal risk (e.g., more than 550 ml in an 8 week period with collection more frequently than 2 times per week)
Contacts and Locations| Contact: Patricia Flynn, MD | 866-278-5833 | info@stjude.org |
| United States, Tennessee | |
| St. Jude Children's Research Hospital | Recruiting |
| Memphis, Tennessee, United States, 38105 | |
| Contact: Patricia Flynn, MD 866-278-5833 info@stjude.org | |
| Principal Investigator: Patricia Flynn, MD | |
| Principal Investigator: | Patricia Flynn, MD | St. Jude Children's Research Hospital |
More Information
Additional Information:
No publications provided
| Responsible Party: | St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT01344941 History of Changes |
| Other Study ID Numbers: | XPD09-022 HIVBLD |
| Study First Received: | April 27, 2011 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by St. Jude Children's Research Hospital:
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Vaccine response Human Lymphocytes |
Additional relevant MeSH terms:
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HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on June 18, 2013