Human Immune Responses Toward HIV-1 Envelope Antigens

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Human Immune Responses Toward HIV-1 Envelope Antigens

Conditions
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HIV Infection

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>The first group will comprise individuals who have received a St. Jude HIV-1 vaccine and who have exhibited sustained immune responses | |
| Group 2<br>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. | |
| Group 3<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific B cell and T cell responses in humans who received St Jude HIV-1 Vaccine | 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. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanism of HIV-1 envelope processing B cell and T cell activities | 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. | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccine response, Human Lymphocytes