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The primary objectives of this study is to
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | The first group will comprise individuals who have received a St. Jude HIV-1 vaccine and who have exhibited sustained immune responses | ||
| 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. | ||
| 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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| 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 |
| 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. |
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Inclusion Criteria:
Group 1 (Vaccinees) only Inclusion Criteria:
Group 2 (HIV positive) only Inclusion Criteria:
Group 3 (HIV negative) only Inclusion Criteria:
Exclusion Criteria:
Group 2 (HIV positive) only Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Flynn, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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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.
| 5 years |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |