HIV Infection
Conditions
Keywords
Vaccine response, Human Lymphocytes
Brief summary
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
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.
Interventions
None listed
Sponsors
St. Jude Children's Research Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specific B cell and T cell responses in humans who received St Jude HIV-1 Vaccine | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanism of HIV-1 envelope processing B cell and T cell activities | 5 years | 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. |
Countries
United States
Outcome results
None listed