Human Immune Responses Toward HIV-1 Envelope Antigens (HIVBLD)
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.
|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.
|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)|
The first group will comprise individuals who have received a St. Jude HIV-1 vaccine and who have exhibited sustained immune responses
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344941
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Patricia Flynn, MD||St. Jude Children's Research Hospital|