Human Immune Responses Toward HIV-1 Envelope Antigens (HIVBLD)
|ClinicalTrials.gov Identifier: NCT01344941|
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : November 5, 2015
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 or disease|
|Study Type :||Observational|
|Actual Enrollment :||8 participants|
|Official Title:||Human Immune Responses Toward HIV-1 Envelope Antigens|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
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.
- Specific B cell and T cell responses in humans who received St Jude HIV-1 Vaccine [ Time Frame: 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.
- Mechanism of HIV-1 envelope processing B cell and T cell activities [ Time Frame: 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.
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|