Human Immune Responses Toward HIV-1 Envelope Antigens (HIVBLD)
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|