NCT01344941|Completed
Human Immune Responses Toward HIV-1 Envelope Antigens
HIVBLD
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HIVBLD
Sponsor study identifier
observational
8
1 country
1
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)The primary objectives of this study is to
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
April 27, 2011
Actual (reported)April 29, 2011
Actual (reported)November 2015
Actual (reported)November 2015
Actual (reported)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
Mechanism of HIV-1 envelope processing B cell and T cell activities
5 years
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.
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.
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
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.
Patricia Flynn, MD
St. Jude Children's Research Hospital
8 participants (actual enrollment reported by the registry).
First Submitted
April 27, 2011
First Posted
April 29, 2011
Study Start
March 2010
Date type not reportedThis date has not been verified as actual or estimated.
Examining the Role of Genetics in Determining the Immune Response to an HIV Vaccine in HIV-Uninfected Adult Twins
Contact the study team to confirm eligibility.
Primary Completion
November 2015
Actual (reported)Study Completion
November 2015
Actual (reported)Last Updated
November 5, 2015
Record last verified: 2015-11
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Source: ClinicalTrials.gov.
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