Human Immune Responses Toward HIV-1 Envelope Antigens

Completed

• Conditions: HIV Infection

• Registration Number: NCT01344941
• Lead Sponsor: St. Jude Children's Research Hospital

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.

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-04-28
• Study First Posted: 2011-04-29
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-04
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 Exclusion Criteria:

• Participant is enrolled in other clinical trials that include any blood sampling such that the cumulative blood draws would exceed that established as constituting minimal risk (e.g., more than 550 ml in an 8 week period with collection more frequently than 2 times per week)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States