Human Immune Responses Toward HIV-1 Envelope Antigens (HIVBLD)

St. Jude Children's Research Hospital

Status: Completed

Conditions: HIV Infection

Study type: Observational

Funder types: Other

Identifiers

NCT01344941

XPD09-022 HIVBLD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

8 participants in 3 patient groups

Group 1

Description:

The first group will comprise individuals who have received a St. Jude HIV-1 vaccine and who have exhibited sustained immune responses

Group 2

Description:

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.

Group 3

Description:

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.