Human Immune Responses Toward HIV-1 Envelope Antigens

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.

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)