Clinical trial NCT01344941: Human Immune Responses Toward HIV-1 Envelope Antigens
Official title: Human Immune Responses Toward HIV-1 Envelope Antigens
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Keywords: Vaccine response
Human Lymphocytes
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Specific B cell and T cell responses in humans who received St Jude HIV-1 Vaccine
timeFrame: 5 years
Secondary outcomes:
measure: Mechanism of HIV-1 envelope processing B cell and T cell activities
timeFrame: 5 years
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Patricia Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References: