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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT01344941
First received: April 27, 2011
Last updated: November 27, 2013
Last verified: November 2013

April 27, 2011
November 27, 2013
March 2010
December 2015   (final data collection date for primary outcome measure)
Specific B cell and T cell responses in humans who received St Jude HIV-1 Vaccine [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01344941 on ClinicalTrials.gov Archive Site
Mechanism of HIV-1 envelope processing B cell and T cell activities [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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.
Mechanism of HIV-1 envelope processing B cell and T cell activities [ Time Frame: 5 years ] [ Designated as safety issue: No ]
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.
Not Provided
Not Provided
 
Human Immune Responses Toward HIV-1 Envelope Antigens
Human Immune Responses Toward HIV-1 Envelope Antigens

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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.

Non-Probability Sample

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.

HIV Infection
Not Provided
  • Group 1
    The first group will comprise individuals who have received a St. Jude HIV-1 vaccine and who have exhibited sustained immune responses
  • Group 2
    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
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
8
December 2016
December 2015   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01344941
XPD09-022 HIVBLD
No
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
Not Provided
Principal Investigator: Patricia Flynn, MD St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP