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
  Purpose

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.

Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Human Immune Responses Toward HIV-1 Envelope Antigens

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples Without DNA

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.


Enrollment: 8
Study Start Date: March 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344941

Locations
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Patricia Flynn, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01344941     History of Changes
Other Study ID Numbers: XPD09-022 HIVBLD
Study First Received: April 27, 2011
Last Updated: November 27, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
Vaccine response
Human Lymphocytes

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on April 15, 2014