Safety of and Immune Response to a DNA HIV Vaccine Followed By an Adenoviral Vector HIV Vaccine in Healthy Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00125970
First received: June 30, 2005
Last updated: November 7, 2012
Last verified: November 2012

June 30, 2005
November 7, 2012
September 2005
February 2008   (final data collection date for primary outcome measure)
  • Local and systemic adverse reactions [ Time Frame: Measured after each injection and for 12 months after the first injection ] [ Designated as safety issue: Yes ]
  • Unfractionated IFN-γ ELISpot responses to HIV-1 peptide pools as performed by the VRC laboratory [ Time Frame: Measured at Day 196 ] [ Designated as safety issue: No ]
  • Unfractionated IFN-γ ELISpot responses to HIV-1 peptide pools as performed by the FHCRC laboratory [ Time Frame: Measured at Day 210 ] [ Designated as safety issue: No ]
  • CD4 and CD8 T cell responses to HIV-1 peptide pools as measured by flow cytometry-based intracellular cytokine staining (ICS) assay as performed by the VRC laboratory [ Time Frame: Measured at Day 196 ] [ Designated as safety issue: No ]
  • CD4 and CD8 T cell responses to HIV-1 peptide pools as measured by flow cytometry-based ICS assay as performed by the FHCRC laboratory [ Time Frame: Measured at Day 210 ] [ Designated as safety issue: No ]
  • immunogenicity
  • social impacts (negative experiences or problems reported by the participants)
  • Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse and serious experiences)
Complete list of historical versions of study NCT00125970 on ClinicalTrials.gov Archive Site
  • Humoral immune response to HIV-1 as measured by neutralizing antibody and binding assays [ Time Frame: Measured through Month 36 ] [ Designated as safety issue: No ]
  • Unfractionated IFN-γ ELISpot responses to HIV-1 as performed by the FHCRC or the VRC laboratories [ Time Frame: Measured at Days 70, 210, and 364 ] [ Designated as safety issue: No ]
  • CD4 and CD8 T cell responses to HIV-1 as measured by flow cytometry-based ICS assay as performed by the FHCRC or the VRC laboratories [ Time Frame: Measured at Days 70, 210, and 364 ] [ Designated as safety issue: No ]
  • Vaccine-induced HIV-specific T cell responses to individual peptide pools as measured by IFN-γ ELISpot and ICS as performed by the FHCRC or the VRC laboratories [ Time Frame: Measured through Month 36 ] [ Designated as safety issue: No ]
  • Cross-clade cellular immune responses to HIV-1 Gag-Pol-Nef peptides from clades A and C as assessed by IFN-γ ELISpot and ICS assays as performed by the FHCRC or the VRC laboratories [ Time Frame: Measured through Month 36 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Safety of and Immune Response to a DNA HIV Vaccine Followed By an Adenoviral Vector HIV Vaccine in Healthy Adults
A Phase II Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiclade HIV-1 DNA Plasmid Vaccine, VRC-HIVDNA016-00-VP, Followed By a Multiclade Recombinant Adenoviral Vector HIV-1 Vaccine Boost, VRC-HIVADV014-00-VP, in HIV-1 Uninfected Adult Participants

The purpose of the study is to determine the safety of and immune response to a DNA HIV vaccine followed by an adenoviral vector HIV vaccine in HIV uninfected adults.

The worldwide HIV/AIDS epidemic may only be controlled through development of a safe and effective vaccine that will prevent HIV infection. DNA vaccines are inexpensive to construct, readily produced in large quantities, and stable for long periods of time. This study will evaluate the safety and immunogenicity of an experimental multiclade HIV vaccine, VRC-HIVDNA016-00-VP, followed by a similarly structured adenovirus-vectored vaccine boost, VRC-HIVADV014-00-VP, in HIV uninfected adults. The DNA plasmids in both the vaccines code for proteins from HIV subtypes A, B, and C, which together represent 90% of new HIV infections in the world. Participants in this study will be recruited in North America, South America, and Africa.

Each volunteer will participate in the study for 36 months. Participants will be randomly assigned to one of two groups. Group 1 participants will receive the DNA HIV vaccine at study entry and at Months 1 and 2. At Month 6, Group 1 participants will receive an injection of the adenoviral vector HIV vaccine. Group 2 participants will receive placebo at study entry and Months 1, 2, and 6. There will be 17 study visits, which will occur at study entry and every 2 weeks thereafter until Day 70; at Month 6 and every 2 weeks thereafter until Day 210; and Months 9.5, 12, 18, 24, 30, and 36. A physical exam, adverse events reporting, HIV and pregnancy prevention counseling, and medication history will occur at each visit. Blood and urine collection will occur at selected visits.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
HIV Infections
  • Biological: VRC-HIVDNA016-00-VP
    4 mg administered in deltoid
    Other Name: Multiclade HIV-1 DNA Plasmid Vaccine
  • Biological: VRC-HIVADV014-00-VP
    1 x 10^10 PU administered in deltoid
    Other Name: rAD
  • Biological: VRC-HIVDNA016-00-VP placebo
    1 mL administered at study entry and Months 1 and 2
    Other Names:
    • DNA HIV placebo vaccine
    • Phosphate buffered saline
  • Biological: VRC-HIVADV014-00-VP placebo
    1 mL administered at Month 6
    Other Names:
    • rAD placebo
    • VRC-DILUENT013-DIL-VP
  • Experimental: 1
    DNA HIV vaccine administered at study entry and at Months 1 and 2 and adenoviral vector HIV vaccine administered at Month 6
    Interventions:
    • Biological: VRC-HIVDNA016-00-VP
    • Biological: VRC-HIVADV014-00-VP
  • Placebo Comparator: 2
    DNA HIV vaccine placebo administered at study entry and at Months 1 and 2 and adenoviral vector HIV vaccine placebo administered at Month 6
    Interventions:
    • Biological: VRC-HIVDNA016-00-VP placebo
    • Biological: VRC-HIVADV014-00-VP placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
480
January 2010
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HIV uninfected
  • Has access to a participating HIV Vaccine Trials Unit (HVTU) and willing to be followed for the duration of the study
  • Willing to receive HIV test results
  • Good general health
  • Willing to use acceptable forms of contraception
  • Completed at least 12 years of schooling (South African participants only)

Exclusion Criteria:

  • HIV vaccines in prior HIV vaccine trial
  • Immunosuppressive medications within 168 days prior to first study vaccine administration
  • Blood products within 120 days prior to first study vaccine administration
  • Immunoglobulin within 60 days prior to first study vaccine administration
  • Live attenuated vaccines within 30 days prior to first study vaccine administration
  • Investigational research agents within 30 days prior to first study vaccine administration
  • Subunit or killed vaccines within 14 days prior to first study vaccine administration
  • Current tuberculosis prophylaxis or therapy
  • Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health
  • Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
  • Any job-related responsibility that would interfere with the study
  • Serious adverse reaction to vaccines. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Active syphilis infection
  • Unstable asthma
  • Diabetes mellitus type 1 or 2
  • Thyroid disease requiring treatment
  • Serious angioedema within the past 3 years
  • Uncontrolled hypertension
  • Bleeding disorder
  • Cancer. If a participant has had surgery to remove the cancer and, in the opinion of the investigator, the cancer is not likely to recur during the study period, the participant is not excluded.
  • Seizure disorder
  • Asplenia
  • Mental illness that would interfere with compliance with the protocol
  • Other conditions that, in the judgment of the investigator, would interfere with the study
  • Pregnant or breastfeeding
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Brazil,   Haiti,   Jamaica,   South Africa
 
NCT00125970
HVTN 204, 10061
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Michael Keefer, MD University of Rochester
Study Chair: Gavin Churchyard, MBBCh, FCP, MMed, PhD Aurum Health Research Limited
National Institute of Allergy and Infectious Diseases (NIAID)
November 2012

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