Safety of and Immune Response to a DNA Vaccine and a Recombinant HIV-1-MVA Vaccine, Separately and in Combination, in Healthy Adults

This study has been completed.
Sponsor:
Collaborators:
HIV Vaccine Trials Network
Pharmexa-Epimmune
Bavarian Nordic
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00428337
First received: January 29, 2007
Last updated: May 30, 2013
Last verified: May 2013

January 29, 2007
May 30, 2013
April 2007
Not Provided
Safety of vaccination, as measured by number of adverse events, local and systemic reactogenicity signs and symptoms, changes in electrocardiogram (ECG), cardiac troponin I levels, and differences in other safety laboratory measures [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
Safety of vaccination, as measured by number of adverse events, local and systemic reactogenicity signs and symptoms, changes in electrocardiogram (ECG), cardiac troponin I levels, and differences in other safety laboratory measures from baseline
Complete list of historical versions of study NCT00428337 on ClinicalTrials.gov Archive Site
  • HIV-specific intracellular cytokine staining (ICS) assay and/or interferon-gamma ELISA responses [ Time Frame: At 2 weeks following the third and fourth injection ] [ Designated as safety issue: No ]
  • Vaccinia-specific neutralizing binding assays performed on serum samples from participants receiving the MVA vaccine [ Time Frame: At 2 weeks following the final vaccination ] [ Designated as safety issue: No ]
  • Self reports on social impact of participation in study [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • HIV-specific intracellular cytokine staining (ICS) assay and/or interferon-gamma ELISA responses at 2 weeks following third and fourth vaccination
  • vaccinia-specific neutralizing binding assays performed on serum samples from participants receiving the MVA vaccine obtained two weeks following the final vaccination
  • self reports on social impact of participation in study
Not Provided
Not Provided
 
Safety of and Immune Response to a DNA Vaccine and a Recombinant HIV-1-MVA Vaccine, Separately and in Combination, in Healthy Adults
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of DNA Vaccine EP-1233 and Recombinant MVA-HIV Polytope Vaccine MVA-mBN32, Separately and in a Combined Prime-boost Regimen, When Given to Healthy, Vaccinia-naive, HIV-1-uninfected Adults

The purpose of this study is to determine the safety of and immune response to two experimental vaccines, designed for use in combination, for the prevention of HIV infection in healthy adults.

The worldwide HIV/AIDS epidemic may only be controlled through the development of a safe and effective vaccine that will prevent HIV infection. DNA-based vaccines alone promote a weak immune response but when used as priming immunogens, followed by a recombinant viral vaccine that is a very attenuated vaccinia (smallpox) vaccine presenting the same immunogens as a booster, immunization with such a combination regimen seems to induce much stronger responses. EP-1233 is a DNA-HIV-recombinant vaccine designed to interact with CD4 (helper-inducer) and CD8 (cytotoxic) T lymphocytes (T cells) to prime CD4 and CD8 cells to respond to HIV components. MVA-mBN32 is a HIV-recombinant viral (MVA) vaccine that through other ways of interacting with CD4 and CD8 cells to immunize (boost) with similar HIV immunogens, may result in a stronger immune response.

The purpose of this study is to determine the safety of and immune response to two experimental vaccines for the prevention of HIV infection, individually and in combination, in healthy adults who have not been previously vaccinated against smallpox. Participants will be randomly assigned to one of three groups. All participants will receive injections at Days 0, 28, 84, and 168 of the study. Participants assigned to Group 1 will receive, on Day 0, one injection in each arm of EP-1233 or placebo and the same study product (EP-1233 or the DNA placebo) on Day 28. Thereafter, each Group 1 participant will receive one injection of MVA-mBN32 or placebo on Days 84 and 168. Groups 2 and 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 2 will receive only the DNA vaccine EP-1233 (or placebo) in each arm on all injection days. Participants in Group 3 will not begin enrollment until safety and immunogenicity data from Group 1 have been evaluated. Participants assigned to Group 3 will receive a consistent regimen of MVA-mBN32 (or placebo) on all injection days. Participants will be required to keep a symptom log for 3 days after each injection and attend clinical visits on Day 0, 14, 28, 42, 84, 98, 168, 182, 273, and 364 of the study. At each of the 10 visits, a physical exam, cardiac assessment, and HIV risk reduction and prevention counseling will occur. Blood collection will occur on Days 0, 14, 42, 98, 182, 273, and 364. Urine collection will occur on Days 14, 42, 98, and 182.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
HIV Infections
  • Biological: EP-1233
    DNA-HIV-recombinant vaccine
  • Biological: MVA-mBN32
    HIV-recombinant viral vaccine
  • Experimental: 1
    Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0 and 28 and one injection of MVA-mBN32 or placebo in each arm on Days 84 and 168
    Interventions:
    • Biological: EP-1233
    • Biological: MVA-mBN32
  • Experimental: 2
    Participants will receive one injection of DNA vaccine EP-1233 or placebo in each shoulder on Days 0, 28, 84, and 168
    Intervention: Biological: EP-1233
  • Experimental: 3
    Participants will receive one injection of MVA-mBN32 or placebo in each arm on Days 0, 28, 84, and 168
    Intervention: Biological: MVA-mBN32

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
August 2008
Not Provided

Inclusion Criteria:

  • Good general health

Exclusion Criteria:

  • Previous receipt of smallpox vaccination
  • HIV-infected
  • Hepatitis B surface antigen positive
  • Participation in prior HIV vaccination trial
  • Immunosuppressive medications within 168 days prior to study entry
  • Receipt of blood products within 120 days of study entry
  • Receipt of live attenuated, medically indicated subunit, or killed (inactivated) vaccines within 30 days of study entry
  • Certain abnormal lab values
  • Pregnant or breastfeeding
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00428337
HVTN 067, 10394
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
  • HIV Vaccine Trials Network
  • Pharmexa-Epimmune
  • Bavarian Nordic
Study Chair: Geoffrey Gorse Saint Louis University School of Medicine
Study Chair: Christine Mhorag Hay University of Rochester
National Institute of Allergy and Infectious Diseases (NIAID)
May 2013

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