Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00111605
First received: May 23, 2005
Last updated: September 7, 2012
Last verified: September 2012

May 23, 2005
September 7, 2012
Not Provided
Not Provided
Safety, as judged by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious experiences [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
  • Safety, as judged by local and systemic reactogenicity signs and symptoms; laboratory measures of safety; and adverse and serious experiences
  • immunogenicity, as judged by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and by intracellular cytokine staining (ICS)
Complete list of historical versions of study NCT00111605 on ClinicalTrials.gov Archive Site
Immunogenicity, as judged by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and by intracellular cytokine staining (ICS) [ Time Frame: Throughout the study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults
A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Gag DNA Vaccine With or Without IL-12 DNA Adjuvant, Boosted With Homologous Plasmids in Healthy, HIV-1 Uninfected Adult Participants

The purpose of this study is to evaluate the safety and tolerability of an experimental HIV vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a vaccine. This study will also determine the safety and tolerability of an experimental HIV vaccine boosted with two adjuvants.

The HIV epidemic is a major global health challenge, causing tremendous human suffering and economic loss throughout the world. The need for a safe, effective, and affordable HIV preventive vaccine is critical. This study will determine the safety and immunogenicity of an experimental HIV vaccine, HIV-1 gag DNA, given with or without an IL-12 adjuvant and boosted HIV-1 gag DNA with or without IL-12 DNA adjuvant.

This study will comprise two parts (Parts A and B). Part A will last 9 months and Part B, 15 months. Part A will consist of 48 participants enrolled in 4 groups. Group 1 participants will be randomly assigned to receive the gag DNA vaccine or placebo. Participants in Groups 2, 3, and 4 will be randomly assigned to receive the gag DNA vaccine and either 100 mcg, 500 mcg, or 1,500 mcg IL-12 DNA or placebo. Vaccinations for Groups 1 through 4 will be given intramuscularly and will occur at study entry and at Months 1 and 3.

Part B will consist of 96 participants, enrolled in 3 groups. Participants in Part B will receive their first vaccination 2 weeks after Part A participants receive their second vaccination. Group 5 participants will receive either the HIV-1 gag DNA vaccine or placebo. Group 6 participants will receive either the HIV-1 gag DNA vaccine plus IL-12 DNA or placebo. Vaccinations for Groups 5 and 6 will occur at study entry and at Months 1, 3, 6, and 9. Group 7 participants will receive either the gag DNA vaccine plus IL-12 DNA or placebo at study entry and at Months 1 and 3. Throughout the study, blood and urine collections will occur, physical exams will be conducted, HIV testing and counseling will be offered, and interviews and questionnaires will be completed.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
HIV Infections
  • Biological: HIV-1 gag DNA
    A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid
  • Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant
    Injection IL-12 DNA adjuvant intramuscularly into the deltoid
  • Biological: CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)
    A 1 mL intramuscular injection in the deltoid
  • Biological: Sodium chloride injection (0.9%)

    All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid.

    Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273.

  • Experimental: 1
    HIV gag DNA vaccine or placebo on Days 0, 28, and 84
    Interventions:
    • Biological: HIV-1 gag DNA
    • Biological: Sodium chloride injection (0.9%)
  • Experimental: 2
    HIV gag DNA vaccine plus 100 mcg of IL-12 or placebo on Days 0, 28, and 84
    Interventions:
    • Biological: HIV-1 gag DNA
    • Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant
    • Biological: Sodium chloride injection (0.9%)
  • Experimental: 3
    HIV gag DNA vaccine plus 500 mcg of IL-12 or placebo on Days 0, 28, and 84
    Interventions:
    • Biological: HIV-1 gag DNA
    • Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant
    • Biological: Sodium chloride injection (0.9%)
  • Experimental: 4
    HIV gag DNA vaccine plus 1,500 mcg of IL-12 or placebo on Days 0, 28, and 84
    Interventions:
    • Biological: HIV-1 gag DNA
    • Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant
    • Biological: Sodium chloride injection (0.9%)
  • Experimental: 5
    HIV gag DNA vaccine or placebo on Days 0, 28, 84, 168, and 273
    Interventions:
    • Biological: HIV-1 gag DNA
    • Biological: Sodium chloride injection (0.9%)
  • Experimental: 6
    HIV gag DNA vaccine plus IL-12 or placebo on Days 0, 28, and 84 plus CTL MEP/RC529-SE/GM-SCF booster vaccine on Days 168 and 273
    Interventions:
    • Biological: HIV-1 gag DNA
    • Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant
    • Biological: CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)
    • Biological: Sodium chloride injection (0.9%)
  • Experimental: 7
    HIV gag DNA vaccine plus IL-12 DNA adjuvant or placebo on Days 0 and 84
    Interventions:
    • Biological: HIV-1 gag DNA
    • Biological: Sodium chloride injection (0.9%)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
144
May 2008
Not Provided

Inclusion Criteria:

  • HIV uninfected
  • Access to a participating HIV Vaccine Trials Unit (HVTU)
  • Willing to receive HIV test results
  • Willing and able to comply with all study requirements
  • In good general health
  • Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit. More information about this criterion can be found in the protocol.
  • Hepatitis B surface antigen negative
  • Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
  • Weighs of or greater than 110 pounds (50 kg)

Exclusion Criteria:

  • HIV infection
  • HIV vaccines or placebos in prior HIV trial
  • Immunosuppressive medications within 168 days prior to first study vaccination
  • Blood products within 120 days prior to first study vaccination
  • Live attenuated vaccines within 30 days prior to first study vaccination
  • Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
  • Pneumococcal vaccine within 14 days prior to first study vaccination
  • Allergy treatment with antigen injections within 30 days prior to first study vaccination
  • Current anti-tuberculosis (TB) preventive therapy or treatment
  • 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
  • Allergies to local amide-type anesthetics
  • Serious adverse reactions to vaccines, including hypersensitivity and related symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
  • Autoimmune disease or immunodeficiency
  • Active syphilis infection. Participants who have been fully treated for syphilis over 6 months prior to study entry are not excluded.
  • Moderate to severe asthma. More information on this criterion can be found in the protocol.
  • Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
  • Thyroid disease or surgical removal of the thyroid requiring medication during the 12 months prior to study entry
  • Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry, with episodes requiring medication in the 2 years prior to study entry
  • Hypertension that is not well controlled by medication OR blood pressure of 150/100 or higher at study entry
  • Body mass index (BMI) of 40 or greater OR BMI of 35 or greater, if certain criteria are met. More information about these criteria can be found in the protocol.
  • Bleeding disorder
  • Cancer. Participants with surgically removed cancer that, in the opinion of the investigator, is unlikely to recur are not excluded.
  • Absence of the spleen
  • Plans to become pregnant during the study
  • Pregnancy or breastfeeding

Exclusion Criterion for Participants in Part B:

  • Allergies to yeast-derived products
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Thailand
 
NCT00111605
HVTN 060, 10057
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Spyros Kalams, MD Vanderbilt University
Study Chair: Scott Parker, MD University of Alabama at Birmingham
National Institute of Allergy and Infectious Diseases (NIAID)
September 2012

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