Evaluating the Safety and Immune Response to Three Different DNA HIV Vaccines Administered With a MVA-CMDR Boost Vaccine in Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and immune response to three DNA vaccines
      and a MVA-CMDR vaccine that may boost the immune response to the DNA vaccines in healthy,
      HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate the safety, tolerability, and immunogenicity to four different HIV
      vaccines in healthy, HIV-uninfected adults. The vaccines include three DNA vaccines-DNA Nat-B
      env, DNA CON-S env, and DNA Mosaic env-and a vaccine called MVA-CMDR that may boost the
      immune response to the DNA vaccines.

      The study will enroll healthy, HIV-uninfected participants aged 18 to 50 years. Participants
      will be randomly assigned to one of three groups and will receive either one of the
      experimental vaccine regimens or a placebo vaccine regimen. Group 1 participants will receive
      the DNA Nat-B env and MVA-CMDR vaccines or placebo. Group 2 participants will receive the DNA
      CON-S env and MVA-CMDR vaccines or placebo. Group 3 participants will receive DNA Mosaic env
      and MVA-CMDR vaccines or placebo.

      All participants will receive one of their assigned vaccines at study entry (Month 0), and
      Months 1, 2, 4, and 8.

      Total study duration will be either 3 years after enrollment (for participants in the United
      States) or 5 years after enrollment (for participants in Switzerland). For all participants,
      study visits will occur at study entry (Month 0), and Months 0.5, 1, 1.5, 2, 2.5, 4, 4.5, 8,
      8.25, 8.5, 11, 13.75, and 14. After the last study visit, participants will be contacted
      annually by phone or e-mail for a total of 3 (U.S. participants) or 5 (Switzerland
      participants) years to answer questions about their health.

      All study visits will include a physical exam, HIV risk reduction counseling, and an
      interview and/or questionnaire. Select study visits will include blood collection, urine and
      stool collection, HIV testing, an electrocardiogram (ECG), and a pregnancy test for
      participants who were born female. For participants receiving the MVA-CMDR vaccine, select
      study visits may also include an assessment of cardiac symptoms.
    

Intervention name(s): DNA Nat-B env; DNA CON-S env; DNA Mosaic env; MVA-CMDR; Placebo for DNA Nat-B env; Placebo for DNA CON-S env; Placebo for DNA Mosaic env; Placebo for MVA-CMDR
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): 4 mg to be administered as 1 mL intramuscularly (IM) by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated); 4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated); 4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated); 1×10^8 plaque forming units (pfu) to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated); Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated); Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated); Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated); Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated)
Other intervention name(s): Modified Vaccinia Virus Ankara (MVA-CMDR)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention