Evaluating the Safety of and Immune Response to an HIV Vaccine Followed by Booster, Administered by Two Devices, in 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 of and immune response to an HIV vaccine,
      administered using two different devices, followed by a vaccine boost, in healthy,
      HIV-uninfected adults.
    

Detailed description: 
      Despite advances in treatment, HIV/AIDS rates remain high in low- and middle-income countries
      in resource-limited areas of the world. Preventive HIV vaccines would be an effective way to
      decrease the spread of HIV/AIDS. This study will evaluate an experimental HIV preventive
      vaccine followed by booster: the PENNVAX-G DNA vaccine and the Modified Vaccinia
      Ankara-Chiang Mai Double Recombinant (MVA-CMDR) booster vaccine. The MVA virus is a mild form
      of a vaccinia virus that is used in smallpox vaccines and does not cause smallpox infection.
      It has been safely used in vaccines for many years. Study researchers will examine if the
      combination of the two vaccines will provide an effective way for the body to build a defense
      against HIV. The PENNVAX-G vaccine will be administered to participants using one of two
      devices-the Biojector 2000 needleless device or the CELLECTRA intramuscular (IM)
      electroporation (EP) device-to evaluate how the immune response to the vaccine changes based
      on the device that is used. The purpose of this study is to evaluate the safety and
      immunogenicity of the PENNVAX-G vaccine, administered by either Biojector 2000 injection or
      CELLECTRA EP, followed by an MVA-CMDR vaccine boost, in healthy, HIV-uninfected adults.

      This study will be conducted in two parts. Participants in the first part of the study will
      attend a baseline study visit, and they will undergo blood and urine collection, a medical
      history review, physical examination, and HIV testing counseling. All participants will
      receive the PENNVAX-G vaccine at baseline and Day 28. They will be randomly assigned to
      receive the vaccine by either the Bioinjector 2000 needleless device or the CELLECTRA IM EP
      device. On Days 84 and 168, all participants will receive the MVA-CMDR vaccine by IM
      injection delivered via needle and syringe. Participants will remain in the clinic for 1 hour
      after each vaccination for observation and vital sign monitoring, and they will record their
      temperatures and any symptoms in a diary for 7 days after each vaccination. Study staff will
      contact participants 1 to 2 days after each vaccination for follow-up monitoring. In addition
      to the vaccination study visits, participants will attend study visits at Weeks 1, 2, 4, 5,
      6, 13, 14, 25, 26, 37, 50, and 52 and will repeat the baseline study procedures.

      At the conclusion of the first part of the study, participants' study data will be reviewed
      and the safety of the vaccine regimen will be determined. If the regimen is found to be safe,
      then the second part of the study will begin. Participants in the second part of the study
      will be randomly assigned to receive the PENNVAX-G vaccine administered by either the
      Bioinjector 2000 device or the CELLECTRA EP device at baseline and Day 28, followed by the
      MVA-CDMR boost at Days 84 and 168, or they will receive placebo PENNVAX-G vaccine
      administered by either the Bioinjector 2000 device or the CELLECTRA EP device at baseline and
      Day 28, followed by a placebo MVA-CDMR boost at Days 84 and 168. All study visits and
      procedures that occurred during the first part of the study will also take place in the
      second part of the study.

      Participants in the second part of the study will have the option of enrolling in a substudy.
      The purpose of the substudy is to evaluate the antibody response of the reproductive tract
      mucosa to the PENNVAX-G DNA, MVA-CDMR, and placebo vaccines administered in the main part of
      study. The substudy will also evaluate the effectiveness of using the Instead Softcup as a
      collection method to collect vaginal secretions for testing. Mucosal specimens and urine
      samples will be collected from participants at the screening visit and during the Week 2, 6,
      14, 26, and 50 study visits.
    

Intervention name(s): PENNVAX-G DNA Vaccine; MVA-CMDR Vaccine; Placebo PENNVAX-G Vaccine; Placebo MVA-CMDR Vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): PENNVAX-G DNA (HIV-1 env A, C, and D, and consensus gag plasmids) vaccine; 4 mg administered IM as a total volume of 1 mL; MVA-CMDR live attenuated modified vaccinia ankara vector (HIV-1 CM235 env/CM240 gag/pol); 1 x 10^8 plaque-forming unit (pfu) administered IM by needle and syringe as a volume of 1 mL in either deltoid; Sodium Chloride Injection USP, 0.9%; Sodium Chloride Injection USP, 0.9%
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HIV Preventive Vaccine