Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA
Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA
NCT ID: NCT03181789 Phase: PHASE1 Status: COMPLETED Enrollment: 56 Completion: 2020-04-29
Conditions
HIV Infections
Interventions
p24CE1/2 pDNA Vaccine, p55^gag pDNA Vaccine, IL-12 pDNA Adjuvant, Placebo, Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device
Summary
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55\^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
Primary Outcome
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness