Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA

Phase 1 Completed 56 enrolled National Institute of Allergy and Infectious Diseases (NIAID)

RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start: 2017-10-18
Primary completion: 2019-10-25
Completion: 2020-04-29

Publications

Kalams SA, Felber BK, Mullins JI, Scott HM, Allen MA, De Rosa SC, Heptinstall J, Tomaras GD, Hu J, DeCamp AC, Rosati M, Bear J, Pensiero MN, Eldridge J, Egan MA, Hannaman D, McElrath MJ, Pavlakis GN; HIV Vaccine Trials Network 119(HVTN 119) Study Team. Focusing HIV-1 Gag T cell responses to highly conserved regions by DNA vaccination in HVTN 119. JCI Insight. 2024 Aug 1;9(18):e180819. doi: 10.1172/jci.insight.180819.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	IL-12 pDNA Adjuvant	Other / unclassified	—	Intramuscular
Subject	p24CE1/2 pDNA Vaccine	Vaccine	—	Intramuscular
Subject	p55gag	Unknown	—	Intramuscular

Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA

Summary

Timeline

Publications

Drugs

Indications