Evaluating the Safety and Immunogenicity of PENNVAX®-GP DNA Vaccine and IL-12 Plasmid, Delivered Via Intradermal or Intramuscular Electroporation in Healthy, HIV-Uninfected Adults

Phase 1 Completed 94 enrolled National Institute of Allergy and Infectious Diseases (NIAID)

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The study will evaluate the safety and tolerability of the PENNVAX®-GP HIV-1 DNA vaccine and interleukin 12 (IL-12) DNA adjuvant, given by intradermal (ID) or intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.

Timeline

Start: 2015-08
Primary completion: 2017-06-08
Completion: 2017-12-20

Publications

De Rosa SC, Edupuganti S, Huang Y, Han X, Elizaga M, Swann E, Polakowski L, Kalams SA, Keefer MC, Maenza J, Lu Y, Wise MC, Yan J, Morrow MP, Khan AS, Boyer JD, Humeau L, White S, Pensiero M, Sardesai NY, Bagarazzi ML, Weiner DB, Ferrari G, Tomaras GD, Montefiori DC, Corey L, McElrath MJ; HIV Vaccine Trials Network (HVTN) 098 Study Team. Robust antibody and cellular responses induced by DNA-only vaccination for HIV. JCI Insight. 2020 Jul 9;5(13):e137079. doi: 10.1172/jci.insight.137079.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	PENNVAX-GP	Vaccine	0.6 mg	Intrathecal
Subject	PENNVAX-GP	Vaccine	0.8 mg	Intrathecal
Subject	PENNVAX-GP	Vaccine	8 mg	Intrathecal
Subject	interleukin-12	Protein / enzyme biologic	0.2 mg	Intrathecal
Subject	interleukin-12	Protein / enzyme biologic	1 mg	Intrathecal

Evaluating the Safety and Immunogenicity of PENNVAX®-GP DNA Vaccine and IL-12 Plasmid, Delivered Via Intradermal or Intramuscular Electroporation in Healthy, HIV-Uninfected Adults

Summary

Timeline

Publications

Drugs

Indications