Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP(®) DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults

Edupuganti, Srilatha; C. De Rosa, Stephen; Elizaga, Marnie; Lu, Yiwen; Han, Xue; Huang, Yunda; Swann, Edith; Polakowski, Laura; A. Kalams, Spyros; Keefer, Michael; Maenza, Janine; C. Wise, Megan; Yan, Jian; Morrow, Matthew P.; Khan, Amir S.; Boyer, Jean D.; Humeau, Laurent; White, Scott; Sardesai, Niranjan Y.; Bagarazzi, Mark L.; Gilbert, Peter B.; Kublin, James G.; Corey, Lawrence; Weiner, David B.

Background: Several techniques are under investigation to improve the immunogenicity of HIV-1 DNA vaccine candidates. DNA vaccines are advantageous due to their ease of design, expression of multiple antigens, and safety. Methods: The HVTN 098 trial assessed the PENNVAX(®)-GP DNA vaccine (encoding HIV env, gag, pol) administered with or without plasmid IL-12 at 0-, 1-, 3-, and 6-month timepoints via intradermal (ID) or intramuscular (IM) electroporation (EP) in healthy, adult participants. We report on safety, tolerability, and acceptability. Results: HVTN 098 enrolled 94 participants: 85 received PENNVAX(®)-GP and nine received placebo. Visual analog scale (VAS) pain scores immediately after each vaccination were lower in the ID/EP than in the IM/EP group (medians 4.1–4.6 vs. 6–6.5, p < 0.01). IM/EP participants reported greater pain and/or tenderness at the injection site. Most ID/EP participants had skin lesions such as scabs/eschars, scars, and pigmentation changes, which resolved within 6 months in 51% of participants (24/55). Eighty-two percent of IM/EP and 92% of ID/EP participant survey responses showed acceptable levels of discomfort. Conclusions: ID/EP and IM/EP are distinct experiences; however, HIV-1 DNA vaccination by either route was safe, tolerable and acceptable by most study participants.