1. Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP® DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults
- Author
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Srilatha Edupuganti, Stephen C. De Rosa, Marnie Elizaga, Yiwen Lu, Xue Han, Yunda Huang, Edith Swann, Laura Polakowski, Spyros A. Kalams, Michael Keefer, Janine Maenza, Megan C. Wise, Jian Yan, Matthew P. Morrow, Amir S. Khan, Jean D. Boyer, Laurent Humeau, Scott White, Niranjan Y. Sardesai, Mark L. Bagarazzi, Peter B. Gilbert, James G. Kublin, Lawrence Corey, David B. Weiner, on behalf of the HVTN 098 Study Team, and the NIAID-Funded HIV Vaccine Trials Network
- Subjects
intramuscular ,intradermal ,electroporation ,HIV vaccine ,DNA vaccine ,IL-12 ,Medicine - Abstract
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.
- Published
- 2020
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