Intramuscular and Intradermal Electroporation of HIV-1 PENNVAX-GP® DNA Vaccine and IL-12 Is Safe, Tolerable, Acceptable in Healthy Adults
Year: 2020
Type: article
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.
Source: Vaccines
Authors: 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 Morrow, Amir Khan, Jean Boyer, Laurent Humeau, Scott White, Niranjan Sardesai, Mark Bagarazzi, Peter Gilbert, James Kublin, Lawrence Corey, David Weiner, on behalf of the HVTN 098 Study Team, the NIAID-Funded HIV Vaccine Trials Network
Language: English
Topic: HIV Research and Treatment
Subfield: Virology
Field: Immunology and Microbiology
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $1,901
Awards: G1276011396, G1384187122, G1386795942, G1406424272, G1432718094, G1805005405, G2358037835, G2479014473, G35885623, G390975780, G4099673573, G5161777734, G5469398932, G5565402114, G5830198247, G623310766, Synthetic DNA & Novel Env Vaccine for HIV, G7522203623, G7656363126, G8059771280, G819814859, G8728558912, G9000299352, HIV Vaccine Trials Network Laboratory Center, HIV Vaccines Clinical Trials Network Leadership and Operations Center, Emory Specialized Center of Research Excellence (SCORE) on Sex Differences, G926868656
OpenAlex ID: W3111112554