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

Vaccines

the NIAID-Funded HIV Vaccine Trials Network¹  on behalf of the HVTN 098 Study Team¹  Michael Keefer²  Edith Swann³  Laura Polakowski³  Srilatha Edupuganti⁴  Jean D. Boyer⁵  Megan C. Wise⁵  Mark L. Bagarazzi⁵  Niranjan Y. Sardesai⁵  Amir S. Khan⁵  Laurent Humeau⁵  Scott White⁵  Jian Yan⁵  Matthew P. Morrow⁵  James G. Kublin⁶  Yunda Huang⁶  Marnie Elizaga⁶  Janine Maenza⁶  Peter B. Gilbert⁶  Lawrence Corey⁶  Yiwen Lu⁶  Stephen C. De Rosa⁶  Xue Han⁶  Spyros A. Kalams⁷  David B. Weiner⁸ 

[1] ;Department of Medicine, University of Rochester School of Medicine & Dentistry, Rochester, NY 14642, USA;Division of AIDS, NIH, Bethesda, MD 20892, USA;Division of Infectious Disease, Department of Medicine, Emory University, Atlanta, GA 30322, USA;Inovio Pharmaceuticals Inc. Plymouth Meeting, PA 19462, USA;Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA 98109, USA;Vanderbilt University Medical Center, Nashville, TN 37232, USA;Wistar Institute, Philadelphia, PA 19104, USA;

关键词: intramuscular;    intradermal;    electroporation;    HIV vaccine;    DNA vaccine;    IL-12;   

DOI  :  10.3390/vaccines8040741

来源: DOAJ

【 摘 要 】

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.

【 授权许可】

Unknown