Dataset Information

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

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.

SUBMITTER: Edupuganti S

PROVIDER: S-EPMC7762306 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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

Edupuganti Srilatha S C De Rosa Stephen S Elizaga Marnie M Lu Yiwen Y Han Xue X Huang Yunda Y Swann Edith E Polakowski Laura L A Kalams Spyros S Keefer Michael M Maenza Janine J C Wise Megan M Yan Jian J Morrow Matthew P MP Khan Amir S AS Boyer Jean D JD Humeau Laurent L White Scott S Sardesai Niranjan Y NY Bagarazzi Mark L ML Gilbert Peter B PB Kublin James G JG Corey Lawrence L Weiner David B DB On Behalf Of The Hvtn Study Team The Niaid-Funded Hiv Vaccine Trials Network

Vaccines 20201207 4

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.<h4>Methods</h4>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 ...[more]

PMID: 33297341

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