Inovio announced breakthrough preliminary results of its HIV vaccine, PENNVAX-GP, from the HVTN 098 trial, a study supported by the HIV Vaccine Trials Network and the National Institute of Allergy and Infectious Diseases.

The randomized, placebo-controlled multi-center study evaluated a 4-dose intradermal (ID) or intramuscular (IM) vaccination schedule in combination with IL-12, a DNA encoded immune activator. The results showed that the HIV vaccine regimen elicited some of the highest overall levels of immune response rates seen in human studies. 

Overall, 71 of 76 participants (93%) showed detectable CD4+ or CD8+ responses to at least one of the vaccine’s four antigens: env A, env C, gag, or pol. Both arms of the study demonstrated significant positive results in both T cell response (27 of 28 in ID arm, 27 of 27 in IM arm) and HIV env-specific antibody response (27 of 28 in ID arm, 19 of 21 in IM arm). One difference between the two arms was that patients vaccinated via ID administration received 1/5th the dose of vaccine compared to the comparator IM group. 

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“These results are among the highest ever responses we’ve seen with an HIV vaccine, and they are remarkably consistent with our recent data reported from our Ebola, Zika and MERS clinical trials in terms of demonstrating nearly 100% vaccine response rates with very favorable safety profile. Furthermore, our newer and more tolerable intradermal vaccine delivery device showed that we can elicit very high immune responses at a much lower dose,” stated Dr. J. Joseph Kim, President & CEO of Inovio. 

PENNVAX-GP is a combination vaccine consisting of four HIV antigens (env A, env C, gag, and pol), aimed to generate both antibody immune responses and T-cell immune responses against multiple HIV strains. The vaccine is currently being developed as both a preventative and therapeutic vaccine against HIV.

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