BALTIMORE--(BUSINESS WIRE)--Profectus BioSciences, Inc., a developer of the next generation of vaccines addressing high-value unmet indications in biodefense, infectious and emerging diseases, announced today the initiation of a phase 1 study evaluating the safety and immunogenicity of a therapeutic HIV vaccine strategy.
HIV-infected adults on stable antiretroviral therapy (ART) will receive the Profectus multi-antigen HIV plasmid DNA (MAg-pDNA: env, gag, pol, nef, tat and vif) vaccine administered with the Profectus GENEVAX™ interleukin-12 (IL-12) pDNA adjuvant, delivered using the TriGrid™ electroporation (EP) delivery system licensed from Ichor Medical Systems, as a priming vaccine. This will be followed by booster immunization with the Profectus recombinant vesicular stomatitis virus (rVSV)-vectored HIV vaccine delivered by intramuscular injection. The randomized, double-blind, placebo-controlled study is in support of the HIV Cure Agenda and is being sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The study, which will enroll 30 HIV-infected adults, is being conducted by NIAID’s Dr. Michael Sneller under a protocol designated Theravax 13-I-0141.
Pre-clinical studies conducted by Profectus have demonstrated that the prime-boost delivery of the HIV pDNA and HIV rVSV vaccines results in an HIV-specific cell-mediated immune (CMI) response of significantly increased magnitude and functionality as compared to delivery of the HIV pDNA or HIV rVSV vaccines alone. To address the goals of the HIV Cure Agenda the effect of vaccination on the rate of decay of the HIV-infected, CD4+ T-cell reservoir and the effect on rebound viremia following analytical treatment interruption will also be tested.
