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INOVIO Collaborates with GuardRX and Geneva University Hospitals for Heterologous Booster Clinical Trial of its Ebola DNA Vaccine Candidate, INO-4201
Clinical trial evaluates INO-4201 as potential booster vaccine following initial vaccination with Ervebo, an FDA-approved Ebola vaccine PLYMOUTH MEETING, Pa.,
About this update from Inovio Pharmaceuticals, Inc.
[{"type":"text","content":"Clinical trial evaluates INO-4201 as potential booster vaccine following initial vaccination with Ervebo, an FDA-approved Ebola vaccine\n\n\nPLYMOUTH MEETING, Pa., Nov. 16, 2021 /PRNewswire/ -- INOVIO (NASDAQ: INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases, cancer, and HPV-associated diseases, today announced that several volunteers have been dosed with its DNA-based, intradermal Ebola vaccine candidate, INO-4201, as part of a randomized, placebo-controlled, Phase 1b clinical trial (NCT04906629). The trial will assess whether INO-4201 can be used as a booster in healthy volunteers previously vaccinated with rVSV-ZEBOV (Ervebo®1), an FDA- and EMA-approved viral-based vector Ebola vaccine. It follows INOVIO's pre-clinical and Phase 1 trials which suggested to investigators that INO-4201 was well-tolerated and resulted in 100% seroconversion after two doses.\n\"We are excited to begin this Phase 1b trial with our intradermal DNA vaccine candidate INO-4201 as a potential Ebola booster vaccine,\" said Laurent Humeau, Ph.D., Chief Scientific Officer, INOVIO. \"Due to the potential for anti-vector immunity after primary Ervebo vaccination, boosting with the same vaccine several years later may not be possible. INOVIO's DNA vaccine candidate INO-4201 has the potential to serve as a booster in the setting of prior Ervebo vaccination depending on its tolerability after multiple administrations. Furthermore, our DNA vaccine candidates could offer scalability and allow for room-temperature storage critical to transportation within tropical environments.\"\nInvestigators plan to recruit approximately 50 healthy volunteers to participate in the clinical trial. The trial will evaluate the safety, tolerability, and immunogenicity of INO-4201 in healthy adult volunteers who previously received a single intramuscular injection of rVSV-ZEBOV (Ervebo). Ervebo is approved by the U.S. Food and Drug Administration (FDA) for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older as a single dose administration. Ervebo is a replication-competent, live, attenuated recombinant vesicular stomatitis virus (rVSV) -based vaccine.\nTrial participants will be randomized to either INO-4201 or placebo (4:1 ratio) and will recei...