eClinical Technology and Industy News

INOVIO Reports Positive Phase 1b Results for INO-4201 as an Ebola Booster for rVSV-ZEBOV (Ervebo®)


  • INO-4201 found to be well-tolerated in the trial
  • Humoral responses were boosted in 100% (36 of 36) of treated participants

Excerpt from the Press Release:

PLYMOUTH MEETING, Pa., Feb. 2, 2023 /PRNewswire/ — INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer, and infectious diseases, today announced positive results from a Phase 1b clinical trial evaluating INO-4201, a DNA vaccine candidate, as a booster in healthy adult participants who previously received a single injection of Ervebo. In the trial, INO-4201 was well-tolerated and boosted humoral responses in 100% (36 of 36) of treated participants.

INO-4201 was evaluated in a 46-participant randomized, placebo-controlled Phase 1b trial (NCT04906629) to assess its safety, tolerability, and immunogenicity in healthy adult participants who previously received a single injection of Ervebo, a vaccine approved by the U.S. Food and Drug Administration for the prevention of disease caused by Zaire ebolavirus in individuals 18 years of age and older. The participants were dosed with 1 mg of INO-4201 injected intradermally followed by electroporation using our investigational proprietary smart device, CELLECTRA®. The trial was designed to test whether INO-4201 can be used as a booster in healthy participants previously vaccinated with Ervebo. The trial was spearheaded by Global Urgent and Advanced Research and Development (GuardRX), sponsored by Geneva University Hospitals, and funded by the U.S. Defense Advanced Research Projects Agency (DARPA).

Dr. Angela Huttner, MD, Infectious Disease Consultant, Geneva University Hospitals, and the lead investigator of the study, said, “INO-4201 was well-tolerated and all treated participants responded to the booster vaccine. These are encouraging results since our participants were initially vaccinated with Ervebo three to seven years ago. We remain grateful to our participants for their critical role in the development of this vaccine candidate, which we hope will be a key player in future Ebola Virus Disease prevention.”

Click the button below to read the entire Press Release:

Continue Reading The Press Release

Discover What Sets TrialStat Apart From Ordinary EDC Platforms

Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?

Archives