Dosing of the first volunteers for a Phase 1b clinical trial of Ebola vaccine candidate INO-4201 began this week to assess whether the vaccine could function as a booster for healthy, previously vaccinated patients.
The latest study followed positive results from pre-clinical and Phase 1 trials of the INOVIO-created DNA vaccine. Those trials demonstrated the vaccine as well-tolerated and capable of a 100 percent seroconversion rate after two doses. Now, investigators want to determine if it could help those vaccinated with rVSV-ZEBOV, or Ervebo, another Ebola vaccine approved by the U.S. Food and Drug Administration (FDA).
“We are excited to begin this Phase 1b trial with our intradermal DNA vaccine candidate INO-4201 as a potential Ebola booster vaccine,” Dr. Laurent Humeau, Chief Scientific Officer at INOVIO, said. “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.”
INO-4201 can remain stable at room temperature for more than a year, but that lifespan jumps to five years if kept refrigerated. Of particular use for areas where Ebola is endemic, it also has the advantage of not needing to be frozen during transport or storage.
The Phase 1b trial will be randomized and placebo-controlled, with approximately 50 volunteers. It will focus on the safety, tolerability, and immunogenicity of INO-4201 in previously vaccinated adult volunteers. Primary results will be tracked and studied for 14 days, while the levels of antibodies that bind to the Ebola virus surface glycoprotein antigen will be charted for four weeks after injection. The non-profit GuardRX will coordinate the trial, and Geneva University Hospitals will sponsor it.
“We are grateful to our volunteers for their critical role in the development of this vaccine, which we hope will be a key player in future Ebola Virus Disease prevention,” said Dr. Angela Huttner, Infectious Disease Consultant for Geneva University Hospitals, and the lead investigator of the study.
The U.S. Defense Advanced Research Projects Agency (DARPA) funded the trial.