Enrollment opens for recombinant Ebola vaccine

Enrollment has begun for a phase 1 clinical trial of a recombinant nanoparticle vaccine for the treatment of Ebola virus, according to a press release from the vaccine’s manufacturer.

Developed by Novavax, the Ebola GP vaccine is an Ebola virus glycoprotein recombinant vaccine candidate administered with the company’s saponin-based adjuvant Matrix-M. Since development began after publication of the virus’ genetic sequence last September, the vaccine has shown positive results in various animal models.

“In less than 5 months, Novavax has validated its Ebola GP vaccine with compelling animal data, including complete protection against a lethal Ebola challenge in nonhuman primates, leading to the initiation of this phase 1 clinical trial,” Stanley C. Erck, president and CEO of Novavax, said in the press release. “Additionally, like our other recombinant vaccine candidates, our Ebola GP vaccine can be rapidly scaled-up to produce millions of doses.”

The trial, which is being conducted in Australia, will evaluate the safety and immunogenicity of the vaccine with and without adjuvant in 230 adult participants. Each will receive two intramuscular injections during the study, with concentrations of the immunoglobulin G antibody to the Ebola Makona strain glycoprotein measured also.

“The strong immune responses observed in our animal immunogenicity models and the protection observed in the nonhuman primate challenge models, confirm that our Ebola GP vaccine is an important candidate for consideration,” Gregory Glenn, MD, senior vice president of Novavax’s research and development, said in the release. “The use of a sequence reflecting the current circulation Makona strain of Ebola virus, along with the observed dose-sparing and enhanced antibody quality by the addition of our Matrix-M adjuvant, compelled the company to move to clinical testing.”

As of Feb. 12, there have been 9,177 deaths and 22,894 confirmed cases of Ebola virus, according to WHO.