US-based biopharmaceutical firm Novavax has started enrolment in a Phase I clinical trial of its Ebola virus glycoprotein (GP) recombinant nanoparticle vaccine candidate adjuvanted with Matrix-M (Ebola GP Vaccine) in healthy subjects.
The company began development of its Ebola GP Vaccine shortly after the publication of the genetic sequence of the 2014 Ebola Makona strain, which is responsible for the current Ebola outbreak in West Africa.
Novavax president and CEO Stanley Erck said: "In less than five months, Novavax has validated its Ebola GP Vaccine with compelling animal data, including complete protection against a lethal Ebola challenge in non-human primates, leading to the initiation of this Phase I clinical trial.
"With our ongoing efforts to develop our vaccine against the A/H7N9 influenza strain, this is the second novel strain of an emerging virus with pandemic potential, for which Novavax has been able to construct and produce a vaccine, subsequently demonstrate immunogenicity in one or more relevant animal models, and initiate a clinical trial.
"Additionally, like our other recombinant vaccine candidates, our Ebola GP Vaccine can be rapidly scaled-up to produce millions of doses. Creating new vaccines in such an expeditious manner exemplifies Novavax’ ability to respond to a variety of global infectious disease threats."
The randomised, observer-blinded, dose-ranging Phase I Ebola GP Vaccine clinical trial is conducted in Australia. During the trial, each subject will be given two intramuscular injections, one each on study days zero and 21.
The trial is designed to evaluate the safety and immunogenicity of the vaccine, with and without Matrix-M adjuvant, in 230 healthy adult subjects between 18 and 50 years of age.
Apart from the trial’s primary aim of evaluating safety in these subjects, the trial will also assess immunogenicity as measured by concentrations of serum IgG antibodies to the Ebola Makona strain glycoprotein.
The trial’s secondary endpoints include epitope-specific immune responses to the Ebola GP antigen as measured by serum titers in an ELISA assay using known-neutralising monoclonal antibodies, as well as serum Ebola virus neutralising antibody reciprocal titers, the company noted.
The start of this Phase I trial is supported by significant immunogenicity and efficacy data, which showed that the Ebola GP Vaccine is the first subunit Ebola GP-based vaccine to provide protection in non-human primates.
Image: Electron micrograph of an Ebola virus virion. Photo: courtesy of CDC/Cynthia Goldsmith.