Researchers at the biotechnology company Novavax have begun enrollment in a clinical trial of a coronavirus vaccine called NVX-CoV2373. The vaccine will be tested in the trial's Phase 1 portion for safety and immunogenicity, which is its ability to provoke an immune response in the body.
If the results of the trial show promise, Phase 2 testing will follow later in the summer.
NVX-CoV2373 is a vaccine engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19. It contains an antigen derived from the coronavirus spike protein, a viral protein highly recognized by the body's immune system. It also contains Matrix-M™, an adjuvant created by Novavax used to enhance the body's immune system's reaction to the vaccine.
In preliminary testing of animal models, the vaccine showed high immunogenicity and high levels of neutralizing antibodies (antibodies needed to successfully fight the virus), according to a press release. Researchers are hopeful the vaccine will also be successful in humans.
In Phase 1 of the trial, 130 healthy participants between the ages of 18 and 59 will be enrolled at two sites in Australia. Participants will receive either the vaccine or a placebo. The study will also test the vaccine with and without the Matrix-M™ adjuvant as well as in two dose sizes, 5 and 25 micrograms.
Phase 2 of the clinical trial is expected to take place in multiple countries, including the United States. It will continue to assess immune response and safety as well as COVID-19 disease reduction in a broader age range.
"Administering our vaccine in the first participants of this clinical trial is a significant achievement, bringing us one step closer toward addressing the fundamental need for a vaccine in the fight against the global COVID‑19 pandemic," said Stanley C. Erck, President and Chief Executive Officer of Novavax, in a press release.
The trial is being conducted in a Phase 1/2 approach that will allow for rapid advancement between the phases. Results from Phase 1 are expected in July 2020.