Another COVID-19 Vaccine Enter in Phase 1/2 of Clinical Trial

Transmission electron micrograph of SARS-CoV-2 virus particles, isolated from a patient. Image © NIAID/Flickr

Be optimistic, we have one more COVID-19 vaccine in the list and it is entering into phase 1 of its' two clinical trials.

On May 25, 2020, a company called Novavax, Inc. announced enrollment of the first participants for the trail of COVID-19 vaccine.

  • The Clinical trial started on May 25, 2020.

  • First volunteer participants are already enrolled.

  • Estimated Primary Completion Date is December 31, 2020, and Estimated Study Completion Date July 31, 2021

The phase 1 clinical trial of Novavax vaccine candidate - NVX‑CoV2373 already initiated in May 2020 and the company estimated the number of participants for phase 1 will be 131.

Novavax, Inc. is a biotechnology company that is committed to delivering novel products to prevent a broad range of infectious diseases. For the development of a vaccine, this company uses innovative proprietary recombinant nanoparticle vaccine technology. The vaccine candidates are genetically engineered three-dimensional nanostructures by which the developed vaccine will efficiently and effectively respond to both known and emerging disease threats.

Novavax is testing the Phase 1 clinical trial for the vaccine candidate NVX‑CoV2373. NVX‑CoV2373 is a stable prefusion protein made using its proprietary nanoparticle technology and it includes Novavax's proprietary Matrix‑M™ adjuvant. This adjuvant will enhance the immune responses and stimulate high levels of neutralizing antibodies.

Stanley C. Erck, President and Chief Executive Officer of Novavax said, "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." Erck added, "We look forward to sharing the clinical results in July and, if promising, quickly initiating the Phase 2 portion of the trial."

Novavax will conduct phase 1 of the clinical trial in two parts. Phase 1 will includes a randomized, observer-blinded, placebo-controlled trial designed. This will allow them to evaluate the immunogenicity and safety of NVX‑CoV2373 that is both adjuvanted with Matrix‑M and unadjuvanted. They will assess two doses of sizes 5 and 25 micrograms, with Matrix‑M adjuvant and without adjuvant.

Novavax expects that NVX‑CoV2373's phase 2 of the clinical trial will be conducted in multiple countries including the United States. In this phase, they will track and observe safety and COVID‑19 disease reduction in a broader age range

The company believes that this phase 1/2 approach will allow them for the rapid advancement of NVX‑CoV2373.

NVX‑CoV2373 is identified by Novavax as its leading SARS-CoV-2 candidate and had already passed the pre-clinical test. In the preclinical trial, NVX‑CoV2373 demonstrated efficient binding with receptors targeted by the virus, which is regarded as a critical aspect of effective vaccine protection. NVX‑CoV2373 showed high immunogenicity together with high levels of neutralizing antibodies and these results provide strong evidence that the vaccine candidate will be highly immunogenic in humans, potentially leading to protection from COVID‑19 and thus helping to control the spread of this disease.

Dr. Richard Hatchett, CEO of CEPI said, "Entering clinical trials is an important step on the path to delivering a safe, effective, and globally accessible vaccine against COVID-19. Vaccines provide our best hope of permanently defeating this pandemic, so it is encouraging to see rapid progress being made in the development of Novavax's vaccine candidate. CEPI's priority in building our portfolio has been to focus on vaccine candidates with the potential to be developed at speed and scale and made globally accessible. Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay."

Coalition for Epidemic Preparedness Innovations (CEPI) is an innovative partnership between public, private, philanthropic, and civil society organizations, launched in 2017, to develop vaccines to stop future epidemics.

NVX‑CoV2373 was created using Novavax's recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and it also contains Matrix-M™ adjuvant which enhances the immune response and stimulates high levels of neutralizing antibodies.

The company expects the results of phase 1 clinical trial in July of 2020.