Novavax Announces Enrollment of First Participants in Phase 1/2 Clinical Trial of COVID-19 Vaccine Candidate NVX-CoV2373

Strategic Insights -

Novavax, a biotechnology company, has announced the enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX-CoV2373. The trial, conducted in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), aims to evaluate the safety and immunogenicity of the vaccine in approximately 130 healthy participants aged 18-59 years. The trial will assess two dose sizes (5 and 25 micrograms) with and without Novavax' patented saponin-based Matrix-M adjuvant, and will provide preliminary immunogenicity and safety results in July 2020. If successful, the Phase 2 portion of the trial will be initiated promptly to assess immunity, safety, and COVID-19 disease reduction in a broader age range.

Key Takeaways:

  • The Phase 1/2 clinical trial of NVX-CoV2373 is a randomized, observer-blinded, placebo-controlled trial designed to evaluate the immunogenicity and safety of the vaccine in healthy participants aged 18-59 years.
  • The trial will assess two dose sizes (5 and 25 micrograms) with and without Novavax' patented saponin-based Matrix-M adjuvant.
  • The trial is being conducted in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI), which is investing up to $388 million of funding to advance clinical development of NVX-CoV2373.
  • Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.
  • If successful, the Phase 2 portion of the trial will be initiated promptly to assess immunity, safety, and COVID-19 disease reduction in a broader age range.
  • Novavax' identical vaccine candidate, NanoFlu, met all primary objectives in its pivotal Phase 3 clinical trial in older adults.
  • The Coalition for Epidemic Preparedness Innovations (CEPI) has initiated 9 partnerships to develop vaccines against the novel coronavirus, including Novavax' NVX-CoV2373.

Statistics:

  • The trial will enroll approximately 130 healthy participants aged 18-59 years.
  • The trial will assess two dose sizes (5 and 25 micrograms) with and without Novavax' patented saponin-based Matrix-M adjuvant.
  • CEPI is investing up to $388 million of funding to advance clinical development of NVX-CoV2373.
  • Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.

Sources:

  • GlobeNewswire, "Novavax Announces Enrollment of First Participants in Phase 1/2 Clinical Trial of COVID-19 Vaccine Candidate NVX-CoV2373" (May 25, 2020)
  • clinicaltrials.gov, "A Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of NVX-CoV2373 in Healthy Adults 18-59 Years of Age"
  • Novavax, "Novavax Initiates Development of COVID-19 Vaccine Candidate with CEPI and WHO Partnership" (May 2020)
  • CEPI, "CEPI Launches Nine Partnerships to Develop COVID-19 Vaccines" (May 2020)