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

Strategic Insights -

Novavax, Inc., a late-stage biotechnology company, has announced the enrollment of the first participants in a Phase 1/2 clinical trial of its coronavirus vaccine candidate, NVX CoV2373. This trial is a significant step towards addressing the need for a vaccine in the fight against the global COVID-19 pandemic. The trial will evaluate the immunogenicity and safety of NVX CoV2373, both adjuvanted with Matrix M and unadjuvanted, in approximately 130 healthy participants aged 18 to 59 years at two sites in Australia.

Key Takeaways:

  • The Phase 1/2 clinical trial is being conducted in two parts, with the Phase 1 portion evaluating the immunogenicity and safety of NVX CoV2373 in 130 healthy participants in Australia.
  • The trial will assess two dose sizes (5 and 25 micrograms) with Matrix M and without, and the results are expected in July 2020.
  • The Phase 2 portion of the trial will be conducted in multiple countries, including the United States, and will assess immunity, safety, and COVID-19 disease reduction in a broader age range.
  • The Coalition for Epidemic Preparedness Innovations (CEPI) is supporting the trial with funding and has invested up to $388 million to advance the clinical development of NVX CoV2373.
  • NVX CoV2373 demonstrated high immunogenicity and high levels of neutralizing antibodies in preclinical trials, providing strong evidence that the vaccine candidate will be highly immunogenic in humans.
  • The vaccine candidate incorporates Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
  • Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July 2020.

Statistics:

  • 130 healthy participants will be enrolled in the Phase 1 portion of the trial.
  • 2 dose sizes (5 and 25 micrograms) with Matrix M and without will be assessed in the Phase 1 portion of the trial.
  • The Phase 2 portion of the trial will assess immunity, safety, and COVID-19 disease reduction in a broader age range.
  • CEPI has invested up to $388 million to advance the clinical development of NVX CoV2373.

Sources:

  • GlobeNewswire, "Novavax Announces Enrollment of First Participants in Phase 1/2 Clinical Trial of NVX CoV2373, Its COVID-19 Vaccine Candidate", May 26, 2020
  • ClinicalTrials.gov, "A Study to Evaluate the Safety and Immunogenicity of NVX-CoV2373, a SARS-CoV-2 Vaccine Candidate, in Healthy Adults", May 2020
  • CEPI, "About CEPI"
  • Novavax, "About Novavax"
  • Novavax, "About NVX-CoV2373"
  • Novavax, "About Matrix-M"