Trial to enroll up to 30000 volunteers across approximately 115 sites in the US and Mexico.
Novavax announced today it has initiated a phase 3 clinical trial, PREVENT-19, for its investigational COVID-19 vaccine, NVX-CoV2373.
The trial will be conducted in the United States and Mexico to evaluate the efficacy, safety, and immunogenicity of the vaccine candidate.
For its vaccine, the Gaithersburg, MD-based company is using a full-length, prefusion spike protein made using Novavax’ recombinant nanoparticle technology and the company’s proprietary saponin-based Matrix-M adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C and is shipped in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels.
“With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world’s population,” President and CEO Stanley Erck, Novavax, said. “We thank our colleagues and partners who continue to work with us to urgently advance our commercial-scale manufacturing processes, and we are grateful for the hard work and assistance from Operation Warp Speed, the US FDA, and the government of Mexico on this program.”
Novavax is also conducting a phase 3 study in the United Kingdom, a phase 2b safety and efficacy study in South Africa, and has an ongoing phase 1/2 trial in the US and Australia.
Data from these trials are expected as soon as early first quarter 2021, although timing depends on transmission rates in the regions.