#NVAX today announced the publication in The New England Journal of Medicine of Phase 1 data from its Phase 1/2 clinical trial of NVX‑CoV2373, its COVID‑19 vaccine candidate adjuvanted with Matrix‑M™, in healthy adults 18-59 years of age.
Phase 1 Results Summary
NVX-CoV2373 was well-tolerated and reactogenicity events were generally mild
There were no severe (Grade 3) unsolicited adverse events (AEs); the vast majority of AEs were mild and deemed not related to vaccination. No serious AEs were reported. Safety follow-up continues.
All subjects in the 5 µg group developed anti-spike IgG antibodies after a single dose of vaccine, many of which included neutralizing antibody responses to wild-type virus
100 percent of participants developed wild-type virus neutralizing antibody responses after Dose 2
Both 5 µg and 25 adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300
Anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease
Matrix-M adjuvant was dose-sparing, with the lower 5 µg dose of NVX‑CoV2373 performing comparably with the of 25 µg dose
Cellular immune responses measured in a subset of participants demonstrated induction of antigen-specific polyfunctional CD4+ T cell responses with a strong Th1 phenotype bias
NVX-CoV2373 has a favorable product profile; it is stable and will allow handling in a liquid formulation that can be stored at 2°C to 8°C, allowing for successful cold chain management with existing infrastructure
See manuscript for more details.
See press release for more details.
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