Novavax Announces Positive Phase 1 Data for its COVID-19 Vaccine Candidate
- Phase 1 portion of the Phase 1/2 clinical trial evaluated two doses of Novavax’ COVID-19 vaccine across two dose levels (5 and 25 µg) in 131 healthy adults ages 18-59 years
- NVX-CoV2373 was generally well-tolerated and had a reassuring safety profile
- The vaccine induced neutralization titers in 100% of participants
- Both 5 µg and 25 µg adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300
- Matrix-M™ adjuvant induced robust polyfunctional CD4+ T cell responses
- Conference call to be held on
Tuesday, August 4at 5:00 p.m. ET. Detailed data slides will be posted at 4:30 p.m. ETon novavax.com.
NVX-CoV2373 was well-tolerated and had a reassuring safety profile.
Overall, the vaccine was well-tolerated and reactogenicity events were generally mild. Following Dose 1, tenderness and pain were the most frequent local symptoms and systemic events were individually less frequent with headache, fatigue and myalgia being reported most commonly. As expected, following Dose 2, greater reactogenicity was reported, although the majority of symptoms were reported as ≤ Grade 1. The average duration of events was < 2 days.
Unsolicited adverse events were collected through 28 days after Dose 2. There were no severe (Grade 3) unsolicited adverse events, and the vast majority of adverse events were mild and deemed not related to vaccination. No serious adverse events (SAEs) were reported and safety follow-up continues.
NVX-CoV2373 induced neutralization titers in 100% of participants; 5 µg adjuvanted dose group peak GMT: 3,906 (95% CI: 2,556; 5,970).
All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.
Matrix-M™ adjuvant induced robust polyfunctional CD4+ T cell responses.
The adjuvant was dose-sparing, with the lower 5 µg dose of NVX‑CoV2373 performing comparably with the 25 µg dose. Cellular immune responses were measured in a subset of participants, and NVX‑CoV2373 induced antigen-specific polyfunctional CD4+ T cell responses with a strong bias toward the Th1 phenotype (IFN-g, IL-2, and TNF-a).
Favorable product profile.
NVX-CoV2373 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.
“The Phase 1 data demonstrate that NVX-CoV2373 with our Matrix-M adjuvant is a well‑tolerated COVID-19 vaccine with a robust immunogenicity profile,” said
The trial was supported by funding from the
For further information, including media-ready images, b-roll, downloadable resources and more, click here.
A webcast of the conference call can also be accessed via a link on the home page of the
NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection.
Novavax’ patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.
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Source: Novavax, Inc.