NEJM: Phase 1-2 clinical trials have shown that the NVX-CoV2373 candidate vaccine is safe and induces a strong immune response.

September 13, 2020 /--- Novavax corporation developed NVX-CoV2373 is a recombinant SARS-CoV-2 (recombinant SARS-CoV-2, rSARS-CoV-2) nanoparticle vaccine, composed of the full-length trimer SARS-CoV-2 hedgehog protein (S protein) and Matrix-M1.
in a new study, researchers from Novovax, the University of Maryland School of Medicine, Baylor School of Medicine, The Nucleus Network in Australia and Q-Pharm in Australia conducted a randomized, placebo-controlled 1-1-1 in 131 healthy adults. Phase 2 clinical trials to assess the safety and immunogenicity of this rSARS-CoV-2 vaccine (doses of 5 and 25 sg, containing or not containing Matrix-M1 adulations, which the observer was not aware of in the trial group distribution).
study was recently published in the journal NEJM under the title "Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine".
from NEJM, 2020, doi:10.1056/NEJMoa2026920.
phase 1 clinical trial, vaccinations included two intramuscular injections, 21 days apart.
the main results are regenerative, laboratory values (serum chemistry and hematology), assess safety based on the U.S. Food and Drug Administration's (FDA) toxicity score, and anti-S protein IgG reaction (in the enzyme-linked immunosorption test (ELISA) unit meter).
secondary results include actively reported adverse events, wild virus mesocondation (micro-neutration trials) and T-cell reactions (cytokine staining).
IgG and micro-neutrheidation results were compared with 32 (IgG) and 29 (medium) recovery serum samples from COVID-19 patients, most of whom had symptoms.
the researchers conducted a primary analysis on the 35th day.
after randomization, 83 participants received the NVX-CoV2373 vaccine with adulation, 25 participants received the NVX-CoV2373 vaccine without adulation, and 23 participants received a placebo.
no serious adverse events were found.
most of the participants did not have reactive primary or had a lighter reactive primary, which was more common when using adverbations, but for short durations (on average, 2 days).
one participant had mild fever that lasted 1 day.
most participants reported mild adverse events;
adrenatic can enhance the immune response, save antigen doses, and induce a type 1 auxiliary T-cell (Th1) response.
geometric average anti-S protein IgG reaction (ELISA unit: 63160) and the melioth reaction (3906) induced by the two doses of the 5 μg adversant vaccination programme exceeded the geometric average response of the recovery serum in most patients with symptoms (8344 and 983, respectively).
35 days after receiving the vaccine, NVX-CoV2373 appears to be safe, causing an immune response that exceeds that of COVID-19 patients.
the Th1 esoteric reaction induced by Matrix-M1 adulents in CD4-T cells.
(bioon.com) Reference: Cheryl Keech et al. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. NEJM, 2020, doi:10.1056/NEJMoa2026920.