NEJM: Phase 1-2 clinical trials have shown that the NVX-CoV2373 vaccine candidate is safe

The NVX-CoV2373 developed by Novavax corporation in the United States is a recombinant SARS-CoV-2 (recombinant SARS-CoV-2, rSARS-CoV-2) nanoparticle vaccine consisting of a full-length trimer SARS-CoV-2 tingling protein (S protein) and Matrix-M1 adjuvant.
in a new study, researchers from Novovax, the University of Maryland School of Medicine, Baylor School of Medicine, The Nucleus Network of Australia, and Q-Pharm in Australia conducted a random, 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 ad adhesives, which the observer did not know was assigned to the test group).
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 reactive originality; laboratory values (serum chemistry and hematology), assess safety based on the U.S. Food and Drug Administration(FDA) toxicity score; and anti-S protein IgG reactions (in enzymatic immunosorption tests (ELISA) units).
secondary results include actively reported adverse events, wild virus mesoconding (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 adrenatures, 25 participants received the NVX-CoV2373 vaccine without adages, and 23 participants received a placebo.
no serious adverse events were found.
most participants did not have reactive primary or had a lighter reactional originality, which was more common when using adverbations, but for short durations (average ≤2 days).
one participant had mild fever that lasted 1 day.
most participants reported mild adverse events;
adrenatics 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 adversizer 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 the recovery period serum in patients with COVID-19.
the Th1 esoteric reaction induced by matrix-M1 adulents in CD4-T cells.
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. This article is sourced from Bio Valley, for more information please download Bio Valley APP (