Brief Review of Phase 1–2 Trial SARSCOV2 Recombinant Spike Protein Nanoparticle Vaccine— Keech 2020

This is a brief audio review. In the article Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine published, 2020 by Keech and Colleagues, The outcomes and key points are as noted: Adverse events were noted in 47 patients. The two-dose 5-μg adjuvanted regimen induced geometric mean anti-spike IgG (63,160 ELISA units) and neutralization (3906) responses that exceeded geometric mean responses in convalescent serum from mostly symptomatic Covid-19 patients (8344 and 983, respectively). This was a Phase 1 and Phase 2, randomized controlled trial, (placebo controlled, observer blinded) with 83 patients who were Patients 18 to 59 years old, men and non-pregnant women, Body mass index between 17 to 35. Exclusion criteria: Persons with history of SARS or COVID19, individuals of history of a positive COVID19 test, persons exposed to SARSCOV2 infected individuals, persons working in occupations with high risk for exposure to SARSCOV2.

Cheryl Keech, M.D., Ph.D., Gary Albert, M.S., Iksung Cho, M.S., Andreana Robertson, M.S., Patricia Reed, B.S., Susan Neal, Joyce S. Plested, Ph.D., Mingzhu Zhu, Ph.D., Shane Cloney-Clark, B.S., Haixia Zhou, Ph.D., Gale Smith, Ph.D., Nita Patel, M.S., et al., December 10, 2020 N Engl J Med 2020; 383:2320-2332 DOI: 10.1056/NEJMoa2026920