id author title date pages extension mime words sentences flesch summary cache txt cord-332832-kjppd6uz Ward, B. J. Phase 1 trial of a Candidate Recombinant Virus-Like Particle Vaccine for Covid-19 Disease Produced in Plants 2020-11-06 .txt text/plain 7024 466 58 (ClinicalTrials.gov number NCT04450004) Methods: The study was a randomized, partially-blinded, prime-boost 21 days apart, dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of CoVLP at three dose levels (3.75 microgram, 7.5 microgram, and 15 microgram) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in 180 SARS-CoV-2 seronegative healthy adults 18 to 55 years of age. We report here the results of a Phase 1 study initiated in July 2020 evaluating the safety, 203 tolerability and immunogenicity of two doses, 21-days apart of 3.75, 7.5 or 15 µg of a virus-204 like-particle vaccine candidate for Covid-19 produced in plants (hereafter called CoVLP). ; https://doi.org/10.1101/2020.11.04.20226282 doi: medRxiv preprint Like any early-phase clinical trial, this study has several limitations beyond the obvious 459 concern regarding small group size when testing multiple dose levels and formulations 460 (n=20/group). ./cache/cord-332832-kjppd6uz.txt ./txt/cord-332832-kjppd6uz.txt