Safety and Immunogenicity of the Convacell^® Recombinant N Protein COVID-19 Vaccine.

ABSTRACT: We have developed Convacell^®-a COVID-19 vaccine based on the recombinant nucleocapsid (N) protein of SARS-CoV-2. This paper details Convacell's^® combined phase I/II and IIb randomized, double-blind, interventional clinical trials. The primary endpoints were the frequency of adverse effects (AEs) and the titers of specific anti-N IgGs induced by the vaccination; secondary endpoints included the nature of the immune response. Convacell^® demonstrated high safety in phase I with no severe AEs detected, 100% seroconversion by day 42 and high and sustained for 350 days anti-N IgG levels in phase II. Convacell^® also demonstrated a fused cellular and humoral immune response. Phase IIb results showed significant post-vaccination increases in circulating a

SUBMITTER: Rabdano S 

PROVIDER: S-EPMC10821050 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature