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Safety and Immunogenicity of the Convacell ® Recombinant N Protein COVID-19 Vaccine.
- Source :
- Vaccines; Jan2024, Vol. 12 Issue 1, p100, 19p
- Publication Year :
- 2024
-
Abstract
- We have developed Convacell<superscript>®</superscript>—a COVID-19 vaccine based on the recombinant nucleocapsid (N) protein of SARS-CoV-2. This paper details Convacell's<superscript>®</superscript> 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<superscript>®</superscript> 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<superscript>®</superscript> also demonstrated a fused cellular and humoral immune response. Phase IIb results showed significant post-vaccination increases in circulating anti-N IgG and N protein-specific IFNγ<superscript>+</superscript>-producing PBMC quantities among 438 volunteers. Convacell<superscript>®</superscript> showed same level of immunological efficacy for single and double dose vaccination regimens, including for elderly patients. The clinical studies indicate that Convacell<superscript>®</superscript> is safe and highly immunogenic. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 2076393X
- Volume :
- 12
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- Vaccines
- Publication Type :
- Academic Journal
- Accession number :
- 175131904
- Full Text :
- https://doi.org/10.3390/vaccines12010100