| Autor: |
Rabdano, Sevastyan, Ruzanova, Ellina, Makarov, Denis, Vertyachikh, Anastasiya, Teplykh, Valeriya, Rudakov, German, Pletyukhina, Iuliia, Saveliev, Nikita, Zakharov, Konstantin, Alpenidze, Diana, Vasilyuk, Vasiliy, Arakelov, Sergei, Skvortsova, Veronika |
| Předmět: |
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| Zdroj: |
Vaccines; Jan2024, Vol. 12 Issue 1, p100, 19p |
| Abstrakt: |
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 anti-N IgG and N protein-specific IFNγ+-producing PBMC quantities among 438 volunteers. Convacell® showed same level of immunological efficacy for single and double dose vaccination regimens, including for elderly patients. The clinical studies indicate that Convacell® is safe and highly immunogenic. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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