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N protein-based COVID-19 vaccine shows 85.2% efficacy and a strong safety profile, offering a crucial alternative for patients struggling with traditional spike protein vaccines amid emerging variants.
According to a recent study published in ‘Journal of Infection’, a newly developed COVID-19 vaccine based on the nucleocapsid (N) protein has shown remarkable efficacy and a strong safety profile, positioning it as a potential game-changer in the global vaccination campaign. This vaccine could effectively tackle immune escape variants and serve as an alternative for individuals who do not respond well to spike (S) protein-based vaccines.
While first-generation vaccines targeting the spike protein have been successful, the advent of SARS-CoV-2 variants has led to immune escape, diminishing their effectiveness. Additionally, some individuals struggle to develop a robust immune response to S protein-based vaccines, creating a pressing need for alternative strategies that are less prone to mutations and offer long-lasting protection.
To assess the safety and efficacy of this innovative full-length recombinant N protein vaccine, Sevastyan O Rabdano et al. conducted a phase 3 clinical trial in the Russian Federation with 5,229 adult participants (BMI=18.5-30 kg/m²), who had no significant clinical abnormalities. They were randomized to receive N protein vaccine 50 µg (number of patients=3486) or a placebo (number of patients=1743) administered intramuscularly. The trial ran from May till August 2023. The main outcome was the occurrence of polymerase chain reaction (PCR)-confirmed symptomatic COVID-19 more than 15 days after vaccination within 180 days.
Results revealed that only 8 cases of PCR-confirmed symptomatic COVID-19 befell in the vaccine group (0.23%), compared to 27 cases in the placebo group (1.55%), deciphering an impressive vaccine efficacy of 85.2% (p < 0.0001). Most reported adverse events were mild, such as local injection site reactions. No serious vaccine-related adverse events were found. These findings support further development and possible implementation of N protein-based vaccines in the ongoing battle against COVID-19.
Journal of Infection
N-protein vaccine is effective against COVID-19: Phase 3, randomized, double-blind, placebo-controlled clinical trial
Sevastyan O Rabdano et al.
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