Immunogenicity and In Vivo Protective Effects of Recombinant Nucleocapsid-Based SARS-CoV-2 Vaccine Convacell®

Rabdano, Sevastyan O.; Ruzanova, Ellina; Pletyukhina, Iuliia V.; Savelev, Nikita; Kryshen, Kirill; Katelnikova, A.E.; Beltyukov, Petr P.; Fakhretdinova, Liliya N.; Safi, Ariana; Rudakov, German O.; Arakelov, Sergei A.; Andreev, I. M.; Кофиади, И.А.; Khaitov, Musa; Valenta, Rudolf; Kryuchko, Daria S.; Berzin, Igor; Belozerova, Natalia S.; Evtushenko, Anatoly E.; Truhin, Viktor P.; Skvortsova, Veronika

doi:10.3390/vaccines11040874

Cited by 10 publications

(13 citation statements)

References 77 publications

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“…We have developed a COVID-19 vaccine Convacell® based on the full-length nucleocapsid (N) protein of SARS-CoV-2, produced in an Escherichia coli recombinant protein platform (5).…”

Section: Introductionmentioning

confidence: 99%

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N-protein vaccine Convacell® is effective against COVID-19: phase 3, randomized, double-blind, placebo-controlled clinical trial

Rabdano,

Ruzanova,

Vertyachikh

et al. 2024

Preprint

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We have developed a Convacell®, a COVID-19 vaccine based on the conservative viral nucleocapsid (N) protein. The N protein is evolutionary conservative and is abundantly expressed on the surface of infected cells, allowing anti-N immune response generated by Convacell® to rapidly clear infected cells and provide long-lasting protection against COVID-19. Convacell® has been demonstrated to be safe and highly immunogenic, creating immune responses lasting over a year, in phase I/II and IIb clinical trials. Phase IIb clinical trial has also demonstrated that a single dose vaccination regimen with Convacell® is sufficient to provide an immune response. Here we report the finding of the phase III clinical trial of Convacell®. Two groups of volunteers from Russia have been either vaccinated with a single dose of Convacell® or injected with placebo, and then monitored for incidence of COVID-19 and adverse effects. Anti-N antibody titers at admission were also analyzed, to take into account for potential effects of previous virus encounters. Disease incidence over 6 months results indicate an overall vaccine efficacy of 85.2% (95% confidence interval: 67.4-93.3%). Additionally, Convacell® has shown a good safety profile. Overall, Convacell® demonstrated highly desirable qualities and good performance as a vaccine and can be considered as valuable COVID-19 preventative measure.

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“…We have developed a COVID-19 vaccine Convacell® based on the full-length nucleocapsid (N) protein of SARS-CoV-2, produced in an Escherichia coli recombinant protein platform (5).…”

Section: Introductionmentioning

confidence: 99%

“…COVID-19 vaccines based on the N protein have already been described as promising in multiple papers (6)(7)(8)(9)(10)(11)(12). Previously, Convacell® has been shown to be effective in protecting from severe disease in preclinical trials (5) and highly immunogenic and safe in phase I, II and IIb clinical trials (13).…”

Section: Introductionmentioning

confidence: 99%

N-protein vaccine Convacell® is effective against COVID-19: phase 3, randomized, double-blind, placebo-controlled clinical trial

Rabdano,

Ruzanova,

Vertyachikh

et al. 2024

Preprint

Self Cite

View full text Add to dashboard Cite

show abstract

“…To diversify the current armamentarium of COVID-19 vaccines with alternative antigens options, we have developed our vaccine Convacell ® [ 5 , 6 ]. Convacell ® is based on the full-length nucleocapsid (N) protein of SARS-CoV-2, produced in an Escherichia coli recombinant protein platform.…”

Section: Introductionmentioning

confidence: 99%

“…A dose of Convacell ® contains 50 μg of protein N with the Wuhan SARS-CoV-2 variant sequence. The N protein is highly conserved and less prone to accumulate mutations than the commonly used in vaccines spike (S) protein [ 9 , 10 , 11 , 12 , 13 , 14 ], which allows Convacell ® to generate long-lasting [ 5 ] and broadly acting [ 15 ] immune responses. The N protein is also abundantly expressed in cells after infection [ 16 , 17 ] and exposed on the infected cells membranes [ 18 , 19 ], ensuring that infected cells are highly likely to be targeted by N-specific immune responses.…”

Section: Introductionmentioning

confidence: 99%

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

Rabdano,

Ruzanova,

Makarov

et al. 2024

Vaccines

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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.

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Vaccine adjuvants for infectious disease in the clinic

Goetz,

Thotathil,

Zhao

et al. 2024

Bioengineering & Transla Med

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Adjuvants, materials added to vaccines to enhance the resulting immune response, are important components of vaccination that are many times overlooked. While vaccines always include an antigen to tell the body what to vaccinate to, of equal importance the adjuvant provides the how, a significant factor in producing a complete response. The adjuvant space has been slow to develop with the first use of an adjuvant in a licensed vaccine occurring in the 1930s, and remaining the only adjuvant in licensed vaccines for the next 80 years. However, with vaccination at the forefront of protection against new and complex pathogens, it is important to consider all components when designing an effective vaccine. Here we summarize the adjuvant space in licensed vaccines as well as the novel adjuvant space in clinical trials with a specific focus on the materials utilized and their resulting impact on the immune response. We discuss five major categories of adjuvant materials: aluminum salts, nanoparticles, viral vectors, TLR agonists, and emulsions. For each category, we delve into the current clinical trials space, the impact of these materials on vaccination, as well as some of the ways in which they could be improved. Adjuvants present an exciting opportunity to improve vaccine responses and stability, this review will help inform about the current progress of this space.Translational impact statementIn the aftermath of the COVID‐19 pandemic, vaccines for infectious diseases have come into the spotlight. While antigens have always been an important focus of vaccine design, the adjuvant is a significant tool for enhancing the immune response to the vaccine that has been largely underdeveloped. This article provides a broad review of the history of adjuvants and, the current vaccine adjuvant space, and the progress seen in adjuvants in clinical trials. There is specific emphasis on the material landscape for adjuvants and their resulting mechanism of action. Looking ahead, while the novel vaccine adjuvant space features exciting new technologies and materials, there is still a need for more to meet the protective needs of new and complex pathogens.

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Immunogenicity and In Vivo Protective Effects of Recombinant Nucleocapsid-Based SARS-CoV-2 Vaccine Convacell®

Cited by 10 publications

References 77 publications

N-protein vaccine Convacell® is effective against COVID-19: phase 3, randomized, double-blind, placebo-controlled clinical trial

N-protein vaccine Convacell® is effective against COVID-19: phase 3, randomized, double-blind, placebo-controlled clinical trial

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

Vaccine adjuvants for infectious disease in the clinic

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