Immunogenicity and in vivo protective effects of recombinant nucleocapsid-based SARS-CoV-2 vaccine Convacell®

Rabdano, Sevastyan O.; Ruzanova, Ellina; Pletiukhina, Iuliia; 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; Kruchko, Daria; Berzin, Igor; Belozerova, Natalia S.; Evtushenko, Anatoly E.; Трухин, В. П.; Скворцова, В. В.

doi:10.22541/au.167608809.97775460/v1

Cited by 6 publications

(9 citation statements)

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“…Convacell®'s protection is evidently long lasting, given the lack of convergence between the placebo and vaccinated groups' COVID-19 incidence rates over the 180~195 days of observation in this study. Based on the immune response longevity data obtained in the previous phases of Convacell®'s study (13), we can reasonably assume that Convacell®'s protection should last at least a year, given that vaccinated individuals are positive for anti-N antibodies for at least a year after vaccination.…”

Section: Discussionmentioning

confidence: 99%

“…The internal nature of the N protein in mature virions does not negatively affect Convacell®'s protectivity, as the N protein is highly expressed in infected cells (26,27) and exposed on their membranes (28,29), which allows such cells to be targeted and eliminated by cytotoxic T-cell (30)(31)(32) and natural killer (NK) cell action (33)(34)(35). Currently, highly efficient infected cell clearance is theorized to be the main protective mechanism of Convacell®-generated immunity, based on the antibody-dependent NK cell activation data obtained in phase II of Convacell®'s clinical trials (13).…”

Section: Discussionmentioning

confidence: 99%

“…The usage of the internal N protein as the main antigen in Convacell® confers on it a number of advantages. The N protein is notably conservative (7,8,21–24), which confers onto Convacell®-generated immune responses both longevity (5) and broad cross-reactivity among SARS-CoV-2 variants (25). The internal nature of the N protein in mature virions does not negatively affect Convacell®’s protectivity, as the N protein is highly expressed in infected cells (26,27) and exposed on their membranes (28,29), which allows such cells to be targeted and eliminated by cytotoxic T-cell (30–32) and natural killer (NK) cell action (33–35).…”

Section: Discussionmentioning

confidence: 99%

“…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). COVID-19 vaccines based on the N protein have already been described as promising in multiple papers (6–12).…”

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%

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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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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

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

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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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The Key to Increase Immunogenicity of Next-Generation COVID-19 Vaccines Lies in the Inclusion of the SARS-CoV-2 Nucleocapsid Protein

Mendoza-Ramírez,

García-Cordero,

Shrivastava

et al. 2024

Journal of Immunology Research

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Vaccination is one of the most effective prophylactic public health interventions for the prevention of infectious diseases such as coronavirus disease (COVID-19). Considering the ongoing need for new COVID-19 vaccines, it is crucial to modify our approach and incorporate more conserved regions of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to effectively address emerging viral variants. The nucleocapsid protein is a structural protein of SARS-CoV-2 that is involved in replication and immune responses. Furthermore, this protein offers significant advantages owing to the minimal accumulation of mutations over time and the inclusion of key T-cell epitopes critical for SARS-CoV-2 immunity. A novel strategy that may be suitable for the new generation of vaccines against COVID-19 is to use a combination of antigens, including the spike and nucleocapsid proteins, to elicit robust humoral and potent cellular immune responses, along with long-lasting immunity. The strategic use of multiple antigens aims to enhance vaccine efficacy and broaden protection against viruses, including their variants. The immune response against the nucleocapsid protein from other coronavirus is long-lasting, and it can persist up to 11 years post-infection. Thus, the incorporation of nucleocapsids (N) into vaccine design adds an important dimension to vaccination efforts and holds promise for bolstering the ability to combat COVID-19 effectively. In this review, we summarize the preclinical studies that evaluated the use of the nucleocapsid protein as antigen. This study discusses the use of nucleocapsid alone and its combination with spike protein or other proteins of SARS-CoV-2.

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Immunogenicity and in vivo protective effects of recombinant nucleocapsid-based SARS-CoV-2 vaccine Convacell®

Cited by 6 publications

References 0 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

Vaccine adjuvants for infectious disease in the clinic

The Key to Increase Immunogenicity of Next-Generation COVID-19 Vaccines Lies in the Inclusion of the SARS-CoV-2 Nucleocapsid Protein

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