Immunogenicity and protectivity of the peptide candidate vaccine against SARS-CoV-2

Abstract

Background: In 2020, the pandemic caused by novel coronavirus infection has become one of the most critical global health challenges during the past century. The lack of a vaccine, as the most effective way to control the novel infection, has prompted the development of a large number of preventive products by the scientific community. We have developed a candidate vaccine (EpiVacCorona) against novel coronavirus infection caused by SARS-CoV-2 that is based on chemically synthesized peptides conjugated to a carrier protein and adsorbed on aluminum hydroxide and studied the specific activity of the developed vaccine.
 Aims: Study of the immunogenicity and protectivity of the peptide candidate vaccine EpiVacCorona.
 Materials and methods: the work was performed using standard molecular biological, virological and histological methods.
 Results: It was demonstrated that EpiVacCorona, when administered twice, spaced 14 days apart, to hamsters, ferrets, and non-human primates (African green monkeys, rhesus macaques) at a dose of 260 g, which is equal to one inoculation dose for humans, induces virus-specific antibodies in 100% of the animals. Experiments in hamsters showed this vaccine to be associated with the dose-dependent immunogenicity. The vaccine was shown to accelerate the elimination of the virus from the upper respiratory tract in ferrets and prevent the development of pneumonia in hamsters and non-human primates following a respiratory challenge with novel coronavirus.
 Conclusions: The results of a preclinical specific activity study indicate that the use of EpiVacCorona has the potential for human vaccination.

SARS-CoV-2 Vaccines Based on the Spike Glycoprotein and Implications of New Viral Variants

“…The only vaccine approved based on Spike epitopes is EpiVacCorona, with emergency use in Russia and Turkmenistan (160). Preclinical tests demonstrated the induction of antibodies against SARS-CoV-2 in 100% of immunized animals (162), however, clinical trials will be required to fully assess the effectiveness of this vaccine (163).…”

COVID-19: comprehensive review on mutations and current vaccines

“…The vaccine showed 90% efficiency as per reports after administration of two doses in 21 days. Reports also revealed the vaccine tolerability, safety, immunogenicity against COVID-19 (Ryzhikov et al 2021 ). The total 3000 study participants participated (Clinical id NCT04527575) in this clinical trial.…”

Counting on COVID-19 Vaccine: Insights into the Current Strategies, Progress and Future Challenges

“…Currently, it is approved for emergency use in Russia, Belarus, and Turkmenistan. Immunogenicity and protectivity of the peptide candidate were assessed in a preclinical study [ 92 ]. EpiVacCorona was administered in two doses (260 μg each) 14 days apart to hamsters, ferrets, African green monkeys, and Rhesus macaques monkeys.…”

“…A phase I/II clinical trial regarding EpiVacCorona (NCT04527575) was conducted with 14 volunteers at stage I aged between 18 and 30 years and 86 volunteers in stage 2 aged between 18 and 60 years [ 92 , 94 ]. Participants were injected with two doses of EpiVacCorona 21 days apart.…”

“…81.8% of the people experienced adverse events after both the first and the second dose. Ryzhikov and colleagues reported mild pain at the injection site as the only adverse effect of EpiVacCorona [ 92 ].…”