A single blind, placebo-controlled randomized study of the safety, reactogenicity and immunogenicity of the “EpiVacCorona” Vaccine for the prevention of COVID-19, in volunteers aged 18–60 years (phase I–II)

Abstract

Vaccination of the population is one of the most effective countermeasures in responding to the pandemic caused by novel coronavirus infection. Therefore, scientists all over the world have been working to develop effective and safe vaccines. We have developed a synthetic peptide vaccine, EpiVacCorona, against novel SARS-CoV-2 coronavirus, which is a suspension for intramuscular administration containing a composition of chemically synthesized peptide immunogens of the S protein of SARS-CoV-2 coronavirus conjugated to a carrier protein and adsorbed on aluminum hydroxide. Phase I–II clinical trials of the vaccine have started that consist of two stages: Stage 1 is an open study of the safety, reactogenicity, and immunological activity of the vaccine with the involvement of 14 volunteers aged 18–30 years; Stage 2 is a single blind, comparative, randomized placebo-controlled study with the involvement of 86 volunteers. The study involved volunteers aged 18–60 years; the vaccine was injected intramuscularly twice, spaced 21 days apart between injections. All local reactions in response to vaccine administration were mild, such as a short-term pain at the injection site. There were no signs of development of local or systemic adverse reactions. The two-dose vaccination scheme induced the production of antibodies, specific to the antigens that make up the vaccine, in 100% of the volunteers. Seroconversion with a neutralizing antibody titer ≥ 1:20 was reported in 100% of the volunteers 21 days following the second immunization dose. No seroconversion was reported in the groups of volunteers vaccinated with a placebo. The peptide-based EpiVacCorona Vaccine has low reactogenicity and is a safe, immunogenic product. Clinical Trials Identifier: NCT04527575.

Flavonoids are promising safe therapy against COVID-19

“…Recently, several vaccine platforms were entered into the clinical evaluation (Le et al 2020). These include (i) Nucleic acid vaccines as mRNA-based-vaccines such as Moderna (Mahase 2020), BioNTech/Pfizer (Müller et al 2021) (Palacios et al 2020) developed by China Sinovac biotech company; (iv) Antigen-based vaccine EpiVacCorona that was developed by the Vector Institute (Ryzhikov et al 2021). On the other hand, the treatments suggested for COVID-19 are limited to those either still in clinical trials such as favipiravir (Pilkington et al 2020), ribavirin (Khalili et al 2020), lopinavir-ritonavir (Dalerba et al 2020), emetine (Choy et al 2020), hydroxychloroquine (Chen et al 2020a), methionine (Zhang et al 2020), homoharringtonine and ivermectin (Elgazzar et al 2020) or initially approved by U.S. FDA such as remdesivir (Beigel et al 2020).…”

An Update on the Pathogenesis of COVID-19 and the Reportedly Rare Thrombotic Events Following Vaccination

“…In this study, the 2-dose vaccination scheme induced the production of antibodies specific to the antigens that make up the vaccine in 100% of the volunteers. 112 No serious adverse events have been reported. Phase 3 clinical trials were registered in March 2021 and have not been published yet.…”

COVID-19: Myths and Reality

“…It is a suspension for intramuscular administra tion that contains a mixture of chemically synthesized peptide immunogens of the SARS CoV 2 S protein con jugated with the protein carrier and adsorbed onto alu minum hydroxide. The first data on its application were published recently [121]. Currently, this vaccine is in phase I II clinical trials.…”