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)

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