免疫原性
接种疫苗
不利影响
随机对照试验
流感疫苗
病毒学
2019年冠状病毒病(COVID-19)
耐受性
临床试验
免疫学
安慰剂对照研究
作者
Alexander B. Ryzhikov,Е. А. Ryzhikov,Marina P. Bogryantseva,S. V. Usova,E. D. Danilenko,E. A. Nechaeva,Oleg V. Pyankov,Olga G. Pyankova,Andrei S. Gudymo,Sergei A. Bodnev,Galina S. Onkhonova,E. S. Sleptsova,V. I. Kuzubov,N. N. Ryndyuk,Z. I. Ginko,V. N. Petrov,A. A. Moiseeva,P. Yu. Torzhkova,Stepan A. Pyankov,T. V. Tregubchak,D. V. Antonec,Elena V. Gavrilova,Rinat A. Maksyutov
出处
期刊:Russian Journal of Infection and Immunity
日期:2021-03-24
卷期号:11 (2): 283-296
被引量:41
标识
DOI:10.15789/2220-7619-asb-1699
摘要
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.
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