Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", on adult volunteers aged 18-60" (Clinical trials, phase I/II). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine sorbed on adult volunteers aged 18-60.
The study is divided into 3 stages. At Stages I and II of the study, a maximum of 300 healthy volunteers aged 18 to 60 years should be screened, of which 200 volunteers meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the tolerability and safety of the vaccine. Stage I includes 15 men and women: Group 1 - 10 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days. Group 2 - 5 volunteers who will receive placebo twice with an interval of 14 days intramuscularly at a dose of 0.5 ml with a post-vaccination observation period of 28 days. Stage II includes 185 volunteers: Group 1 - 140 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days. Group 2 - 45 volunteers who received placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days. Stage III of the study, a maximum of 300 volunteers should be screened, of which 200 volunteers, meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the safety and immunogenicity of the vaccine. Group 3 - 150 volunteers who will receive the vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a period of post-vaccination observation for 6 months. Group 4 - 50 volunteers who will receive placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 6 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
400
Volunteers (10 at the Stage 1; 140 at the Stage 2; 150 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml
Volunteers (5 at the Stage 1; 45 at the Stage 2; 50 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia
Kirov, Russia
FSBSI Chumakov FSC R&D IBP RAS
Moscow, Russia
FGBUZ MSCh No. 163 FMBA of Russia
Novosibirsk, Russia
Eco-Safety Scientific Research Center LLC
Saint Petersburg, Russia
Center for Family Medicine Joint Stock Company (CSM JSC)
Yekaterinburg, Russia
Geometric mean titer (GMT)
The percentage of volunteers with an increase in geometric mean titer of specific antibodies (GMT) on day 28 after the second dose of vaccine / placebo in the virus neutralization test and ELISA.
Time frame: 28 days after second vaccination / placebo
Geometric mean titer (GMT)
Percentage of volunteers with a fourfold (or more) level of seroconversion in the neutralization test and ELISA on days 7 and 14 after the first dose of vaccine / placebo; on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months, 6 months after the second dose of vaccine / placebo.
Time frame: 7 and 14 days after the first vaccination / placebo
Seroconversion rate [Time frame: 7 and 14 days after first vaccination / placebo]
Seroconversion rate on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months, 6 months after second vaccination / placebo.
Time frame: Percentage of volunteers with a fourfold (or more) level of seroconversion in the neutralization reaction and the ELISA reaction on days 7 and 14 after the first dose of vaccine / placebo; on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months,
Level of γ-IFN and subpopulation composition of T-lymphocytes
Levels of γ-IFN and subpopulation composition of T-lymphocytes on days 7 and 14 after the administration of the first dose of vaccine / placebo; on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months, 6 months, after the second dose of vaccine / placebo.
Time frame: 7 and 14 days after the first vaccination / placebo
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)
The frequency of acute respiratory infections (influenza, acute respiratory infections, COVID-19) within six months after the second dose of vaccine / placebo.
Time frame: Within 6 months after the second vaccination / placebo
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)
The severity of acute respiratory infections (influenza, acute respiratory infections, COVID-19) within six months after the second dose of vaccine / placebo.
Time frame: Within 6 months after the second vaccination / placebo
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)
The duration of acute respiratory infections (influenza, acute respiratory infections, COVID-19) within six months after the second dose of vaccine / placebo.
Time frame: Within 6 months after the second vaccination / placebo
Frequency and severity of adverse events
The incidence and severity of adverse events throughout the study period after the first dose of vaccine / placebo
Time frame: Within 6 months after the first dose of vaccine / placebo
Assessment of adverse events
The incidence of adverse events during the study
Time frame: within 6 months after the first dose of vaccine / placebo
Evaluation of clinically significant abnormalities in vital signs
The incidence of clinically significant deviations from the main indicators of vital functions.
Time frame: within 6 months after the first dose frame of vaccine / placebo
Evaluation of clinically significant deviations from laboratory parameters
The incidence of clinically significant deviations from the laboratory parameters.
Time frame: 3, 7, 10 and 14 days after the first vaccination; 4, 7, 14 and 28 days after the second vaccination
Cases of early termination of participation of volunteers in the study
Cases of early termination of the volunteer's use in suggesting the development of AE / SAE associated with the use of study drugs.
Time frame: within 6 months after the introduction of the first dose of vaccine / placebo
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