This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19
- Conditions
- Coronavirus InfectionsVaccine
- Interventions
- Biological: Vaccine for intramuscular injectionOther: Placebo comparator (without active ingredient) for intramuscular injection
- Registration Number
- NCT05046548
- Lead Sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vaccine Vaccine for intramuscular injection At Stage I: Group 1 - 10 volunteers, Vaccine 0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage II: Group 1 - 140 volunteers,Vaccine0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage III: Group 3 - 150 volunteers, Vaccine 0.5 ml, 14 days interval, post-vaccination observation for 6 months. Placebo Placebo comparator (without active ingredient) for intramuscular injection No active ingredient in the placebo At Stage I: Group 2 - 5 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage II: Group 2 - 45 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage III: Group 4 - 50 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 6 months.
- Primary Outcome Measures
Name Time Method Geometric mean titer (GMT) 28 days after second vaccination / placebo 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.
- Secondary Outcome Measures
Name Time Method Geometric mean titer (GMT) 7 and 14 days after the first vaccination / placebo 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.
Evaluation of clinically significant abnormalities in vital signs within 6 months after the first dose frame of vaccine / placebo The incidence of clinically significant deviations from the main indicators of vital functions.
Evaluation of clinically significant deviations from laboratory parameters 3, 7, 10 and 14 days after the first vaccination; 4, 7, 14 and 28 days after the second vaccination The incidence of clinically significant deviations from the laboratory parameters.
Cases of early termination of participation of volunteers in the study within 6 months after the introduction of the first dose of vaccine / placebo Cases of early termination of the volunteer's use in suggesting the development of AE / SAE associated with the use of study drugs.
Assessment of adverse events within 6 months after the first dose of vaccine / placebo The incidence of adverse events during the study
Seroconversion rate [Time frame: 7 and 14 days after first vaccination / placebo] 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, Seroconversion rate on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months, 6 months after second vaccination / placebo.
Level of γ-IFN and subpopulation composition of T-lymphocytes 7 and 14 days after the first vaccination / placebo 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.
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19) Within 6 months after the second vaccination / placebo The duration of acute respiratory infections (influenza, acute respiratory infections, COVID-19) within six months after the second dose of vaccine / placebo.
Frequency and severity of adverse events Within 6 months after the first dose of vaccine / placebo The incidence and severity of adverse events throughout the study period after the first dose of vaccine / placebo
Trial Locations
- Locations (5)
FSBSI Chumakov FSC R&D IBP RAS
🇷🇺Moscow, Russian Federation
Center for Family Medicine Joint Stock Company (CSM JSC)
🇷🇺Yekaterinburg, Russian Federation
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia
🇷🇺Kirov, Russian Federation
Eco-Safety Scientific Research Center LLC
🇷🇺Sankt Peterburg, Russian Federation
FGBUZ MSCh No. 163 FMBA of Russia
🇷🇺Novosibirsk, Russian Federation