Safety, Tolerability and Immunogenicity of Recombinant COVID-19 Vaccine Betuvax-CoV-2
- Conditions
- COVID-19
- Interventions
- Biological: Betuvax-CoV-2Drug: Placebo
- Registration Number
- NCT05270954
- Lead Sponsor
- Human Stem Cell Institute, Russia
- Brief Summary
Randomized, double-blind, multicenter parallel-group clinical study of safety, tolerability and immunogenicity of the Betuvax-CoV-2 vaccine. The aim of this study is to investigate the safety, tolerability and immunogenicity of the Betuvax-CoV-2 Recombinant vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus, suspension for intramuscular administration, 10 μg/ml and 40 μg/ml (Ltd. Institute of New Medical Technologies, Russia) in healthy adult volunteers, aged 18 to 60 (inclusive).
- Detailed Description
Participation of the volunteers in the study includes Visit 0 (screening), Visits 1-4 and Visits 10-13 (on an inpatient basis), Visits 5-9 and Visits 14-20 (on an outpatient basis). During Visits 2 and 11, volunteers receive either a study drug (one of two dosages) or a placebo.
The study includes 116 healthy male and female volunteers aged 18 to 60 (inclusive) years who meet the inclusion criteria.
All volunteers are enrolled in two stages of the study and at each stage they are randomized into two or three groups, respectively.
Taking into account the estimated number of volunteers found by the screening results as not meeting the inclusion criteria (54 people), 170 volunteers are screened in the First and Second stage.
The vaccination course includes two intramuscular injections within a 28-day period.
The first stage of the study:
* Group 1 (10 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first injection of 20 μg (0.5 ml of suspension for intramuscular administration of 40 μg/ml), the second injection of 5 μg (0.5 ml of suspension for intramuscular injection of 10 μg/ml) in 28 days.
* Group 2 (10 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first and second injection of 20 μg (0.5 ml of solution for intramuscular injection of 40 μg/ml) within a 28-day period.
The second stage of the study:
* Group 3 (32 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first injection of 20 μg (0.5 ml of the suspension for intramuscular administration of 40 μg/ml), the second injection of 5 μg (0.5 ml of the suspension for intramuscular injection of 10 μg/ml) in 28 days.
* Group 4 (32 people) will be intramuscularly administered the study drug Betuvax-CoV-2 according to the following scheme: the first and second injection of 20 μg (0.5 ml of solution for intramuscular injection of 40 μg/ml) within a 28-day period.
* Group 5 (32 people) will receive a placebo according to the following scheme: the first and second injections (0.5 ml of sodium chloride 0.9% solution, intramuscularly) within a 28-day period.
Study participants will be closely monitored for their intended outcomes. Key safety outcomes will be centrally reviewed by the Independent Data Monitoring Committee (ICMD). Investigators will be required to report anticipated safety outcomes in a timely manner (within 24 hours if possible) and to record these outcomes in the CRF in a timely manner (within 24 hours if possible).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 116
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 (Phase 1) Betuvax-CoV-2 All volunteers randomized to Group 1 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period. Group 2 (Phase 1) Betuvax-CoV-2 All volunteers randomized to Group 2 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period. Group 3 (Phase 2) Betuvax-CoV-2 All volunteers randomized to Group 3 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 5 μg, twice, within a 28-day period. Group 4 (Phase 2) Betuvax-CoV-2 All volunteers randomized to Group 4 will be administered the Betuvax-CoV-2 drug according to the following scheme: 20 μg + 20 μg, twice, within a 28-day period. Group 5 (Phase 2) Placebo Volunteers randomized to Group 5 will be administered a placebo reference drug (0.9% aqueous sodium chloride solution), twice, within a 28-day period.
- Primary Outcome Measures
Name Time Method Adverse events Within 50 days of the first dose of the study drug/placebo The proportion of the volunteers with any adverse events
Severe adverse events Within 50 days of the first dose of the study drug/placebo The proportion of the volunteers with severe adverse events
Neutralizing anti-SARS-CoV-2 antibodies 90±5 days after the first administration of the study drug/placebo The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)
Total specific anti-SARS-CoV-2 antibodies 90±5 days after the first administration of the study drug/placebo The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
- Secondary Outcome Measures
Name Time Method Geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies 180±5 days after the first administration of the study drug/placebo The proportion of the volunteers with geometric mean titers of the IgM-specific anti-SARS-CoV-2 antibodies (ELISA test)
Severe or extremely severe course of COVID-19, or lethal outcome From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo The proportion of the volunteers with COVID-19 of severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection
Any adverse events Within 180±5 days after the first dose of the study drug/placebo The proportion of the volunteers with any adverse events
IgG-specific anti-SARS-CoV-2 antibodies 180±5 days after the first dose of the study drug/placebo The proportion of the volunteers with an increased level of the IgG-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
IgM-specific anti-SARS-CoV-2 antibodies 180±5 days after the first dose of the study drug/placebo The proportion of the volunteers with an increased level of the IgM-specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Neutralizing anti-SARS-CoV-2 antibodies 180±5 days after the first administration of the study drug/placebo The proportion of the volunteers tested positive for the presence of neutralizing anti-SARS-CoV-2 antibodies (SARS-CoV-2 Surrogate Virus Neutralization Test)
Geometric mean titers of the total anti-SARS-CoV-2 antibodies 180±5 days after the first administration of the study drug/placebo The proportion of the volunteers with geometric mean titers of the total anti-SARS-CoV-2 antibodies (ELISA test)
Geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies 180±5 days after the first administration of the study drug/placebo The proportion of the volunteers with geometric mean titers of the IgG-specific anti-SARS-CoV-2 antibodies (ELISA test)
Specific anti-SARS-CoV-2 cellular immune response (Phase 1) 90±5 days after the first dose of the study drug (only in Phase 1) The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (flow cytometry)
Specific anti-SARS-CoV-2 cellular immune response 180±5 days after the first dose of the study drug/placebo The proportion of the volunteers with a specific anti-SARS-CoV-2 cellular immune response (ELISPOT)
COVID-19 symptoms From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of study drug/placebo The proportion of the volunteers with at least one COVID-19 symptom (fever, chills, dyspnoea, difficulty breathing, cough, sore throat, fatigue, muscle pain, loss or decrease in taste and/or odor, nasal congestion, runny nose, headache, nausea, vomiting, diarrhea) and a PCR-confirmed SARS-CoV-2 infection
Moderate, severe or extremely severe course of COVID-19, or lethal outcome From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo The proportion of the volunteers with COVID-19 of moderate, severe or extremely severe course, or with a lethal outcome, and a PCR-confirmed SARS-CoV-2 infection
Lethal outcome From the 7th day after the second administration of the study drug/placebo till the 180±5 day after the first dose of the study drug/placebo The proportion of the volunteers with lethal outcome, and a PCR-confirmed SARS-CoV-2 infection
Allergic reactions Within 2 hours of the second study drug/placebo administration The proportion of the volunteers with immediate side effects (allergic reactions)
Local post-vaccination reactions Within 7 days after the second administration of the study drug/placebo The proportion of the volunteers with local post-vaccination reactions
Systemic post-vaccination reactions Within 7 days after the second administration of the study drug/placebo The proportion of the volunteers with systemic post-vaccination reactions
Total specific anti-SARS-CoV-2 antibodies 180±5 days after the first administration of the study drug/placebo The proportion of the volunteers with an increased level of the total specific anti-SARS-CoV-2 antibodies by 4 times or more (ELISA test)
Severe local post-vaccination reactions Within 7 days of the second study drug/placebo administration The proportion of the volunteers with \>grade 3 of local post-vaccination reactions
Adverse events of special interest Within 180±5 days after the first dose of the study drug/placebo The proportion of the volunteers with adverse events of special interest, adverse reactions that require medical attention, with newly developed chronic diseases
Prematurely terminated participation Within 180±5 days after the administration of the first dose of the study drug/placebo The proportion of the volunteers who prematurely terminated their participation in the study due to the development of adverse events or severe adverse events associated with the use of the study drug
Severe systemic post-vaccination reactions Within 7 days after the second administration of the study drug/placebo The proportion of the volunteers with \>grade 3 of severe systemic post-vaccination reactions
Severe adverse events Within 180±5 days after the first dose of the study drug/placebo The proportion of the volunteers with severe adverse events
Trial Locations
- Locations (3)
"Eco-Safety" R&D center
🇷🇺Saint Petersburg, Russian Federation
Center of professional medicine
🇷🇺Perm, Russian Federation
Department of Vaccinology, Smorodintsev Research Institute of Influenza of the Ministry of Health of the Russian Federation
🇷🇺Saint Petersburg, Russian Federation