An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac)
1 other identifier
interventional
29,000
1 country
10
Brief Summary
An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of the Immunogenicity and Safety of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine (CoviVac), Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2021
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 7, 2021
CompletedFirst Submitted
Initial submission to the registry
May 24, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2023
CompletedFebruary 8, 2023
February 1, 2023
1.9 years
May 24, 2022
February 6, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficasy assessment
The proportion of vaccinated volunteers who do not have laboratory and clinically confirmed COVID-19 disease within 12 months after the second vaccination for all volunteers
12 month
Secondary Outcomes (9)
Classification by severity of COVID-19
12 month
The proportion of study subjects who died
12 month
The duration of laboratory and clinically confirmed COVID-19 disease.
12 month
The proportion of volunteers from the total number of vaccinated / revaccinated with an increase in the level of the immune response
12 month
Titer of specific antibody titer ≥ 4 times baseline Specific antibody titer ≥ 4 times baseline
12 month
- +4 more secondary outcomes
Study Arms (2)
The study group consisted of 3,500 volunteers who received the CoviVac vaccine
EXPERIMENTALSubgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days and revaccinated at 6 months with one dose of the KoviVac vaccine. Cohort 1 - The first 1000 volunteers of the study group will be used to assess the efficacy + safety + immunogenicity of the vaccine under study. Cohort 2 - Next 1100 volunteers of the study group will be used to analyze the efficacy + safety of the vaccine under study. Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml. The data of 1400 volunteers vaccinated three times with an interval of 21 days will be used to assess the effectiveness + safety + immunogenicity of the vaccine under study.
Control group
OTHERThe data from volunteers from the control group will be used to evaluate the effectiveness of the investigational vaccine.
Interventions
Subgroup 1 - 2100 volunteers who will be vaccinated with the Nobivac vaccine twice with an interval of 21 days intramuscularly at a dose of 0.5 ml and revaccinated at 6 months with one dose of the KoviVac vaccine (0.5 ml). Subgroup 2 - 1400 volunteers who will be vaccinated with CoviVac vaccine three times at intervals of 21 days intramuscularly at a dose of 0.5 ml.
Official data on the number of Covid-19 cases during the study period among 3,500 unvaccinated individuals.
Eligibility Criteria
You may qualify if:
- Age at the time of signing the Informed Consent \* from ≥ 18 to \< 60 years.
- Paul \* Male or female.
- Written Informed consent of volunteers to participate in a clinical trial.
- Volunteers who are able to fulfill Protocol requirements (i.e. answer phone calls, fill out a Self-observation Diary, come to control visits).
- For women capable of childbirth - a negative pregnancy test and consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Women should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals), or be sterile, or in a postmenopausal state.
- For men capable of conception - consent to adhere to adequate methods of contraception (use of contraceptives within a month after the second vaccination). Men and their sexual partners should use methods of contraception with a reliability of more than 90% (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine spirals), or be sterile.
You may not qualify if:
- Volunteers cannot be included in the study if any of the following criteria are present:
- SARS-CoV-2 infection
- \* A case of established COVID-19 disease confirmed by PCR and/or ELISA in the last 6 months.
- Diseases or medical conditions
- Severe and/or uncontrolled diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, gastrointestinal tract, liver, kidneys, hematopoietic, immune systems.
- Is registered at the dispensary for tuberculosis, leukemia, oncological diseases, autoimmune diseases.
- Any confirmed or suspected immunosuppressive or immunodeficiency condition in the anamnesis.
- Splenectomy in the anamnesis.
- Neutropenia (decrease in the absolute number of neutrophils less than 1000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/l) according to anamnesis.
- Anorexia.
- Prior or concomitant therapy
- Vaccination with any vaccine carried out within 30 days before vaccination / the first dose of the studied vaccine or planned administration within 30 days after vaccination / the last dose of the studied vaccine.
- Prior vaccination with an experimental or registered vaccine that may affect the interpretation of the study data (any coronavirus or SARS vaccines).
- Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs (immunoregulatory peptides, cytokines, interferons, immune system effector proteins (immunoglobulins), interferon inducers (cycloferon) during the six months preceding the study, according to anamnesis.
- Treatment with glucocorticosteroids (≥ 20 mg of prednisone, or an analog, for more than 15 days during the last month).
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia
Kirov, 610027, Russia
RUSAL Medical Center LLC
Krasnoyarsk, 660111, Russia
FSBI NIIVS named after I.I. Mechniko
Moscow, 105064, Russia
GBUZ "State Design Bureau named after D.D. Pletnev DZM"
Moscow, 105077, Russia
"Scientific Research Institute of Occupational Medicine named after Academician N.F. Izmerov" (FGBNU "Research Institute of MT")
Moscow, 105275, Russia
CHUZ "Clinical Hospital "Russian Railways-Medicine" named after N.A. Semashko"
Moscow, 109386, Russia
Limited Liability Company "H-Clinic" (LLC "H-Clinic")
Moscow, 127083, Russia
JSC "Medical services" CDL named after N.A.Semashko
Moscow, 129329, Russia
FSBSI Chumakov FSC R&D IBP RAS
Moscow, Russia, 108819, 108819, Russia
Mmc Sogaz Llc
Saint Petersburg, 191186, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2022
First Posted
June 7, 2022
Study Start
July 7, 2021
Primary Completion
June 1, 2023
Study Completion
December 29, 2023
Last Updated
February 8, 2023
Record last verified: 2023-02