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) for Adults Aged 60 Years and Older
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Corona Virus Infection
- Sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
- Enrollment
- 200
- Locations
- 7
- Primary Endpoint
- Frequency of development, type and association with vaccination of adverse events during the study.
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
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" for Adults Aged 60 Years and Older
Detailed Description
An open comparative multicenter prospective study with retrospective data.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Volunteers must meet the following inclusion criteria:
- •Type of participants
- •Healthy volunteers or volunteers with a history of stable diseases that do not meet any of the criteria for non-inclusion in the study.
- •Other inclusion criteria
- •Written informed consent of volunteers to participate in a clinical trial
- •Volunteers who are able to fulfill the Protocol requirements (i.e., fill out a self-observation Diary, come to control visits).
Exclusion Criteria
- •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
- •Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm in diameter) or complication (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a feverish state) to any previous vaccination.
- •Burdened allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, serum sickness in the anamnesis, hypersensitivity or allergic reactions to the introduction of any vaccines in the anamnesis, known allergic reactions to vaccine components, etc.).
- •Guillain-Barre syndrome (acute polyradiculitis) in the anamnesis.
- •The axillary temperature at the time of vaccination is more than 37.0 ° C.
- •Acute infectious diseases (recovery earlier than 4 weeks before vaccination) according to anamnesis.
- •Donation of blood or plasma (in the amount of 450 ml or more) less than 2 months before inclusion in the study.
- •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.
Outcomes
Primary Outcomes
Frequency of development, type and association with vaccination of adverse events during the study.
Time Frame: 6 month
Frequency of development, type and association with vaccination of adverse events during the study.
Titer of specific antibodies
Time Frame: 21 days
The proportion of volunteers from the total number of vaccinated with the level of seroconversion (titer of specific antibodies = 4 times the baseline level) on 21 days after the course of vaccination in the reaction of viral neutralization and / or ELISA.
GMT on day 21 after the course of vaccination
Time Frame: 21 days
The proportion of volunteers with an increase in the level of immune response in the form of geometric mean titers of specific antibodies (GMT) on day 21 after the course of vaccination in the reaction of viral neutralization and / or ELISA.
The frequency of occurrence of clinically significant deviations from the norm of the main indicators of vital functions and laboratory parameters.
Time Frame: 6 month
The frequency of occurrence of clinically significant deviations from the norm of the main indicators of vital functions and laboratory parameters.
Secondary Outcomes
- ARVI, COVID-19(6 month)