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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
Full description
The study group is planned to screen a maximum of 32,000 volunteers inclusive, of which it is planned to include 3,500 men and women aged 18 to 60 years who meet the criteria for inclusion in the study and do not have non-inclusion criteria.
The study group consisted of 3,500 volunteers who received the CoviVac vaccine
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).
Cohorts:
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 - official data on the number of Covid-19 cases during the study period among 3,500 unvaccinated individuals.
The data of the control group volunteers will be used to evaluate the effectiveness of the vaccine under study.
Enrollment
Sex
Ages
Volunteers
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.
Age at the time of signing the Informed Consent * from ≥ 18 to < 60 years.
Paul * Male or female.
The volunteers of the study group must meet the following additional inclusion criteria:
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).
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
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
Other non-inclusion criteria
* Pregnancy or breast-feeding. Participation in any other clinical trial within the last 3 months.
Volunteers of the study group cannot be included in the study if any of the following criteria are present:
Diseases or medical conditions
Exclusion criteria:
Withdrawal of Informed consent by a volunteer;
* The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol;
• Any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study;
* The established fact of pregnancy before the second vaccination;
* The volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation;
* For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as in case of gross violations of the Protocol that may affect the results of the study.
Primary purpose
Allocation
Interventional model
Masking
29,000 participants in 2 patient groups
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Central trial contact
Aydar Ishmukhametov, M.D.,Prof.,Assoc.Mem.of RAS; Andrew Malkin, M.D., Ph.D, MBA
Data sourced from clinicaltrials.gov
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