An Open Comprative Study of the Prophylactic Efficacy and a Non-comparative Study of theImmunogenicity and Safety of the Inactivated Whole-virion Concentrated PurifiedCoronavirus Vaccine (CoviVac) Produced by FSBSI "Chumakov Federal Scientific Center forResearch and Development of Immune-and-Biological Products" for Adults Aged 60 Years andOlder
An open comparative multicenter prospective study with retrospective data.
Biological: CoviVac vaccine (inactivated whole-virion concentrated purified) manufactured by FSBSI "Chumakov FSC R&D IBP RAS"
200 volunteers who will be vaccinated with the CoviVac vaccine three times with an
interval of 21 days intramuscularly at a dose of 0.5 ml.
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.
- 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 according to anamnesis.
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 systemic glucocorticosteroids (≥ 20 mg of prednisone, or an analog,
for more than 15 days during the last month).
- Volunteers who received immunoglobulin preparations or blood transfusion during the
last 3 months prior to the start of the study according to anamnesis.
Other non-inclusion criteria
• Participation in any other clinical trial within the last 3 months.
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;
- Taking unauthorized medications (see section 6.2);
- 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.
State Budgetary Healthcare Institution of the Moscow region "Elektrostal Central City Hospital"
Elektrostal, Moscow Oblast, Russian Federation
Federal State Budgetary Scientific Institution "I.I. Mechnikov Scientific Research Institute of Vaccines and Serums"
Moscow, Russian Federation
FSBSI Chumakov FSC R&D IBP RAS
Moscow, Russian Federation
Private healthcare institution "Clinical Hospital "Russian Railways-Medicine" named after N.A. Semashko"
Moscow, Russian Federation
Limited Liability Company "Scientific Research Center Ecosecurity"
Moscow, Russian Federation
Federal State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency"
Novosibirsk, Russian Federation
Federal State Budgetary Educational Institution of Higher Education "Perm State Medical University named after Academician E.A. Wagner" of the Ministry of Health of the Russian Federation
Perm, Russian Federation
Not Provided