Clinical trial NCT05765773: An Open Comparative Study of the Effectiveness and Incomparable Study of the Immunogenicity and Safety of the Vaccine (CoviVac) for Adults Aged 60 Years and Older
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Corona Virus Infection
Vaccine
COVID-19
Keywords: COVID-19
SARS-Cov-2
Lead sponsor: Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
Sponsor class: OTHER_GOV
First posted: 2023-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.
* 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.

Primary outcomes:
measure: Frequency of development, type and association with vaccination of adverse events during the study.
timeFrame: 6 month
measure: Titer of specific antibodies
timeFrame: 21 days
measure: GMT on day 21 after the course of vaccination
timeFrame: 21 days
measure: The frequency of occurrence of clinically significant deviations from the norm of the main indicators of vital functions and laboratory parameters.
timeFrame: 6 month
Secondary outcomes:
measure: ARVI, COVID-19
timeFrame: 6 month
Other outcomes:
Locations:
city: Elektrostal
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Moscow region "Elektrostal Central City Hospital"
state: Moscow Oblast
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "I.I. Mechnikov Scientific Research Institute of Vaccines and Serums"
city: Moscow
country: Russian Federation
facility: FSBSI Chumakov FSC R&D IBP RAS
city: Moscow
country: Russian Federation
facility: Private healthcare institution "Clinical Hospital "Russian Railways-Medicine" named after N.A. Semashko"
city: Moscow
country: Russian Federation
facility: Limited Liability Company "Scientific Research Center Ecosecurity"
city: Novosibirsk
country: Russian Federation
facility: Federal State Budgetary Healthcare Institution "Medical and Sanitary Unit No. 163 of the Federal Medical and Biological Agency"
city: Perm
country: Russian Federation
facility: 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
Study officials:
References: