Study of the EpiVacCorona Vaccine With the Involvement of Volunteers Aged 60 Years and Above

An Open Study of the Safety, Reactogenicity and Immunogenicity of the Vaccine Based on Peptide Antigens for the Prevention of COVID-19 (EpiVacCorona), With the Involvement of Volunteers Aged 60 Years and Above (Phase III-IV)

The aim of the clinical study is to study the safety, reactogenicity and immunogenicity indicators of the EpiVacCorona vaccine, with the involvement of volunteers aged 60 years and above.

The research tasks are to:

• to evaluate the safety of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older;
• to evaluate the reactogenicity of the EpiVacCorona vaccine when administered twice intramuscularly, with the participation of volunteers aged 60 years and older;
• to identify any adverse effects to the administration of the vaccine;
• to study the humoral and cellular immune responses response following two doses of the EpiVacCorona vaccine, with the participation of volunteers aged 60 and older.

The study will screen a maximum of 180 volunteers, of which it is proposed to include and randomize 150 men and women aged 60 years and older who meet the inclusion criteria and who do not have the exclusion criteria whose data will be used for subsequent safety and immunogenicity analysis.

The 150 volunteers will be vaccinated with the EpiVacCorona vaccine with two doses spaced 21 days apart, intramuscularly, at a dose of 0.5 ml.

The vaccine will be administered in procedure room settings only by a highly qualified specialist (vaccinator).

Inclusion Criteria:

1. Availability of a signed and dated informed consent of the volunteer to participate in a clinical trial, prior to any of the study procedures.
2. Volunteers (men and women) aged 60 and above with stable indicators of basic vital functions.
3. Ability to attend all scheduled visits and all planned procedures and examinations.
4. Postmenopausal women over 60 years old.

Exclusion Criteria:

1. History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or another coronavirus infection (HCoV-229E, HCOV-OC43, HCoV-NL63, HCoV-HKU1).
2. History of exposure to confirmed or suspected cases of SARS-CoV-2 infection within 1 month prior to randomization.
3. Positive for IgM or IgG to SARS-CoV-2 as detected during screening.
4. Positive PCR test for SARS-CoV-2 as detected during screening.
5. Clinically and laboratory (according to PCR data) confirmed disease caused by SARS-CoV-2 coronavirus, at the moment or in the past.
6. Serious post-vaccination reaction (body temperature above 40 °C , hyperemia or edema greater than 8 cm in diameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination; convulsions, with or without of a febrile state) to a previous vaccination in the past.
7. Aggravated allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, history of serum disease, history of hypersensitivity or allergic reactions to the administration of any vaccines, any known allergic reactions to vaccine components, etc.).
8. History of Guillain-Barré syndrome (acute polyradiculitis).
9. Previous vaccination with rabies vaccines within less than 2 months prior to randomization, or planned vaccination with rabies vaccines within 1 month after immunization with the vaccine under study.
10. Hypersensitivity to any component of the product, allergy to vaccine components.
11. Persons in custody in detention facilities and those serving sentences in correctional facilities.
12. Symptoms of any disease at the time of inclusion in the study or if it has passed less than 4 weeks since recovery.
13. History of any acute respiratory illness less than 3 months prior to randomization.
14. Acute infectious or non-infectious diseases, exacerbation of chronic diseases less than 4 weeks prior to randomization.
15. History of tuberculosis (pulmonary and extrapulmonary), cancer, autoimmune diseases, skin diseases (pemphigus, psoriasis, eczema, atopic dermatitis).
16. Long-term use (more than 14 days) of immunosuppressants, systemic glucocorticosteroids or immunomodulatory drugs within 6 months prior to randomization.
17. Vaccination with any vaccine within one month prior to vaccination.
18. Use of immunoglobulin drugs or blood products within 3 months prior to randomization.
19. Acute or chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine system, as well as diseases of the gastrointestinal tract, liver, kidneys, blood, surgery on the gastrointestinal tract (except appendectomy).
20. Participation in other clinical trials less than 3 months prior to randomization.
21. Persons with alcohol or drug abuse (medications or narcotics). Use of more than 10 units of alcohol per week (1 unit of alcohol is equivalent to ½ liter of beer, or 200 ml of wine or 50 ml of alcohol) or history of alcoholism, narcomania or drug (medication) abuse.
22. Mental illness or neurasthenia.
23. Non-compliance with the inclusion criteria.
24. Positive test for HIV, viral hepatitis B and C, or syphilis.
25. Serious concomitant diseases or pathological conditions not listed above, which, according to the investigator's opinion, could complicate the assessment of the study results, including any pathological deviations from the age norms and laboratory norms of blood and urine parameters, clinically significant in the investigator's opinion.
26. Chronic diseases of the cardiovascular, bronchopulmonary, endocrine systems, gastrointestinal tract, liver, kidneys, blood, disease of the endocrine system in the exacerbation phase or that in the decompensation phase in the past or as detected during laboratory and imaging examination.

And:

1. The researcher's decision to exclude the volunteer for the benefit of the volunteer.
2. False inclusion (violation of inclusion and nonex-inclusion criteria) or the appearance of exclusion criteria during the study.
3. The decision of the researcher or the Sponsor to exclude the volunteer from the study due to a clinically significant deviation from the protocol/violation of the protocol.
4. Any undesirable phenomenon requiring the appointment of drugs not authorized by the protocol of this study.
5. Volunteer's refusal to continue his/her participation in the study or his/her lack of discipline.
6. Volunteer's desire to complete the study early for any reason.
7. Volunteer's failure to show up for a scheduled visit without the researcher's warning or loss of communication with the volunteer.
8. Positive urine drug test and / or positive alcohol breath test during the visit.