Study of the Immunogenicity, Safety and Tolerability of the Convacell Vaccine.

NCT ID: NCT05156723

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-19
• Study Completion Date: 2022-12-31

Brief Summary

A two-stage trial will involve healthy volunteers. The first stage is open trial, and the second stage is a double-blind trial with randomization of volunteers into three groups. At stage I of the trial, the maximum number of screened healthy volunteers will be 30 of which 20 men aged 18 to over 60 years. At stage II of the trial, the maximum number of screened healthy volunteers will be 150, of which 135 men and women aged 18 to over 60 years eligible according to the inclusion and exclusion criteria are planned to be included and randomized to collect data that will be used for the subsequent safety and immunogenicity assessment. The enrollment of volunteers at stage II will be competitive.

Detailed Description

Trial product is subunit recombinant vaccine for the prevention of coronavirus infection caused by the SARS-CoV-2 virus.

Vaccination forms humoral and cellular immunity that prevents the development of coronavirus infection caused by the SARS-CoV-2 virus. On the surface of excipients emulsion droplets N-protein is presented to monocytes attracted from the bloodstream due to a local increase in the level of cytokines. Antigen-bearing cells migrate to draining lymph nodes with activation of innate and adaptive immunity cells in them. Due to the activation of natural killer cells in combination with specific antibodies, the mechanism of lysis of infected cells is realized. The nucleocapsid protein (N) is conserved and little susceptible to mutational changes. This makes the vaccine based on it universal for various strains of coronavirus

Conditions

COVID-19; Immunologic Factors; Coronavirus Infections; Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Subunit recombinant vaccine for the prevention of coronavirus infection

5 volunteers have been vaccinated with a single dose (Stage I)

Group Type: EXPERIMENTAL

Subunit recombinant vaccine for the prevention of coronavirus infection

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Group 2: Subunit recombinant vaccine for the prevention of coronavirus infection

15 volunteers have been vaccinated with a single dose (Stage I)

Group Type: EXPERIMENTAL

Subunit recombinant vaccine for the prevention of coronavirus infection

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Group 3: Subunit recombinant vaccine for the prevention of coronavirus infection

45 volunteers will be vaccinated with the coronavirus vaccine intramuscularly twice (Stage II)

Group Type: EXPERIMENTAL

Subunit recombinant vaccine for the prevention of coronavirus infection

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Group 4: Subunit recombinant vaccine for the prevention of coronavirus infection

45 volunteers have been vaccinated with a single dose of the coronavirus vaccine intramuscularly and then treated with a single dose of placebo (Stage II)

Group Type: EXPERIMENTAL

Subunit recombinant vaccine for the prevention of coronavirus infection

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Group 5: Placebo

45 volunteers have been vaccinated with placebo intramuscularly twice (Stage II)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

solution for intramuscular injection, 0.5 ml

Interventions

Subunit recombinant vaccine for the prevention of coronavirus infection

solution for intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Placebo

solution for intramuscular injection, 0.5 ml

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Healthy men and women aged 18 to 60 years old, inclusive.

2. Written informed consent of the volunteer to participate in the clinical trial;

3. BMI within the range of 18.5 ≤ BWI ≤ 30 kg/m2 with the body weight of not less than 55 kg for men, not less than 45 kg for women and not more than 100 kg for volunteers of both sexes.

4. Verified "healthy" status: no deviations from reference values of standard clinical, laboratory and instrumental examinations.

5. Negative HIV 1&2, RPR, HВsAg and HCV RNA tests.

6. Hemodynamic and other vital signs are within normal limits (reference intervals are 60-90 beats/min at rest for HR, up to 22 per minute for RR, body temperature from 35.5 to 36.9 °C; systolic blood pressure (SBP) is considered normal in the range of 100-139 mmHg, diastolic blood pressure (DBP) - in the range of 60-89 mmHg);

7. Volunteers able to fulfill requirements of the Protocol (i.e., fill out the patient's diary, come to follow-up visits);

8. Abstinence from alcohol for 14 days before the start of the trial and until the end of participation in the trial;

9. Abstinence from smoking for 48 hours before the start of the trial and during hospitalization;

10. For fertile women - a negative result of the pregnancy test and consent to observe adequate methods of contraception during the trial and at least two months after vaccination;

11. For fertile men - consent to observe adequate methods of contraception during the trial and at least two months after vaccination, except for men after vasectomy with documented azoospermia, and their sexual partners should use methods of contraception that ensure more than 90% reliability or be incapable of conception after a surgical sterilization or have a natural menopause for at least 2 years

Exclusion Criteria

1. History of influenza or acute respiratory viral infection (ARVI) within 2 months before the start of the trial.

2. A serious post-vaccination reaction (temperature above 40 °C, hyperemia or edema more than 8 cm in diameter) or complications (collapse or shock-like condition that developed within 48 hours after vaccination; convulsions accompanied or not accompanied by a fever due to any previous vaccination).

3. Fever, cough, and shortness of breath within 30 days before vaccination.

4. History of COVID-19.

5. Positive result of the COVID-19 PCR test.

6. Body temperature ≥ 37,0°C.

7. History of allergies.

8. Any vaccination within 30 days before the screening.

9. History of leukemia, tuberculosis, cancer, autoimmune diseases.

10. History of Quincke's edema.

11. Positive blood test results for HIV, syphilis, hepatitis B/C.

12. Volunteers who received immunoglobulin during the last three months before the trial.

13. History of long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the trial.

14. Treatment with glucocorticosteroids, including in small doses, as well as local use of drugs containing steroids (> 10 mg of prednisolone or its equivalent for more than 14 days before the screening).

15. History of any confirmed or suspected immunosuppressive or immunodeficiency condition.

16. History of splenectomy.

17. History of chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, the gastrointestinal tract, liver, kidneys, hematopoietic or immune systems, mental disease in the acute stage or in the decompensation stage.

18. Transfusion of blood or blood components within 4 months before screening.

19. History of acute and chronic infectious diseases.

20. Consumption of more than 10 units of alcohol per week or history of alcohol addiction, drug addiction or abuse of pharmaceutical products.

21. Smoking of more than 10 cigarettes per day.

22. Participation in another clinical trial within the last 90 days.

23. Pregnancy or lactation.

24. Coagulopathy, hemophilia, bleeding disorder.

25. Participation in stage I of this trial (for volunteers of stage II).

26. Transfusion of COVID-19 convalescent plasma within 14 days before the screening, COVID-19 vaccination less than 30 days before the screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Crocus Medical B.V (The Netherlands)

UNKNOWN

Sponsor Role: collaborator

St. Petersburg Research Institute of Vaccines and Sera

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medvitro, LLC

Moscow, , Russia

Research Institute of Vaccines and Serums them. I.I. Mechnikov

Moscow, , Russia

Eco-Safety, LLC

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

01-COVAC-04/21

Identifier Type: -

Identifier Source: org_study_id