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CompletedNCT05156723Updated Aug 30, 2023

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

A Phase 1/2 interventional study of Subunit recombinant vaccine for the prevention of coronavirus infection and Placebo in COVID-19, Immunologic Factors and Coronavirus Infections, sponsored by St. Petersburg Research Institute of Vaccines and Sera. Completed at 3 sites in Russian Federation. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-30.

Sponsored by St. Petersburg Research Institute of Vaccines and Sera · Phase 1/2, Interventional, and Prevention

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jul 2021, registered Nov 2021).
Phase
Phase 1/2
Study type
Interventional
Enrollment
155
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

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

Keywords

  • COVID-19
  • COVID
  • recombinant vaccine
  • nucleocapsid protein
  • cellular immunity
  • SPbSRIVS
  • Convacell
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 155 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

St. Petersburg Research Institute of Vaccines and Sera is the lead sponsor of 15 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
155 participants (actual)

Study arms

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

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

    Biological: Subunit recombinant vaccine for the prevention of coronavirus infection

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

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

    Biological: Subunit recombinant vaccine for the prevention of coronavirus infection

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

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

    Biological: Subunit recombinant vaccine for the prevention of coronavirus infection

  • Experimental
    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)

    Biological: Subunit recombinant vaccine for the prevention of coronavirus infection

  • Placebo comparator
    Group 5: Placebo

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

    Biological: Placebo

Interventions

  • BiologicalSubunit recombinant vaccine for the prevention of coronavirus infection

    solution for intramuscular injection, 0.5 ml

  • BiologicalPlacebo

    solution for intramuscular injection, 0.5 ml

06

What researchers measure

Primary outcomes

  1. Incidence of actively detected local and systemic AEs (Stage I)

    Time frame: During 21 days after initial vaccination

  2. Incidence of actively detected local and systemic AEs (Stage II)

    Time frame: During 21 days after initial vaccination

  3. Increase in geometric mean titers of antibodies to N-protein of SARS-CoV-2 (Stage II)

    Changes from day 0 to days 21 and 42 after the initial vaccination

    Time frame: Days 21 and 42 after the initial vaccination

Secondary outcomes

  1. Incidence of actively detected local AEs

    Time frame: During 7 days after initial vaccination/revaccination

  2. Incidence of actively detected systemic AEs

    Time frame: During 7 days after initial vaccination/revaccination

  3. Incidence of actively detected local AEs

    Time frame: During 21 days after initial vaccination/revaccination

  4. Incidence of actively detected systemic AEs

    Time frame: During 21 days after initial vaccination/revaccination

  5. Incidence of any AEs

    Time frame: During the trial

  6. Number of volunteers hospitalized with COVID-19

    * Total number of SARS-CoV-2 infection cases * Total number of COVID-19 cases * Total number of COVID-19 related deaths

    Time frame: During the trial

  7. Proportion SARS-CoV-2 seropositive volunteers

    Time frame: Day 21 (Stage I and Stage II) and Day 42 (Stage II)

  8. Change in IFN-γ, IL-2 and IL-4 levels

    Time frame: Days 14, 21 (Stage I and Stage II) and Days 28, 42, 90 and 180 (Stage II) after vaccination

  9. Change in the subpopulation composition of T-lymphocytes

    Time frame: Days 14, 21 (Stage I and Stage II) and Days 28, 42, 90 and 180 (Stage II) after vaccination

  10. Change in titer of antibodies to N-protein of SARS-CoV-2

    Time frame: Days 14, 21 (Stage I and Stage II), Days 28, 42, 90 and 180 (Stage II), Days 240, 350 (Stage II, cohort 2) after initial vaccination

  11. Change in the antigen-specific cellular immune response (T-cell response)

    Time frame: Days 14, 21 (Stage II), Days 28, 42, 90 and 180, Days 240, 350 (Stage II, cohort 2) after initial vaccination

  12. Incidence of seroconversion (specific antibodies to N-protein of SARS-CoV-2)

    Time frame: Days 14, 21 (Stage I and Stage II), Days 28, 42, 90 and 180, Days 240, 350 (Stage II, cohort 2) after initial vaccination

07

Study locations

3 sites
  • Medvitro, LLC
    Moscow, Russian Federation
  • Research Institute of Vaccines and Serums them. I.I. Mechnikov
    Moscow, Russian Federation
  • Eco-Safety, LLC
    Saint-Petersburg, Russian Federation
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05156723
Lead sponsor
St. Petersburg Research Institute of Vaccines and Sera
Collaborators
Crocus Medical B.V (The Netherlands)
Responsible party
Sponsor
First posted
Dec 14, 2021
Start date
Jul 19, 2021
Primary completion
Aug 30, 2021
Completion
Dec 31, 2022
Last update
Aug 30, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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