The Objectives of This Study Are Study the Immunogenicity, Safety and Tolerability of the Coronavirus Vaccine in Healthy Adult Volunteer Aged 18 to 60 Years.

Sponsor
St. Petersburg Research Institute of Vaccines and Sera (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05156723
Collaborator
Crocus Medical B.V (The Netherlands) (Other)
155
Enrollment
3
Locations
5
Arms
10.3
Anticipated Duration (Months)
51.7
Patients Per Site
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Biological: Subunit recombinant vaccine for the prevention of coronavirus infection
  • Biological: Placebo
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
155 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
A Double-blind, Randomized, Prospective, Placebo-controlled Trial to Assess the Immunogenicity, Safety, and Tolerability of a Coronavirus Vaccine in Healthy Volunteers Aged 18 to 60 Years
Actual Study Start Date :
Jul 19, 2021
Actual Primary Completion Date :
Aug 30, 2021
Anticipated Study Completion Date :
May 30, 2022

Arms and Interventions

ArmIntervention/Treatment
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
solution for intramuscular injection, 0.5 ml

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
solution for intramuscular injection, 0.5 ml

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
solution for intramuscular injection, 0.5 ml

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
solution for intramuscular injection, 0.5 ml

Placebo Comparator: Group 5: Placebo

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

Biological: Placebo
solution for intramuscular injection, 0.5 ml

Outcome Measures

Primary Outcome Measures

  1. Primary endpoint (Stage I) [Changes from day 0 to day 21 post COVID-19 vaccination]

    • Incidence of actively detected local and systemic SAEs

  2. Primary endpoint (Stage II) [Changes from day 0 to day 21-42 post COVID-19 vaccination]

    Incidence of actively detected local and systemic SAEs. Increase in geometric mean titers of antibodies to N-protein of SARS-CoV-2

Secondary Outcome Measures

  1. Incidence of actively detected SAEs [During 7 days after vaccination/revaccination]

  2. Incidence of actively detected local AEs [During 21 days after initial vaccination/revaccination]

  3. Incidence of actively detected systemic AEs [During 21 days after initial vaccination/revaccination]

  4. Number of volunteers hospitalized with COVID-19 [During the trial]

  5. Proportion SARS-CoV-2 seropositive volunteers [Days 21 and 42]

  6. Change in IFN-γ, IL-2 and IL-4 levels [Days 14, 21, 28, 42, 90 and 180 days after vaccination]

  7. Change in the subpopulation composition of T-lymphocytes [Days 14, 21, 28, 42, 90 and 180 days after vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
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:
  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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Medvitro, LLCMoscowRussian Federation
2Research Institute of Vaccines and Serums them. I.I. MechnikovMoscowRussian Federation
3Eco-Safety, LLCSaint-PetersburgRussian Federation

Sponsors and Collaborators

  • St. Petersburg Research Institute of Vaccines and Sera
  • Crocus Medical B.V (The Netherlands)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
St. Petersburg Research Institute of Vaccines and Sera
ClinicalTrials.gov Identifier:
NCT05156723
Other Study ID Numbers:
  • 01-COVAC-04/21
First Posted:
Dec 14, 2021
Last Update Posted:
Jan 6, 2022
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by St. Petersburg Research Institute of Vaccines and Sera
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2022