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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05156723
Recruitment Status : Active, not recruiting
First Posted : December 14, 2021
Last Update Posted : January 6, 2022
Sponsor:
Collaborator:
Crocus Medical B.V (The Netherlands)
Information provided by (Responsible Party):
St. Petersburg Research Institute of Vaccines and Sera

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 disease Intervention/treatment Phase
COVID-19 Immunologic Factors Coronavirus Infections Respiratory Tract Infections Biological: Subunit recombinant vaccine for the prevention of coronavirus infection Biological: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 19, 2021
Actual Primary Completion Date : August 30, 2021
Estimated Study Completion Date : May 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/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




Primary Outcome Measures :
  1. Primary endpoint (Stage I) [ Time Frame: Changes from day 0 to day 21 post COVID-19 vaccination ]
    • Incidence of actively detected local and systemic SAEs

  2. Primary endpoint (Stage II) [ Time Frame: 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 [ Time Frame: During 7 days after vaccination/revaccination ]
  2. Incidence of actively detected local AEs [ Time Frame: During 21 days after initial vaccination/revaccination ]
  3. Incidence of actively detected systemic AEs [ Time Frame: During 21 days after initial vaccination/revaccination ]
  4. Number of volunteers hospitalized with COVID-19 [ Time Frame: During the trial ]
  5. Proportion SARS-CoV-2 seropositive volunteers [ Time Frame: Days 21 and 42 ]
  6. Change in IFN-γ, IL-2 and IL-4 levels [ Time Frame: Days 14, 21, 28, 42, 90 and 180 days after vaccination ]
  7. Change in the subpopulation composition of T-lymphocytes [ Time Frame: Days 14, 21, 28, 42, 90 and 180 days after vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05156723


Locations
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Russian Federation
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
Sponsors and Collaborators
St. Petersburg Research Institute of Vaccines and Sera
Crocus Medical B.V (The Netherlands)
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Responsible Party: St. Petersburg Research Institute of Vaccines and Sera
ClinicalTrials.gov Identifier: NCT05156723    
Other Study ID Numbers: 01-COVAC-04/21
First Posted: December 14, 2021    Key Record Dates
Last Update Posted: January 6, 2022
Last Verified: November 2021

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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:
COVID-19
COVID
vaccination
Coronaviridae Infections
Coronavirus Infections
SPbSRIVS
Additional relevant MeSH terms:
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Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases