Study of the Immunogenicity, Safety and Tolerability of the Convacell Vaccine.
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
1 other identifier
interventional
155
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Jul 2021
Longer than P75 for phase_1 covid19
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2021
CompletedFirst Submitted
Initial submission to the registry
November 26, 2021
CompletedFirst Posted
Study publicly available on registry
December 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 30, 2023
August 1, 2023
1 month
November 26, 2021
August 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of actively detected local and systemic AEs (Stage I)
During 21 days after initial vaccination
Incidence of actively detected local and systemic AEs (Stage II)
During 21 days after initial vaccination
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
Days 21 and 42 after the initial vaccination
Secondary Outcomes (12)
Incidence of actively detected local AEs
During 7 days after initial vaccination/revaccination
Incidence of actively detected systemic AEs
During 7 days after initial vaccination/revaccination
Incidence of actively detected local AEs
During 21 days after initial vaccination/revaccination
Incidence of actively detected systemic AEs
During 21 days after initial vaccination/revaccination
Incidence of any AEs
During the trial
- +7 more secondary outcomes
Study Arms (5)
Group 1: Subunit recombinant vaccine for the prevention of coronavirus infection
EXPERIMENTAL5 volunteers have been vaccinated with a single dose (Stage I)
Group 2: Subunit recombinant vaccine for the prevention of coronavirus infection
EXPERIMENTAL15 volunteers have been vaccinated with a single dose (Stage I)
Group 3: Subunit recombinant vaccine for the prevention of coronavirus infection
EXPERIMENTAL45 volunteers will be vaccinated with the coronavirus vaccine intramuscularly twice (Stage II)
Group 4: Subunit recombinant vaccine for the prevention of coronavirus infection
EXPERIMENTAL45 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 5: Placebo
PLACEBO COMPARATOR45 volunteers have been vaccinated with placebo intramuscularly twice (Stage II)
Interventions
solution for intramuscular injection, 0.5 ml
Eligibility Criteria
You may qualify if:
- Healthy men and women aged 18 to 60 years old, inclusive.
- Written informed consent of the volunteer to participate in the clinical trial;
- 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.
- Verified "healthy" status: no deviations from reference values of standard clinical, laboratory and instrumental examinations.
- Negative HIV 1\&2, RPR, HВsAg and HCV RNA tests.
- 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);
- Volunteers able to fulfill requirements of the Protocol (i.e., fill out the patient's diary, come to follow-up visits);
- Abstinence from alcohol for 14 days before the start of the trial and until the end of participation in the trial;
- Abstinence from smoking for 48 hours before the start of the trial and during hospitalization;
- 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;
- 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
You may not qualify if:
- History of influenza or acute respiratory viral infection (ARVI) within 2 months before the start of the trial.
- 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).
- Fever, cough, and shortness of breath within 30 days before vaccination.
- History of COVID-19.
- Positive result of the COVID-19 PCR test.
- Body temperature ≥ 37,0°C.
- History of allergies.
- Any vaccination within 30 days before the screening.
- History of leukemia, tuberculosis, cancer, autoimmune diseases.
- History of Quincke's edema.
- Positive blood test results for HIV, syphilis, hepatitis B/C.
- Volunteers who received immunoglobulin during the last three months before the trial.
- History of long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for six months before the trial.
- 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).
- History of any confirmed or suspected immunosuppressive or immunodeficiency condition.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Medvitro, LLC
Moscow, Russia
Research Institute of Vaccines and Serums them. I.I. Mechnikov
Moscow, Russia
Eco-Safety, LLC
Saint Petersburg, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2021
First Posted
December 14, 2021
Study Start
July 19, 2021
Primary Completion
August 30, 2021
Study Completion
December 31, 2022
Last Updated
August 30, 2023
Record last verified: 2023-08