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COVID-19Phase 1/2NCT05156723

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

A Phase 1/2 study testing Subunit recombinant vaccine for the prevention of coronavirus infection in people with COVID-19 and Immunologic Factors, run by St. Petersburg Research Institute of Vaccines and Sera at 3 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Subunit recombinant vaccine for the prevention of coronavirus infection
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
155 participants
Where
3 sitesRussia
Study dates
19 Jul 2021to 31 Dec 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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);
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  • 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

Who cannot join

  • 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.
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  • 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.
  • History of splenectomy.
  • 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.
  • Transfusion of blood or blood components within 4 months before screening.
  • History of acute and chronic infectious diseases.
  • Consumption of more than 10 units of alcohol per week or history of alcohol addiction, drug addiction or abuse of pharmaceutical products.
  • Smoking of more than 10 cigarettes per day.
  • Participation in another clinical trial within the last 90 days.
  • Pregnancy or lactation.
  • Coagulopathy, hemophilia, bleeding disorder.
  • Participation in stage I of this trial (for volunteers of stage II).
  • Transfusion of COVID-19 convalescent plasma within 14 days before the screening, COVID-19 vaccination less than 30 days before the screening

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

  • Medvitro, LLC

    Moscow

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

    Moscow

  • Eco-Safety, LLC

    Saint Petersburg

Other trials in Russia

About this study

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

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

Being tested
Subunit recombinant vaccine for the prevention of coronavirus infection, Placebo
Keywords
COVID-19, COVID, recombinant vaccine, nucleocapsid protein, cellular immunity, SPbSRIVS, Convacell
Medical subject headings
COVID-19, Coronavirus Infections, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subunit recombinant vaccine for the prevention of coronavirus infectionBiological

    solution for intramuscular injection, 0.5 ml

  • PlaceboBiological

    solution for intramuscular injection, 0.5 ml

Study groups in NCT05156723
Study groupRoleWhat they receive
Group 1: Subunit recombinant vaccine for the prevention of coronavirus infectionExperimental5 volunteers have been vaccinated with a single dose (Stage I)
Receives: Biological: Subunit recombinant vaccine for the prevention of coronavirus infection
Group 2: Subunit recombinant vaccine for the prevention of coronavirus infectionExperimental15 volunteers have been vaccinated with a single dose (Stage I)
Receives: Biological: Subunit recombinant vaccine for the prevention of coronavirus infection
Group 3: Subunit recombinant vaccine for the prevention of coronavirus infectionExperimental45 volunteers will be vaccinated with the coronavirus vaccine intramuscularly twice (Stage II)
Receives: Biological: Subunit recombinant vaccine for the prevention of coronavirus infection
Group 4: Subunit recombinant vaccine for the prevention of coronavirus infectionExperimental45 volunteers have been vaccinated with a single dose of the coronavirus vaccine intramuscularly and then treated with a single dose of placebo (Stage II)
Receives: Biological: Subunit recombinant vaccine for the prevention of coronavirus infection
Group 5: PlaceboPlacebo comparator45 volunteers have been vaccinated with placebo intramuscularly twice (Stage II)
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: During 21 days after initial vaccination

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

    Measured: 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

    Measured: Days 21 and 42 after the initial vaccination

Secondary outcomes (12)

  1. Incidence of actively detected local AEs

    Measured: During 7 days after initial vaccination/revaccination

  2. Incidence of actively detected systemic AEs

    Measured: During 7 days after initial vaccination/revaccination

  3. Incidence of actively detected local AEs

    Measured: During 21 days after initial vaccination/revaccination

  4. Incidence of actively detected systemic AEs

    Measured: During 21 days after initial vaccination/revaccination

  5. Incidence of any AEs

    Measured: 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

    Measured: During the trial

  7. Proportion SARS-CoV-2 seropositive volunteers

    Measured: Day 21 (Stage I and Stage II) and Day 42 (Stage II)

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

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start19 Jul 2021
  3. Primary completion30 Aug 2021
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156723
Sponsor's protocol ID
01-COVAC-04/21
Status last verified
Aug 2023
First submitted
26 Nov 2021
Last updated
30 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Subunit recombinant vaccine for the prevention of coronavirus infection in people with COVID-19 and Immunologic Factors, run by St. Petersburg Research Institute of Vaccines and Sera at 3 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of actively detected local and systemic AEs (Stage I) (time frame: During 21 days after initial vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05156723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.

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