COVID-19Phase 2/3NCT05726084
Immunogenicity, Efficacy and Safety Trial of the Convacell Vaccine in Healthy Volunteers Aged 18 Years and Older
A Phase 2/3 study testing Subunit recombinant vaccine for the prevention of coronavirus infection in people with COVID-19 and Coronavirus Infections, run by St. Petersburg Research Institute of Vaccines and Sera at 6 sites in Russia.
Trial summary
The goal of this clinical trial is to assess the immunogenicity, efficacy and safety of the Convacell vaccine in healthy adult volunteers aged 18 years and older. The main questions it aims to answer are: To assess the immunogenicity and safety of single and double dose intramuscular administration of the Convacell… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Coronavirus Infections, Respiratory Tract Infections
- What is being tested?
- Subunit recombinant vaccine for the prevention of coronavirus infection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16,304 participants
- Where
- 6 sitesRussia
- Study dates
- 24 Oct 2022to 30 Dec 2023
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 Years and Older
- Written informed consent of the volunteer to participate in the clinical trial (in paper or electronic form)
- 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
- Absence of clinically significant (according to the investigator) deviations from the reference values of clinical, laboratory and instrumental methods of examination at screening
- 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 in the electronic patient's diary, come to follow-up visits)
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- Abstinence from alcohol from the start of screening until completion of Visit 7 procedures (day 42 ± 2) - for stage 2b
- 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
- Throughout the study, the opportunity to use own smartphone with the ability to fill in the electronic patient's diary
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 within 6 months before screening;
- The level of IgG antibodies to the SARS-CoV-2 N-protein according to semi-quantitative test (Architect, Abbott) ≥ 3 (positivity rate) at screening;
- Positive result of the COVID-19 PCR test or antigen COVID-19 test (rapid test);
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- Body temperature ≥ 37,3°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 according to the examination during the screening period (only for Stage IIb) or according to the history (for Stage III). It is acceptable to use the results of previously performed tests, if their prescription does not exceed 60 days before the date of the screening or based on history;
- 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 (according to history and / or examination on the screening);
- Transfusion of blood or blood components within 4 months before screening;
- Any acute infectious diseases during the screening period or past illnesses within 3 months before the screening visit, any chronic infectious diseases in the acute stage during the screening period;
- 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 previous clinical trials of the Convacell vaccine, a subunit recombinant vaccine for the prevention of coronavirus infection caused by SARS-CoV-2 virus, or any other vaccines to prevent coronavirus infection caused by the virus SARS-CoV-2 for 6 months before screening;
- History of anticovid plasma use;
- Vaccination against COVID-19 within 6 months before screening.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Russia6 sites
Limited Liability Company "OLLA-MED"
Moscow
State budgetary health care institution of the city of Moscow "City Clinical Hospital No. 24 of the Department of Health of the City of Moscow"
Moscow
Limited Liability Company "Scientific Research Center Eco-Safety"
Saint Petersburg
St. Petersburg State Budgetary Health Institution "City Polyclinic No. 117"
Saint Petersburg
Limited Liability Company "Otkrytaya Meditsina"
Tolyatti
Limited Liability Company "Meditsinskiy Diagnosticheskiy Tsentr"
Yaroslavl
About this study
Official title: Multicentre, Double-blind, Randomized, Prospective, Placebo-controlled Trial to Assess the Immunogenicity, Efficacy and Safety of the Coronavirus Vaccine in Healthy Volunteers Aged 18 Years and Older
The goal of this clinical trial is to assess the immunogenicity, efficacy and safety of the Convacell vaccine in healthy adult volunteers aged 18 years and older. The main questions it aims to answer are:
- To assess the immunogenicity and safety of single and double dose intramuscular administration of the Convacell vaccine;
- To assess the epidemiological effectiveness of the Convacell vaccine in the prevention of SARS-CoV-2 infection and development of severe COVID-19 compared with placebo when single or double intramuscular injection.
Read the detailed description
The trial will be conducted in two stages (Stage IIb and Stage III).
- Stage IIb
Participants will be vaccinated one dose or two doses of the Convacell vaccine. Investigators will compare one dose and two doses groups and will choose the best vaccine dosage regimen in terms of immunogenicity and safety.
- Stage III
Participants will be vaccinated the Convacell vaccine or Placebo. Investigators will use the dosage regimen chosen in IIb stage.
- Conditions
- COVID-19, Coronavirus Infections, Respiratory Tract Infections, COVID-19 Respiratory Infection
- Being tested
- Subunit recombinant vaccine for the prevention of coronavirus infection, Placebo
- Keywords
- COVID-19, cellular immunity, nucleocapsid protein, recombinant vaccine, SPbSRIVS, SARS-CoV-2, 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
Also called Convacell
solution for intramuscular injection, 0.5 ml
PlaceboBiological
solution for intramuscular injection, 0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| Convacell, 1 dose (Stage IIb) | Experimental | Participants (230) will be vaccinated Convacell Vaccine, recombinant subunit vaccine for prevention of coronavirus infection, once intramuscularly. A cohort of participants will be allocated (115 participants) for evaluating cell-mediated immunity parameters. Receives: Biological: Subunit recombinant vaccine for the prevention of coronavirus infection |
| Convacell, 2 doses (Stage IIb) | Experimental | Participants (230) will be vaccinated Convacell Vaccine, recombinant subunit vaccine for prevention of coronavirus infection, twice intramuscularly. A cohort of participants will be allocated (115 participants) for evaluating cell-mediated immunity parameters. Receives: Biological: Subunit recombinant vaccine for the prevention of coronavirus infection |
| Convacell, chosen regimen (Stage III) | Experimental | Participants (10 562) will be vaccinated Convacell Vaccine, recombinant subunit vaccine for prevention of coronavirus infection, the regimen chosen in Stage IIb intramuscularly. Receives: Biological: Subunit recombinant vaccine for the prevention of coronavirus infection |
| Placebo, chosen regimen (Stage III) | Placebo comparator | Participants (5 282) will be vaccinated Placebo, the regimen chosen in Stage IIb intramuscularly. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in titer of IgG antibodies to N-protein of SARS-CoV-2 (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0, 42
Frequency of symptomatic COVID-19 with laboratory-confirmed infection within 6 months after vaccination compared with the placebo group (Stage III)
Laboratory confirmation of SARS-CoV-2 infection in accordance with current clinical guidelines can be a PCR study or an antigen test of a swab from the nasopharynx or oropharynx.
The symptomatic form of COVID-19 is the presence of at least one of the following symptoms: fever/chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body pain, headache, loss of the sense of taste or smell, sore throat, nasal congestion or runny nose, nausea or vomiting, diarrhea.
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0-180 (6 months)
Secondary outcomes (24)
Change in titer of IgM antibodies to N-protein of SARS-CoV-2 on day 42 after initial vaccination (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0, 42
Proportion of SARS-CoV-2 seropositive participants on day 42 after initial vaccination (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0, 42
Change in titer of IgG antibodies to N-protein of SARS-CoV-2 on day 42 after initial vaccination (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0, 42
The frequency of seroconversion (appearance of specific antibodies to SARS-CoV-2 N-protein) on day 42 after initial vaccination (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0, 42
Change from Baseline in the Mean Specifically Sensitized T-lymphocytes (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0, 42
Number of volunteers hospitalized with COVID-19 (Stage IIb)
- Total number of SARS-CoV-2 infection cases (laboratory-confirmed)
- Total number of COVID-19 cases (laboratory-confirmed)
- Total number of COVID-19 related deaths
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: through trial Stage IIb; Days 0-49
Frequency of laboratory confirmed asymptomatic SARS-CoV-2 infections within 6 months. after initial vaccination compared with the placebo group (Stage III)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0-180 (6 months)
Frequency of laboratory-confirmed severe COVID-19 (Stage III)
Frequency of laboratory-confirmed severe COVID-19 in accordance with current criteria
- RR > 30/min
- Blood oxygen saturation (SpO2) ≤ 93%
- Oxygenation index (PaO2 /FiO2) ≤ 300 mmHg
- Decreased level of consciousness, agitation
- Unstable hemodynamics (systolic arterial pressure [SBP] less than 90 mm Hg. or diastolic blood pressure [DBP] less than 60 mmHg, diuresis less than 20 ml/hour)
- Lung changes on computed tomography (CT) or radiographs typical for a viral lesion
- Arterial blood lactate > 2 mmol/l
- Assessment on a quick scale (quick Sequential Organ Failure Assessment, qSOFA) > 2 points
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0-180 (6 months)
Overall frequency of all AEs/SAEs (Stage IIb and III)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
Overall frequency of all AEs/SAEs associated with the study drug (Stage IIb and III)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
The frequency of local post-vaccination reactions at the injection site (Stage IIb and III)
- Erythema at the injection site (presence/absence);
- Soreness (presence/absence), including assessment duration of preservation of pain and its intensity: weak, moderate, strong;
- Edema (presence/absence), including diameter infiltrate assessment: weak (up to 2.5 cm), medium (from 2.6 to 5 cm), strong (more than 5 cm or the presence of lymphangitis) reactions;
- Enlargement of regional lymph nodes (presence/absence);
- Induration at the injection site (presence/absence);
- Itching at the injection site (presence/absence).
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0-7 after initial vaccination and revaccination
The frequency of systemic post-vaccination reactions at the injection site (Stage IIb and III)
- Increase in body temperature, including an assessment fever severity: mild (37.3-37.5°C), moderate (37.6-38.5°С) and strong (> 38.5°С);
- Chills;
- Deterioration of general health, malaise;
- Headache;
- Dizziness;
- Loss of appetite;
- Insomnia;
- Nausea, Vomiting, Dyspepsia;
- Diarrhea;
- Body pain or muscle weakness;
- Sweating;
- Pain in the joints;
- Pain in the abdomen;
- Convulsions;
- Myalgia;
- Enlargement of regional lymph nodes.
- Changes in the side of the mucous membranes, the presence of papules, vesicles, erosions.
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0-7 after initial vaccination and revaccination
The frequency of local post-vaccination reactions at the injection site (Stage IIb and III)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0-21 after initial vaccination and revaccination
Frequency of systemic post-vaccination reactions (Stage IIb and III)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Days 0-42 after initial vaccination
The frequency of toxic post-vaccination complications (Stage IIb and III)
Septic conditions, generalized infection.
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
The frequency of allergic post-vaccination complications (Stage IIb and III)
Polymorphous eruption, angioedema, arthralgia, anaphylactic shock.
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
The frequency of neurological post-vaccination complications (Stage IIb and III)
Encephalitis, neuritis, polyneuritis.
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
The presence of allergic reactions (Stage IIb and III)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
Сhange in white blood cell count and relative white blood cell count (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Day 0 (screening), day 28 ± 2 (visit 4)
Сhange in neutrophils count and relative neutrophils count (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Day 0 (screening), day 28 ± 2 (visit 4)
Сhange in lymphocytes count and relative lymphocytes count (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Day 0 (screening), day 28 ± 2 (visit 4)
Сhange in monocyte count and relative monocyte count (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Day 0 (screening), day 28 ± 2 (visit 4)
Сhange in the IgE level (Stage IIb)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: Day 0 (screening), day 28 ± 2 (visit 4)
The proportion of participants with delayed post-vaccination reactions (percent) (Stage IIb and III)
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Measured: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start24 Oct 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16,304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and Sera
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ellina Ruzanova, Study director, St. Petersburg Research Institute of Vaccines and Sera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726084
- Sponsor's protocol ID
- 02-COVAC-02/22
- Status last verified
- Aug 2023
- First submitted
- 17 Jan 2023
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Double-blind, Randomized, Prospective, Placebo-controlled Trial to Assess the Immunogenicity, Efficacy and Safety of the Coronavirus Vaccine in Healthy Volunteers Aged 18 Years and Older
- ClinicalTrials.gov ID
- NCT05726084
- Acronym / sponsor ID
- 02-COVAC-02/22
- Conditions
- COVID-19, Coronavirus Infections, Respiratory Tract Infections, COVID-19 Respiratory Infection
- Keywords
- COVID-19, cellular immunity, nucleocapsid protein, recombinant vaccine, SPbSRIVS, SARS-CoV-2, Convacell
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16,304 participants (estimated)
- Lead sponsor
- St. Petersburg Research Institute of Vaccines and SeraOther government
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the immunogenicity, efficacy and safety of the Convacell vaccine in healthy adult volunteers aged 18 years and older. The main questions it aims to answer are:
- To assess the immunogenicity and safety of single and double dose intramuscular administration of the Convacell vaccine;
- To assess the epidemiological effectiveness of the Convacell vaccine in the prevention of SARS-CoV-2 infection and development of severe COVID-19 compared with placebo when single or double intramuscular injection.
Detailed description
The trial will be conducted in two stages (Stage IIb and Stage III).
- Stage IIb
Participants will be vaccinated one dose or two doses of the Convacell vaccine. Investigators will compare one dose and two doses groups and will choose the best vaccine dosage regimen in terms of immunogenicity and safety.
- Stage III
Participants will be vaccinated the Convacell vaccine or Placebo. Investigators will use the dosage regimen chosen in IIb stage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Convacell, 1 dose (Stage IIb) | Experimental | Biological: Subunit recombinant vaccine for the prevention of coronavirus infectionParticipants (230) will be vaccinated Convacell Vaccine, recombinant subunit vaccine for prevention of coronavirus infection, once intramuscularly. A cohort of participants will be allocated (115 participants) for evaluating cell-mediated immunity parameters. |
| Convacell, 2 doses (Stage IIb) | Experimental | Biological: Subunit recombinant vaccine for the prevention of coronavirus infectionParticipants (230) will be vaccinated Convacell Vaccine, recombinant subunit vaccine for prevention of coronavirus infection, twice intramuscularly. A cohort of participants will be allocated (115 participants) for evaluating cell-mediated immunity parameters. |
| Convacell, chosen regimen (Stage III) | Experimental | Biological: Subunit recombinant vaccine for the prevention of coronavirus infectionParticipants (10 562) will be vaccinated Convacell Vaccine, recombinant subunit vaccine for prevention of coronavirus infection, the regimen chosen in Stage IIb intramuscularly. |
| Placebo, chosen regimen (Stage III) | Placebo comparator | Biological: PlaceboParticipants (5 282) will be vaccinated Placebo, the regimen chosen in Stage IIb intramuscularly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women aged 18 Years and Older
- Written informed consent of the volunteer to participate in the clinical trial (in paper or electronic form)
- 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
- Absence of clinically significant (according to the investigator) deviations from the reference values of clinical, laboratory and instrumental methods of examination at screening
- 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)
Key exclusion criteria (28 listed)
- 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 within 6 months before screening;
- The level of IgG antibodies to the SARS-CoV-2 N-protein according to semi-quantitative test (Architect, Abbott) ≥ 3 (positivity rate) at screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subunit recombinant vaccine for the prevention of coronavirus infectionAlso: Convacellsolution for intramuscular injection, 0.5 ml | Biological | Convacell, 1 dose (Stage IIb), Convacell, 2 doses (Stage IIb), Convacell, chosen regimen (Stage III) |
| Placebosolution for intramuscular injection, 0.5 ml | Biological | Placebo, chosen regimen (Stage III) |
Primary outcome
Change in titer of IgG antibodies to N-protein of SARS-CoV-2 (Stage IIb)
Time frame: Days 0, 42
Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
Frequency of symptomatic COVID-19 with laboratory-confirmed infection within 6 months after vaccination compared with the placebo group (Stage III)
Time frame: Days 0-180 (6 months)
Laboratory confirmation of SARS-CoV-2 infection in accordance with current clinical guidelines can be a PCR study or an antigen test of a swab from the nasopharynx or oropharynx. The symptomatic form of COVID-19 is the presence of at least one of the following symptoms: fever/chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body pain, headache, loss of the sense of taste or smell, sore throat, nasal congestion or runny nose, nausea or vomiting, diarrhea. Outcome Measure is analyzed separately in the 18-60 and >60 age subgroups.
24 secondary outcomes
Change in titer of IgM antibodies to N-protein of SARS-CoV-2 on day 42 after initial vaccination (Stage IIb)
Time frame: Days 0, 42
Proportion of SARS-CoV-2 seropositive participants on day 42 after initial vaccination (Stage IIb)
Time frame: Days 0, 42
Change in titer of IgG antibodies to N-protein of SARS-CoV-2 on day 42 after initial vaccination (Stage IIb)
Time frame: Days 0, 42
The frequency of seroconversion (appearance of specific antibodies to SARS-CoV-2 N-protein) on day 42 after initial vaccination (Stage IIb)
Time frame: Days 0, 42
Change from Baseline in the Mean Specifically Sensitized T-lymphocytes (Stage IIb)
Time frame: Days 0, 42
Number of volunteers hospitalized with COVID-19 (Stage IIb)
Time frame: through trial Stage IIb; Days 0-49
Frequency of laboratory confirmed asymptomatic SARS-CoV-2 infections within 6 months. after initial vaccination compared with the placebo group (Stage III)
Time frame: Days 0-180 (6 months)
Frequency of laboratory-confirmed severe COVID-19 (Stage III)
Time frame: Days 0-180 (6 months)
Overall frequency of all AEs/SAEs (Stage IIb and III)
Time frame: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
Overall frequency of all AEs/SAEs associated with the study drug (Stage IIb and III)
Time frame: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
The frequency of local post-vaccination reactions at the injection site (Stage IIb and III)
Time frame: Days 0-7 after initial vaccination and revaccination
The frequency of systemic post-vaccination reactions at the injection site (Stage IIb and III)
Time frame: Days 0-7 after initial vaccination and revaccination
The frequency of local post-vaccination reactions at the injection site (Stage IIb and III)
Time frame: Days 0-21 after initial vaccination and revaccination
Frequency of systemic post-vaccination reactions (Stage IIb and III)
Time frame: Days 0-42 after initial vaccination
The frequency of toxic post-vaccination complications (Stage IIb and III)
Time frame: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
The frequency of allergic post-vaccination complications (Stage IIb and III)
Time frame: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
The frequency of neurological post-vaccination complications (Stage IIb and III)
Time frame: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
The presence of allergic reactions (Stage IIb and III)
Time frame: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
Сhange in white blood cell count and relative white blood cell count (Stage IIb)
Time frame: Day 0 (screening), day 28 ± 2 (visit 4)
Сhange in neutrophils count and relative neutrophils count (Stage IIb)
Time frame: Day 0 (screening), day 28 ± 2 (visit 4)
Сhange in lymphocytes count and relative lymphocytes count (Stage IIb)
Time frame: Day 0 (screening), day 28 ± 2 (visit 4)
Сhange in monocyte count and relative monocyte count (Stage IIb)
Time frame: Day 0 (screening), day 28 ± 2 (visit 4)
Сhange in the IgE level (Stage IIb)
Time frame: Day 0 (screening), day 28 ± 2 (visit 4)
The proportion of participants with delayed post-vaccination reactions (percent) (Stage IIb and III)
Time frame: through trial Stage IIb (Days 0-49), through trial Stage III (Days 0-196)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellina Ruzanova study director
St. Petersburg Research Institute of Vaccines and Sera
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Subunit recombinant vaccine for the prevention of coronavirus infection in people with COVID-19 and Coronavirus Infections, run by St. Petersburg Research Institute of Vaccines and Sera at 6 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 10 inclusion and 28 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: status not confirmed, 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 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in titer of IgG antibodies to N-protein of SARS-CoV-2 (Stage IIb) (time frame: Days 0, 42). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.