Coronavirus InfectionsPhase 1/2NCT05046548
This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19
A Phase 1/2 study testing Vaccine for intramuscular injection in people with Coronavirus Infections and Vaccine, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products at 5 sites in Russia.
Trial summary
Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", on adult volunteers aged 18-60" (Clinical trials, phase I/II). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Infections, Vaccine
- What is being tested?
- Vaccine for intramuscular injection
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 5 sitesRussia
- Study dates
- 3 Oct 2020to 1 Oct 2021
- 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
- Volunteers must meet the following inclusion criteria:
- Healthy volunteers (men and women) aged 18-60;
- Written informed consent of volunteers to participate in a clinical trial;
- Volunteers who are able to comply with the requirements of the Protocol (i.e. filling out the Self-Observation Diary, come to control visits);
- For women capable of childbearing, a negative pregnancy test and consent to adhere to adequate contraceptive methods (use of contraceptives within six months after the second vaccination). Women should use contraceptive methods that are more than 90% reliable (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine devices), or be sterile or postmenopausal.
- For fertile men, consent to adhere to adequate contraceptive methods for six months after the second vaccination. Men and their sexual partners must use contraceptive methods with more than 90% reliability (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine devices), or be sterile.
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- Non-inclusion criteria:
- Volunteers cannot be included in the study if any of the following criteria are met:
- Medical staff of clinics and polyclinics;
- A history of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63, HCoV-HKU1);
- History of contacts with confirmed or suspected cases of SARS-CoV-2 infection within 1 month;
- Positive IgM or IgG to SARS-CoV-2, found at screening (for volunteers of Phases I and II);
- Positive PCR test for SARS-CoV-2 at screening;
- Clinically and/or laboratory (according to PCR) confirmed disease with SARS-CoV-2 coronavirus at the current time or in history;
- Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more than 8 cm in diameter) or complication (collapse or shock-like state that developed within 48 hours after vaccination; convulsions, accompanied or not accompanied by a febrile state) to any previous vaccination in history;
- Aggravated allergic history (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, history of serum sickness, history of hypersensitivity or allergic reactions to the administration of any vaccines, known allergic reactions to vaccine components, etc.);
- History of Guillain-Barré syndrome (acute polyradiculitis);
- Previous vaccination with rabies vaccines less than 2 months before immunization or planned vaccination with rabies vaccines within 1 month after immunization with investigational vaccines;
- Vaccination with any other vaccine within 1 month preceding vaccination;
- A history of leukemia, tuberculosis, cancer, autoimmune diseases;
- Positive blood test for HIV, syphilis, hepatitis B/C;
- Volunteers who received immunoglobulin preparations or blood transfusions within the last 3 months prior to the start of the study based on the history;
- Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs during the six months preceding the study, according to the history;
- Any history of any confirmed or suspected immunosuppressive or immunodeficient condition;
- Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems, gastrointestinal tract, liver, kidneys, hematopoietic, immune systems, mental illness in exacerbation stage or decompensation stage (recovery earlier than 4 weeks before vaccination) in history;
- Disorder of blood clotting, a tendency to thrombosis in the anamnesis;
- Progressive neurological pathology, a history of convulsive syndrome;
- Diabetes mellitus, hyperthyroidism or other endocrine diseases in history;
- Treatment with glucocorticosteroids, including low doses, as well as topical use of drugs containing steroids (> 10 mg prednisolone, or an equivalent, for more than 14 days in the last three months);
- According to the anamnesis, the volunteer was/is registered in a tuberculosis dispensary and/or a narcological dispensary and/or a neuropsychiatric dispensary and/or others;
- Acute infectious diseases (recovery earlier than 4 weeks before vaccination) according to the history;
- Taking more than 10 units of alcohol per week or anamnestic information about alcoholism, drug addiction, or drug abuse;
- Smoking more than 10 cigarettes a day;
- Participation in any other clinical study within the last 3 months;
- Pregnancy or breastfeeding;
- Axillary temperature at the time of vaccination is more than 37.0 °C;
- Body mass index less than 18 or more than 28 kg/m2;
- Serious concomitant diseases or pathological conditions not listed above, which, according to the investigator, could complicate the evaluation of the study results, including pathological deviations from the age norms and laboratory norms of blood and urine parameters, clinically significant, according to the investigator.
Who cannot join
- Withdrawal of informed consent by a volunteer;
- Serious adverse events or adverse events that do not meet the criteria for severity, the development of which, in the opinion of the investigator, may be detrimental to the health or well-being of the volunteer;
- The need for procedures and/or drug treatment not permitted by the Study Protocol;
- The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol;
- The emergence of non-inclusion criteria during the study;
- The need for surgical intervention;
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- Any condition in a volunteer requiring, in the reasonable opinion of the investigating physician, the withdrawal of the volunteer from the study;
- The volunteer refuses to cooperate or is undisciplined (for example, not showing up for a planned visit without warning the investigator and/or losing contact with the volunteer), or has dropped out of observation;
- For administrative reasons (termination of the study by the Sponsor or regulatory authorities), as well as for gross violations of the protocol that could affect the study results.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Russia5 sites
Federal State Budgetary Educational Institution of Higher Education Kirov State Medical University of the Ministry of Health of Russia
Kirov, 610027
FSBSI Chumakov FSC R&D IBP RAS
Moscow, 108819
FGBUZ MSCh No. 163 FMBA of Russia
Novosibirsk, 630559
Eco-Safety Scientific Research Center LLC
Saint Petersburg, 196143
Center for Family Medicine Joint Stock Company (CSM JSC)
Yekaterinburg, 620043
About this study
Official title: Double-blind, Placebo-controlled, Randomized Study of Tolerability, Safety and Immunogenicity of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years
Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", on adult volunteers aged 18-60" (Clinical trials, phase I/II). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine sorbed on adult volunteers aged 18-60.
Read the detailed description
The study is divided into 3 stages. At Stages I and II of the study, a maximum of 300 healthy volunteers aged 18 to 60 years should be screened, of which 200 volunteers meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the tolerability and safety of the vaccine.
Stage I includes 15 men and women:
Group 1 - 10 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days.
Group 2 - 5 volunteers who will receive placebo twice with an interval of 14 days intramuscularly at a dose of 0.5 ml with a post-vaccination observation period of 28 days.
Stage II includes 185 volunteers:
Group 1 - 140 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days.
Group 2 - 45 volunteers who received placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days.
Stage III of the study, a maximum of 300 volunteers should be screened, of which 200 volunteers, meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the safety and immunogenicity of the vaccine.
Group 3 - 150 volunteers who will receive the vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a period of post-vaccination observation for 6 months.
Group 4 - 50 volunteers who will receive placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 6 months.
- Conditions
- Coronavirus Infections, Vaccine
- Being tested
- Vaccine for intramuscular injection, Placebo comparator (without active ingredient) for intramuscular injection
- Keywords
- COVID-19, Coronavirus infections, Vaccine, SARS-Cov-2, Immunobiological medicine
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaccine for intramuscular injectionBiological
Volunteers (10 at the Stage 1; 140 at the Stage 2; 150 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml
Placebo comparator (without active ingredient) for intramuscular injectionOther
Volunteers (5 at the Stage 1; 45 at the Stage 2; 50 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml
| Study group | Role | What they receive |
|---|---|---|
| Vaccine | Experimental | At Stage I:
Group 1 - 10 volunteers, Vaccine 0.5 ml, 14 days interval, post-vaccination observation period of 28 days.
At Stage II:
Group 1 - 140 volunteers,Vaccine0.5 ml, 14 days interval, post-vaccination observation period of 28 days.
At Stage III:
Group 3 - 150 volunteers, Vaccine 0.5 ml, 14 days interval, post-vaccination observation for 6 months. Receives: Biological: Vaccine for intramuscular injection |
| Placebo | Placebo comparator | No active ingredient in the placebo
At Stage I:
Group 2 - 5 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 28 days.
At Stage II:
Group 2 - 45 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 28 days.
At Stage III:
Group 4 - 50 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 6 months. Receives: Other: Placebo comparator (without active ingredient) for intramuscular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer (GMT)
The percentage of volunteers with an increase in geometric mean titer of specific antibodies (GMT) on day 28 after the second dose of vaccine / placebo in the virus neutralization test and ELISA.
Measured: 28 days after second vaccination / placebo
Secondary outcomes (11)
Geometric mean titer (GMT)
Percentage of volunteers with a fourfold (or more) level of seroconversion in the neutralization test and ELISA on days 7 and 14 after the first dose of vaccine / placebo; on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months, 6 months after the second dose of vaccine / placebo.
Measured: 7 and 14 days after the first vaccination / placebo
Seroconversion rate [Time frame: 7 and 14 days after first vaccination / placebo]
Seroconversion rate on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months, 6 months after second vaccination / placebo.
Measured: Percentage of volunteers with a fourfold (or more) level of seroconversion in the neutralization reaction and the ELISA reaction on days 7 and 14 after the first dose of vaccine / placebo; on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months,
Level of γ-IFN and subpopulation composition of T-lymphocytes
Levels of γ-IFN and subpopulation composition of T-lymphocytes on days 7 and 14 after the administration of the first dose of vaccine / placebo; on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months, 6 months, after the second dose of vaccine / placebo.
Measured: 7 and 14 days after the first vaccination / placebo
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)
The frequency of acute respiratory infections (influenza, acute respiratory infections, COVID-19) within six months after the second dose of vaccine / placebo.
Measured: Within 6 months after the second vaccination / placebo
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)
The severity of acute respiratory infections (influenza, acute respiratory infections, COVID-19) within six months after the second dose of vaccine / placebo.
Measured: Within 6 months after the second vaccination / placebo
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)
The duration of acute respiratory infections (influenza, acute respiratory infections, COVID-19) within six months after the second dose of vaccine / placebo.
Measured: Within 6 months after the second vaccination / placebo
Frequency and severity of adverse events
The incidence and severity of adverse events throughout the study period after the first dose of vaccine / placebo
Measured: Within 6 months after the first dose of vaccine / placebo
Assessment of adverse events
The incidence of adverse events during the study
Measured: within 6 months after the first dose of vaccine / placebo
Evaluation of clinically significant abnormalities in vital signs
The incidence of clinically significant deviations from the main indicators of vital functions.
Measured: within 6 months after the first dose frame of vaccine / placebo
Evaluation of clinically significant deviations from laboratory parameters
The incidence of clinically significant deviations from the laboratory parameters.
Measured: 3, 7, 10 and 14 days after the first vaccination; 4, 7, 14 and 28 days after the second vaccination
Cases of early termination of participation of volunteers in the study
Cases of early termination of the volunteer's use in suggesting the development of AE / SAE associated with the use of study drugs.
Measured: within 6 months after the introduction of the first dose of vaccine / placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start3 Oct 2020
- Primary completion15 Oct 2020
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus InfectionsStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046548
- Sponsor's protocol ID
- VKI-I / II-08/20
- Status last verified
- Nov 2021
- First submitted
- 26 Aug 2021
- Last updated
- 12 Nov 2021
- 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 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-controlled, Randomized Study of Tolerability, Safety and Immunogenicity of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years
- ClinicalTrials.gov ID
- NCT05046548
- Acronym / sponsor ID
- VKI-I / II-08/20
- Conditions
- Coronavirus Infections, Vaccine
- Keywords
- COVID-19, Coronavirus infections, Vaccine, SARS-Cov-2, Immunobiological medicine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological ProductsOther government
- Study start
- 3 Oct 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 16 Sep 2021 (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.
Randomized, double-blind, placebo controlled, multi-center clinical trials of the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified vaccine against COVID-19, manufactured by FSBSI "Chumakov FSC R\&D IBP RAS", on adult volunteers aged 18-60" (Clinical trials, phase I/II). Study purpose is to assess the tolerability, safety and immunogenicity of the inactivated whole-virion concentrated purified coronavirus vaccine sorbed on adult volunteers aged 18-60.
Detailed description
The study is divided into 3 stages. At Stages I and II of the study, a maximum of 300 healthy volunteers aged 18 to 60 years should be screened, of which 200 volunteers meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the tolerability and safety of the vaccine.
Stage I includes 15 men and women:
Group 1 - 10 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days.
Group 2 - 5 volunteers who will receive placebo twice with an interval of 14 days intramuscularly at a dose of 0.5 ml with a post-vaccination observation period of 28 days.
Stage II includes 185 volunteers:
Group 1 - 140 volunteers who will receive the Vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days.
Group 2 - 45 volunteers who received placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 28 days.
Stage III of the study, a maximum of 300 volunteers should be screened, of which 200 volunteers, meeting the inclusion criteria and not non-inclusion criteria, should be included and randomized to study the safety and immunogenicity of the vaccine.
Group 3 - 150 volunteers who will receive the vaccine twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a period of post-vaccination observation for 6 months.
Group 4 - 50 volunteers who will receive placebo twice with an interval of 14 days intramuscularly in a dose of 0.5 ml with a post-vaccination observation period of 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Vaccine | Experimental | Biological: Vaccine for intramuscular injectionAt Stage I: Group 1 - 10 volunteers, Vaccine 0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage II: Group 1 - 140 volunteers,Vaccine0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage III: Group 3 - 150 volunteers, Vaccine 0.5 ml, 14 days interval, post-vaccination observation for 6 months. |
| Placebo | Placebo comparator | Other: Placebo comparator (without active ingredient) for intramuscular injectionNo active ingredient in the placebo At Stage I: Group 2 - 5 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage II: Group 2 - 45 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 28 days. At Stage III: Group 4 - 50 volunteers, Placebo 0.5 ml, 14 days interval, post-vaccination observation period of 6 months. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (38 listed)
- Healthy volunteers (men and women) aged 18-60;
- Written informed consent of volunteers to participate in a clinical trial;
- Volunteers who are able to comply with the requirements of the Protocol (i.e. filling out the Self-Observation Diary, come to control visits);
- For women capable of childbearing, a negative pregnancy test and consent to adhere to adequate contraceptive methods (use of contraceptives within six months after the second vaccination). Women should use contraceptive methods that are more than 90% reliable (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine devices), or be sterile or postmenopausal.
- For fertile men, consent to adhere to adequate contraceptive methods for six months after the second vaccination. Men and their sexual partners must use contraceptive methods with more than 90% reliability (cervical caps with spermicide, diaphragms with spermicide, condoms, intrauterine devices), or be sterile.
Key exclusion criteria (9 listed)
- Withdrawal of informed consent by a volunteer;
- Serious adverse events or adverse events that do not meet the criteria for severity, the development of which, in the opinion of the investigator, may be detrimental to the health or well-being of the volunteer;
- The need for procedures and/or drug treatment not permitted by the Study Protocol;
- The volunteer was included in violation of the inclusion/non-inclusion criteria of the Protocol;
- The emergence of non-inclusion criteria during the study;
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 |
|---|---|---|
| Vaccine for intramuscular injectionVolunteers (10 at the Stage 1; 140 at the Stage 2; 150 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml | Biological | Vaccine |
| Placebo comparator (without active ingredient) for intramuscular injectionVolunteers (5 at the Stage 1; 45 at the Stage 2; 50 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml | Other | Placebo |
Primary outcome
Geometric mean titer (GMT)
Time frame: 28 days after second vaccination / placebo
The percentage of volunteers with an increase in geometric mean titer of specific antibodies (GMT) on day 28 after the second dose of vaccine / placebo in the virus neutralization test and ELISA.
11 secondary outcomes
Geometric mean titer (GMT)
Time frame: 7 and 14 days after the first vaccination / placebo
Seroconversion rate [Time frame: 7 and 14 days after first vaccination / placebo]
Time frame: Percentage of volunteers with a fourfold (or more) level of seroconversion in the neutralization reaction and the ELISA reaction on days 7 and 14 after the first dose of vaccine / placebo; on day 7, day 14, day 28, 2 months, 3 months, 4 months, 5 months,
Level of γ-IFN and subpopulation composition of T-lymphocytes
Time frame: 7 and 14 days after the first vaccination / placebo
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)
Time frame: Within 6 months after the second vaccination / placebo
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)
Time frame: Within 6 months after the second vaccination / placebo
Cases of acute respiratory diseases (influenza, acute respiratory infections, COVID-19)
Time frame: Within 6 months after the second vaccination / placebo
Frequency and severity of adverse events
Time frame: Within 6 months after the first dose of vaccine / placebo
Assessment of adverse events
Time frame: within 6 months after the first dose of vaccine / placebo
Evaluation of clinically significant abnormalities in vital signs
Time frame: within 6 months after the first dose frame of vaccine / placebo
Evaluation of clinically significant deviations from laboratory parameters
Time frame: 3, 7, 10 and 14 days after the first vaccination; 4, 7, 14 and 28 days after the second vaccination
Cases of early termination of participation of volunteers in the study
Time frame: within 6 months after the introduction of the first dose of vaccine / placebo
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vaccine for intramuscular injection in people with Coronavirus Infections and Vaccine, run by Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products at 5 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 38 inclusion and 9 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 12 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Geometric mean titer (GMT) (time frame: 28 days after second vaccination / placebo). 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 12 Nov 2021.