Covid19Phase 3NCT04540419
Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19
A Phase 3 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people with Covid19, run by NPO Petrovax at 7 sites in Russia.
Trial summary
This study is a phase III clinical trial to evaluate efficacy, reactogenicity and safety of the vaccine Ad5-nCoV compared with placebo in volunteers at the age from 18 to 85 years，with the randomized, double-blind design Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 7 sitesRussia
- Study dates
- 11 Sep 2020to 30 Jul 2021
- Phase
- Phase 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of signed and dated Informed Consent of volunteer for participation in this study.
- Men and women at the age of 18-85 years.
- Bodyweight index 18.5-30.0 kg/m2.
- The negative result of the test, performed by using PCR, for the presence of SARS-CoV-2 RNA at the stage of screening.
- Negative result for anti-SARS-CoV-2 IgM and IgG antibodies at the stage of screening.
- No history of the diagnosis COVID-19.
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- Absence of close contacts with individuals, suspicious for infection SARS-CoV-2, or individuals, in whom the diagnosis COVID-19 was confirmed in laboratory within the last 14 days.
- Absence of signs of respiratory infection within the last 14 days.
- Negative results of human immunodeficiency virus (HIV), syphilis, hepatitis B and hepatitis C tests.
- According to historical data and results of screening examination, a volunteer has no diseases and/or conditions, which in view of Investigator, may influence the safety of volunteer participation and evaluation of study results.
- Volunteer consent for using safe contraceptive methods through all the study.
Who cannot join
- Positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain).
- Axillary body temperature ≥37.1 °C at the time of screening/randomization.
- Systolic blood pressure more than 139 mm Hg or less than 100 mm Hg and/or diastolic blood pressure more than 90 mm Hg or less than 60 mm Hg.
- Clinical significant abnormal laboratory and/or instrumental parameters at screening examination.
- Acute infectious diseases less than 4 weeks ahead of conduction of screening procedures.
- Acute and acute course of chronic diseases of GIT, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems.
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- History of blood and hematopoietic organ diseases.
- History of diabetes mellitus.
- History of epilepsy, epileptic syndrome, seizures.
- History of congenital and acquired immunodeficiency, HIV-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases.
- History malignancies.
- Using immunotropic preparations (immunomodulators, immunostimulators, immunodepressants), antiallergic, cytotoxic preparations for more than 10 sequential days within the last 3 months (except for inhalant and local using glucocorticoids [GCS] or using specified preparations less than 4 weeks ahead of the screening.
- Using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening.
- Using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization.
- Blood donation or loss (≥450 mL of blood or plasma) less than 3 months ahead of the screening.
- Vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study.
- Anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses.
- Major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening.
- Carrying out of body piercing procedures, an appendix of tattoo less than 1 month ahead of conduction of screening procedures and through all the study.
- Pregnancy or breast-feeding period.
- Participation in another clinical study within 3 months ahead of the screening.
- Psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of Study Protocol.
- Volunteers, who are Clinical Site staff.
- Other reasons, not allowing the volunteer to take part in this study in view of the study physician.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Russia7 sites
Federal budgetary institution of science "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protectionand Human Welfare
Moscow, 111123
State Budgetary Institution of Healthcare of the City of Moscow "City Polyclinic No. 2of the Department of Healthcare of the City of Moscow"
Moscow, 117556
Federal State Autonomous Educational Institution of Higher Education "First MoscowState Medical University named after I.M. Sechenov "of the Ministry of Health of the Russian Federation
Moscow, 119991
Limited Liability Company "Research Center Eco-safety"
Saint Petersburg, 196143
Federal State Budgetary Institution "Research Institute of Influenza named after A.A.Smorodintsev "of the Ministry of Health of the Russian Federation
Saint Petersburg, 197376
Private health care institution "Clinical hospital 'Russian Railways - Medicine' of the city of Yaroslavl"
Yaroslavl, 150030
Municipal budgetary institution "Central City Hospital No. 7"
Yekaterinburg, 620137
About this study
Official title: Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group Study Evaluating Efficacy, Reactogenicity and Safety of Recombinant Vaccine Ad5-nCoV Against Novel Coronavirus Infection in Adult Volunteers
This study is a phase III clinical trial to evaluate efficacy, reactogenicity and safety of the vaccine Ad5-nCoV compared with placebo in volunteers at the age from 18 to 85 years，with the randomized, double-blind design
Read the detailed description
A total of 500 healthy adult volunteers at the age from 18 to 85 years will be randomized into two treatment (vaccination) groups in ratio 3:1 by double-blind design.
Volunteers in group 1 (n=375) will be administered a single dose of the vaccine Ad5-nCoV (5E10vp).
Volunteers in group 2 (n=125): will be administered a single dose of placebo. Vaccine Ad5-nCoV or placebo will be administered intramuscularly into the deltoid muscle of the arm at a single dose of 0.5 mL (1 prefilled syringe).
- Conditions
- Covid19
- Being tested
- Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Biological
Intramuscular administration
PlaceboBiological
Intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| Ad5-nCoV single dose | Experimental | 375 subjects, Ad5-nCoV containing 5E10 vp, single dose Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Placebo single dose | Placebo comparator | 125 subjects, Placebo containing 0 vp, single dose Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Superiority of the vaccine Ad5-nCoV to placebo by the level of seroconversion
Proportion of subjects with four-fold and higher increment of anti-receptor-binding domain antibodies [receptor-binding domain, RBD] of S-protein SARS-CoV-2).
Measured: Day 28 after vaccination
Secondary outcomes (32)
Immunogenicity of the vaccine Ad5-nCoV compared with placebo (titer of SARS-CoV-2 antibodies)
Geometric mean titer of RBD и S-protein SARS-CoV-2 antibodies.
Measured: Day 14, 28 and after 6 months after vaccination.
Immunogenicity of the vaccine Ad5-nCoV compared with placebo (level of seroconversion)
Level of seroconversion (proportion of persons with four-fold and higher increment of RBD и S-protein SARS-CoV-2 antibodies).
Measured: Day 14, 28 and after 6 months after vaccination.
Immunogenicity of the vaccine Ad5-nCoV compared with placebo (rise of SARS-CoV-2 antibodies)
Geometric mean fold rise of RBD и S-protein SARS-CoV-2 antibodies.
Measured: Day 14, 28 and after 6 months after vaccination.
Immunogenicity of the vaccine Ad5-nCoV compared with placebo (T-cell response)
Quantity of T-cells.
Measured: Day 14, 28 and after 6 months after vaccination.
Frequency of confirmed COVID-19
Frequency of confirmed COVID-19 (confirmed case of COVID-19: presence of clinical signs and positive result of laboratory test for RNA of virus SARS-CoV-2) (exploratory analysis).
Measured: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
Frequency of confirmed cases of COVID-19, requiring hospitalization
Frequency of confirmed cases of COVID-19, requiring hospitalization. (confirmed case of COVID-19: presence of clinical signs and positive result of laboratory test for RNA of virus SARS-CoV-2) (exploratory analysis).
Measured: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
Frequency of cases with severe course of COVID-19
Frequency of cases with severe course of COVID-19 (confirmed case of COVID-19: presence of clinical signs and positive result of laboratory test for RNA of virus SARS-CoV-2) (exploratory analysis).
Measured: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
Frequency of death due to COVID-19.
Frequency of death due to COVID-19 (exploratory analysis).
Measured: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
Reactogenicity of the vaccine Ad5-nCoV compared with placebo
Frequency and character of general and local postvaccinal reactions.
Measured: Day 0 (day of vaccination), Day 2, Day 7
Frequency and character of adverse events and serious adverse events.
Frequency and character of adverse events and serious adverse events.
Measured: Day 0 - Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (blood pressure)
Results of evaluation of vital parameters:
- Systolic blood pressure
- Diastolic blood pressure The researcher evaluates each of the vital parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (heart rate)
Results of evaluation of vital parameters:
- Heart rate. The researcher evaluates each of the vital parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (respiratory rate)
Results of evaluation of vital parameters:
- Respiratory rate. The researcher evaluates each of the vital parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of physical examination
Results of physical examination includes examination of organs and systems:
General state Ears, nose, throat Skin and examination of the injection site The lymph nodes The cardiovascular system Respiratory system Nervous system Abdominal organs Kidneys and urinary system Musculoskeletal system.
During the physical examination, the researcher evaluates each of the systems in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography (Heart rate)
Results of electrocardiography:
- Heart rate (HR) The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography
Results of electrocardiography:
- Intervals RR, PQ, QT
- QRS complex
- Corrected QT interval (QTcF). The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry (enzymes)
Results of serum chemistry:
alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LDH).
The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry
Results of serum chemistry:
total bilirubin, creatinine, urea, fasting glucose. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry
Results of serum chemistry:
total protein, C-reactive protein. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hemoglobin)
Results of complete blood count: hemoglobin The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hematocrit)
Results of complete blood count: hematocrit.
The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocytes)
Results of complete blood count: erythrocytes.
The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count
Results of complete blood count: platelets, leukocytes and leukocyte formula (neutrophils, lymphocytes, monocytes, eosinophils, basophils (absolute number).
The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocyte sedimentation rate)
Results of complete blood count: erythrocyte sedimentation rate
The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram
Results of coagulogram:
activated partial thromboplastin time, prothrombin time.
The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram (fibrinogen)
Results of coagulogram: fibrinogen.
The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (relative density)
Results of clinical urinalysis: relative density. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (pH)
Results of clinical urinalysis: pH. The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis
Results of clinical urinalysis: leukocytes, erythrocytes, cylinders . The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (protein)
Results of clinical urinalysis: protein . The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (glucose)
Results of clinical urinalysis:glucose . The researcher evaluates each of the parameter in the normal / abnormal categories. Clinically significant abnormalities should be reported as adverse events.
Measured: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of determination of immunoglobulin E serum concentrations.
Results of determination of immunoglobulin E serum concentrations.
Measured: Day -7-1 (Screening), Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start11 Sep 2020
- Primary completion19 Jun 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- NPO Petrovax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CanSino Biologics Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540419
- Sponsor's protocol ID
- Prometheus_Rus
- Status last verified
- Apr 2024
- First submitted
- 17 Aug 2020
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lioznov D, Amosova I, Sheetikov SA, Zornikova KV, Serdyuk Y, Efimov GA, Tsyferov M, Khmelevskii M, Afanasiev A, Khomyakova N, Zubkov D, Tikhonov A, Zhu T, Barreto L, Dzutseva V. Immunogenicity and safety of a recombinant adenovirus type-5 COVID-19 vaccine in adults: Data from a randomised, double-blind, placebo-controlled, single-dose, phase 3 trial in Russia. PLoS One. 2023 Mar 8;18(3):e0278878. doi: 10.1371/journal.pone.0278878. eCollection 2023.
PubMed 36888640
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double Blind, Placebo Controlled Parallel Group Study Evaluating Efficacy, Reactogenicity and Safety of Recombinant Vaccine Ad5-nCoV Against Novel Coronavirus Infection in Adult Volunteers
- ClinicalTrials.gov ID
- NCT04540419
- Acronym / sponsor ID
- Prometheus_Rus
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- NPO PetrovaxIndustry (pharma, biotech, devices)
- Collaborators
- CanSino Biologics Inc.
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 19 Jun 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 7 Sep 2020 (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.
This study is a phase III clinical trial to evaluate efficacy, reactogenicity and safety of the vaccine Ad5-nCoV compared with placebo in volunteers at the age from 18 to 85 years，with the randomized, double-blind design
Detailed description
A total of 500 healthy adult volunteers at the age from 18 to 85 years will be randomized into two treatment (vaccination) groups in ratio 3:1 by double-blind design.
Volunteers in group 1 (n=375) will be administered a single dose of the vaccine Ad5-nCoV (5E10vp).
Volunteers in group 2 (n=125): will be administered a single dose of placebo. Vaccine Ad5-nCoV or placebo will be administered intramuscularly into the deltoid muscle of the arm at a single dose of 0.5 mL (1 prefilled syringe).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ad5-nCoV single dose | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)375 subjects, Ad5-nCoV containing 5E10 vp, single dose |
| Placebo single dose | Placebo comparator | Biological: Placebo125 subjects, Placebo containing 0 vp, single dose |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Presence of signed and dated Informed Consent of volunteer for participation in this study.
- Men and women at the age of 18-85 years.
- Bodyweight index 18.5-30.0 kg/m2.
- The negative result of the test, performed by using PCR, for the presence of SARS-CoV-2 RNA at the stage of screening.
- Negative result for anti-SARS-CoV-2 IgM and IgG antibodies at the stage of screening.
Key exclusion criteria (24 listed)
- Positive history of allergy, drug intolerance, including increased sensibility to any of components of the test drug product, as well as the history of serious adverse events in the administration of vaccines (such as allergic reactions, respiratory disturbance, angioedema, stomach pain).
- Axillary body temperature ≥37.1 °C at the time of screening/randomization.
- Systolic blood pressure more than 139 mm Hg or less than 100 mm Hg and/or diastolic blood pressure more than 90 mm Hg or less than 60 mm Hg.
- Clinical significant abnormal laboratory and/or instrumental parameters at screening examination.
- Acute infectious diseases less than 4 weeks ahead of conduction of screening procedures.
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 |
|---|---|---|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Intramuscular administration | Biological | Ad5-nCoV single dose |
| PlaceboIntramuscular administration | Biological | Placebo single dose |
Primary outcome
Superiority of the vaccine Ad5-nCoV to placebo by the level of seroconversion
Time frame: Day 28 after vaccination
Proportion of subjects with four-fold and higher increment of anti-receptor-binding domain antibodies [receptor-binding domain, RBD] of S-protein SARS-CoV-2).
32 secondary outcomes
Immunogenicity of the vaccine Ad5-nCoV compared with placebo (titer of SARS-CoV-2 antibodies)
Time frame: Day 14, 28 and after 6 months after vaccination.
Immunogenicity of the vaccine Ad5-nCoV compared with placebo (level of seroconversion)
Time frame: Day 14, 28 and after 6 months after vaccination.
Immunogenicity of the vaccine Ad5-nCoV compared with placebo (rise of SARS-CoV-2 antibodies)
Time frame: Day 14, 28 and after 6 months after vaccination.
Immunogenicity of the vaccine Ad5-nCoV compared with placebo (T-cell response)
Time frame: Day 14, 28 and after 6 months after vaccination.
Frequency of confirmed COVID-19
Time frame: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
Frequency of confirmed cases of COVID-19, requiring hospitalization
Time frame: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
Frequency of cases with severe course of COVID-19
Time frame: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
Frequency of death due to COVID-19.
Time frame: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
Reactogenicity of the vaccine Ad5-nCoV compared with placebo
Time frame: Day 0 (day of vaccination), Day 2, Day 7
Frequency and character of adverse events and serious adverse events.
Time frame: Day 0 - Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (blood pressure)
Time frame: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (heart rate)
Time frame: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (respiratory rate)
Time frame: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of physical examination
Time frame: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography (Heart rate)
Time frame: Day -7-1 (Screening), Day 2
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography
Time frame: Day -7-1 (Screening), Day 2
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry (enzymes)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hemoglobin)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hematocrit)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocytes)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocyte sedimentation rate)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram (fibrinogen)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (relative density)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (pH)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (protein)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (glucose)
Time frame: Day -7-1 (Screening), Day 2, Day 28
To evaluate safety of the vaccine Ad5-nCoV by its effect on results of determination of immunoglobulin E serum concentrations.
Time frame: Day -7-1 (Screening), Day 28
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 23 Apr 2024.
- Derived from this study: PubMed 36888640Lioznov D, Amosova I, Sheetikov SA, Zornikova KV, Serdyuk Y, Efimov GA, Tsyferov M, Khmelevskii M, Afanasiev A, Khomyakova N, Zubkov D, Tikhonov A, Zhu T, Barreto L, Dzutseva V. Immunogenicity and safety of a recombinant adenovirus type-5 COVID-19 vaccine in adults: Data from a randomised, double-blind, placebo-controlled, single-dose, phase 3 trial in Russia. PLoS One. 2023 Mar 8;18(3):e0278878. doi: 10.1371/journal.pone.0278878. eCollection 2023.
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Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people with Covid19, run by NPO Petrovax at 7 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 24 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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 phase mean?
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?
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?
Superiority of the vaccine Ad5-nCoV to placebo by the level of seroconversion (time frame: Day 28 after vaccination). 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 NCT04540419, which also lists 1 linked publication.
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 23 Apr 2024.