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| Name | Class |
|---|---|
| CanSino Biologics Inc. | INDUSTRY |
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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
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ad5-nCoV single dose | Experimental | 375 subjects, Ad5-nCoV containing 5E10 vp, single dose |
|
| Placebo single dose | Placebo Comparator | 125 subjects, Placebo containing 0 vp, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) | Biological | Intramuscular administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Day 28 after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 14, 28 and after 6 months after vaccination. |
| Immunogenicity of the vaccine Ad5-nCoV compared with placebo (level of seroconversion) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal budgetary institution of science "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protectionand Human Welfare | Moscow | 111123 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36888640 | Derived | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Placebo | Biological | Intramuscular administration |
|
Level of seroconversion (proportion of persons with four-fold and higher increment of RBD и S-protein SARS-CoV-2 antibodies). |
| 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. | 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. | 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). | 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). | 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). | 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). | 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. | 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. | 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:
| 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. | 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. | 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. | 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. | Day -7-1 (Screening), Day 2 |
| To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography | Results of electrocardiography:
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Day -7-1 (Screening), Day 28 |
| 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 | Russia |
| 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 | Russia |
| Limited Liability Company "Research Center Eco-safety" | Saint Petersburg | 196143 | Russia |
| 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 | Russia |
| Private health care institution "Clinical hospital 'Russian Railways - Medicine' of the city of Yaroslavl" | Yaroslavl | 150030 | Russia |
| Municipal budgetary institution "Central City Hospital No. 7" | Yekaterinburg | 620137 | Russia |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |