A Phase 3 interventional study of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) and Placebo in Covid19, sponsored by NPO Petrovax. Completed at 7 sites in Russian Federation. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-23.
Sponsored by NPO Petrovax · Phase 3, Interventional, and Prevention
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).
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 500 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →NPO Petrovax is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
375 subjects, Ad5-nCoV containing 5E10 vp, single dose
Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
125 subjects, Placebo containing 0 vp, single dose
Biological: Placebo
Intramuscular administration
Intramuscular administration
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).
Time frame: Day 28 after vaccination
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.
Time frame: 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).
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)
Geometric mean fold rise of RBD и S-protein 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)
Quantity of T-cells.
Time frame: 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).
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
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).
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
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).
Time frame: 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).
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
Frequency and character of general and local postvaccinal reactions.
Time frame: 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.
Time frame: 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.
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)
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.
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)
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.
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
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.
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)
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.
Time frame: 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.
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)
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.
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
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.
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
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.
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)
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.
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)
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.
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)
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.
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
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.
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)
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.
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
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.
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)
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.
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)
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.
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)
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.
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
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.
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)
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.
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)
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.
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.
Results of determination of immunoglobulin E serum concentrations.
Time frame: Day -7-1 (Screening), Day 28
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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NPO Petrovax