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Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04540419
Recruitment Status : Active, not recruiting
First Posted : September 7, 2020
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
CanSino Biologics Inc.
Information provided by (Responsible Party):
NPO Petrovax

Tracking Information
First Submitted Date  ICMJE August 17, 2020
First Posted Date  ICMJE September 7, 2020
Last Update Posted Date November 13, 2020
Actual Study Start Date  ICMJE September 11, 2020
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2020)
  • 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. ]
    Geometric mean titer of RBD и S-protein SARS-CoV-2 antibodies.
  • Immunogenicity of the vaccine Ad5-nCoV compared with placebo (level of seroconversion) [ Time Frame: Day 14, 28 and after 6 months after vaccination. ]
    Level of seroconversion (proportion of persons with four-fold and higher increment of RBD и S-protein SARS-CoV-2 antibodies).
  • 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. ]
    Geometric mean fold rise of RBD и S-protein SARS-CoV-2 antibodies.
  • Immunogenicity of the vaccine Ad5-nCoV compared with placebo (T-cell response) [ Time Frame: Day 14, 28 and after 6 months after vaccination. ]
    Quantity of T-cells.
  • 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 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).
  • 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 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).
  • 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 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).
  • Frequency of death due to 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 (exploratory analysis).
  • Reactogenicity of the vaccine Ad5-nCoV compared with placebo [ Time Frame: Day 0 (day of vaccination), Day 2, Day 7 ]
    Frequency and character of general and local postvaccinal reactions.
  • Frequency and character of adverse events and serious adverse events. [ Time Frame: Day 0 - Month 6 ]
    Frequency and character of adverse events and serious adverse events.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography [ Time Frame: Day -7-1 (Screening), Day 2 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 ]
    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.
  • 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 of determination of immunoglobulin E serum concentrations.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19
Official Title  ICMJE 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
Brief 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    Intramuscular administration
  • Biological: Placebo
    Intramuscular administration
Study Arms  ICMJE
  • Experimental: Ad5-nCoV single dose
    375 subjects, Ad5-nCoV containing 5E10 vp, single dose
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Placebo single dose
    125 subjects, Placebo containing 0 vp, single dose
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 4, 2020)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date November 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Presence of signed and dated Informed Consent of volunteer for participation in this study.
  2. Men and women at the age of 18-85 years.
  3. Bodyweight index 18.5-30.0 kg/m2.
  4. The negative result of the test, performed by using PCR, for the presence of SARS-CoV-2 RNA at the stage of screening.
  5. Negative result for anti-SARS-CoV-2 IgM and IgG antibodies at the stage of screening.
  6. No history of the diagnosis COVID-19.
  7. 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.
  8. Absence of signs of respiratory infection within the last 14 days.
  9. Negative results of human immunodeficiency virus (HIV), syphilis, hepatitis B and hepatitis C tests.
  10. 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.
  11. Volunteer consent for using safe contraceptive methods through all the study.

Exclusion Criteria:

  1. 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).
  2. Axillary body temperature ≥37.1 °C at the time of screening/randomization.
  3. 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.
  4. Clinical significant abnormal laboratory and/or instrumental parameters at screening examination.
  5. Acute infectious diseases less than 4 weeks ahead of conduction of screening procedures.
  6. Acute and acute course of chronic diseases of GIT, liver, kidneys, cardiovascular, respiratory, nervous and endocrine systems.
  7. History of blood and hematopoietic organ diseases.
  8. History of diabetes mellitus.
  9. History of epilepsy, epileptic syndrome, seizures.
  10. History of congenital and acquired immunodeficiency, HIV-infection, lymphoma, leukaemia, systemic lupus erythematosus, juvenile rheumatoid arthritis or other autoimmune diseases.
  11. History malignancies.
  12. 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.
  13. Using immunoglobulin preparations or blood transfusion less than 3 months ahead of the screening.
  14. Using antipyretics (including non-steroidal anti-inflammatory agents and anilides) within 24 hours ahead of randomization.
  15. Blood donation or loss (≥450 mL of blood or plasma) less than 3 months ahead of the screening.
  16. Vaccination within 6 mon. ahead of screening or reluctance to refuse from the administration of any other vaccine during the study.
  17. Anamnestic data/data on alcoholism, narcomania, drug abuse, mental illnesses.
  18. Major surgery planned within the nearest 6 months or underwent within the last 6 months ahead of the screening.
  19. 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.
  20. Pregnancy or breast-feeding period.
  21. Participation in another clinical study within 3 months ahead of the screening.
  22. Psychic, physical and other reasons, not allowing a volunteer to adhere to conditions and procedures of Study Protocol.
  23. Volunteers, who are Clinical Site staff.
  24. Other reasons, not allowing the volunteer to take part in this study in view of the study physician.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04540419
Other Study ID Numbers  ICMJE Prometheus_Rus
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NPO Petrovax
Study Sponsor  ICMJE NPO Petrovax
Collaborators  ICMJE CanSino Biologics Inc.
Investigators  ICMJE Not Provided
PRS Account NPO Petrovax
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP