Clinical trial NCT04540419: Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) Against COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Covid19
Lead sponsor: NPO Petrovax
Sponsor class: INDUSTRY
Collaborators: name: CanSino Biologics Inc.
First posted: 2020-09-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Superiority of the vaccine Ad5-nCoV to placebo by the level of seroconversion
timeFrame: Day 28 after vaccination
Secondary outcomes:
measure: Immunogenicity of the vaccine Ad5-nCoV compared with placebo (titer of SARS-CoV-2 antibodies)
timeFrame: Day 14, 28 and after 6 months after vaccination.
measure: Immunogenicity of the vaccine Ad5-nCoV compared with placebo (level of seroconversion)
timeFrame: Day 14, 28 and after 6 months after vaccination.
measure: Immunogenicity of the vaccine Ad5-nCoV compared with placebo (rise of SARS-CoV-2 antibodies)
timeFrame: Day 14, 28 and after 6 months after vaccination.
measure: Immunogenicity of the vaccine Ad5-nCoV compared with placebo (T-cell response)
timeFrame: Day 14, 28 and after 6 months after vaccination.
measure: Frequency of confirmed COVID-19
timeFrame: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
measure: Frequency of confirmed cases of COVID-19, requiring hospitalization
timeFrame: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
measure: Frequency of cases with severe course of COVID-19
timeFrame: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
measure: Frequency of death due to COVID-19.
timeFrame: Within 6 months after vaccination (except for COVID-19 cases within 14 days after vaccination)
measure: Reactogenicity of the vaccine Ad5-nCoV compared with placebo
timeFrame: Day 0 (day of vaccination), Day 2, Day 7
measure: Frequency and character of adverse events and serious adverse events.
timeFrame: Day 0 - Month 6
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (blood pressure)
timeFrame: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (heart rate)
timeFrame: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on vital parameters (respiratory rate)
timeFrame: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of physical examination
timeFrame: Day -7-1 (Screening), Day 0, Day 2, Day 7, Day 14, Day 28, Month 6
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography (Heart rate)
timeFrame: Day -7-1 (Screening), Day 2
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of electrocardiography
timeFrame: Day -7-1 (Screening), Day 2
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry (enzymes)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of serum chemistry
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hemoglobin)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (hematocrit)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocytes)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of complete blood count (erythrocyte sedimentation rate)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of coagulogram (fibrinogen)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (relative density)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (pH)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (protein)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of clinical urinalysis (glucose)
timeFrame: Day -7-1 (Screening), Day 2, Day 28
measure: To evaluate safety of the vaccine Ad5-nCoV by its effect on results of determination of immunoglobulin E serum concentrations.
timeFrame: Day -7-1 (Screening), Day 28
Other outcomes:
Locations:
city: Ekaterinburg
country: Russian Federation
facility: Municipal budgetary institution "Central City Hospital No. 7"
city: Moscow
country: Russian Federation
facility: Federal budgetary institution of science "Central Research Institute of Epidemiology" of the Federal Service for Surveillance on Consumer Rights Protectionand Human Welfare
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of Healthcare of the City of Moscow "City Polyclinic No. 2of the Department of Healthcare of the City of Moscow"
city: Moscow
country: Russian Federation
facility: 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
city: Saint Petersburg
country: Russian Federation
facility: Limited Liability Company "Research Center Eco-safety"
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "Research Institute of Influenza named after A.A.Smorodintsev "of the Ministry of Health of the Russian Federation
city: Yaroslavl
country: Russian Federation
facility: Private health care institution "Clinical hospital 'Russian Railways - Medicine' of the city of Yaroslavl"
Study officials:
References: