Phase I/II Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Canada
NCT ID: NCT04398147
Last Updated: 2020-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
696 participants
INTERVENTIONAL
2020-08-01
2021-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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phase ⅠLow single dose (18-<55)
12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
phase ⅠPlacebo low single dose (18-<55)
6 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
Placebo
Intramuscular administration
phase ⅠLow 2 dose (18-<55)
12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
phase ⅠPlacebo low 2 dose (18-<55)
6 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Placebo
Intramuscular administration
phase ⅠLow single dose (65-<85)
12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
phase ⅠPlacebo low single dose (65-<85)
3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
Placebo
Intramuscular administration
phase ⅠLow 2 dose (65-<85)
12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
phase ⅠPlacebo low 2 dose (65-<85)
3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Placebo
Intramuscular administration
phase ⅠMedium single dose (65-<85)
12 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
phase ⅠPlacebo medium single dose (65-<85)
3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
Placebo
Intramuscular administration
phase ⅠMedium 2 dose (65-<85)
12 subjects, Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
phase ⅠPlacebo medium 2 dose (65-<85)
3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Placebo
Intramuscular administration
Phase II Low single dose (18-<55)
50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Phase II placebo low single dose (18-<55)
10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration
Placebo
Intramuscular administration
Phase II Low 2 dose (18-<55)
50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Phase II placebo low 2 dose (18-<55)
10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Placebo
Intramuscular administration
Phase II Low single dose (55-<85)
50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Phase II placebo low single dose (55-<85)
10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration
Placebo
Intramuscular administration
Phase II Low 2 dose (55-<85)
50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Phase II placebo low 2 dose (55-<85)
10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Placebo
Intramuscular administration
Phase II medium single dose (55-<85)
50 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Phase II placebo medium single dose (55-<85)
10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration
Placebo
Intramuscular administration
Phase II medium 2 dose (55-<85)
50 subjects，Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Phase II placebo medium 2 dose (55-<85)
10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Placebo
Intramuscular administration
Phase II Low 1 or 2 dose (18-<55)
100 subjects，Ad5-nCoV containing 5E10 vp, 1or2 dose, Intramuscular administration ，according to the Previous trial results
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Phase II placebo 1 or 2 dose (18-<55)
20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration
Placebo
Intramuscular administration
Phase II Low or medium dosage 1 or 2 dose (55-<85)
100 subjects，Ad5-nCoV containing 5E10 vp or 10E10vp, 1or2 dose, Intramuscular administration，according to the Previous trial results
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Phase II placebo Low or medium,1 or 2 dose (55-<85)
20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration
Placebo
Intramuscular administration
Interventions
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Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
Intramuscular administration
Placebo
Intramuscular administration
Eligibility Criteria
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Inclusion Criteria
* Able to provide consent to participate in and having signed an Informed Consent Form (ICF);
* Able and willing to complete all the scheduled study procedures during the whole study follow-up period (about 6-8 months, depending on group);
* Negative result of HIV, hepatitis B and C screening;
* Oral temperature \< 38.0℃;
* Negative IgG and IgM antibodies against COVID-19;
* Negative result of real-time quantitative PCR screening of nasopharyngeal swabs/sputum for SARS-CoV-2;
* A body mass index (BMI) between 18-35;
* Hematological examination is within normal range, or no greater than a grade 1 abnormality and no clinical significance as assessed by the study investigator (including white blood cell count, lymphocyte count, neutrophil count, eosinophil count, platelet, hemoglobin, alanine aminotransferase ALT, aspartate aminotransferase AST, total bilirubin, blood glucose and creatinine);
* Transient mild laboratory abnormalities may be rescreened once and the participant will be deemed eligible if the laboratory repeat test is normal as per local laboratory normal values and investigator assessment.
* Good general health status, as determined by history and physical examination no greater than 14 days prior to administration of the test article.
* If female of child-bearing potential and heterosexually active, has practiced adequate contraception for 30 days prior to injection, has a negative pregnancy test on the day of injection, and has agreed to continue adequate contraception until 180 days after injection. (Please refer to the glossary for the definition of child-bearing potential and adequate contraception).
Exclusion Criteria
* Allergic history to any vaccine, or allergic to any ingredient of the Ad5-nCoV;
* Woman is pregnant or lactating, positive urine pregnancy test or plan to become pregnant during the next 6 months;
* Any acute febrile disease (oral temperature ≥38.0℃ or active infectious disease on the day of vaccination;
* Medical history of SARS (SARS-CoV-1);
* Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension not controlled with medication;
* Serious chronic disease such as asthma, diabetes and thyroid disease, etc.;
* Congenital or acquired angioedema;
* Immunodeficiency, asplenia or functional asplenia;
* Platelet disorder or other bleeding disorder that may cause intramuscular injection contraindication;
* Immunosuppressive medication, anti-allergic, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray for allergic rhinitis, surface corticosteroid therapy for acute non-complicated dermatitis) in the last 6 months;
* Prior administration of blood products in last 4 months;
* Other vaccination(s) or investigational drugs within 1 month before study onset, or planned use during the study period;
* Prior administration of live attenuated vaccine within 1 month before study onset;
* Prior administration of subunit or inactivated vaccine within 14 days before study onset;
* Current anti-tuberculosis therapy;
18 Years
84 Years
ALL
Yes
Sponsors
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Beijing Institute of Biotechnology
OTHER
Canadian Center for Vaccinology
OTHER
CanSino Biologics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Scott A Halperin, MD
Role: PRINCIPAL_INVESTIGATOR
Canadian Center for Vaccinology
Joanne M Langley, MD
Role: PRINCIPAL_INVESTIGATOR
Canadian Center for Vaccinology
Locations
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Canadian Center for Vaccinology
Halifax, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Ad5-nCoV-2020003
Identifier Type: -
Identifier Source: org_study_id
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