Phase I/II Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Canada
A Randomized, Observer-Blind, Dose-escalation Phase I/II Clinical Trial of Ad5-nCoV Vaccine in Healthy Adults From 18 to <85 Years of Age in Canada
1 other identifier
interventional
696
1 country
1
Brief Summary
This study is a phase I /II adaptive clinical trial to evaluate the safety, tolerability and the Immunogenicity of Ad5-nCoV in healthy adults from 18 to \<55 and 65 to \<85 years of age，with the randomized, observer-blind, dose-escalation design
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Aug 2020
Typical duration for phase_1 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
May 21, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedJuly 2, 2020
May 1, 2020
1.4 years
May 18, 2020
June 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Incidence of the Solicited AE in all groups
The occurrence of Solicited AE in all groups within 0-6 days after each vaccination;
0-6 days after each vaccination
Incidence of Unsolicited AE in all groups
The occurrence of Unsolicited AE in all groups within 0-28 days after each vaccination.
0-28 days after each vaccination
Incidence of Serious adverse events (SAE) in all groups
The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
6 months after the final vaccination
Secondary Outcomes (10)
Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 (ELISA method);
Day 0, Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group
Seroconversion rate of the IgG antibody against SARS-CoV-2(ELISA method )
Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group
Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2(ELISA method);
Day 14, Day 28, Day 84 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group
Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)
Day 0, Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group
Seroconversion rate of the neutralizing antibody against SARS-CoV-2(Pseudo-viral neutralization assay)
Day 14, Day 28 and Day 168 after vaccination in the one dose group and Day 14, 28, 56, 70, 84, and 224 in the two dose group
- +5 more secondary outcomes
Study Arms (28)
phase ⅠLow single dose (18-<55)
EXPERIMENTAL12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
phase ⅠPlacebo low single dose (18-<55)
PLACEBO COMPARATOR6 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
phase ⅠLow 2 dose (18-<55)
EXPERIMENTAL12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
phase ⅠPlacebo low 2 dose (18-<55)
PLACEBO COMPARATOR6 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
phase ⅠLow single dose (65-<85)
EXPERIMENTAL12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
phase ⅠPlacebo low single dose (65-<85)
PLACEBO COMPARATOR3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
phase ⅠLow 2 dose (65-<85)
EXPERIMENTAL12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
phase ⅠPlacebo low 2 dose (65-<85)
PLACEBO COMPARATOR3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
phase ⅠMedium single dose (65-<85)
EXPERIMENTAL12 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration
phase ⅠPlacebo medium single dose (65-<85)
PLACEBO COMPARATOR3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
phase ⅠMedium 2 dose (65-<85)
EXPERIMENTAL12 subjects, Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration
phase ⅠPlacebo medium 2 dose (65-<85)
PLACEBO COMPARATOR3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Phase II Low single dose (18-<55)
EXPERIMENTAL50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Phase II placebo low single dose (18-<55)
PLACEBO COMPARATOR10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration
Phase II Low 2 dose (18-<55)
EXPERIMENTAL50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Phase II placebo low 2 dose (18-<55)
PLACEBO COMPARATOR10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Phase II Low single dose (55-<85)
EXPERIMENTAL50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Phase II placebo low single dose (55-<85)
PLACEBO COMPARATOR10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration
Phase II Low 2 dose (55-<85)
EXPERIMENTAL50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Phase II placebo low 2 dose (55-<85)
PLACEBO COMPARATOR10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Phase II medium single dose (55-<85)
EXPERIMENTAL50 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration
Phase II placebo medium single dose (55-<85)
PLACEBO COMPARATOR10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration
Phase II medium 2 dose (55-<85)
EXPERIMENTAL50 subjects，Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration
Phase II placebo medium 2 dose (55-<85)
PLACEBO COMPARATOR10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Phase II Low 1 or 2 dose (18-<55)
EXPERIMENTAL100 subjects，Ad5-nCoV containing 5E10 vp, 1or2 dose, Intramuscular administration ，according to the Previous trial results
Phase II placebo 1 or 2 dose (18-<55)
PLACEBO COMPARATOR20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration
Phase II Low or medium dosage 1 or 2 dose (55-<85)
EXPERIMENTAL100 subjects，Ad5-nCoV containing 5E10 vp or 10E10vp, 1or2 dose, Intramuscular administration，according to the Previous trial results
Phase II placebo Low or medium,1 or 2 dose (55-<85)
PLACEBO COMPARATOR20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration
Interventions
Intramuscular administration
Intramuscular administration
Eligibility Criteria
You may qualify if:
- Healthy adults from 18 to \<55 and 65-\<85 years of age at the time of enrollment;
- 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).
You may not qualify if:
- Personal history of seizure disorder, encephalopathy or psychosis;
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CanSino Biologics Inc.lead
- Beijing Institute of Biotechnologycollaborator
- Canadian Center for Vaccinologycollaborator
Study Sites (1)
Canadian Center for Vaccinology
Halifax, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott A Halperin, MD
Canadian Center for Vaccinology
- PRINCIPAL INVESTIGATOR
Joanne M Langley, MD
Canadian Center for Vaccinology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2020
First Posted
May 21, 2020
Study Start
August 1, 2020
Primary Completion
December 20, 2021
Study Completion
December 30, 2021
Last Updated
July 2, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share