COVID-19Phase 1/2NCT04398147
Phase I/II Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Canada
A Phase 1/2 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people with COVID-19, run by CanSino Biologics Inc. at 1 site in Canada.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 696 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2020to 30 Dec 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 13Show fewer
- 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).
- Inclusion criteria for the phase II portion of the study will be detailed in an amended synopsis/study protocol.
Who cannot join
- 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;
Show all 17Show fewer
- 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;
- Any condition that in the opinion of the investigators may interfere with the participants' compliance or evaluation of study objectives or informed consent (i.e. medical, psychological, social or other conditions, etc.) Exclusion criteria for the phase II portion of the study will be detailed in an amended synopsis/study protocol.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Canadian Center for Vaccinology
Halifax
Scott A Halperin, MD, 902-470-8141, scott.halperin@dal.ca
About this study
Official title: 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
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
Read the detailed description
A total of 96 healthy adult volunteers will be vaccinated in phase I stepwised according to the dose-escalation design from the younger adults(18 to <55) to the older adults(65 to <85). There are 2 dosage level used in this phase: 5E10vp and 10E10vp, and 2 dose schedules: single dose and 2 dose. According to the pre-defined adaptive design standards, the trial will moved from Phase I to Phase II. In the phase II portion, A total of 600 healthy adult volunteers will be vaccinated according to the dose-escalation design from the younger adults(18 to <55) to the older adults(55 to <85). There are 2 dosage levels and schedules used in this phase，and will determine a final dose and schedule by the end. Some cohorts in the phase II trial will be included in the subsequent phase III trial.
- Conditions
- COVID-19
- Being tested
- Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector), Placebo
- Keywords
- COVID-19, vaccine, Ad5, Safety, Immunogenicity, Dose-escalation, SARS-CoV-2
- Medical subject headings
- COVID-19, Alzheimer Disease 5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Biological
Intramuscular administration
PlaceboBiological
Intramuscular administration
| Study group | Role | What they receive |
|---|---|---|
| phase ⅠLow single dose (18-<55) | Experimental | 12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| phase ⅠPlacebo low single dose (18-<55) | Placebo comparator | 6 subjects, Placebo containing 0 vp, single dose, Intramuscular administration Receives: Biological: Placebo |
| phase ⅠLow 2 dose (18-<55) | Experimental | 12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| phase ⅠPlacebo low 2 dose (18-<55) | Placebo comparator | 6 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Placebo |
| phase ⅠLow single dose (65-<85) | Experimental | 12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| phase ⅠPlacebo low single dose (65-<85) | Placebo comparator | 3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration Receives: Biological: Placebo |
| phase ⅠLow 2 dose (65-<85) | Experimental | 12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| phase ⅠPlacebo low 2 dose (65-<85) | Placebo comparator | 3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Placebo |
| phase ⅠMedium single dose (65-<85) | Experimental | 12 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| phase ⅠPlacebo medium single dose (65-<85) | Placebo comparator | 3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration Receives: Biological: Placebo |
| phase ⅠMedium 2 dose (65-<85) | Experimental | 12 subjects, Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| phase ⅠPlacebo medium 2 dose (65-<85) | Placebo comparator | 3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Placebo |
| Phase II Low single dose (18-<55) | Experimental | 50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Phase II placebo low single dose (18-<55) | Placebo comparator | 10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration Receives: Biological: Placebo |
| Phase II Low 2 dose (18-<55) | Experimental | 50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Phase II placebo low 2 dose (18-<55) | Placebo comparator | 10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Placebo |
| Phase II Low single dose (55-<85) | Experimental | 50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Phase II placebo low single dose (55-<85) | Placebo comparator | 10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration Receives: Biological: Placebo |
| Phase II Low 2 dose (55-<85) | Experimental | 50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Phase II placebo low 2 dose (55-<85) | Placebo comparator | 10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Placebo |
| Phase II medium single dose (55-<85) | Experimental | 50 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Phase II placebo medium single dose (55-<85) | Placebo comparator | 10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration Receives: Biological: Placebo |
| Phase II medium 2 dose (55-<85) | Experimental | 50 subjects，Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Phase II placebo medium 2 dose (55-<85) | Placebo comparator | 10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Receives: Biological: Placebo |
| Phase II Low 1 or 2 dose (18-<55) | Experimental | 100 subjects，Ad5-nCoV containing 5E10 vp, 1or2 dose, Intramuscular administration ，according to the Previous trial results Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Phase II placebo 1 or 2 dose (18-<55) | Placebo comparator | 20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration Receives: Biological: Placebo |
| Phase II Low or medium dosage 1 or 2 dose (55-<85) | Experimental | 100 subjects，Ad5-nCoV containing 5E10 vp or 10E10vp, 1or2 dose, Intramuscular administration，according to the Previous trial results Receives: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) |
| Phase II placebo Low or medium,1 or 2 dose (55-<85) | Placebo comparator | 20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of the Solicited AE in all groups
The occurrence of Solicited AE in all groups within 0-6 days after each vaccination;
Measured: 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.
Measured: 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.
Measured: 6 months after the final vaccination
Secondary outcomes (10)
Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 (ELISA method);
Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 measured on 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 (ELISA method);
Measured: 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 )
Seroconversion rate (%of subjects with 4-fold or greater increase in antibody level) of the IgG antibody against SARS-CoV-2 measured on 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 (ELISA method );
Measured: 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);
Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2 measured on 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 (ELISA method);
Measured: 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)
Geometric mean titer (GMT) of the neutralizing antibody against SARS-CoV-2 measured on 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 (Pseudo-viral neutralization assay)
Measured: 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)
Seroconversion rate of the neutralizing antibody against SARS-CoV-2 measured on 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(Pseudo-viral neutralization assay);
Measured: 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
Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 (Pseudo-viral neutralization assay)
Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 measured on 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 (Pseudo-viral neutralization assay)
Measured: 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
Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector
Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector measured on 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;
Measured: 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
Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector
Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector measured on 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
Measured: 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
cellular immune response by ELISpot
The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot
Measured: on Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group
cellular immune response by ICS
The positive rate of IFN-γ, TNF-α, and IL-2 expressed by CD4+ and CD8+ T lymphocytes stimulated by S protein overlapping peptide library detected by Intracellular Cytokine Staining (ICS);
Measured: Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start1 Aug 2020 (estimated)
- Primary completion20 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 696 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CanSino Biologics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biotechnology, Canadian Center for Vaccinology
- Responsible party
- Sponsor
- Investigators
- Scott A Halperin, MD, Principal investigator, Canadian Center for VaccinologyJoanne M Langley, MD, Principal investigator, Canadian Center for Vaccinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398147
- Sponsor's protocol ID
- Ad5-nCoV-2020003
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04398147
- Acronym / sponsor ID
- Ad5-nCoV-2020003
- Conditions
- COVID-19
- Keywords
- COVID-19, vaccine, Ad5, Safety, Immunogenicity, Dose-escalation, SARS-CoV-2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 696 participants (estimated)
- Lead sponsor
- CanSino Biologics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Institute of Biotechnology, Canadian Center for Vaccinology
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A total of 96 healthy adult volunteers will be vaccinated in phase I stepwised according to the dose-escalation design from the younger adults(18 to <55) to the older adults(65 to <85). There are 2 dosage level used in this phase: 5E10vp and 10E10vp, and 2 dose schedules: single dose and 2 dose. According to the pre-defined adaptive design standards, the trial will moved from Phase I to Phase II. In the phase II portion, A total of 600 healthy adult volunteers will be vaccinated according to the dose-escalation design from the younger adults(18 to <55) to the older adults(55 to <85). There are 2 dosage levels and schedules used in this phase，and will determine a final dose and schedule by the end. Some cohorts in the phase II trial will be included in the subsequent phase III trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 28
| Arm | Type | Receives |
|---|---|---|
| phase ⅠLow single dose (18-<55) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration |
| phase ⅠPlacebo low single dose (18-<55) | Placebo comparator | Biological: Placebo6 subjects, Placebo containing 0 vp, single dose, Intramuscular administration |
| phase ⅠLow 2 dose (18-<55) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration |
| phase ⅠPlacebo low 2 dose (18-<55) | Placebo comparator | Biological: Placebo6 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration |
| phase ⅠLow single dose (65-<85) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration |
| phase ⅠPlacebo low single dose (65-<85) | Placebo comparator | Biological: Placebo3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration |
| phase ⅠLow 2 dose (65-<85) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration |
| phase ⅠPlacebo low 2 dose (65-<85) | Placebo comparator | Biological: Placebo3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration |
| phase ⅠMedium single dose (65-<85) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)12 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration |
| phase ⅠPlacebo medium single dose (65-<85) | Placebo comparator | Biological: Placebo3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration |
| phase ⅠMedium 2 dose (65-<85) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)12 subjects, Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration |
| phase ⅠPlacebo medium 2 dose (65-<85) | Placebo comparator | Biological: Placebo3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration |
| Phase II Low single dose (18-<55) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration |
| Phase II placebo low single dose (18-<55) | Placebo comparator | Biological: Placebo10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration |
| Phase II Low 2 dose (18-<55) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration |
| Phase II placebo low 2 dose (18-<55) | Placebo comparator | Biological: Placebo10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration |
| Phase II Low single dose (55-<85) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration |
| Phase II placebo low single dose (55-<85) | Placebo comparator | Biological: Placebo10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration |
| Phase II Low 2 dose (55-<85) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration |
| Phase II placebo low 2 dose (55-<85) | Placebo comparator | Biological: Placebo10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration |
| Phase II medium single dose (55-<85) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)50 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration |
| Phase II placebo medium single dose (55-<85) | Placebo comparator | Biological: Placebo10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration |
| Phase II medium 2 dose (55-<85) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)50 subjects，Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration |
| Phase II placebo medium 2 dose (55-<85) | Placebo comparator | Biological: Placebo10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration |
| Phase II Low 1 or 2 dose (18-<55) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)100 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 comparator | Biological: Placebo20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration |
| Phase II Low or medium dosage 1 or 2 dose (55-<85) | Experimental | Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)100 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 comparator | Biological: Placebo20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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℃;
Key exclusion criteria (17 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Intramuscular administration | Biological | Phase II Low 1 or 2 dose (18-<55), Phase II Low 2 dose (18-<55), Phase II Low 2 dose (55-<85), Phase II Low or medium dosage 1 or 2 dose (55-<85), Phase II Low single dose (18-<55), Phase II Low single dose (55-<85), Phase II medium 2 dose (55-<85), Phase II medium single dose (55-<85), phase ⅠLow 2 dose (18-<55), phase ⅠLow 2 dose (65-<85), phase ⅠLow single dose (18-<55), phase ⅠLow single dose (65-<85), phase ⅠMedium 2 dose (65-<85), phase ⅠMedium single dose (65-<85) |
| PlaceboIntramuscular administration | Biological | Phase II placebo 1 or 2 dose (18-<55), Phase II placebo Low or medium,1 or 2 dose (55-<85), Phase II placebo low 2 dose (18-<55), Phase II placebo low 2 dose (55-<85), Phase II placebo low single dose (18-<55), Phase II placebo low single dose (55-<85), Phase II placebo medium 2 dose (55-<85), Phase II placebo medium single dose (55-<85), phase ⅠPlacebo low 2 dose (18-<55), phase ⅠPlacebo low 2 dose (65-<85), phase ⅠPlacebo low single dose (18-<55), phase ⅠPlacebo low single dose (65-<85), phase ⅠPlacebo medium 2 dose (65-<85), phase ⅠPlacebo medium single dose (65-<85) |
Primary outcome
Incidence of the Solicited AE in all groups
Time frame: 0-6 days after each vaccination
The occurrence of Solicited AE in all groups within 0-6 days after each vaccination;
Incidence of Unsolicited AE in all groups
Time frame: 0-28 days after each vaccination
The occurrence of Unsolicited AE in all groups within 0-28 days after each vaccination.
Incidence of Serious adverse events (SAE) in all groups
Time frame: 6 months after the final vaccination
The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
10 secondary outcomes
Geometric mean titer (GMT) of the IgG antibody against SARS-CoV-2 (ELISA method);
Time frame: 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 )
Time frame: 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);
Time frame: 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)
Time frame: 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)
Time frame: 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
Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 (Pseudo-viral neutralization assay)
Time frame: 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
Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector
Time frame: 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
Geometric mean increase ratio (GMI) of the neutralizing antibody against adenovirus type 5 vector
Time frame: 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
cellular immune response by ELISpot
Time frame: on Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group
cellular immune response by ICS
Time frame: Day 0, Day 14, Day 28 and Day 168 in the one dose group and Day 0, 14, 28, 56, 70, 84, and 224 in the two dose group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott A Halperin, MD principal investigator
Canadian Center for Vaccinology
Joanne M Langley, MD principal investigator
Canadian Center for Vaccinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in people with COVID-19, run by CanSino Biologics Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luis H Barreto, PhD/MBA (416-294-5840, drluisbarreto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of the Solicited AE in all groups (time frame: 0-6 days after each vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.