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Virus Therapy

Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for COVID-19

Phase 1 & 2
Waitlist Available
Led By Scott A Halperin, MD
Research Sponsored by CanSino Biologics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months after the final vaccination
Awards & highlights

Study Summary

This trial is testing a new vaccine for safety, tolerability, and effectiveness in adults ages 18-55 and 65-85.

Eligible Conditions
  • COVID-19
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months after the final vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months after the final vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Serious adverse events (SAE) in all groups
Incidence of Unsolicited AE in all groups
Incidence of the Solicited AE in all groups
Secondary outcome measures
Geometric Mean Increase Ratio (GMI) of the specific antibody against SARS-CoV-2(ELISA method);
Geometric Mean Titer (GMT) of the neutralizing antibody against adenovirus type 5 vector
Geometric mean increase ratio (GMI) of neutralizing antibody against SARS-CoV-2 (Pseudo-viral neutralization assay)
+7 more

Trial Design

28Treatment groups
Experimental Treatment
Placebo Group
Group I: phase ⅠMedium single dose (65-<85)Experimental Treatment1 Intervention
12 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration
Group II: phase ⅠMedium 2 dose (65-<85)Experimental Treatment1 Intervention
12 subjects, Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration
Group III: phase ⅠLow single dose (65-<85)Experimental Treatment1 Intervention
12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Group IV: phase ⅠLow single dose (18-<55)Experimental Treatment1 Intervention
12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Group V: phase ⅠLow 2 dose (65-<85)Experimental Treatment1 Intervention
12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Group VI: phase ⅠLow 2 dose (18-<55)Experimental Treatment1 Intervention
12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Group VII: Phase II medium single dose (55-<85)Experimental Treatment1 Intervention
50 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration
Group VIII: Phase II medium 2 dose (55-<85)Experimental Treatment1 Intervention
50 subjects，Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration
Group IX: Phase II Low single dose (55-<85)Experimental Treatment1 Intervention
50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Group X: Phase II Low single dose (18-<55)Experimental Treatment1 Intervention
50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
Group XI: Phase II Low or medium dosage 1 or 2 dose (55-<85)Experimental Treatment1 Intervention
100 subjects，Ad5-nCoV containing 5E10 vp or 10E10vp, 1or2 dose, Intramuscular administration，according to the Previous trial results
Group XII: Phase II Low 2 dose (55-<85)Experimental Treatment1 Intervention
50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Group XIII: Phase II Low 2 dose (18-<55)Experimental Treatment1 Intervention
50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
Group XIV: Phase II Low 1 or 2 dose (18-<55)Experimental Treatment1 Intervention
100 subjects，Ad5-nCoV containing 5E10 vp, 1or2 dose, Intramuscular administration ，according to the Previous trial results
Group XV: Phase II placebo low single dose (18-<55)Placebo Group1 Intervention
10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration
Group XVI: Phase II placebo Low or medium,1 or 2 dose (55-<85)Placebo Group1 Intervention
20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration
Group XVII: phase ⅠPlacebo medium single dose (65-<85)Placebo Group1 Intervention
3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
Group XVIII: Phase II placebo low 2 dose (55-<85)Placebo Group1 Intervention
10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Group XIX: phase ⅠPlacebo low 2 dose (65-<85)Placebo Group1 Intervention
3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Group XX: phase ⅠPlacebo medium 2 dose (65-<85)Placebo Group1 Intervention
3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Group XXI: phase ⅠPlacebo low single dose (65-<85)Placebo Group1 Intervention
3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
Group XXII: Phase II placebo low 2 dose (18-<55)Placebo Group1 Intervention
10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Group XXIII: Phase II placebo medium 2 dose (55-<85)Placebo Group1 Intervention
10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Group XXIV: Phase II placebo low single dose (55-<85)Placebo Group1 Intervention
10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration
Group XXV: Phase II placebo medium single dose (55-<85)Placebo Group1 Intervention
10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration
Group XXVI: Phase II placebo 1 or 2 dose (18-<55)Placebo Group1 Intervention
20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration
Group XXVII: phase ⅠPlacebo low single dose (18-<55)Placebo Group1 Intervention
6 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
Group XXVIII: phase ⅠPlacebo low 2 dose (18-<55)Placebo Group1 Intervention
6 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad5-nCoV
Not yet FDA approved

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Canadian Center for VaccinologyOTHER
10 Previous Clinical Trials
5,346 Total Patients Enrolled
2 Trials studying COVID-19
1,545 Patients Enrolled for COVID-19
Beijing Institute of BiotechnologyOTHER
8 Previous Clinical Trials
46,388 Total Patients Enrolled
5 Trials studying COVID-19
45,658 Patients Enrolled for COVID-19
CanSino Biologics Inc.Lead Sponsor
32 Previous Clinical Trials
63,675 Total Patients Enrolled
16 Trials studying COVID-19
51,111 Patients Enrolled for COVID-19

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Phase I/II Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Canada
2020. "Phase I/II Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Canada". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04398147.
All > Adenovirus > Coronavirus
~149 spots leftby Apr 2025
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