Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase I/II Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Canada

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04398147
Recruitment Status : Not yet recruiting
First Posted : May 21, 2020
Last Update Posted : July 2, 2020
Sponsor:
Collaborators:
Beijing Institute of Biotechnology
Canadian Center for Vaccinology
Information provided by (Responsible Party):
CanSino Biologics Inc.

Tracking Information
First Submitted Date  ICMJE May 18, 2020
First Posted Date  ICMJE May 21, 2020
Last Update Posted Date July 2, 2020
Estimated Study Start Date  ICMJE August 1, 2020
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2020)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
  • Solicited AE in all groups [ Time Frame: 0-6 days after each vaccination ]
    Solicited AE in all groups within 0-6 days after each vaccination;
  • Unsolicited AE in all groups [ Time Frame: 0-28 days after each vaccination ]
    Unsolicited AE in all groups within 0-28 days after each vaccination.
  • Serious adverse events (SAE) in all groups [ Time Frame: 6 months after the final vaccination ]
    Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
  • 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 ]
    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);
  • 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 ]
    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 );
  • 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 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);
  • 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 ]
    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)
  • 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 ]
    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);
  • 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 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)
  • 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 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;
  • 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 ]
    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
  • 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 ]
    The positive rate of IFN-γ stimulated by S protein overlapping peptide library detected by ELISpot
  • 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 ]
    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);
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I/II Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Canada
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
    Intramuscular administration
  • Biological: Placebo
    Intramuscular administration
Study Arms  ICMJE
  • Experimental: phase ⅠLow single dose (18-<55)
    12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: phase ⅠPlacebo low single dose (18-<55)
    6 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: phase ⅠLow 2 dose (18-<55)
    12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: phase ⅠPlacebo low 2 dose (18-<55)
    6 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: phase ⅠLow single dose (65-<85)
    12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: phase ⅠPlacebo low single dose (65-<85)
    3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: phase ⅠLow 2 dose (65-<85)
    12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: phase ⅠPlacebo low 2 dose (65-<85)
    3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: phase ⅠMedium single dose (65-<85)
    12 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: phase ⅠPlacebo medium single dose (65-<85)
    3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: phase ⅠMedium 2 dose (65-<85)
    12 subjects, Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: phase ⅠPlacebo medium 2 dose (65-<85)
    3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: Phase II Low single dose (18-<55)
    50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Phase II placebo low single dose (18-<55)
    10 subjects,Placebo containing 0 vp, single dose, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: Phase II Low 2 dose (18-<55)
    50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Phase II placebo low 2 dose (18-<55)
    10 subjects,Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: Phase II Low single dose (55-<85)
    50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Phase II placebo low single dose (55-<85)
    10 subjects,Placebo containing 0 vp, single dose, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: Phase II Low 2 dose (55-<85)
    50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Phase II placebo low 2 dose (55-<85)
    10 subjects,Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: Phase II medium single dose (55-<85)
    50 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Phase II placebo medium single dose (55-<85)
    10 subjects,Placebo containing 0 vp, single dose, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: Phase II medium 2 dose (55-<85)
    50 subjects,Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Phase II placebo medium 2 dose (55-<85)
    10 subjects,Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: 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
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Phase II placebo 1 or 2 dose (18-<55)
    20 subjects,placebo containing 0 vp, 1or2 dose, Intramuscular administration
    Intervention: Biological: Placebo
  • Experimental: 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
    Intervention: Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
  • Placebo Comparator: Phase II placebo Low or medium,1 or 2 dose (55-<85)
    20 subjects,placebo containing 0 vp, 1or2 dose, Intramuscular administration
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 18, 2020)
696
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2021
Estimated Primary Completion Date December 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria for the phase I portion of the study:

  • 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).

Inclusion criteria for the phase II portion of the study will be detailed in an amended synopsis/study protocol.

Exclusion criteria for the phase I portion of the study:

  • 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;
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Luis H Barreto, PhD/MBA 416-294-5840 drluisbarreto@gmail.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04398147
Other Study ID Numbers  ICMJE Ad5-nCoV-2020003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party CanSino Biologics Inc.
Study Sponsor  ICMJE CanSino Biologics Inc.
Collaborators  ICMJE
  • Beijing Institute of Biotechnology
  • Canadian Center for Vaccinology
Investigators  ICMJE
Principal Investigator: Scott A Halperin, MD Canadian Center for Vaccinology
Principal Investigator: Joanne M Langley, MD Canadian Center for Vaccinology
PRS Account CanSino Biologics Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP