Phase I/II Clinical Trial of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Canada
- Conditions
- COVID-19
- Interventions
- Biological: Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)Biological: Placebo
- Registration Number
- NCT04398147
- Lead Sponsor
- CanSino Biologics Inc.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 696
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Phase II Low single dose (18-<55) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration phase ⅠPlacebo medium single dose (65-<85) Placebo 3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration Phase II placebo low single dose (55-<85) Placebo 10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration Phase II placebo low single dose (18-<55) Placebo 10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration Phase II placebo medium single dose (55-<85) Placebo 10 subjects，Placebo containing 0 vp, single dose, Intramuscular administration Phase II placebo 1 or 2 dose (18-<55) Placebo 20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration phase ⅠPlacebo low single dose (18-<55) Placebo 6 subjects, Placebo containing 0 vp, single dose, Intramuscular administration phase ⅠLow 2 dose (18-<55) 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 6 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration phase ⅠLow single dose (65-<85) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration phase ⅠLow single dose (18-<55) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 12 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration phase ⅠLow 2 dose (65-<85) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 12 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration phase ⅠMedium single dose (65-<85) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 12 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration Phase II Low 2 dose (18-<55) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 50 subjects, Ad5-nCoV containing 5E10 vp, 2 dose 56 days apart, Intramuscular administration Phase II medium 2 dose (55-<85) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 50 subjects，Ad5-nCoV containing 10E10 vp, 2 dose 56 days apart, Intramuscular administration Phase II Low or medium dosage 1 or 2 dose (55-<85) 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 ⅠPlacebo low single dose (65-<85) Placebo 3 subjects, Placebo containing 0 vp, single dose, Intramuscular administration phase ⅠPlacebo low 2 dose (65-<85) Placebo 3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Phase II placebo medium 2 dose (55-<85) Placebo 10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Phase II Low 1 or 2 dose (18-<55) 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 ⅠMedium 2 dose (65-<85) 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 3 subjects, Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Phase II placebo low 2 dose (18-<55) Placebo 10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Phase II placebo Low or medium,1 or 2 dose (55-<85) Placebo 20 subjects，placebo containing 0 vp, 1or2 dose, Intramuscular administration Phase II Low 2 dose (55-<85) 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 10 subjects，Placebo containing 0 vp, 2 dose 56 days apart, Intramuscular administration Phase II medium single dose (55-<85) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 50 subjects, Ad5-nCoV containing 10E10 vp, single dose, Intramuscular administration Phase II Low single dose (55-<85) Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 50 subjects, Ad5-nCoV containing 5E10 vp, single dose, Intramuscular administration
- Primary Outcome Measures
Name Time Method Incidence of the Solicited AE in all groups 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 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 6 months after the final vaccination The occurrence of Serious adverse events (SAE) in all groups within 6 months after the final vaccination.
- Secondary Outcome Measures
Name Time Method 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 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 ) 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 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 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 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 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
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 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) 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) 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);
cellular immune response by ICS 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);
cellular immune response by ELISpot 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
Trial Locations
- Locations (1)
Canadian Center for Vaccinology
🇨🇦Halifax, Canada