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

Phase 1

• Conditions: COVID-19

• 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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Study First Posted: 2020-05-21
• Last Update Submitted: 2020-06-30
• Last Update Posted: 2020-07-02
• Study Start: 2020-08-01
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 696

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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);
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
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)

Trial Locations

Locations (1)

Canadian Center for Vaccinology; 🇨🇦 Halifax, Canada