NCT04398147

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 696 (estimated)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 84 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)	Intramuscular administration
BIOLOGICAL	Placebo	Intramuscular administration

Timeline

• Start date: 2020-08-01
• Primary completion: 2021-12-20
• Completion: 2021-12-30
• First posted: 2020-05-21
• Last updated: 2020-07-02

Locations

1 site across 1 country: Canada