NCT04568811

The Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine

The Single-center, Open-label Phase I Clinical Trial of Booster Vaccination of Adenovirus Type-5 Vectored COVID-19 Vaccine in Healthy Adults Aged 18-60 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Jiangsu Province Centers for Disease Control and Prevention · Network
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This study is a phase I clinical trial of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine 6 months after prime vaccination. The investigators intent to evaluate the safety and immunogenicity of booster vaccination of adenovirus type-5 vectored COVID-19 vaccine in healthy adults aged aged 18-60 years.

Detailed description

The 2019 novel-coronavirus (2019-nCov) is the cause of a cluster of unexplained pneumonia that started in Hubei province in China. It has manifest into a global health crisis with escalating confirmed cases and spread across many countries. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of diseases caused by COVID-19 can be tough for current treatment. This is a single-center, open-label phase I clinical trial of booster vaccination in healthy 18 to 60 years of age, inclusive, who has been prime vaccinated with adenovirus type-5 vectored COVID-19 vaccine. This clinical trial is designed to assess the safety and immunogenicity of booted vaccination of adenovirus type-5 vectored COVID-19 vaccine manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.

Conditions

• Adenovirus Type-5 Vectored COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Adenovirus Type-5 Vectored COVID-19 Vaccine	Low dose adenovirus type-5 vectored COVID-19 vaccine (5E10 vp)

Timeline

• Start date: 2020-09-26
• Primary completion: 2020-10-25
• Completion: 2021-09-11
• First posted: 2020-09-29
• Last updated: 2022-03-31

Locations

1 site across 1 country: China