Trials / Completed
CompletedNCT04313127
Phase I Clinical Trial of a COVID-19 Vaccine in 18-60 Healthy Adults
A Single-center,Open-label，Dose-escalating Phase I Clinical Trial to Evaluate Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Healthy Adults Aged 18-60 Years Old
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 108 (actual)
- Sponsor
- CanSino Biologics Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- 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. The investigators intent to evaluate the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) .
Detailed description
This is a single-center,open-label，dose-escalating phase I clinical trial in healthy 18 to 60 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) manufactured by Beijing Institute of Biotechnology and CanSino Biologics Inc.One hundred and eight subjects will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of experimental vaccine or placebo on Days 1 in the deltoid muscle.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) | Intramuscular other name:Ad5-nCoV |
Timeline
- Start date
- 2020-03-16
- Primary completion
- 2021-01-20
- Completion
- 2021-02-20
- First posted
- 2020-03-18
- Last updated
- 2021-08-04
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04313127. Inclusion in this directory is not an endorsement.