NCT02401373

A Phase I Trial to Evaluate Ad5-EBOV in Healthy Adult Africans in China.

A Phase 1, Dose-escalation, Open Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of the Recombinant Human Type 5 Adenovirus Vector Based Ebola Vaccine (Ad5-EBOV) in Healthy Adult Africans Aged Between 18-60 Years in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a single center, open, dose-escalation phase 1 clinical trial. This study will determine the safety and side-effect profile, and immunogenicity of an investigational Ad5-EBOV vaccine in Healthy Adult Africans aged between 18-60 years in China.

Detailed description

This is a single center, open, dose-escalation clinical trial. According to the Chinese guidelines for vaccine clinical trial, the sample size of a phase 1 clinical trial should be at least 20. In this study, a total of 60 participants will be included.30 participants will be firstly recruited and assigned to receive the low dose Ad5-EBOV. After the safety of the low dose vaccination is confirmed, another 30 participants will be recruited and assigned to receive the high dose Ad5-EBOV. The whole follow-up period for each participant will be 28 days.

Conditions

• Ebola Virus Disease

Interventions

Type	Name	Description
BIOLOGICAL	Ad5-EBOV	intramuscular injection

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2015-03-27
• Last updated: 2015-07-16

Locations

1 site across 1 country: China