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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02401373
Study type	Interventional
Source	First Affiliated Hospital of Zhejiang University
Contact
Status	Completed
Phase	Phase 1
Start date	March 2015
Completion date	July 2015

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