Ebola Virus Disease Clinical Trial
Official title:
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
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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