Open-label phase I clinical trial of Ad5-EBOV in Africans in China.

ABSTRACT:

Background

To determine the safety and immunogenicity of a novel recombinant adenovirus type 5 vector based Ebola virus disease vaccine (Ad5-EBOV) in Africans in China.

Methods

A phase 1, dose-escalation, open-label trial was conducted. 61 healthy Africans were sequentially enrolled, with 31 participants receiving one shot intramuscular injection and 30 participants receiving a double-shot regimen. Primary and secondary end points related to safety and immunogenicity were assessed within 28 d after vaccination. This study was registered with ClinicalTrials.gov (NCT02401373).

Results

Ad5-EBOV is well tolerated and no adverse reaction of grade 3 or above was observed. 53 (86.89%) participants reported at least one adverse reaction within 28 d of vaccination. The most co

SUBMITTER: Wu L 

PROVIDER: S-EPMC5612469 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature