CTU Bern (Clinical Trials Unit)

Ebola ça Suffit trial

The Ebola ça Suffit trial used a novel design to test the efficacy and effectiveness of a new vaccine to prevent Ebola virus disease. CTU Bern was responsible for the data management and contributed to the study design.

This phase III, cluster-randomized ring vaccination trial was conducted in Guinea, West Africa during the outbreak of the 2015-Ebola-epidemic. After laboratory confirmation of a new Ebola virus disease case, clusters of all this case contacts‘ and contacts of contacts‘ were defined and randomly allocated 1:1 to immediate vaccination or delayed (21 days later) vaccination with a recombinant, replication-competent vesicular stomatitis virus-based vaccine expressing a surface glycoprotein of Zaire Ebolavirus (rVSV-ZEBOV) (one dose of 2 × 107 plaque-forming units, administered intramuscularly in the deltoid muscle). Overall, more than 100 clusters with more than 5000 participants were enrolled in the trial. The first interim analysis showed that the vaccine is highly efficacious.

The efficient design and the comparably very quick set-up of the trial allowed the generation of highly quality evidence during a public health emergency.

Services

Study development and planning

CTU Bern was involved in the planning phase of the trial and contributed to the trial design.

Data management

CTU Bern was responsible for the data management including the set-up of the data center in Conakry, Guinea. A local REDCap (http://project-redcap.org/) installation was used for data entry and storage. The circumstances (public health emergency situation) and the situation in Conakry required a pragmatic approach while maintaining scientific standards and conformity to International Conference on Harmonization – Good Clinical Practice requirements. Routine reports and data preparation for statistical analysis were coordinated and done in Bern.

Selected publications

Ebola ça Suffit Ring Vaccination Trial Consortium. The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola. BMJ 2015; 351: h3740. doi: 10.1136/bmj.h3740.

Henao-Restrepo AM, et al. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomized trial. Lancet 2015; 386: 857-66. doi: 10.1016/S0140-6736(15)61117-5.