The SAGE recommendations further state that “opportunities should be sought to assess the efficacy of other candidate EVD vaccines, such as in health care and front-line workers in areas that are not at high risk for EVD and are thus not eligible to receive the rVSV-ZEBOV vaccine in current study protocols and SAGE recommendations. Particular consideration should be given to the inclusion of pregnant and lactating women into vaccine research. Data on use of the vaccine in paediatric populations in such trials should be recorded (SAGE 2018).”
Bearing the above in mind, the World Health Organization invited on 23 January 2019 representatives from EVD-at risk countries, international clinical trial experts and experts in the field of Ebola vaccine RCTs (in particular trialists, and statisticians) and representatives of funding agencies and vaccine developers with the aim to outline study designs and the critical steps towards the evaluation of Ebola candidate vaccines in the context of this outbreak. List of participants and summary of Declaration of Conflict of Interest are in Annexe 1.
The objectives of this consultation were: (i) to review and discuss the existing body of evidence of the most advanced candidate vaccines; (ii) to review trial design options and exchange views on potential study design options to be implemented in the context of the current EVD outbreak; (iii) to discuss criteria that could inform national authorities of affected countries on the adequate candidate Ebola vaccines to be selected for evaluation under the proposed clinical trials and; (iii) to discuss a framework for an efficient and sustainable collaborative approach across countries and this and future outbreaks.