Ebola Virus Disease Clinical Trial
Official title:
An Open-label, Single Arm Study to Provide Additional Information on Safety and Effectiveness of rVSVΔG-ZEBOV-GP
Interventional, single arm, open-label, non-randomized, phase IIIb study to accumulate additional data on safety and effectiveness of one dose of rVSVΔG-ZEBOV-GP against Ebola virus disease.
Ebola Virus Disease remains ill-known by populations, creating fear and mistrust, is highly
contagious, requiring strict isolation measures and with only supportive therapy available
that has limited impact on case-fatality which remains high (30 -80%).1 Among vaccines in
development, the rVSVΔG-ZEBOV-GP vaccine has given the most promising results in terms of
efficacy and safety having been evaluated now in more than 10,000 individuals.
Ring vaccination is a known strategy to control epidemics with specific transmission chains
and has been successfully implemented to eradicate smallpox. Ring vaccination enhances
standard public health measures of contact tracing, isolation, and community engagement and
could be effective when such measures are in place. Building on the interim results of the
Ebola ça Suffit trial, there is a need for continued access to a vaccine of which available
results suggest that it is safe and likely efficacious against EVD. Although only isolated
cases have been reported in Guinea, Sierra Leone and Liberia in 2016, 10 the risk of
resurgence or of continued isolated cases in West Africa remains. Moreover, a new outbreak
with Ebola Zaïre could start any moment in any of the countries where previous outbreaks
occurred as in for example Democratic Republic of Congo and Uganda.
However, the unusual design of the ring trial and the decision to abandon the control group
because of strong evidence that the vaccine prevented disease means there may not be enough
data to ensure approval from regulatory agencies. Therefore, additional information is still
required to consolidate knowledge on the rVSVΔG-ZEBOV-GP vaccine to support regulatory
approval and licensure for future access. Additional information is also needed on ring
vaccination and contextual adaptations to this approach to ensure its feasibility and
effectiveness in the control of Ebola outbreaks in potentially diverse contexts.
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