The road to the EBOVAC-Salone clinic in Kambia, Sierra Leone
The clinic, in Kambia, Sierra Leone, where the EBOVAC-Salone trial took place.
The EBOVAC-Salone clinic infrastructure was upgraded in Kambia, Sierra Leone, including the installation of a satellite for internet connectivity.
The biometric traits of the participant, including an iris scan, are captured to verify the identity of the participant when visiting the clinic.
The flipchart contains drawings made by a Sierra Leonean artist, and is used to support the consenting process.
Participants can receive recorded voice messages on their mobile phone to remind them of clinic visits and keep them engaged with the trial.
According to the World Health Organization (WHO Ebola Situation Report in January 2016, the recent Ebola outbreak killed more than 11,300 people in West Africa, including nearly 500 healthcare workers. Weak and overburdened healthcare systems in the three affected countries (Liberia, Sierra Leone and Guinea) have been severely damaged. This, together with the lack of trust in health systems among affected communities, has resulted in even more deaths from preventable diseases such as measles and malaria.
Although the Ebola outbreak was largely brought under control by the end of 2015, the biggest lesson healthcare authorities have learned is that the Ebola virus will always return while reservoirs of infection remain largely beyond our control. Tools must be developed to end it while simultaneously preparing for and trying to prevent the next epidemic.
Janssen is partnering with leading global research and non-governmental organizations to accelerate the development and deployment for study purposes of an investigational prime-boost Ebola vaccine regimen. A safety and immunogenicity study called EBOVAC-Salone is currently being conducted in healthy volunteers in the Kambia district in northern Sierra Leone.
Given the many misconceptions about Ebola amongst the local population and the level of distrust in health systems and vaccines in general, it was clear that the execution of the EBOVAC-Salone study would be a challenging undertaking. Therefore a project for the deployment, acceptance and compliance of vaccination regimens (EBODAC) was set up as part of the Innovative Medicines Initiatives Ebola+ Programme supported by the European Commission and the European Federation of Pharmaceutical Industries (EFPIA) to ensure that the investigational vaccine would be well accepted and successfully deployed amongst communities in West Africa for the purposes of the study.
EBODAC has developed three levers to maximize the impact of its awareness and development efforts:
- A community engagement strategy
- Identification tools to ensure correct administration of the investigational vaccine and
- Mobile technology to reinforce engagement and awareness
Here’s a closer look at each lever.
A Community Engagement Strategy
Local people have been recruited and trained to staff the engagement teams interacting with the Kambia community in Sierra Leone. The community liaison officers are working closely together with the local authorities and communities to build awareness and address potential rumours related to the vaccine study. Building further on the Sierra Leone National Communication Strategy for Ebola Response, the EBODAC team on the ground developed engagement strategies including house-to-house visits and public meetings with key stakeholders. In support of EBOVAC-Salone, posters, leaflets and flipcharts have been developed with artwork from local artists. The flip charts are specifically used to support the informed consent process of volunteers for the study, many of whom are illiterate.
Identification Tools to Ensure Correct Administration of the Investigational Vaccine
Ensuring the right volunteer receives both prime and boost of the investigational vaccine regimen at the right time is the challenge. This has required us to implement an innovative state- of-the-art identification technology. Taking into consideration cultural acceptance, a dedicated team developed a solution based on validated finger printing & iris scan technology that enables positive recognition of study participants.
Printer technology ensures that laminated vaccination cards can be printed on the spot. All these tools can be carried around in a robust and durable kit and can operate independently for more than eight hours to overcome electricity outages.
Mobile Technology to Reinforce Engagement and Awareness
To ensure volunteers remain engaged with the study and attend clinic visits, EBODAC has created a mobile application to send customized messages to consenting volunteers that have a mobile phone. They will receive voice reminders in four local languages or in English about their clinic visit. Participants receive targeted messages on their phones with vaccine related information ensuring they remain engaged in the study. Furthermore, the mobile technology platform supports the vaccination team e.g. by providing a list of participants expected to attend a study visit.
The solutions developed through EBODAC have been very well accepted by EBOVAC-Salone participants and the technologies are performing robustly. Based on current experience, the EBODAC team has now started preparing lessons learned to facilitate a smooth roll-out of a licensed vaccine regimen, should it receive regulatory approval from the relevant Regulatory Authorities. The ultimate aim of the EBODAC team is to develop scalable tools and strategies that can be deployed by local teams beyond the scope of this project.
About the Investigational Ebola Vaccine Regimen
Janssen’s investigational Ebola vaccine regimen is a ‘prime-boost’ regimen, in which two doses are given several weeks apart. The first dose ‘primes’ the immune system, while the second ‘boost’ reinforces its effects with the goal of potentially strengthening and optimizing the duration of the immunity.
This investigational vaccine regimen was discovered in a collaborative research program with the National Institutes of Health (NIH). This program received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, under Contract Numbers HHSN272200800056C, and HHSN272201000006I and HHSN272201200003I. The MVA-BN-Filo material used in phase 1 studies was produced under NIAID/Fisher BioServices contract #FBS-004-009 and NIH contract HHSN272200800044C.EBOVAC1, EBOVAC2 and EBOMAN have received funding from the Innovative Medicines Initiative 2 Joint Undertaking, a joint undertaking between the European Union and EFPIA, under grant numbers 115854 (EBOVAC1), 115861 (EBOVAC2) and 115850 (EBOMAN).
In September 2015, Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, was awarded $28.5 million from The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services, to help accelerate the development of the prime-boost vaccine regimen.