The EBO-PEP Project
The project objectives
General objective
The EBO-PEP clinical trial aims to strengthen the response to filovirus outbreaks by evaluating the effectiveness of post-exposure prophylaxis (PEP) strategies in people who have been exposed and are at risk of developing a filovirus disease, such as Ebola virus disease.
Specific objectives
Specific objectives 1
To conduct a multicenter, multi-epidemic phase III clinical trial to evaluate the efficacy of different post-exposure prophylaxis (PEP) interventions in people at high risk of developing filovirus disease following exposure.
The trial will be :
- Multicenter: The trial is being prepared for implementation in Guinea, the Democratic Republic of the Congo, Liberia, Sierra Leone, and any other country where a filovirus outbreak may occur.
- Multi-outbreak: The trial is designed to be conducted across multiple successive filovirus outbreaks.
In the context of the current Ebola Bundibugyo outbreak in the Democratic Republic of the Congo, the trial will initially assess the efficacy of the direct-acting antiviral obeldesivir, compared with placebo, administered within 5 days after high-risk exposure, to prevent the development of Ebola Bundibugyo virus disease.
Specific objective 2
To strengthen the capacity of clinical researchers and enhance community knowledge and engagement in filovirus research.
The EBO-PEP team is committed to strengthening the skills of African researchers so that they can lead all aspects of clinical trial implementation: initiation, planning, preparation, coordination, and execution. The long-term goal is to promote sustainable, locally led ownership of EVD research.
This capacity-building effort will include a training program in the countries involved in the trial, aimed at strengthening clinical research skills among researchers.
Through this capacity building plan, the EBO-PEP project aims to establish and sustain a multi-country, multicenter network of clinical researchers, laboratory experts, scientific engineers, and social science specialists across Africa.
Crédits photo : John Wessels/ALIMA
Specific objective 3
Communication and Advocacy:
Scaling up a post-exposure prophylaxis (PEP) strategy for individuals at high risk of filovirus disease requires effective communication and coordination among a broad range of stakeholders, including national and international regulatory agencies, ethics committees, policymakers, ministries of health, healthcare professionals and researchers, pharmaceutical companies, and regional health institutions.
Medicine access :
To facilitate access to treatment, the consortium will collaborate with relevant stakeholders to advance policy changes, support local adoption of PEP strategies, and advocate for reduced treatment costs.
Cost-effectiveness analysis :
Assessing the cost-effectiveness of post-exposure prophylaxis (PEP) is essential to inform health policy in resource-limited settings. The EBO-PEP project is developing an economic evaluation model comparing PEP interventions with vaccination strategies. In addition, the study will analyse the barriers and facilitators affecting the availability of these essential health products for the management of filovirus diseases in sub-Saharan Africa.