The EBO-PEP Project

The project objectives

General objective

The overall objective of the EBO-PEP project is to strengthen the therapeutic arsenal against Ebola Virus Disease (EVD) by evaluating a post-exposure prophylaxis (PEP) strategy for high-risk contacts.

Specific objectives

Specific objectives 1

To implement a multicenter, multi-epidemic Phase III clinical trial to assess the effectiveness of monoclonal antibodies (mAbs) used as PEP for individuals who are high-risk contacts of EVD cases.

The trial will evaluate the efficacy of administering a monoclonal antibody, Inmazeb® combined with vaccination with Ervebo® compared with vaccination alone, within 5 days of high-risk contact, to reduce the risk of developing MVE.

The test will be :

  • Multicenter : prepared and configured to be deployed in Guinea, the Democratic Republic of the Congo, Liberia, Sierra Leone, and any additional country experiencing an EVD outbreak.
  • Multi-epidemic: able to span multiple successive outbreaks in order to reach the required sample size.

Specific objective 2

To strengthen the capacity of clinical researchers and increase community knowledge and engagement in Ebola 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 strengthening includes a training program in the target countries to build expertise in clinical research and EVD management.

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

To support the adoption of PEP strategies for high-risk contacts through strategic communication and targeted advocacy with key stakeholders.

Communication and Advocacy:

Scaling up PEP for high-risk contacts requires effective communication and coordination among various actors, including national and international regulatory agencies, ethics committees, policymakers, ministries of health, healthcare professionals, researchers, pharmaceutical companies, and regional health institutions.

A scientific consultation facilitated by the African Vaccine Regulatory Forum (AVAREF) brought together ethics committees and national regulatory agencies from the target countries to validate the clinical trial protocol.

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. Efforts will also focus on establishing a global stockpile of EVD therapeutics under the leadership of WHO and Africa CDC to ensure preparedness for future outbreaks.

Cost-effectiveness analysis :

Assessing the cost-effectiveness of PEP, alone or in combination with vaccination, is essential for guiding health policies in resource-limited settings. The EBO-PEP project is developing an economic evaluation model comparing PEP regimens to vaccination. In addition, the project will analyze the barriers and enabling factors influencing the availability of these essential health products for EVD management in Sub-Saharan Africa.