MPX-RESPONSE project

Origin of the MPX-RESPONSE project

In 2022, the multi-country outbreak of mpox (Monkeypox) virus disease was declared a public health emergency of international concern by the World Health Organization (WHO). One year later, in July 2023, the end of the emergency was announced but ongoing reported cases have been kept under surveillance as the threat of new outbreaks remains real. More recently, since November 2023, an unprecedented mpox epidemic has been reported the Democratic Republic of Congo (DRC) and extended to several African countries, caused by various viral clades and in particular by newly identified clade Ib, which led the WHO to declare again a PHEIC linked to mpox on 14 August 2024.

A better understanding of the disease will allow effective strategies for patient management and treatment, preventing a global health crisis.

MPX-RESPONSE project partners

This project involves 16 leading international scientifc partners:

1. ANRS MIE /INSERM,
2. Oslo Universitetssykehus HF, Oslo, Norway
3. Universita degli studi di Verona, Verona, Italy
4. Inserm Transfert SA, France
5. Assistance Publique des Hôpitaux de Paris, Paris, France
6. Servicio Madrileno de Salud, Madrid, Spain
7. European Clinical Research Alliance on Infectious Diseases, Utrecht, Netherlands
8. Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
9. Universiteit Antwerpen, Antwerpen, Belgium
10. Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
11. Fundacao Oswaldo Cruz, Brazil
12. Norwegian Institute of Public Health, Folkehelseinstituttet, Norway
13. PANTHER, France
14. Universitat Basel, Basel, Switzerland
15. University of Geneva, Geneva, Switzerland
16. Fundación Huésped, Argentina

Methodology and studies of the MPX-RESPONSE project

Based on WHO « Core » protocol

In response to the 2022 outbreak of mpox disease, the World Health Organization (WHO) has promoted a structured and coordinated approach to prevent redundant research efforts and expedite the assessment of treatments against mpox disease. A group of experts, convened by the WHO and ANRS MIE, has been tasked with developing a core protocol, designed to promote global collaboration. Trials seeking to support this collaborative exchange are encouraged to adopt standardized inclusion criteria and endpoints. The UNITY, MOSA and EPOXI protocols were developed based on the WHO core protocol. While inclusion criteria are adapted to the local context, all three studies share the same primary endpoint, enabling possibility to pool data and promptly reach more robust conclusions.

The MPX-RESPONSE project includes three randomized clinical trials (RCTs)

The protocols of all three trials are based on the WHO CORE protocol, designed for a global trial assessing drug safety and efficacy in treating human mpox (tecovirimat), with the goal of securing marketing authorization from the EMA, if the treatment demonstrates positive results.

1. UNITY trial : Coordinated and sponsored by ANRS MIE. Geographical coverage: International (Argentina, Brazil, Switzerland)
2. MOSA trial : Coordinated and sponsored by PANTHER. Geographical coverage: Sub-Saharan African countries (endemic mpox regions)
3. EPOXI trial : Coordinated by Ecraid and with Universitair medisch centrum Utrecht as scientific sponsor. Geographical coverage: Europe

The MPX-RESPONSE project include one cohort : MOSAIC cohort

The objective of this observational study is to deepen our understanding of the clinical and virological outcomes in patients diagnosed with mpox. This approach aims to provide a comprehensive insight into the natural history of the disease. This cohort, in addition to European Union countries, is conducted in United Kingdom and Switzerland. Oxford University is the sponsor of the study and ANRS MIE the sponsor representative in European Union.

Organisation

MPX-RESPONSE is organized into 4 Work Packages (WP)

• WP1 : COORDINATION, lead by ANRS MIE
• WP 2 : MOSAIC COHORT, lead by Assistance Publique des Hôpitaux de Paris
• WP 3 : EPOXI TRIAL, lead by European Clinical Research Alliance for Infectious Diseases (Ecraid),
• WP 4 : UNITY AND CLINICAL STUDIES, lead by Oslo University Hospital