LAB-Net as Central Laboratory and Biobank for EPOXI

LAB-Net, Laboratory of Medical Microbiology, University of Antwerp, will serve as the Central Laboratory and Biobank for the European randomised clinical trial on mPOX Infection (EPOXI).

EPOXI, co-ordinated by the University Medical Centre Utrecht, The Netherlands, aims to determine the effect of different treatment and management options on the outcomes of human mpox infections. Tecovirimat is the first antiviral drug that will be investigated for its safety and effectiveness in the management of mpox infection.

LAB-Net will be responsible for providing material to all of the investigational sites for the sample collection, processing and storage at – 80 °C. LAB-Net is currently finalizing the Sample Collection and Management Manual, which describes how to collect, process and store samples correctly. During the study, skin or mucosal swabs will be collected from all patients.

In addition, some or all of the following specimens will be collected from a well-defined subset of patients: blood samples for serum and plasma, throat and rectal swabs, and semen. At regular intervals, these samples will be shipped from the local sites to the Central Laboratory where skin and mucosal swabs will be aliquoted. Aliquots of swabs, blood and semen samples will be sent for analysis to the Erasmus Medical Centre in Rotterdam. The remaining aliquots will be biobanked by LAB-Net at the University of Antwerp.

Currently, LAB-Net is assisting the study team with site selection, and has developed a laboratory feasibility questionnaire and sent it to laboratories. Based on the responses, local laboratories are being evaluated for eligibility to participate in this study.

ABOUT EPOXI

The EPOXI study is a part of the MPX-RESPONSE project, which aims to conduct clinical trials that aim to improve the management of mpox infections and further inform public health policy. EPOXI is a randomized controlled double-blinded interventional trial comparing tecovirimat with placebo. However, other interventions can be added in the future through protocol amendments. It will randomise in a 2:1 ratio 650 adults (≥18 years) diagnosed with active mpox skin or mucosal lesions. Recruitment will be conducted at hospitals and outpatient clinics, including specialised clinics for sexual health/sexually transmitted disease in six to ten European countries (starting with Portugal, Spain, France, Belgium, the Netherlands and Germany). EPOXI involves obtaining skin swabs from 650 participants, and throat swabs, anal swabs, blood samples, and semen from approximately 100 participants.