Mpox comprehensive assessment for responsive immunisation in emergency outbreaks (MpoxCARE): study protocol

Mpox disease is endemic to several regions of sub-Saharan Africa, with transmission occurring through close contact with infected animals or humans. Increasing case numbers in East Africa led the African Centre for Disease Control and Prevention to declare a Public Health Emergency of Continental Security on 13th August 2024 related to a new virus variant (clade 1b). The Mpox CARE study aims to establish clinical and epidemiology data to develop innovative immunodiagnostic tests, facilitating models for sub-clinical disease exposure, transmission and future vaccine strategies (Part A). Furthermore, we aim to evaluate and optimize vaccine cold-chain (VCC) systems to support Mpox vaccine deployment while ensuring the continued provision of childhood immunizations (Part B). This study will recruit up to 650 participants to three study groups according to Mpox exposure status and/or vaccination in Rwanda. All enrolled participants will be asked to provide demographic information, relevant medical history, up to 20mLs of venous blood and a dried blood spot capillary blood sample. For Part A of the study, samples will undergo testing for quantitative analysis of total serum antibody to Mpox specific proteins using an enzyme-linked immunosorbent assay (ELISA) and test a novel point-of-care (POC) lateral flow test to determine positive/negative qualitative serostatus. For Part B, we will collect data on VCC equipment, inventories and methods of vaccine distribution. The results of this project aim to (a) validate a blood-based ELISA assay for the detection of Mpox immunity in a target population of Rwanda, (b) generate an estimate of sero-positivity to Mpox in Rwanda, (c) evaluate the clinical performance of a novel POC lateral flow test for Mpox serostatus and (d) understand the VCC requirements for additional vaccine deployment for disease control. Detecting antibodies for sub-clinical Mpox cases improves disease mapping and transmission patterns in endemic African regions. Novel POC immunodiagnostics can enhance community healthcare and decentralise efforts to understand Mpox seroepidemiology. Understanding VCC requirements for deployment of genetic vaccines, alongside regular vaccine provision to pregnant women, and children offers insights for management of future vaccine-preventable disease outbreaks. Clinicaltrials.gov trial registration number NCT06887556, registered 20th March 2025.