Marburg virus persistence and clinical complications among recovered persons in Rwanda: a longitudinal study protocol

Marburg virus (MARV) causes a potentially highly lethal haemorrhagic fever disease that threatens global health security, and knowledge of viral persistence, long-term clinical outcomes among recovered persons and protective immunity remain limited. Existing protocols and technical guidelines provide a framework for safe sample collection, clinical monitoring and outbreak response, yet systematic approaches to investigate these aspects in African settings are scarce. This protocol describes the Partnership Research on MARV (PREMAV) following the 2024 outbreak in Rwanda. PREMAV is a longitudinal study that was initiated to investigate the persistence of MARV in body fluids of recovered persons, characterises associated clinical complications, identifies factors associated with viral persistence, classifies the protective immune response and discovers genomic variants during viral persistence.

This is a protocol for a prospective cohort study that enrolled individuals who survived Marburg virus disease (MVD), individuals with natural antibodies for MARV, close contacts and low risk controls in Rwanda. Participants will undergo serial sampling of blood, urine, semen and other relevant specimens over 24 months post-recovery. This will be combined with continuous clinical assessments, and laboratory analyses will include molecular detection, serological profiling, immunological assays and genomic viral characterisation. Statistical analysis will integrate the various datasets to determine associations.

This study will adhere to the Declaration of Helsinki and obtain approval from the Rwanda National Ethics Committee. Written informed consent will be obtained from all participants with additional safeguards for vulnerable groups. Confidentiality will be ensured through de-identification and secure data storage. All biological samples will be handled in compliance with national and international biosafety standards. Psychosocial support will be provided to address stigma and mental health needs among survivors. The study will generate critical evidence on MARV persistence, clinical sequelae and risk factors, informing survivor care guidelines, transmission mitigation strategies and future outbreak preparedness. Findings will be disseminated through peer-reviewed publications, conferences and policy briefs targeting national and global stakeholders. De-identified data and genomic sequences will be curated and shared through secure platforms and public repositories in line with ethical and regulatory requirements.