The SUNSHINE phase Ia/b trial for the InvaplexAR-Detox/dmLT vaccine, a new vaccine candidate against shigellosis, has started on 10 October 2024 with the first administration of the vaccine at the Leiden University Medical Center (LUMC), Leiden, Netherlands.
Shigellosis is a major public health concern, especially in low-resource settings, where it leads to severe diarrhoea, particularly affecting children under five. The infection spreads through contaminated water and food, causing an estimated 80–165 million cases and up to 64,000 deaths (1) among children under 5 in lower-income countries annually. Additionally, Shigella infections are increasingly difficult to treat due to the rise of antimicrobial resistance (AMR). The World Health Organization (WHO) has listed Shigella as a priority pathogen for the development of new vaccines (2), but despite decades of research there is currently no licensed vaccine available.
This first-in-human trial aims to evaluate the safety and immunogenicity of the vaccine, marking a significant milestone in the fight against shigellosis, a bacterial infection caused by Shigella species. The trial, part of the ShigaPlexIM project, is coordinated by European Vaccine Initiative (EVI), who oversees the clinical trial monitoring. Once the vaccine’s safety is confirmed, the trial will continue in a Shigella endemic setting at the Centre for Infectious Disease Research (CIDRZ) in Zambia.
The InvaplexAR-Detox antigen is provided by the Walter Reed Army Institute of Research (WRAIR), PATH is providing the dmLT adjuvant and the University of Gothenburg (UGOT) is responsible for setting up the immunology assays. If proven safe and effective, the vaccine could significantly reduce the global burden of shigellosis, particularly in vulnerable populations. This trial is an important step towards achieving that goal, with the potential to improve health outcomes worldwide.
Images: LUMC team ready to start the first vaccination; Participant receiving his first administration; LUMC investigators processing the blood sample; Vials ready for blood collection.
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This project is part of the EDCTP2 Programme supported by the European Union (RIA2018V-2308)
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