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Planning robust clinical trials for Shigella vaccines: A simulation-based evaluation of the impact of naturally-acquired immunity on vaccine performance

2025-12-12 epidemiology Title + abstract only
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BackgroundSeveral Shigella vaccine candidates are in late stages of development, and the design of large Phase 3 trials in target populations is underway. Immunologic catch up by unvaccinated infants to vaccinated infants, which is determined by the trial site-specific force of infection, may modify the vaccine efficacy (VE) estimates observed in such trials. To set expectations and support optimal planning of future Shigella vaccine trials, we aimed to quantify the potential bias of VE estimate...

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