The abstract is read at the publisher; the summary is JClub's.
WRSs2 live-attenuated Shigella sonnei vaccine provided 89% efficacy (95% CI 71–96; p<0·0001) against committee-adjudicated shigellosis in USA adults.
- Why it matters: No licensed shigella vaccine exists despite the disease’s burden as a cause of bacterial diarrhoea and dysentery. This trial addresses the need for efficacy and safety evidence in a controlled human infection setting.
- What they did: In a phase 2, double-blind, randomized, placebo-controlled trial in the USA, healthy adults aged 18–49 received two-dose or one-dose WRSs2 or placebo, then were orally challenged with ~1·5 × 10 3 CFU of S sonnei 53G. Endpoint review committee-adjudicated shigellosis was the primary endpoint, with safety assessed in all vaccinated participants.
- The result: Shigellosis occurred in 3 (9%) of 34 pooled two-dose recipients versus 21 (81%) of 26 placebo recipients, yielding 89% vaccine efficacy. Grade 3 post-vaccination adverse events occurred in 6 participants, leading to dose reduction and eligibility changes after the first DSMB review, with no vaccine-related serious adverse events or deaths.
The findingWhy it mattersWhat they didThe result
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