Sanofi and Johnson & Johnson’s E. coli Vaccine Candidate Fails to Meet Efficacy Endpoints in Phase III E.mbrace Study

13 February 2025 | Thursday | News

Independent analysis reveals insufficient effectiveness in preventing invasive E. coli infections, leading to the termination of the study, though no safety concerns were identified.
Picture Courtesy | Public Domain

Picture Courtesy | Public Domain

Interim analysis of data from the Phase III E.mbrace study (clinical trial identifier: NCT04899336), conducted by an independent data monitoring committee, revealed that the vaccine candidate against the E. coli strains responsible for extraintestinal infections, developed by Sanofi and Johnson & Johnson, was not sufficiently effective in preventing invasive E. coli infections, compared to placebo. No safety signals related to the vaccine candidate were detected, and throughout the study, the investigators ensured that participants who had developed an E. coli infection received prompt treatment and care. Following the committee's conclusion, the E.mbrace study was terminated.

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