Johnson & Johnson discontinues Phase 3 E.mbrace study for E. coli vaccine; trial shows insufficient efficacy compared to placebo in preventing invasive E. coli disease

TITUSVILLE, N.J., February 13, 2025 – Johnson & Johnson announced today a scheduled review of the Phase 3 E.mbrace study (NCT04899336) conducted by an independent data monitoring committee (IDMC) determined that Johnson & Johnson and Sanofi’s investigational vaccine for extraintestinal pathogenic E. coli (ExPEC) was not sufficiently efficacious at preventing invasive E. coli disease (IED) compared to placebo among study participants. No safety signals related to the vaccine were identified.

As a result of the IDMC’s determination, the E.mbrace study is being discontinued. As study sponsor, Johnson & Johnson will continue appropriate safety follow-ups for currently enrolled participants. Study investigators and participants are being notified. Further analyses of the data are underway and will be shared with the scientific community in due course.

About the Phase 3 E.mbrace Study
The Phase 3 E.mbrace study is a randomized, double-blind, placebo-controlled, multicenter, interventional study evaluating the efficacy, safety, and immunogenicity of a single dose of the investigational extraintestinal pathogenic E. coli (ExPEC) vaccine candidate (ExPEC9V) compared to a placebo in the prevention of invasive disease, also known as invasive E. coli disease (IED), which includes sepsis and bacteremia (blood infections).

The IDMC conducted a scheduled review of the data available to date, which showed the number of IED cases was similar in both the placebo and active arms of the study, indicating the vaccine regimen did not provide sufficient protection. The study is not expected to meet its primary endpoint.

In October 2023, Janssen Pharmaceuticals, Inc., a Johnson & Johnson company, and Sanofi announced a development and commercialization agreement for the investigational vaccine.