EXPECT Studies Enrollment in Full Swing

On 9 March 2020, COMBACTE-NET’s EXPECT-1 study reached 54% of its target of 6000 enrolled subjects.

Spain enrolled over 1000 subjects and has finalized enrollment, exceeding their target of 750 subjects. Japan is very close to its target of 750 subjects, while Germany and the United Kingdom need to be fully activated yet. Italy started late, but is catching up very well. France, Canada and the USA are steadily enrolling.

The EXPECT-1 study is the first COMBACTE study in which participants are enrolled in primary healthcare through close collaboration of the local research teams with general practice networks. Study participants are community-dwelling people in stable health aged 60 years and older. The first subject was enrolled on 30 September 2019 in France.

As of 9 March 2020, the EXPECT-2 study has been activated in five out of the eight participating countries. Spain has already recruited its target of 30 subjects and together with the recruitment in Canada, France, Japan and the USA, 109 (45%) of the 240 participants have already been enrolled. Germany, the United Kingdom and Italy will be activated soon. The first subject was enrolled on 24 October 2019 in France.

About EXPECT

Extraintestinal pathogenic Escherichia coli (ExPEC) are a leading and rising cause of bacterial invasive disease worldwide. The emergence of multidrug resistance among ExPEC strains such as E. coli sequence type 131:O25B, represents a major challenge for the treatment of ExPEC infections. Prevention is becoming more and more important, however, to date, there is no vaccine available to prevent invasive ExPEC disease (IED).

The EXPECT-1 study is a prospective observational pilot study to obtain insight in the feasibility and design of a Phase 3 study, where the efficacy and safety of the Janssen 10-valent ExPEC vaccine candidate (EXPEC10V) is planned to be investigated. General practitioners (GPs) in a maximum of 8 countries are asked to recruit a total of 6,000 study participants (750 per country). These participants are adults aged 60 years or older in stable health, with at least 50% of these having a history of urinary tract infection in the 10 years before enrollment. An important objective is to evaluate the feasibility of capturing hospital admissions (including those due to IED) of study participants during the follow-up period of 12 months.

The EXPECT-2 study is a prospective, multicenter, hospital-based epidemiology study with one participating hospital site in each of 8 countries (only Japan has 2 sites). Study participants are hospitalized IED patients aged 60 years or older. The EXPECT 2 study objective is to assess the O-serotype and O-genotype distribution in E. coli isolates causing IED overall and by subgroup based on risk factors, and  to compare the clinical criteria of IED used by the study site with the proposed clinical case definition of IED for future clinical studies.