There is little awareness about Invasive Escherichia coli Disease (IED), despite the important burden and treatment challenges associated with it. Back in 2018, Janssen Vaccines & Prevention began its collaboration within COMBACTE-NET, through the two observational and epidemiological EXPECT-1 and EXPECT-2 studies. The results provided important information for designing and executing a currently running phase III clinical vaccine efficacy trial called E.mbrace.
We spoke to Jan Poolman (Head of Bacterial Vaccine Discovery and Early Development) and Jeroen Geurtsen (Head of Molecular Bacteriology and Bacterial Epidemiology) from Janssen Vaccines & Prevention about the collaboration between them and COMBACTE-NET.
Jan Poolman: “Vaccine development is a public-private partnership activity. To understand the epidemiology, the public health impact of a vaccine, vaccine companies collaborate with public health organizations. The network that COMBACTE-NET provided was a great fit for us to learn more about IED and what the impact of IED is on patients. Especially considering our plan to eventually run a phase III vaccine efficacy trial.”
Jeroen Geurtsen: “One of the issues is that the overall awareness of IED in the public domain is low. However, if you look at the scientific data, IED poses an important burden with E. coli being the number-one bacterial pathogen associated with invasive disease, including potentially lifethreatening bacteremia and sepsis, as well as the number-one bacterial pathogen associated with antimicrobial resistance-related deaths. Generating further evidence and data supporting the health impact both at patient level as well as at population level is of critical importance. Collaborating with healthcare providers across Europe provided an important opportunity to increase knowledge on the disease and raise the awareness on the disease burden.”
Transfer of knowledge
Jan Poolman: “What we brought to the table was a focused approach on how to develop a vaccine against IED in the future”.
Jeroen Geurtsen: “I believe an important contribution from Janssen has been the transfer of knowledge into the COMBACTE-NET consortium. The experience acquired by the network on the clinical profile of the disease as well as analysis of the associated clinical isolates can be applied in case future vaccines or other preventative strategies may become available.”
“Vaccine development is a public-private partnership activity”
Jeroen Geurtsen: “Both the population and the scientific community benefit from collaborations like this. The two observational and epidemiological studies provided important information for designing and executing a currently running phase III clinical vaccine efficacy trial called E.mbrace. The studies helped us further shape and test the clinical case definition for IED and better understand the impact of the disease at individual patient level. An important result from the collaboration was the operational infrastructure that is now also partially embedded in our phase III study. Some of the sites and principal investigators that participated in the EXPECT studies are now also participating in E.mbrace. Through the manuscripts that should soon be published, we aim to raise further awareness on IED in the public domain, and among healthcare professionals.”
Jan Poolman: “E.mbrace is an event-driven study. That was another important aspect the consortium looked at in EXPECT-1: capturing the IED cases as efficiently as possible. What systems can be used, how fast are they, how is the information flowing – and applying that in the phase III trial. Every case you miss can cause delays down the road and can impact your study. The takeaway is that COMBACTE-NET contributed to the development of novel preventive strategies, such as vaccines. It contributed to raising the overall awareness of the importance and impact of IED, especially at a patient level. What does it mean for a person to suffer from IED? What happens to them in the hospital? What do the E. coli isolates that caused the disease look like?”
Jeroen Geurtsen: “The road to a phase III vaccine efficacy trial, and a phase III trial itself, is very complex. Like a thousand-piece puzzle, in which COMBACTE-NET has provided several important pieces.”