With the establishment of InFECT-NL at the end of 2024, this question could well be answered with a resounding ‘YES’ in the near future. InFECT-NL is an initiative of the university medical centres; Radboudumc, UMC Utrecht, Amsterdam UMC and LUMC, with the ambition to involve all academic centres in the Netherlands. This collaboration should enable the Netherlands to have an even greater impact on infectious disease control by pooling knowledge and experience. In addition, the initiative is supported by the Centre for Human Drug Research (CHDR), an international leader in early clinical research and facilitated by FAST.

New challenges in infectious disease control
Vaccines, antibiotics and antivirals have made incredible contributions to the prevention and cure of infectious diseases. However, no vaccines or treatment exist for some infectious diseases, and the emergence of drug resistance in pathogens can seriously complicate the treatment of infected patients. Not to mention pathogens that we do not yet know about but may cause problems in the future. So new vaccines and drugs are needed but their development is complex, time-consuming and expensive. So the question is: can it be done smarter, faster and cheaper?

InFECT-NL’s unique approach builds on three reinforcing pillars:

1. Connecting and conducting (basic) research to support product development against infectious diseases.
2. Coordinating and managing an innovation cluster to improve the efficiency of infectious disease research.
3. Realising an early-stage infectious disease clinical research unit (INFECTA).

‘The A-team’
The reputation of the initiating institutes in doing research in infectious diseases and immunology is excellent so the willingness to pool that knowledge and expertise and use it to develop new vaccines and drugs is special and promising. It lays a foundation for a scientific ‘A-team’. In addition, the realisation of an early-stage infection unit for clinical research on infectious diseases is crucial for accelerating vaccine and drug research without sacrificing safety.

The high demands of vaccine development
Vaccine development is a lengthy and costly process. Vaccines are capable of eliciting an immunological response that can protect against a pathogen. For a vaccine to be registered, it must be plausible that the immunological response it induces can actually protect against the disease it is targeting, and this positive effect must far outweigh any drawbacks, such as side effects. After all, vaccines are given to healthy people who might never contract the disease against which the vaccine protects them even without vaccination, it is a precaution like wearing a seatbelt in the car.

Proving that a vaccine works is costly
Proving vaccine effectiveness is usually done in costly phase 3 field studies, in which large groups of people are given a vaccine or placebo to then see if the disease is less common in vaccinated people. These types of studies are very costly due to thousands of participants and a long follow-up period, take place late in the vaccine development process, when a lot of time and money has already been spent, and unfortunately regularly show that a vaccine provides no, or insufficient, protection.

Alternative ways to make the efficacy of a vaccine plausible are so far only used for vaccines targeting diseases with unpredictable outbreaks such as Ebola, Chikungunya, zika, etc. Thus, animal models are used to demonstrate the protective effect of vaccines after which (conditional) approval can be obtained based on a similar immune response in humans. But no representative animal models exist for some infectious diseases.

Controlled Human Infection Models (CHIM)
CHIM studies are seen as an innovative way to get an early picture of vaccine efficacy in humans. CHIM studies involve exposing healthy volunteers to the vaccine-targeted pathogen after vaccination with an experimental vaccine or placebo in a controlled environment.

Of course, vaccine studies using a CHIM also have limitations. For instance, the studies are usually done in healthy adults and the time of exposure to the pathogen after vaccination, as well as the amount of the pathogen, is the same for everyone. So the studies do not necessarily give a representative picture of the efficacy of a vaccine in the population for which it is ultimately intended.

Both positive and negative CHIM data are valuable
If the efficacy of the vaccine can be demonstrated, this may lower the threshold for starting a large phase 3 study, after all, much of the business risk has been removed. In addition, it may become possible in the future, based on CHIM data and combined with sufficient results regarding the safety of the vaccine, to get conditional approval from the authorities. The vaccine will then become available more quickly to those who need it. If the CHIM study fails to demonstrate efficacy, the vaccine developer may have to go back to the drawing board but at least the high costs of a large phase 3 study doomed to failure will have been avoided and the ‘appetite’ to continue working on an improved version of the vaccine will hopefully be preserved.

An important role for InFECT-NL
The innovation pursued by InFECT-NL naturally goes far beyond setting up an early-stage infection unit for clinical research into infectious diseases. It is the network, of private and public parties with shared societal goals and complementary knowledge and skills, that can make the difference. Through a combination of commercial and non-commercial activities, InFECT-NL aims to be self-sufficient and to contribute sustainably to the development of drugs and vaccines against infectious diseases with high societal impact. It offers the opportunity to test and ‘de-risk’ early vaccine concepts that may make them even more interesting for pharma companies to take on further development. InFECT-NL is definitely a unique initiative with very impressive leadership and expectations are therefore high.

About Hanneke Schuitemaker
Hanneke Schuitemaker is currently the Chief Scientific Officer of Valneva, a European multinational company specialising in vaccines against infectious diseases. Previously, as Global Head Viral Vaccine Discovery & Translational Medicine at Johnson & Johnson Innovative Medicine, she was responsible for the development of vaccines against viral infectious diseases. Hanneke was trained as a medical biologist, did her PhD research at Sanquin on the disease course of HIV infection and led academic research there for a long time. She has been Professor of Virology at Amsterdam UMC since 2004 and sits on the Board of the InFECT-NL foundation on behalf of FAST.