Clinical conduct in contained (inpatient) setting up to biosafety level (BSL) 3
Human Infection Trials
What makes Vaccinopolis truly unique is its ability to conduct so-called Human Infection Challenge studies.
Within the confines of a contained (inpatient) setting, clinical trials are conducted with a focus on Biosafety Level (BSL) 3, ensuring heightened safety measures. Volunteers participating in these trials are subjected to a controlled environment throughout the trial period.
Key Points:
"Human Infection Challenge studies mean that test subjects are first given a vaccine or a placebo and then deliberately given a diluted dose of a pathogen. This allows researchers to test more quickly whether and how a certain candidate vaccine works. These studies are needed to accelerate our understanding of infectious diseases and the development of novel vaccines and treatments."
Ellen Jansen
Head of the Human Challenge Trial Unit
Facility
The Human Challenge Trial Unit has a capacity of 30 beds up to Biosafety Level 3 and consists of 3 zones. Depending on the requirements of the trial the zones can be interconnected.
The unit is designed to and operates in a manner to prevent the spread of infectious pathogens.
Expertise
We are equipped to facilitate the clinical conduct of a trial involving various viruses, bacteria, and parasites, provided that the challenge agent and model are supplied by the sponsor. In instances where the sponsor is unable to provide the challenge agent and model, Vaccinopolis has a diverse portfolio and pipeline to offer alternative solutions for advancing research and development in the field.
Challenge trial unit
Each subject room is aquipped for BSL-3 containment:
The unit has separate entries and exits fot personnel and material with full access control, decontamination requirements, autoclave and VHP-MAL.
Track record
Discover our track record on the human challenge studies performances and experience in planning, conducting, and completing different clinical trials.
Our expertise in shedding or GMO IMP candidate trials
In addition to human infection studies, the facility can be utilized for the quarantine phase of shedding trials and clinical trials involving the contained use of Investigational Medicinal Products (IMPs) containing Genetically Modified Organisms (GMOs).
In 2017, the Center for the Evaluation of Vaccinations conducted a unique study with the two vaccines. Two groups of fifteen volunteers lived in complete quarantine for 28 days in the container village Poliopolis at the University of Antwerp. The study was funded by the Bill & Melinda Gates Foundation.
Key features Poliopolis 2017:
Number of subjects randomized to date: 30
Scientific advice
Before submitting a trial for approval in Belgium, we recommend that sponsors seek scientific advice from FAMPH (Federal Agency for Medicines and Health Products) in advance. Our team is available to assist in this process. For detailed information on content and timelines, please refer to the guidance available on the FAMPH website.
