Human Challenge Trial Unit
Clinical conduct in contained (inpatient) setting (under biosafety level 2 or 3)
What makes Vaccinopolis truly unique is its ability to conduct so-called human infection trials. Volunteers participating in these trials are subjected to a controlled environment throughout the infectious period of the clinical trial.
Key Points:
Human infection trials
Also known as human challenge trials or controlled human infection model “CHIM” trials.
Clinical trials that deliberately expose volunteers to an infectious pathogen “challenge agent” under well controlled conditions to evoke an infection. They have the power to rapidly accelerate the development of much-needed vaccines and treatments.
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Expertise
Human infection trials
We are able to perform almost all trials if the pathogen (challenge agent) and model are provided by the sponsor.
Simultaneously we are developing our own models in collaboration with strategic partners.
Vaccinopolis current internal portfolio and pipeline for challenge agents & models:
Virusses
Available
Under development / negotiation
Bacteria
Available
Under development / negotiation
Parasites
Available
Under development / negotiation
Shedding or contained use trials (GMO IMP)
Poliopolis 2017
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Facility
The Human Challenge Trial Unit is designed to and operates in a manner to prevent the spread of infectious pathogens. It has a capacity of 30 beds and consists of 3 areas. Depending on the requirements of the trial the areas can be interconnected.
No pathogen can escape
Control over air, wastewater, material & personnel flow
All 30 subject rooms:
The unit has separate entries and exits for personnel and material with full access control, decontamination requirements, autoclave and VHP-MAL.
Area 1
Used for screening and follow-up of non-infectious volunteers.
Consists of 5 consultation & sample collection rooms and one storage room.
Area 2
Used during the quarantine phase of a human infection trial under biosafety level 2 conditions when infected subjects are not confined in their individual room.
Consist of several recreational areas where you can watch TV, play pingpong or biljart, a kitchen with seating area and a laundry room.
Area 3
Used during the quarantine phase of a human challenge trial under biosafety level 2 or 3 conditions.
Consists of 30 individual subject rooms, a nursing station and a laboratory for sample processing.
Can be interconnected with zone 2 for trials where infected volunteers are allowed to leave their room.