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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:

Focusses on vaccines, therapeutics & monoclonals
Designed to and operates in a manner to prevent the spread of infectious pathogens
The unit has a up to 30-bed quarantine capacity ensuring the seamless execution of protocols and comprehensive monitoring of volunteers under controlled settings

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

Influenza
Under development / negotiation

SARS-CoV-2
Respiratory Syncytial Virus (RSV)

Bacteria

Available

Under development / negotiation

Streptococcus

Parasites

Available

Malaria
Under development / negotiation

Vaccinopolis Poliopolis

Shedding or contained use trials (GMO IMP)

Poliopolis 2017

30 subjects
Container village with complete quarantine for 28 days
Novel live-attenuated type-2 polio vaccines (OPV2)
Funded by Bill & Melinda Gates Foundation

Do you want to hear more about our capabilities and available slots?

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:

Have an antechamber for donning/doffing of staff
Have an individual bathroom
Are sealed for airtightness
Are equipped with materials allowing easy gaseous disinfection after ending the trial
HVAC system equipped with HEPA filters on pulsion and extraction
Collection of all liquid waste and treatment by the effluent decontamination system

The unit has separate entries and exits for personnel and material with full access control, decontamination requirements, autoclave and VHP-MAL.

Vaccinopolis human challenge trial
Vaccinopolis human challenge trial area

Area 1

Used for screening and follow-up of non-infectious volunteers.

Consists of 5 consultation & sample collection rooms and one storage room.

Vaccinopolis human challenge trial area

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.

Vaccinopolis human challenge trial area

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 Area 2 for trials where infected volunteers are allowed to leave their room.

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