Our Human Challenge Unit provides a purpose‑built, regulatory‑aligned environment for conducting controlled infection studies and early‑phase clinical trials. With specialist clinical teams and end‑to‑end operational oversight, we deliver high‑quality data safely, efficiently, and at scale.
hVIVO’s Human Challenge Unit and Clinical Delivery services support:
Biotechs developing vaccines, antivirals, and immunomodulators needing fast, high‑quality data
Pharma organisations running complex early‑phase studies requiring rigorous clinical controls
CRO partners looking for specialised challenge capabilities and operational excellence
Our Human Challenge Unit is a highly controlled clinical environment used to conduct human challenge trials, early‑phase studies, intensive PK/PD sampling, and quarantine‑based research. It is specifically engineered to ensure participant safety, pathogen containment, and high‑fidelity clinical data capture.
Pharma organisations running complex early‑phase studies requiring rigorous clinical controls
CRO partners looking for specialised challenge capabilities and operational excellence
Our Human Challenge Unit is a highly controlled clinical environment used to conduct human challenge trials, early‑phase studies, intensive PK/PD sampling, and quarantine‑based research. It is specifically engineered to ensure participant safety, pathogen containment, and high‑fidelity clinical data capture.
Our hVIVO Process
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Study Design & Set‑Up
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Participant Screening & Recruitment
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Admission to the Human Challenge Unit
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Dosing / Viral Challenge Inoculation
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In‑Unit Monitoring & Sampling
- Discharge & Follow‑Up
Clinical Infrastructure
- Purpose‑built quarantine units with negative‑pressure rooms and hepafilters in each room
- High-frequency sampling capabilities. Air and Mask sampling to measure pathogen particles directly from participants mask or pathogen in the air
- On‑site specialist laboratories for seamless hand over
- 24/7 medical coverage
- Digital eSource and remote monitoring systems
- GCP‑compliant SOPs and quality frameworks
Why hVIVO?
- World leaders in human challenge studies
- Integrated clinical, laboratory, and scientific expertise
- Predictable and accelerated timelines
- Regulatory confidence
- Specialist teams dedicated to maintaining the highest standards of infection control
Related Resources
Explore our blogs and resources on Virus & Bacteria Production & Characterisation for Human Challenge Trials, covering GMP manufacturing and scientific characterisation approaches used to develop safe, infectious challenge agents for high-fidelity clinical studies.
From RSV to hMPV: Building the Next Generation of Respiratory Challenge Models
Controlled Human Infection Model's (CHIM) in your backpack: how Human Challenge Trials support regulatory approval of travel vaccines
Unravelling the hMPV Surge: From Media Attention to Vaccine Development
Why are Biotech’s & Pharma Using Human Challenge Studies for Drug Development?
Tripledemic Takedown: How Human Challenge Trials are Ideal to Expedite Multivalent Vaccine Development
Empowering Next‑Gen Infectious Disease & Vaccine Development
Human Challenge Studies: Their Conduct and Safety Aspects
Human Challenge Trials as a tool in raising funding
UK Life Sciences Sector Plan 2025: What it Means for the Future of Clinical Research
The UK Regulatory Competitiveness in an ever changing world
