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Human Challenge Trials

Human Challenge Trials | Faster Early Efficacy & PoC

Human challenge trials provide a highly controlled and scientifically rigorous environment to evaluate the early efficacy of vaccines, antivirals, monoclonals, and immunomodulators. By exposing healthy adult participants to a well‑characterised viral or bacterial strain in a controlled setting, these studies deliver precise, early readouts that de‑risk development and accelerate decision‑making. hVIVO’s validated challenge models, integrated clinical and laboratory capabilities, and rapid data turnaround enable sponsors to reach proof‑of‑concept up to 3.5× faster than traditional outpatient trials.

Proven to accelerate PoC up to 3.5× faster

Controlled viral/bacterial exposure for precise efficacy measurement

Integrated clinical and laboratory environment enabling rapid hand off for data analysis and decision making

End‑to‑end challenge model design, delivery, and interpretation

Human Challenge Services

Virus production, characterisation

hVIVO develops, manufactures, and characterises high‑quality, GMP‑compliant challenge agents used in human challenge trials. Our end‑to‑end approach ensures safety, reproducibility, and scientific integrity.

Human challenge unit and clinical delivery

Our Human Challenge Unit provides a purpose‑built, regulatory‑aligned environment for conducting controlled infection studies and early‑phase clinical trials.

Regulatory strategy and advice

Our regulatory consultants have significant experience with the FDA, MHRA and EMA relating to Human Challenge Trials. They have supported numerous sponsors with submissions for FDA Fast Track Designation and EMA Prime. We help anticipate regulatory challenges, streamline submissions, and accelerate progression through the regulatory landscape.

Laboratory services and sample analytics

hVIVO provides specialised laboratory services that underpin the scientific rigor, safety, and reliability of human challenge studies. Our integrated labs deliver high‑quality virology, immunology, molecular and bacteria data to accelerate vaccine and therapeutic development.

Participant screening and recruitment for human challenge trials

hVIVO recruits, screens and selects healthy volunteers for human challenge studies using robust ethical, scientific and medical frameworks. Our recruitment and screening pathway ensures participant safety while providing high‑quality, well‑characterised study cohorts.

RSV Model

hVIVO has completed a number of studies for RSV including for vaccines and anti-virals as well as immunomodulators. With models for both RSV-A (Memphis) RSV-B (London) hVIVO is the only CRO with the ability to complete human challenge trials using both models. Find out how hVIVO can support RSV drug and vaccine development.

Influenza Model

hVIVO has over 30 years of scientific expertise studying influenza and more than 25 years conducting human challenge studies. The organisation has delivered numerous studies for industry, governmental and academic partners, forming the most widely used commercial influenza challenge models. Find out how hVIVO can support your research.

COVID-19 Model

hVIVO has extensive experience in delivery of human challenge trials for therapies and vaccines against SARS-CoV-2 having been the main contractor for the UK Government during the Covid-19 Pandemic. With 3 models, including the original pre-alpha SARS-CoV-2 strain, Delta and BA5 Omicron model that we have characterised in previously vaccinated, antibody positive participants ready for booster vaccine and antiviral efficacy testing.

HRV Model

We have an approved and well characterised rhinovirus (HRV‑16) that has been used to safely infect individuals in a large number of viral challenge studies carried out at our human challenge unit in London. Find out how hVIVO can support your research

hMPV Model

Our hMPV challenge model is the world’s only contemporary strain hMPV challenge model and uses an A2 strain that was isolated from patient with a recent community acquired infection. The model showcases strong infectivity rates and the induction of symptomatic disease in healthy volunteers. Find out more on how hVIVO can support your research

Malaria

Here at hVIVO, we are developing further capability and capacity in its unique Human Challenge facilities to assist in the advancement of novel antimalarial drug and vaccine candidates and is now able to offer a Direct Venous Inoculation (DVI), Controlled Human Malaria Infection (CHMI) model for estimations of efficacy.

Virus Induced Exacerbations (Asthma & COPD Challenge)

Through our deep scientific knowledge in respiratory disease, hVIVO supports drug developers to study and develop new treatments for the exacerbations of asthma, COPD (Chronic Obstructive Pulmonary Disease) and other respiratory diseases such as bronchiectasis and antivirals through the use of Human Challenge Trials

Why These Services Fit Together

Human challenge trials require seamless integration across scientific design, clinical operations, laboratory analytics, and regulatory alignment. Each component contributes to generating early, high‑resolution efficacy signals.

Integrated Expertise

hVIVO brings together virology, immunology, molecular biology, CMC, biometrics, medical writing, clinical operations, and modelling experts to support every stage of a human challenge programme.

FAQ

What are human challenge trials and why are they used?

Human challenge trials involve exposing healthy adult participants to a well‑characterised viral or bacterial strain in a controlled clinical environment to generate efficacy signals for vaccines, antivirals, monoclonals, and immunomodulators. They provide precise, early readouts that help de‑risk development and accelerate proof‑of‑concept decision‑making.

How do hVIVO’s integrated capabilities accelerate proof‑of‑concept?

hVIVO’s validated challenge models, integrated clinical and laboratory capabilities, and rapid data turnaround enable sponsors to reach proof‑of‑concept up to 3.5× faster than traditional outpatient trials by ensuring seamless coordination between scientific design, clinical delivery, laboratory analytics, and regulatory alignment.

Human Challenge Trials

Human Challenge Services

Why These Services Fit Together

Integrated Expertise

FAQ

News & Resources

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

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