Influenza Challenge Studies

Experts leading the way in flu challenge studies

The Challenge

Seasonal influenza (“flu”) causes significant morbidity and mortality each year and a pandemic influenza continues to pose a worldwide threat. Government health agencies and a large number of academic, public and private organisations and consortiums are encouraging the development of universal / broad spectrum flu vaccines.

Novel correlates of protection are being explored, with humoral and cellular immune responses now more than ever at the forefront of vaccine research. The controlled human model of infection with contemporaneous wild-type influenza viral strains will play a unvaluable role in this development process and the rapid validation of new vaccine candidates.

Proven flu disease models
We have been studying influenza for over 20 years,conducting influenza human challenge studies with our flu disease models for more than 15 years.

We have delivered numerous flu challenge studies for a range of industry, governmental and academic partners, making our tool the most well-used commercial flu disease models available on the market.

As the industry leader in conducting human viral challenge studies, our team has developed a large Virobase, of clinical data paired with virological, host genetics and immunology data, combined with an extensive biorepository of blood and respiratory samples. This “Virometrics” resource, in conjunction with our unique insight into the host response to viral disease, allows us to tailor study designs to each Investigational Medicinal Product (IMP).

Flu Vaccines

Conceptual Challenges:

Demonstrating efficacy of novel vaccines in the field is time-consuming, costly and associated with risk

Initial exposure to virus unknown
Variation in circulating strains
Large study size and long duration
Difficult to power for clinical efficacy
Seasonality limitations
Complicated Biomarker identification

Our Human Challenge Models: Towards a deeper understanding

Effective exploration of vaccine efficacy & correlates of protection
Match study design to IMP mechanism of action
Controlled Immunological investigation
Host Response Analysis

Primary Endpoints:

Reduction in incidence of symptomatic infection
Reduction in disease severity

Antivirals/Treatments

Conceptual Challenges:

Establishing efficacy of antivirals in early clinical trials is challenging

Initial exposure to virus unknown
Dose ranging and timing difficult
Comorbidities and other confounders

Our Human Challenge Models: Towards a deeper understanding

Clinical proof of concept and dosing finding delivered in a controlled setting

Study design matched to IMP mechanism of action
Optimisation of treatment timing
Time-dependent measurements of biomarkers
Triggered-dosing options (symptoms or virological)
Controlled strain exposure
Consistent placebo response
Flu season independent
Efficient resistance monitoring

Immunomodulators

Conceptual Challenges:

Demonstrating clinical efficacy in early-stage field trials is challenging

Baseline prior to infection unachievable, difficult to establish host response
Effect with/without standard of care treatment difficult to establish
Large study size and duration
Seasonality limitations
Circulating strain variation
Biomarker identification difficult
Initial exposure to virus unknown

Our Human Challenge Models: Towards a deeper understanding

Clinical proof-of concept and dosing finding delivered in a controlled setting

Controlled quarantine environments
Baseline well established prior to infection
Appropriate for both prophylaxis and treatment
Flexible dosing and timing
Establish safety & efficacy to impact infected subjects host response
Investigate and demonstrate target engagement
Controlled combination-treatment with drug and standard of care or antivirals

Influenza Factsheet

Provide early human proof of concept and proof of efficacy data to support selection of best IMP candidates

Reduced costs as the model requires only a small number of subjects investigated over a shorter period of time to deliver an efficacy outcome

Study management
Deliver quality results (GCLP)
Meeting client needs and timelines
Trials conducted using controlled settings and processes

Bespoke quarantine unit in Whitechapel, London for conducting challenge studies:

62 en-suite rooms
Well characterised challenge virus (GMP)
Exact exposure time to virus
Controlled dose of virus administrated
Quarantine discharge and follow up
Standard 28 days can be up to 1 year
Immunogenicity (e.g. PBMC)
Seroconversion and mucosal immunoglobulins

If you’re a potential customer, job seeker, health professional or an investor, find out how we can help you.

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