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
hVIVO has 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, hVIVO 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 hVIVO 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
hVIVO 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
hVIVO 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
hVIVO 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 hVIVO can help you.

Contact hVIVO
chevron-down