RSV vaccines & treatments

The Challenge

Respiratory syncytial virus (RSV) is the single most important cause of lower respiratory tract infection (LRTI) in infants and young children worldwide and can cause LRTI in elderly and immunocompromised patients; it is associated with significant morbidity and mortality in these populations. However, RSV is recognised as a significant cause of respiratory illness in all age groups and there are no effective licensed therapies generally available. Novel correlates of protection are being explored and developing vaccine correlates can assist to bridging other populations. Healthy volunteer human challenge models will play a major role in the development process.

Validated RSV Model

Created a novel RSV challenge model now validated across multiple studies.

Conducted a number of human RSV challenge studies for a range of customers:
• Currently, the only validated RSV challenge model commercially available
• Validated across multiple studies with vaccines and antivirals directed towards RSV

Vaccines

Conceptual Challenges
  • Testing proof of concept in the target population (pediatrics or elderly)

  • No clear product development pathway

  • Correlates of infection are poorly understood

  • Lack of fully translatable immunogenicity animal models

Flu Vaccines

hVIVO Human Challenge Models: Towards a deeper understanding
  • Healthy adult model enables fast efficient proof of concept demonstration and safety in disease model before moving to at risk populations in field trials

  • Elderly (60+) model, enables demonstration of proof of concept in target population with weakened immunity

  • For vaccines, both options facilitate efficient investigation of known and novel correlates of vaccine protective effect

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Antivirals/Treatments

Conceptual Challenges
  • Testing proof of concept in the target population (pediatrics or elderly)

  • Correlates of infection are poorly understood

  • Lack of fully translatable immunogenicity animal models

Flu Vaccines

hVIVO Human Challenge Models: Towards a deeper understanding

Study design matched to investigational product mechanism of actions

  • Optimisation of treatment timing

  • Time-dependent measurements of biomarkers

  • Triggered-dosing options (time or virological)

  • Controlled strain exposure

  • Consistent placebo response

  • Efficient resistance monitoring

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Immunomodulators

Conceptual Challenges
  • Limited RSV immunomodulators in development

  • Limited focus on adult/elderly populations

Flu Vaccines

hVIVO Human Challenge Models: Towards a deeper understanding
  • Well 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

Click for the full RSV Fact Sheet

RSV Scientific Papers