A Large Scope of Investigation CHIM provides for a carefully controlled, systematic and efficient method of evaluating efficacy where outside variables may be substantially reduced or even eliminated. Subjects are prescreened prior to being deliberately infected with a live challenge agent and are then continuously monitored for several weeks within a sequestered environment; eliminating the risks of comorbidity and co-infection.
The challenge model is not only helpful as a proof-of-concept for effectiveness, but also as proof-of-mechanism for new targets e.g. in asthma and is increasingly being employed outside of academia.
Subjects are tested to determine viral shedding and the data is utilized to construct a viral Area Under Curve (vAUC). Measurements of efficacy are related to reductions in the size of the vAUC as well as changes in cumulative symptom scores. The challenge model also enables detailed assessment of immune parameters that may help in identifying correlates of infection and disease. Due to the intense sampling scheme after vaccination and knowledge of the time of infection, the immunological parameters associated with disease may be translated into correlates of protection and outcome measures.
SGS has extensive experience with a wide range of pharmacological techniques and interventions as developed over several decades. SGS and CPU / HCT specialist provisions include: • Different challenge techniques (e.g. virus, histamine, LPS) in both healthy volunteers and patient populations • Prolonged periods of quarantine and intense sampling regimens • Screening large volunteer populations for difficult IC/EC or other protocol criteria • Laboratory assays with complex sampling and/or preparation requirements for biomarker analysis (virus, protective antibodies, cellular immunity (PBMC), other)
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