Life Sciences Human Challenge Clinical Trials
Human Challenge Clinical trials from SGS help prove efficacy, reduce risk and maximise outcomes throughout the development of a new drug or vaccine.
Human Challenge Trials (HCT) or Controlled Human Infection Models (CHIM) are an extremely effective way of validating treatment efficacy using real-world symptomology studies. Our Human Challenge Trials help to support pre-clinical evidence of efficacy, minimise the risk and maximise the outcomes when progressing a new drug or vaccine into pivotal clinical studies.
Specialised SGS R&D facilities
Our Human Challenge Unit (HCU) is embedded in our Clinical Pharmacology Unit, based in Antwerp, Belgium, and consists of a 20-bed, Biosafety or Containment Level 2-Q compliant, quarantine facility.
The quarantine unit employs leading infection control technologies, including a negative pressure, HEPA-filtering and airlock system, with individualised, en-suite compartments for infected volunteers.
A dedicated CL2 laboratory is equipped with a flow cabinet, acid cabinet, dedicated work space and workflows to handle specific (viral/other) cultures.
A wide range of investigations
Our Human Challenge Trials provide a carefully defined, systematised and effective method in which a number of variables can be controlled, reducing complexity or ‘noise’ in the data. Plus, subjects are continuously monitored for safety signals in a sequestered environment.
We offer in-depth experience with most of the possible pharmacological techniques for this type of study. The Human Challenge Model enables detailed assessment of immune parameters, helping to identify immunological correlates of infection and disease.
Our solutions include:
- A wide variety of challenging agents and techniques (e.g. virus, histamine and LPS) in healthy volunteers and patients
- Prolonged quarantine
- Screening large volunteer populations for serosusceptibility and complex inclusion/exclusion criteria
- Laboratory assays, using cryptic or hard to access body fluid or tissue samples and the preparation of specimens for complex biomarker analyses, such as virus, protective antibodies and cellular immunity (PBMC), etc.
Novel virus as experimental challenge agent
We have recently developed a new wild-type strain of influenza A H3N2 virus in eggs. This agent shows little attenuation over circulating strains and has a high attack rate (≥100%) plus a consistent shedding profile. Our challenge agent manufacture has been undertaken in strict accordance with Good Manufacturing Practice (cGMP) to ensure that regulatory guidelines in both the US and EU (FDA and EMA) are met. The H3N2 agent is approved for use as a challenge agent in studies demonstrating the early efficacy of influenza drugs and vaccines in healthy volunteers.
As a result, we can help you:
- Obtain meaningful results with this challenge model with sample sizes that are substantially lower than for community-based studies of naturally acquired infection
- Reduce clinical development costs for new vaccines or antiviral agents
- Avoid initial efficacy studies in much larger populations. The use of a challenge trial within a CPU/HCU minimises safety risks for infected volunteers and means testing may be undertaken year-round
- Facilitate the development of prophylactics / therapeutics, new small and large molecules, as well as early safety assessments in healthy volunteers or patients with respiratory diseases (asthma / COPD)
The technique is not only a recognised tool for providing proof-of-concept regarding efficacy, but also provides predictive data for effectiveness and proof-of-mechanism for new targets, e.g. in asthma.
Challenge trials are used worldwide for many different organisms as part of the dose-selection process for new drugs. HCTs provide valuable data to assist in the up and down-selection of candidates to inform decisions and may provide additional safety signals when combined with pre-clinical data.
Contact us today to learn how we can help with your Human Challenge Clinical trial.