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Clinical Trials

‘The IDB can offer logistics, high-throughput capacity and scientific expertise’

The IDB is located adjacent to two Clinical Research Facilities (CRF) at Guy’s and St Thomas’ Hospitals and is thus is uniquely placed to offer its logistical expertise, services and infrastructure to medical researchers wishing to conduct clinical trials.The IDB’s organisation covers the collection and transport of clinical samples using commercial couriers through to robots for isolating DNA and RNA from samples. Trials involving interventions require ethical permissions beyond the remit of the IDB Governance Committee: these may be organized independently of the IDB or alternatively, subjects can be consented for the trial and for IDB donation so that excess materials can be retained and used in subsequent studies. The IDB is currently involved in five clinical trials and three (CHERUB, HIRD and HIV ageing) use such dual consenting process Figure 1.

The IDB as a Facilitator of Clinical Trials


Figure 1

A prime example of the type of study that the IDB facilitated is the Human Immune Response Dynamics (HIRD) study.This is a world leading investigation of how the immune system responds to the H1N1 (‘swine flu’) vaccine. Blood samples are collected from overnight fasted, reclining volunteers at the CRF at St Thomas’ Hospital collected between 8 and 10 a.m. Two pre-vaccination PVB samples are taken prior to intramuscular injection with PandremixTM H1N1 vaccine. Subsequent blood donations were made on days +1 (visit three), +7 (visit four) and +14 (visit five) and on day +65 (visit six). To date (April 2011) over 170 volunteers have had their PVB samples from all six visits archived by the IDB around 70 further subjects are entering the investigation. At the peak of blood collection the IDB was processing between 8 and 10 pints of blood per week. The HIRD study will result in high quality research outputs. For example, changes in the expression of each (~36,000 per individual) human gene in lymphocytes for 75 subjects following immunization and compared these results to actual protein levels in plasmas have been determined (e.g. Figure 2). Such data will produce important new insights into the human physiological response to antigenic insults.

Example of a transcriptome analysis of lymphocytes after H1N1 vaccination


Figure 2

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