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SGS’s first malaria human challenge trial will take place in Belgium this month

SGS logo 19.2.19

Clinical and bioanalytical contract solutions provider SGS will commence its first malaria volunteer infection study (VIS) in Belgium this month (February 2019) on behalf of Medicines for Malaria Venture (MMV). The study will assist in the development of an advanced candidate compound, a potential long-acting injectable chemoprotective drug from the anti-malarial drug pipeline developed by MMV and its partners.

The primary objective of the trial is to test the efficacy of MMV’s experimental compound in killing malaria parasites in the liver before they can develop and reach the bloodstream, thus providing protection from the disease. The trial will be conducted in SGS’ dedicated 20-bed unit at Antwerp’s Stuivenberg Hospital.

SGS’ Human Challenge Unit provides level 2 containment and has full isolation capabilities for participants. The VIS trial will involve the intravenous inoculation of 24 healthy volunteers (divided into 2 cohorts of 12 subjects) with living, infectious, cryopreserved malaria parasites. Approved antimalarial drugs will be given to any subject who is diagnosed as malaria positive through a highly sensitive blood test to ensure rapid parasite clearance, thus eliminating the risk of them developing symptoms or transmissible disease in both the placebo and the active drug arms of the study. During the containment period (days 1 to 13 following inoculation) subjects will be closely monitored by resident medical and clinical staff. From day 14 until day 28, daily ambulatory visits to the CPU will allow safety measures to be undertaken. At the ‘end-of-trial’ (EOT) a final follow-up visit will be scheduled (at day 35) to review subject safety prior to discharge. Should MMV’s experimental compound be observed to achieve its endpoints (following statistical analysis of the safety and efficacy data), a further titration study to determine the optimal dose of medication will be undertaken at the end of 2019.

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Last modified onTuesday, 19 February 2019 08:31