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QUANTITATIVE REAL-TIME POLYMERASE CHAIN REACTION FOR MALARIA DIAGNOSIS AND ITS USE IN MALARIA VACCINE CLINICAL TRIALS

The demand for an effective malaria vaccine is high, with millions of people being affected by the disease every year. A large variety of potential vaccines are under investigation worldwide, and when tested in clinical trials, researchers need to extract as much data as possible from every vaccinated and control volunteer. The use of quantitative real-time polymerase chain reaction (PCR), carried out in real-time during the clinical trials of vaccines designed to act against the liver stage of the parasite’s life cycle, provides more information than the gold standard method of microscopy alone and increases both safety and accuracy. PCR can detect malaria parasites in the blood up to 5 days before experienced microscopists see parasites on blood films, with a sensitivity of 20 parasites/mL blood. This PCR method has so far been used to follow 137 vaccinee and control volunteers in Phase IIa trials in Oxford and on 220 volunteer samples during a Phase IIb field trial in The Gambia.

Received September 28, 2004. Accepted for publication January 22, 2005.

Acknowledgments: We are grateful to Ian Poulton and Simon Correa for assistance with the clinical trials and to TCS Biosciences Ltd (Buckingham, UK) for the gift of the Optimal and Rapimal kits. This work was supported by the Wellcome Trust and Malaria Vaccine Initiative at PATH.

^* Address correspondence to Sarah C. Gilbert, Wellcome Trust Centre for Human Genetics, University of Oxford, Roosevelt Drive, Oxford, OX3 7BN, United Kingdom. E-mail: sarah.gilbert{at}well.ox.ac.uk

Authors’ addresses: Laura Andrews, Rikke F. Andersen, Adrian V. S. Hill, and Sarah C. Gilbert, Wellcome Trust Centre for Human Genetics, University of Oxford, Roosevelt Drive, Oxford, OX3 7BN, UK, Telehone: +44 1865 287500, Fax: +44 1865 287686. Daniel Webster, Susanna Dunachie, R. Michael Walther, Philip Bejon, Angela Hunt-Cooke, Gillian Bergson, and Frances Sanderson, Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, OX3 7LJ, UK, Telehone: +44 1865 857401, Fax: +44 1865 857471.

Reprint requests: Sarah C. Gilbert, Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK.

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