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Am. J. Trop. Med. Hyg., 76(3), 2007, pp. 486-493
Copyright © 2007 by The American Society of Tropical Medicine and Hygiene

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LOW-LEVEL MALARIA INFECTIONS DETECTED BY A SENSITIVE POLYMERASE CHAIN REACTION ASSAY AND USE OF THIS TECHNIQUE IN THE EVALUATION OF MALARIA VACCINES IN AN ENDEMIC AREA

EGERUAN B. IMOUKHUEDE*, LAURA ANDREWS, PAUL MILLIGAN, TAMARA BERTHOUD, KALIFA BOJANG, DAVIS NWAKANMA, JAMILA ISMAILI, CAROLINE BUCKEE, FANTA NJIE, SAIKOU KEITA, MAIMUNA SOWE, TRUDIE LANG, SARAH C. GILBERT, BRIAN M. GREENWOOD, AND ADRIAN V. S. HILL
Medical Research Council Laboratories, Fajara, The Gambia; London School of Hygiene & Tropical Medicine, London, UK; Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford, Oxford, UK

The feasibility of using a sensitive polymerase chain reaction (PCR) to evaluate malaria vaccines in small group sizes was tested in 102 adult Gambian volunteers who received either the malaria vaccine regimen FP9 ME-TRAP/MVA ME-TRAP or rabies vaccine. All volunteers received the antimalarial drugs primaquine and Lapdap plus artesunate to eliminate malaria parasites. Volunteers in a further group received an additional single treatment with sulfadoxine-pyrimethamine (SP) to prevent new infections. There was substantially lower T-cell immunogenicity than in previous trials with this vaccine regimen and no protection against infection in the malaria vaccine group. Using the primary endpoint of 20 parasites per mL, no difference was found in the prevalence of low-level infections in volunteers who received SP compared with those who did not, indicating that SP did not reduce the incidence of very low-density infection. However, SP markedly reduced the incidence of higher density infections. These findings support the feasibility and potential of this approach to screen pre-erythrocytic vaccines for efficacy against infection in small numbers of vaccinees in endemic areas.

Received July 23, 2006. Accepted for publication October 27, 2006.

Acknowledgments: The authors thank the field team led by Sheriff Jobe and the volunteers for their patience and understanding; the safety monitor Ousman Nyan; the head of the MRC Farafenni Field Station, Sam Dunyo; members of the Data Safety and Monitoring Board (Diana Lockwood, Richard Hayes, and Automan Gaye); and trial monitors Ceri McKenna and Carol Hall. The contribution of the Malaria Vaccine Initiative at PATH to earlier clinical trials of these vaccines is acknowledged. The Gates Malaria Partnership at the London School of Hygiene and Tropical Medicine, which receives support from the Bill and Melinda Gates Foundation, and the University of Oxford sponsored the study with additional funding from the Wellcome Trust.

Disclosure: AVSH is a co-founder of and shareholder in Oxxon Therapeutics plc, which is developing prime-boost vaccination for therapeutic applications. AVSH is a Wellcome Trust Principal Research Fellow, and EBI was, at the time of the study, a Gates Malaria Partnership Training Fellow. EBI is currently in the employment of the European Malaria Vaccine Initiative.

* Address correspondence to Egeruan Babatunde Imoukhuede, European Malaria Vaccine Initiative, 12 Bell House, Ewen Crescent, Tulse Hill, London, UK. E-mail: ebimoukhuede{at}hotmail.co.uk

Authors’ addresses: Egeruan Babatunde Imoukhuede, European Malaria Vaccine Initiative, 12 Bell House, Ewen Crescent, Tulse Hill, London, UK, Telephone: +44 (0) 2086748318, Fax: +44 (0) 2032560070, E-mail: ebimoukhuede{at}hotmail.co.uk. Laura Andrews, Sarah C. Gilbert, and Adrian V. S. Hill, Wellcome Trust Centre for Human Genetics, University of Oxford, UK, Telephone: +44 (0) 1865 287592. Paul Milligan, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK, Telephone: +44 (0) 207927 2126. Tamara Berthoud, Caroline Buckee, and Trudie Lang, Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford, UK, Telephone: +44 (0) 1865 857444. Kalifa Bojang, Davis Nwakanma, Jamila Ismaili, Fanta Njie, Saikou Keita, and Maimuna Sowe, Medical Research Council Laboratories, Fajara, The Gambia, Telephone: +220 4495442. Brian Greenwood, Gates Malaria Partnership, London School of Hygiene and Tropical Medicine, Keppel Street, London, UK, Telephone: +44 (0) 207 299 407.






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