Authors:
, , , , , , , , , , , , , , , , , and
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-
1
Phillips RS, 2001. Current status of malaria and potential for control. Clin Microbiol Rev 14 :208–226.
-
2
Chulay JD, Schneider I, Cosgriff TM, Hoffman SL, Ballou WR, Quakyi IA, Carter R, Trosper JH, Hockmeyer WT, 1986. Malaria transmitted to humans by mosquitoes infected from cultured Plasmodium falciparum.Am J Trop Med Hyg 35 :66–68.
-
3
Gordon DM, McGovern TW, Krzych U, Cohen JC, Schneider I, LaChance R, Heppner DG, Yuan G, Hollingdale M, Slaoui M, Hauser P, Voet P, Sadoff JC, Ballou WR, 1995. Safety, immunogenicity, and efficacy of a recombinantly produced Plasmodium falciparum circumsporozoite protein-hepatitis B surface antigen subunit vaccine. J Infect Dis 171 :1576–1585.
-
4
Bojang KA, Milligan PJ, Pinder M, Vigneron L, Alloueche A, Kester KE, Ballou WR, Conway DJ, Reece WH, Gothard P, Yamuah L, Delchambre M, Voss G, Greenwood BM, Hill A, McAdam KP, Tornieporth N, Cohen JD, Doherty T, 2001. Efficacy of RTS, S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial. Lancet 358 :1927–1934.
-
5
Birkett A, Lyons K, Schmidt A, Boyd D, Oliveira GA, Siddique A, Nussenzweig R, Calvo-Calle JM, Nardin E, 2002. A modified hepatitis B virus core particle containing multiple epitopes of the Plasmodium falciparum circumsporozoite protein provides a highly immunogenic malaria vaccine in preclinical analyses in rodent and primate hosts. Infect Immun 70 :6860–6870.
-
6
McConkey SJ, Reece WH, Moorthy VS, Webster D, Dunachie S, Butcher G, Vuola JM, Blanchard TJ, Gothard P, Watkins K, Hannan CM, Everaere S, Brown K, Kester KE, Cummings J, Williams J, Heppner DG, Pathan A, Flanagan K, Arulanantham N, Roberts MT, Roy M, Smith GL, Schneider J, Peto T, Sinden RE, Gilbert SC, Hill AV, 2003. Enhanced T-cell immunogenicity of plasmid DNA vaccines boosted by recombinant modified vaccinia virus Ankara in humans. Nat Med 9 :729–735.
-
7
Walther M, Dunachie S, Keating S, Berthoud T, Schmidt A, Maier C, Andrews L, Gilbert S, Poulton I, Webster D, Dubovsky F, Tierney E, Sarpotdar P, Correa S, Huntcooke A, Butcher G, Williams J, 2005. Safety, immunogenicity and efficacy of a pre-erythrocytic malaria candidate vaccine, ICC-1132 formulated in Seppic ISA 720. Vaccine 23 :857–864.
-
8
Webster DP, Dunachie S, Vuola JM, Berthoud T, Keating S, Laidlaw SM, McConkey SJ, Poulton I, Andrews L, Andersen RF, Bejon P, Butcher G, Sinden R, Skinner MA, Gilbert SC, Hill AV, 2005. Enhanced T cell-mediated protection against malaria in human challenges by using the recombinant poxviruses FP9 and modified vaccinia virus Ankara. Proc Natl Acad Sci U S A 102 :4836–4841.
-
9
Bejon P, Andrews L, Andersen RF, Dunachie S, Webster D, Walther M, Gilbert SC, Peto T, Hill AV, 2005. Calculation of liver-to-blood inocula, parasite growth rates, and preerythrocytic vaccine efficacy, from serial quantitative polymerase chain reaction studies of volunteers challenged with malaria sporozoites. J Infect Dis 191 :619–626.
-
10
Ohrt C, Purnomo M, Sutamihardja MA, Tang D, Kain KC, 2002. Impact of microscopy error on estimates of protective efficacy in malaria-prevention trials. J Infect Dis 186 :540–546.
-
11
Snounou G, Viriyakosol S, Zhu XP, Jarra W, Pinheiro L, do Rosario VE, Thaithong S, Brown KN, 1993. High sensitivity of detection of human malaria parasites by the use of nested polymerase chain reaction. Mol Biochem Parasitol 61 :315–320.
-
12
Hermsen CC, Telgt DS, Linders EH, van de Locht LA, Eling WM, Mensink EJ, Sauerwein RW, 2001. Detection of Plasmodium falciparum malaria parasites in vivo by real-time quantitative PCR. Mol Biochem Parasitol 118 :247–251.
-
13
Perandin F, Manca N, Calderaro A, Piccolo G, Galati L, Ricci L, Medici MC, Arcangeletti MC, Snounou G, Dettori G, Chezzi C, 2004. Development of a real-time PCR assay for detection of Plasmodium falciparum, Plasmodium vivax, and Plasmodium ovale for routine clinical diagnosis. J Clin Microbiol 42 :1214–1219.
-
14
Chaorattanakawee S, Natalang O, Hananantachai H, Nacher M, Brockman A, Krudsood S, Looareesuwan S, Patarapotikul J, 2003. Storage duration and polymerase chain reaction detection of Plasmodium falciparum from blood spots on filter paper. Am J Trop Med Hyg 69 :42–44.
-
15
Meis JF, Rijntjes PJ, Verhave JP, Ponnudurai T, Hollingdale MR, Smith JE, Sinden RE, Jap PH, Meuwissen JH, Yap SH, 1986. Fine structure of the malaria parasite Plasmodium falciparum in human hepatocytes in vitro. Cell Tissue Res 244 :345–350.
-
16
Simpson JA, Aarons L, Collins WE, Jeffery GM, White NJ, 2002. Population dynamics of untreated Plasmodium falciparum malaria within the adult human host during the expansion phase of the infection. Parasitology 124 :247–263.
-
17
Moorthy VS, Imoukhuede EB, Keating S, Pinder M, Webster D, Skinner MA, Gilbert SC, Walraven G, Hill AV, 2004. Phase 1 evaluation of 3 highly immunogenic prime-boost regimens, including a 12-month reboosting vaccination, for malaria vaccination in Gambian men. J Infect Dis 189 :2213–2219.
-
18
WHO/AFRO, 2004. Malaria Country Profiles—The Gambia, 57– 59. Available at http://www.afro.who.int/malaria/country-profile/gambia.pdf
-
19
Welch SG, McGregor IA, Williams K, 1977. The Duffy blood group and malaria prevalence in Gambian West Africans. Trans R Soc Trop Med Hyg 71 :295–296.
-
20
Miller LH, Mason SJ, Clyde DF, McGinniss MH, 1976. The resistance factor to Plasmodium vivax in blacks. The Duffy-blood-group genotype, FyFy. N Engl J Med 295 :302–304.
-
21
Rubio JM, Benito A, Roche J, Berzosa PJ, Garcâia ML, Micâo M, Edâu M, Alvar J, 1999. Semi-nested, multiplex polymerase chain reaction for detection of human malaria parasites and evidence of Plasmodium vivax infection in Equatorial Guinea. Am J Trop Med Hyg 60 :183–187.
-
22
Church LW, Le TP, Bryan JP, Gordon DM, Edelman R, Fries L, Davis JR, Herrington DA, Clyde DF, Shmuklarsky MJ, Schneider I, McGovern TW, Chulay JD, Ballou WR, Hoffman SL, 1997. Clinical manifestations of Plasmodium falciparum malaria experimentally induced by mosquito challenge. J Infect Dis 175 :915–920.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1093 | 897 | 289 |
| Full Text Views | 386 | 12 | 3 |
| PDF Downloads | 126 | 14 | 4 |
QUANTITATIVE REAL-TIME POLYMERASE CHAIN REACTION FOR MALARIA DIAGNOSIS AND ITS USE IN MALARIA VACCINE CLINICAL TRIALS
LAURA ANDREWS
LAURA ANDREWS
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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RIKKE F. ANDERSEN
RIKKE F. ANDERSEN
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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DANIEL WEBSTER
DANIEL WEBSTER
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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SUSANNA DUNACHIE
SUSANNA DUNACHIE
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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R. MICHAEL WALTHER
R. MICHAEL WALTHER
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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PHILIP BEJON
PHILIP BEJON
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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ANGELA HUNT-COOKE
ANGELA HUNT-COOKE
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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GILLIAN BERGSON
GILLIAN BERGSON
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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FRANCES SANDERSON
FRANCES SANDERSON
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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ADRIAN V. S. HILL
ADRIAN V. S. HILL
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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SARAH C. GILBERT
SARAH C. GILBERT
Wellcome Trust Centre for Human Genetics, University of Oxford, Oxford, UK; Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital, University of Oxford, Oxford, United Kingdom
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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.
Author Notes
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-
1
Phillips RS, 2001. Current status of malaria and potential for control. Clin Microbiol Rev 14 :208–226.
-
2
Chulay JD, Schneider I, Cosgriff TM, Hoffman SL, Ballou WR, Quakyi IA, Carter R, Trosper JH, Hockmeyer WT, 1986. Malaria transmitted to humans by mosquitoes infected from cultured Plasmodium falciparum.Am J Trop Med Hyg 35 :66–68.
-
3
Gordon DM, McGovern TW, Krzych U, Cohen JC, Schneider I, LaChance R, Heppner DG, Yuan G, Hollingdale M, Slaoui M, Hauser P, Voet P, Sadoff JC, Ballou WR, 1995. Safety, immunogenicity, and efficacy of a recombinantly produced Plasmodium falciparum circumsporozoite protein-hepatitis B surface antigen subunit vaccine. J Infect Dis 171 :1576–1585.
-
4
Bojang KA, Milligan PJ, Pinder M, Vigneron L, Alloueche A, Kester KE, Ballou WR, Conway DJ, Reece WH, Gothard P, Yamuah L, Delchambre M, Voss G, Greenwood BM, Hill A, McAdam KP, Tornieporth N, Cohen JD, Doherty T, 2001. Efficacy of RTS, S/AS02 malaria vaccine against Plasmodium falciparum infection in semi-immune adult men in The Gambia: a randomised trial. Lancet 358 :1927–1934.
-
5
Birkett A, Lyons K, Schmidt A, Boyd D, Oliveira GA, Siddique A, Nussenzweig R, Calvo-Calle JM, Nardin E, 2002. A modified hepatitis B virus core particle containing multiple epitopes of the Plasmodium falciparum circumsporozoite protein provides a highly immunogenic malaria vaccine in preclinical analyses in rodent and primate hosts. Infect Immun 70 :6860–6870.
-
6
McConkey SJ, Reece WH, Moorthy VS, Webster D, Dunachie S, Butcher G, Vuola JM, Blanchard TJ, Gothard P, Watkins K, Hannan CM, Everaere S, Brown K, Kester KE, Cummings J, Williams J, Heppner DG, Pathan A, Flanagan K, Arulanantham N, Roberts MT, Roy M, Smith GL, Schneider J, Peto T, Sinden RE, Gilbert SC, Hill AV, 2003. Enhanced T-cell immunogenicity of plasmid DNA vaccines boosted by recombinant modified vaccinia virus Ankara in humans. Nat Med 9 :729–735.
-
7
Walther M, Dunachie S, Keating S, Berthoud T, Schmidt A, Maier C, Andrews L, Gilbert S, Poulton I, Webster D, Dubovsky F, Tierney E, Sarpotdar P, Correa S, Huntcooke A, Butcher G, Williams J, 2005. Safety, immunogenicity and efficacy of a pre-erythrocytic malaria candidate vaccine, ICC-1132 formulated in Seppic ISA 720. Vaccine 23 :857–864.
-
8
Webster DP, Dunachie S, Vuola JM, Berthoud T, Keating S, Laidlaw SM, McConkey SJ, Poulton I, Andrews L, Andersen RF, Bejon P, Butcher G, Sinden R, Skinner MA, Gilbert SC, Hill AV, 2005. Enhanced T cell-mediated protection against malaria in human challenges by using the recombinant poxviruses FP9 and modified vaccinia virus Ankara. Proc Natl Acad Sci U S A 102 :4836–4841.
-
9
Bejon P, Andrews L, Andersen RF, Dunachie S, Webster D, Walther M, Gilbert SC, Peto T, Hill AV, 2005. Calculation of liver-to-blood inocula, parasite growth rates, and preerythrocytic vaccine efficacy, from serial quantitative polymerase chain reaction studies of volunteers challenged with malaria sporozoites. J Infect Dis 191 :619–626.
-
10
Ohrt C, Purnomo M, Sutamihardja MA, Tang D, Kain KC, 2002. Impact of microscopy error on estimates of protective efficacy in malaria-prevention trials. J Infect Dis 186 :540–546.
-
11
Snounou G, Viriyakosol S, Zhu XP, Jarra W, Pinheiro L, do Rosario VE, Thaithong S, Brown KN, 1993. High sensitivity of detection of human malaria parasites by the use of nested polymerase chain reaction. Mol Biochem Parasitol 61 :315–320.
-
12
Hermsen CC, Telgt DS, Linders EH, van de Locht LA, Eling WM, Mensink EJ, Sauerwein RW, 2001. Detection of Plasmodium falciparum malaria parasites in vivo by real-time quantitative PCR. Mol Biochem Parasitol 118 :247–251.
-
13
Perandin F, Manca N, Calderaro A, Piccolo G, Galati L, Ricci L, Medici MC, Arcangeletti MC, Snounou G, Dettori G, Chezzi C, 2004. Development of a real-time PCR assay for detection of Plasmodium falciparum, Plasmodium vivax, and Plasmodium ovale for routine clinical diagnosis. J Clin Microbiol 42 :1214–1219.
-
14
Chaorattanakawee S, Natalang O, Hananantachai H, Nacher M, Brockman A, Krudsood S, Looareesuwan S, Patarapotikul J, 2003. Storage duration and polymerase chain reaction detection of Plasmodium falciparum from blood spots on filter paper. Am J Trop Med Hyg 69 :42–44.
-
15
Meis JF, Rijntjes PJ, Verhave JP, Ponnudurai T, Hollingdale MR, Smith JE, Sinden RE, Jap PH, Meuwissen JH, Yap SH, 1986. Fine structure of the malaria parasite Plasmodium falciparum in human hepatocytes in vitro. Cell Tissue Res 244 :345–350.
-
16
Simpson JA, Aarons L, Collins WE, Jeffery GM, White NJ, 2002. Population dynamics of untreated Plasmodium falciparum malaria within the adult human host during the expansion phase of the infection. Parasitology 124 :247–263.
-
17
Moorthy VS, Imoukhuede EB, Keating S, Pinder M, Webster D, Skinner MA, Gilbert SC, Walraven G, Hill AV, 2004. Phase 1 evaluation of 3 highly immunogenic prime-boost regimens, including a 12-month reboosting vaccination, for malaria vaccination in Gambian men. J Infect Dis 189 :2213–2219.
-
18
WHO/AFRO, 2004. Malaria Country Profiles—The Gambia, 57– 59. Available at http://www.afro.who.int/malaria/country-profile/gambia.pdf
-
19
Welch SG, McGregor IA, Williams K, 1977. The Duffy blood group and malaria prevalence in Gambian West Africans. Trans R Soc Trop Med Hyg 71 :295–296.
-
20
Miller LH, Mason SJ, Clyde DF, McGinniss MH, 1976. The resistance factor to Plasmodium vivax in blacks. The Duffy-blood-group genotype, FyFy. N Engl J Med 295 :302–304.
-
21
Rubio JM, Benito A, Roche J, Berzosa PJ, Garcâia ML, Micâo M, Edâu M, Alvar J, 1999. Semi-nested, multiplex polymerase chain reaction for detection of human malaria parasites and evidence of Plasmodium vivax infection in Equatorial Guinea. Am J Trop Med Hyg 60 :183–187.
-
22
Church LW, Le TP, Bryan JP, Gordon DM, Edelman R, Fries L, Davis JR, Herrington DA, Clyde DF, Shmuklarsky MJ, Schneider I, McGovern TW, Chulay JD, Ballou WR, Hoffman SL, 1997. Clinical manifestations of Plasmodium falciparum malaria experimentally induced by mosquito challenge. J Infect Dis 175 :915–920.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1093 | 897 | 289 |
| Full Text Views | 386 | 12 | 3 |
| PDF Downloads | 126 | 14 | 4 |