1921
Volume 93, Issue 6
  • ISSN: 0002-9637
  • E-ISSN: 1476-1645

Abstract

Abstract

Controlled human malaria infection (CHMI) is a powerful tool to evaluate malaria vaccine and prophylactic drug efficacy. Until recently CHMI was only carried out by the bite of infected mosquitoes. A parenteral method of CHMI would standardize sporozoite (PfSPZ) administration, eliminate the need for expensive challenge facility infrastructure, and allow for use of many strains. Recently, intradermal (ID) injection of aseptic, purified, cryopreserved PfSPZ was shown to induce malaria; however, 100% infection rates were not achieved by ID injection. To optimize ID PfSPZ dosing so as to achieve 100% infection, 30 adults aged 18–45 years were randomized to one of six groups composed of five volunteers each. The parameters of dose (1 × 10 versus 5 × 10 PfSPZ total dose per volunteer), number of injections (two versus eight), and aliquot volume per ID injection (10 μL versus 50 μL) were studied. Three groups attained 100% infection: 1 × 10 PfSPZ in 50 μL/2 doses, 1 × 10 PfSPZ in 10 μL/2 doses, and 5 × 10 PfSPZ in 10 μL/8 doses. The group that received 5 × 10 PfSPZ total dose in eight 10 μL injections had a 100% infection rate and the shortest prepatent period (mean of 12.7 days), approaching the prepatent period for the current CHMI standard of five infected mosquitoes.

[open-access] This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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2015-12-09
2017-11-21
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References

  1. Stoute JA, Slaoui M, Heppner DG, Momin P, Kester KE, Desmons P, Wellde BT, Garcon N, Krzych U, Marchand M, RTS,S Malaria Vaccine Evaluation Group, , 1997. A preliminary evaluation of a recombinant circumsporozoite protein vaccine against Plasmodium falciparum malaria. N Engl J Med 336: 8691.[Crossref]
  2. Gordon DM, McGovern TW, Krzych U, Cohen JC, Schneider I, LaChance R, Heppner DG, Yuan G, Hollingdale M, Slaoui M, , 1995. Safety, immunogenicity, and efficacy of a recombinantly produced Plasmodium falciparum circumsporozoite protein-hepatitis B surface antigen subunit vaccine. J Infect Dis 171: 15761585.[Crossref]
  3. Moorthy VS, Diggs C, Ferro S, Good MF, Herrera S, Hill AV, Imoukhuede EB, Kumar S, Loucq C, Marsh K, Ockenhouse CF, Richie TL, Sauerwein RW, , 2009. Report of a consultation on the optimization of clinical challenge trials for evaluation of candidate blood stage malaria vaccines, 18–19 March 2009, Bethesda, MD, USA. Vaccine 27: 57195725.[Crossref]
  4. Kester KE, McKinney DA, Tornieporth N, Ockenhouse CF, Heppner DG, Hall T, Krzych U, Delchambre M, Voss G, Dowler MG, Palensky J, Wittes J, Cohen J, Ballou WR, , 2001. Efficacy of recombinant circumsporozoite protein vaccine regimens against experimental Plasmodium falciparum malaria. J Infect Dis 183: 640647.[Crossref]
  5. Roestenberg M, Bijker EM, Sim BK, Billingsley PF, James ER, Bastiaens GJ, Teirlinck AC, Scholzen A, Teelen K, Arens T, van der Ven AJ, Gunasekera A, Chakravarty S, Velmurugan S, Hermsen CC, Sauerwein RW, Hoffman SL, , 2013. Controlled human malaria infections by intradermal injection of cryopreserved Plasmodium falciparum sporozoites. Am J Trop Med Hyg 88: 513.[Crossref]
  6. Shekalaghe S, Rutaihwa M, Billingsley PF, Chemba M, Daubenberger CA, James ER, Mpina M, Ali JO, Schindler T, Huber E, Gunasekera A, Manoj A, Simon B, Saverino E, Church LW, Hermsen CC, Sauerwein RW, Plowe C, Venkatesan M, Sasi P, Lweno O, Mutani P, Hamad A, Mohammed A, Urassa A, Mzee T, Padilla D, Ruben A, Sim BK, Tanner M, Abdulla S, Hoffman SL, , 2014. Controlled human malaria infection of Tanzanians by intradermal injection of aseptic, purified, cryopreserved Plasmodium falciparum sporozoites. Am J Trop Med Hyg 91: 471480.[Crossref]
  7. Gaziano TA, Young CR, Fitzmaurice G, Atwood S, Gaziano JM, , 2008. Laboratory-based versus non-laboratory-based method for assessment of cardiovascular disease risk: the NHANES I Follow-up Study cohort. Lancet 371: 923931.[Crossref]
  8. Patchen LC, Mount DL, Schwartz IK, Churchill FC, , 1983. Analysis of filter-paper-absorbed, finger-stick blood samples for chloroquine and its major metabolite using high-performance liquid chromatography with fluorescence detection. J Chromatogr A 278: 8189.[Crossref]
  9. Mount DL, Nahlen BL, Patchen LC, Churchill FC, , 1989. Adaptations of the Saker-Solomons test: simple, reliable colorimetric field assays for chloroquine and its metabolites in urine. Bull World Health Organ 67: 295300.
  10. Lyke KE, Laurens M, Adams M, Billingsley PF, Richman A, Loyevsky M, Chakravarty S, Plowe CV, Sim BK, Edelman R, Hoffman SL, , 2010. Plasmodium falciparum malaria challenge by the bite of aseptic Anopheles stephensi mosquitoes: results of a randomized infectivity trial. PLoS One 5: e13490.[Crossref]
  11. Laurens MB, Billingsley P, Richman A, Eappen AG, Adams M, Li T, Chakravarty S, Gunasekera A, Jacob CG, Sim BK, Edelman R, Plowe CV, Hoffman SL, Lyke KE, , 2013. Successful human infection with P. falciparum using three aseptic Anopheles stephensi mosquitoes: a new model for controlled human malaria infection. PLoS One 8: e68969.
  12. Spring MD, Cummings JF, Ockenhouse CF, Dutta S, Reidler R, Angov E, Bergmann-Leitner E, Stewart VA, Bittner S, Juompan L, Kortepeter MG, Nielsen R, Krzych U, Tierney E, Ware LA, Dowler M, Hermsen CC, Sauerwein RW, de Vlas SJ, Ofori-Anyinam O, Lanar DE, Williams JL, Kester KE, Tucker K, Shi M, Malkin E, Long C, Diggs CL, Soisson L, Dubois MC, Ballou WR, Cohen J, Heppner DG, Jr, 2009. Phase 1/2a study of the malaria vaccine candidate apical membrane antigen-1 (AMA-1) administered in adjuvant system AS01B or AS02A. PLoS One 4: e5254.[Crossref]
  13. McCutchan TF, de la Cruz VF, Lal AA, Gunderson JH, Elwood HJ, Sogin ML, , 1988. Primary sequences of two small subunit ribosomal RNA genes from Plasmodium falciparum . Mol Biochem Parasitol 28: 6368.[Crossref]
  14. Gunderson JH, Sogin ML, Wollett G, Hollingdale M, de la Cruz VF, Waters AP, McCutchan TF, , 1987. Structurally distinct, stage-specific ribosomes occur in Plasmodium . Science 238: 933937.[Crossref]
  15. Epstein JE, Tewari K, Lyke KE, Sim BK, Billingsley PF, Laurens MB, Gunasekera A, Chakravarty S, James ER, Sedegah M, Richman A, Velmurugan S, Reyes S, Li M, Tucker K, Ahumada A, Ruben AJ, Li T, Stafford R, Eappen AG, Tamminga C, Bennett JW, Ockenhouse CF, Murphy JR, Komisar J, Thomas N, Loyevsky M, Birkett A, Plowe CV, Loucq C, Edelman R, Richie TL, Seder RA, Hoffman SL, , 2011. Live attenuated malaria vaccine designed to protect through hepatic CD8+ T cell immunity. Science 334: 425480.[Crossref]
  16. 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: 619626.[Crossref]
  17. Roestenberg M, O'Hara GA, Duncan CJ, Epstein JE, Edwards NJ, Scholzen A, van der Ven AJ, Hermsen CC, Hill AV, Sauerwein RW, , 2012. Comparison of clinical and parasitological data from controlled human malaria infection trials. PLoS One 7: e38434.[Crossref]
  18. Sheehy SH, Spencer AJ, Douglas AD, Sim BK, Longley RJ, Edwards NJ, Poulton ID, Kimani D, Williams AR, Anagnostou NA, Roberts R, Kerridge S, Voysey M, James ER, Billingsley PF, Gunasekera A, Lawrie AM, Hoffman SL, Hill AV, , 2013. Optimising controlled human malaria infection studies using cryopreserved parasites administered by needle and syringe. PLoS One 8: e65960.[Crossref]
  19. Mordmuller B, Supan C, Sim BKL, Gómez-Pérez GP, Ospina Salazar CL, Held J, Bolte S, Esen M, Tschan S, Joanny F, Calle CL, Gunasekera A, James SL, Billingsley P, Richman A, Chakravarty S, Legarda A, Muñoz J, Antonijoan RM, Ballester MR, Hoffman SL, Alonso PL, Kremsner PG, , 2015. Direct venous inoculation of Plasmodium falciparum sporozoites for controlled human malaria infection: a dose-finding trial in two centres. Malar J 14: 117.[Crossref]
  20. Choumet V, Attout T, Chartier L, Khun H, Sautereau J, Robbe-Vincent A, Brey P, Huerre M, Bain O, , 2012. Visualizing non infectious and infectious Anopheles gambiae blood feedings in naive and saliva-immunized mice. PLoS One 7: e50464.[Crossref]
  21. Seder RA, Chang LJ, Enama ME, Zephir KL, Sarwar UN, Gordon IJ, Holman LA, James ER, Billingsley PF, Gunasekera A, Richman A, Chakravarty S, Manoj A, Velmurugan S, Li M, Ruben AJ, Li T, Eappen AG, Stafford RE, Plummer SH, Hendel CS, Novik L, Costner PJ, Mendoza FH, Saunders JG, Nason MC, Richardson JH, Murphy J, Davidson SA, Richie TL, Sedegah M, Sutamihardja A, Fahle GA, Lyke KE, Laurens MB, Roederer M, Tewari K, Epstein JE, Sim BK, Ledgerwood JE, Graham BS, Hoffman SL, , 2013. Protection against malaria by intravenous immunization with a nonreplicating sporozoite vaccine. Science 341: 13591365.[Crossref]
  22. Robert V, Awono-Ambene HP, Le Hesran JY, Trape JF, , 2000. Gametocytemia and infectivity to mosquitoes of patients with uncomplicated Plasmodium falciparum malaria attacks treated with chloroquine or sulfadoxine plus pyrimethamine. Am J Trop Med Hyg 62: 210216.
  23. White NJ, , 2008. How antimalarial drug resistance affects post-treatment prophylaxis. Malar J 7: 9.[Crossref]
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Supplementary Data

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  • Received : 08 May 2015
  • Accepted : 30 Jul 2015

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