TY - JOUR
T1 - Controlled human malaria infections by intradermal injection of cryopreserved Plasmodium falciparum sporozoites
AU - Roestenberg, Meta
AU - Bijker, Else M.
AU - Sim, B. Kim Lee
AU - Billingsley, Peter F.
AU - James, Eric R.
AU - Bastiaens, Guido J.H.
AU - Teirlinck, Anne C.
AU - Scholzen, Anja
AU - Teelen, Karina
AU - Arens, Theo
AU - Van Der Ven, André J.A.M.
AU - Gunasekera, Anusha
AU - Chakravarty, Sumana
AU - Velmurugan, Soundarapandian
AU - Hermsen, Cornelus C.
AU - Sauerwein, Robert W.
AU - Hoffman, Stephen L.
PY - 2013/1
Y1 - 2013/1
N2 - Controlled human malaria infection with sporozoites is a standardized and powerful tool for evaluation of malaria vaccine and drug efficacy but so far only applied by exposure to bites of Plasmodium falciparum (Pf)-infected mosquitoes. We assessed in an open label Phase 1 trial, infection after intradermal injection of respectively 2,500, 10,000, or 25,000 aseptic, purified, vialed, cryopreserved Pf sporozoites (PfSPZ) in three groups (N = 6/group) of healthy Dutch volunteers. Infection was safe and parasitemia developed in 15 of 18 volunteers (84%), 5 of 6 volunteers in each group. There were no differences between groups in time until parasitemia by microscopy or quantitative polymerase chain reaction, parasite kinetics, clinical symptoms, or laboratory values. This is the first successful infection by needle and syringe with PfSPZ manufactured in compliance with regulatory standards. After further optimization, the use of such PfSPZ may facilitate and accelerate clinical development of novel malaria drugs and vaccines.
AB - Controlled human malaria infection with sporozoites is a standardized and powerful tool for evaluation of malaria vaccine and drug efficacy but so far only applied by exposure to bites of Plasmodium falciparum (Pf)-infected mosquitoes. We assessed in an open label Phase 1 trial, infection after intradermal injection of respectively 2,500, 10,000, or 25,000 aseptic, purified, vialed, cryopreserved Pf sporozoites (PfSPZ) in three groups (N = 6/group) of healthy Dutch volunteers. Infection was safe and parasitemia developed in 15 of 18 volunteers (84%), 5 of 6 volunteers in each group. There were no differences between groups in time until parasitemia by microscopy or quantitative polymerase chain reaction, parasite kinetics, clinical symptoms, or laboratory values. This is the first successful infection by needle and syringe with PfSPZ manufactured in compliance with regulatory standards. After further optimization, the use of such PfSPZ may facilitate and accelerate clinical development of novel malaria drugs and vaccines.
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U2 - 10.4269/ajtmh.2012.12-0613
DO - 10.4269/ajtmh.2012.12-0613
M3 - Article
C2 - 23149582
AN - SCOPUS:84872362601
SN - 0002-9637
VL - 88
SP - 5
EP - 13
JO - American Journal of Tropical Medicine and Hygiene
JF - American Journal of Tropical Medicine and Hygiene
IS - 1
ER -