期刊
AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
卷 88, 期 1, 页码 5-13出版社
AMER SOC TROP MED & HYGIENE
DOI: 10.4269/ajtmh.2012.12-0613
关键词
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资金
- Top Institute Pharma (TI Pharma) [T4-102]
- European Malaria Vaccine Development Association
- Mozaiek grant from the Netherlands Organization for Scientific Research
- Small Business Innovation Research (SBIR) from the National Institute of Allergy and Infectious Diseases at the National Institute of Health (NIAID/NIH) [R44AI058375-03, R44AI058375-04, R44AI058375- 05, R44AI058375-05S1]
- PATH Malaria Vaccine Initiative [07984]
- NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES [R44AI058375] Funding Source: NIH RePORTER
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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