drugset / Trial / NCT02836002
Controlled Human Malaria Infection Model for Evaluation of Transmission-Blocking Interventions - Study 1
Phase 1/2
Completed
29 enrolled
Radboud University Medical Center
QIMR Berghofer Medical Research Institute · collabThe PATH Malaria Vaccine Initiative (MVI) · collab
RandomizedParallel-groupOpen-labelOther
Summary
This is a single-center, open label study. The primary aim of this project is to develop a controlled human malaria infection transmission model ("CHMI-trans") or "challenge model" to evaluate the capacity of vaccines, biologics (monoclonal antibodies, or mAbs), and drugs to block malaria parasite transmission by assessing infectiousness of Plasmodium falciparum (Pf) gametocyte carriers for Anopheles mosquitoes.
Timeline
- Start
- 2016-06
- Primary completion
- 2017-06-29
- Completion
- 2017-06-29
Publications
- Results Reuling IJ, van de Schans LA, Coffeng LE, Lanke K, Meerstein-Kessel L, Graumans W, van Gemert GJ, Teelen K, Siebelink-Stoter R, van de Vegte-Bolmer M, de Mast Q, van der Ven AJ, Ivinson K, Hermsen CC, de Vlas S, Bradley J, Collins KA, Ockenhouse CF, McCarthy J, Sauerwein RW, Bousema T. A randomized feasibility trial comparing four antimalarial drug regimens to induce Plasmodium falciparum gametocytemia in the controlled human malaria infection model. Elife. 2018 Feb 27;7:e31549. doi: 10.7554/eLife.31549.
- Post A, Kabore B, Reuling IJ, Bognini J, van der Heijden W, Diallo S, Lompo P, Kam B, Herssens N, Lanke K, Bousema T, Sauerwein RW, Tinto H, Jacobs J, de Mast Q, van der Ven AJ. The XN-30 hematology analyzer for rapid sensitive detection of malaria: a diagnostic accuracy study. BMC Med. 2019 May 31;17(1):103. doi: 10.1186/s12916-019-1334-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | piperaquine | Small molecule | 480 mg | — |
| Subject | piperaquine | Small molecule | 960 mg | — |
| Subject | pyrimethamine | Small molecule | 25 mg | — |
| Subject | pyrimethamine | Small molecule | 50 mg | — |
| Subject | sulfadoxine | Small molecule | 500 mg | — |
| Subject | sulfadoxine | Small molecule | 1000 mg | — |
| Background | Atovaquone | Small molecule | 1000 mg | — |
| Background | Proguanil | Small molecule | 400 mg | — |