drugset / Trial / NCT02780154
PfSPZ Challenge in Non-immune Adults in Baltimore, USA
RandomizedParallel-groupDouble-blindPrevention
Summary
This is a single center, randomized and controlled human study to optimize controlled human malaria infection (CHMI) administered by direct venous inoculation (DVI). 36 healthy adults aged between 18 and 45 years, will be randomized to one of five groups and will be inoculated with PfSPZ Challenge DVI. Participation duration is estimated to be 2 months, while the study duration is planned to be 4 months. The primary objective of this study is to assess the safety and reactogenicity of PfSPZ Challenge administered by DVI using 7G8 and NF54 P. falciparum strains.
Timeline
- Start
- 2016-08-25
- Primary completion
- 2016-12-15
- Completion
- 2016-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PfSPZ (7G8) | Vaccine | 800 unknown | Intravenous |
| Subject | PfSPZ (7G8) | Vaccine | 1600 unknown | Intravenous |
| Subject | PfSPZ (7G8) | Vaccine | 3200 unknown | Intravenous |
| Subject | PfSPZ (7G8) | Vaccine | 4800 unknown | Intravenous |
| Subject | PfSPZ (NF54) | Vaccine | 3200 unknown | Intravenous |