This Phase 1 study, conducted in malaria-naïve adults in Australia, was designed to determine whether controlled human malaria infection using the Plasmodium vivax-induced blood-stage malaria model could reliably infect Anopheles stephensi mosquitoes—potentially offering a means of testing efficacy of transmission-blocking vaccines.
The study was designed with two objectives:
- Evaluate induced blood-stage malaria (IBSM) infection with Plasmodium vivax as a reliable and reproducible model in assessing malaria vaccine candidates.
- Evaluate the safety of the IBSM model.
Outcomes/Next steps: Findings were published in PLoS Neglected Tropical Diseases in 2016.
A variety of local and systemic reactions were noted in subjects; however, these were found to be in line with reactogenicity experienced in previous studies.
The IBSM model was found to be safe and well-tolerated, with potential to be a useful tool in assessing transmission-blocking interventions.
Griffin P, Pasay C, Elliott S, Sekuloski S, Sikulu M, et al. Safety and reproducibility of a clinical trial system using induced blood stage Plasmodium vivax infection and its potential as a model to evaluate malaria transmission. PLoS Neglected Tropical Diseases. 2016;10(12):e0005139.