Table 1 Major outcomes on the clinical development plan
From: Clinical development of placental malaria vaccines and immunoassays harmonization: a workshop report
• Phase Ia and Ib clinical trials could be a single Phase I staggered clinical trial |
• The Phase Ia stage of the clinical trial would be in adults from malaria non-endemic population in Europe and the Phase Ib stage would target nulligravid adults from endemic population |
• Phase II clinical trials will target nulligravid women from an endemic region and will include dose escalation, age group de-escalation, and exploratory data on interactions with other vaccines |
• Phase III clinical trials would be in the target nulligravid population in endemic region |