EVI round table on "The Challenge of Developing a Pregnancy Associated Malaria Vaccine" was a great success with many comments and an active discussion among the 70-80 participants.
PAM vaccine clinical development will have to overcome the following challenges:
- To define the preferred product characteristics of placental malaria vaccine
- To define the relevant immunogenicity and safety criteria for GO No GO criteria after phase Ia/b clinical trial
- To prepare reference standards and standardised functional assays
- To design phase IIb clinical trials in view of ethics and regulatory aspects on vaccination of child-bearing age women
- To set up consultation of ethicists and regulators for the design of clinical development plan and clinical trials
EVI team would like to thank all the speakers and more specifically Lars Hviid who stepped in to replace Michal Fried who unfortunately could not come.
The some presentations are available using the links below:
O Doumbo "Pregnancy Associated Malaria: the urgent need of new control /elimination tools & PAM vaccines development in Africa"
S Issifou "Overview of the clinical development plan of a var2CSA-based pregnancy associated malaria (PAM) vaccine"