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[Note: This case study was originally published in 2009. Download a PDF or read the case study here.]

Malaria kills close to a million people every year and sickens many millions more. Most of the casualties of this disease are young children under the age of five living in sub-Saharan Africa. In an effort to stem deaths from malaria, the PATH Malaria Vaccine Initiative (MVI) has collaborated with GlaxoSmithKline Biologicals (GSK Bio) to evaluate the RTS,S malaria vaccine candidate. This is thought to be the first full vaccine development collaboration between a product development partnership (PDP) and a large pharmaceutical partner. However, that is not the only “first” designation with which the project is likely to be labeled.

Lessons Learned:

• Maintaining close collaboration and ongoing communication among project partners is critical.
• Robust systems (financial, management, etc.) are needed to enable the conduct of complex clinical trials across multiple centers.
• Ongoing support for capacity-building at study centers, including helping to ensure capacity for crisis communications planning and media relations at trial sites is of primary importance.
• Flexibility — being able to respond effectively and adapt to unanticipated developments or findings — is essential during the ever-changing testing phase.