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Methods for Determining Vaccine Efficacy and Effectiveness and the Main Barriers to Developing a Fully Deployable Malaria Vaccine

The past few years have witnessed the appearance of public-private partnerships and a significant increase of resources devoted to the development of malaria vaccines. Lessons have been learned on different approaches to the clinical development plan for a vaccine candidate, including different clinical trial phases and endpoints and methods to conduct them. Improved understanding of mechanisms underlying naturally acquired immunity, definitions of surrogate markers of protection, including improved in vitro assays and animal models, and strengthened capacity in malaria-endemic countries to conduct clinical trials would accelerate the development of malaria vaccines. We are closer to having a first-generation vaccine being registered. The impact of this vaccine and subsequent products will need to be evaluated under program conditions in the context of comprehensive malaria control activities. Deployment of a safe and effective malaria vaccine administered in early childhood could become a major public health tool, particularly in sub-Saharan Africa.

Received August 21, 2006. Accepted for publication September 22, 2007.

^* Address correspondence to Caterina Guinovart, Barcelona Center for International Health Research, Hospital Clínic/Institut d’Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Rosselló 132, 4t E-08036 Barcelona, Spain. E-mail: cguinova{at}clinic.ub.es

Authors’ address: Caterina Guinovart and Pedro L. Alonso, Barcelona Center for International Health Research, Hospital Clínic/Institut d’Investigacions Biomèdiques August Pi i Sunyer, Universitat de Barcelona, Rosselló 132, 4t E-08036 Barcelona, Spain, Telephone: 34-93-227-5706, Fax: 34-93-227-9853, E-mails: cguinova{at}clinic.ub.es and palonso{at}clinic.ub.es.