Assessment of humoral immune responses in malaria vaccine trials.

Clinical trials for new vaccine candidates evaluate safety and tolerability of future vaccines. In some studies immunogenicity is an additional exploratory aim. For this purpose immunological assays have to be established and further developed for future multicentre studies. The implementation of immunological assays and the different logistic conditions worldwide display new challenges for scientists working in this field. This article shows this process on a recently conducted phase Ia clinical trial at the Institute of Tropical Medicine in Tübingen, Germany, to evaluate the safety and immunogenicity of a new malaria vaccine candidate. The group for clinical trials and immunology is the interphase for the establishment of immunological assays and their implementation in clinical trials.