Experience and challenges from clinical trials with malaria vaccines in Africa.

Grace Mwangoka,Shubis Kafuruki,Marcel Tanner,Bernhards Ogutu,Beverly Msambichaka,Seif Shekalaghe,Salim Abdulla,Tutu Mzee,Nahya Salim,Maxmillian Mpina

doi:10.1186/1475-2875-12-86

Abstract

Malaria vaccines are considered amongst the most important modalities for potential elimination of malaria disease and transmission. Research and development in this field has been an area of intense effort by many groups over the last few decades. Despite this, there is currently no licensed malaria vaccine. Researchers, clinical trialists and vaccine developers have been working on many approached to make malaria vaccine available.African research institutions have developed and demonstrated a great capacity to undertake clinical trials in accordance to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) standards in the last decade; particularly in the field of malaria vaccines and anti-malarial drugs. This capacity is a result of networking among African scientists in collaboration with other partners; this has traversed both clinical trials and malaria control programmes as part of the Global Malaria Action Plan (GMAP). GMAP outlined and support global strategies toward the elimination and eradication of malaria in many areas, translating in reduction in public health burden, especially for African children. In the sub-Saharan region the capacity to undertake more clinical trials remains small in comparison to the actual need.However, sustainability of the already developed capacity is essential and crucial for the evaluation of different interventions and diagnostic tools/strategies for other diseases like TB, HIV, neglected tropical diseases and non-communicable diseases. There is urgent need for innovative mechanisms for the sustainability and expansion of the capacity in clinical trials in sub-Saharan Africa as the catalyst for health improvement and maintained.

Highlights

Every year approximately 250 million clinical malaria cases are reported [1] with about one million deaths in sub-Saharan Africa, mostly in children under five years of age [2]
The largest phase III malaria vaccine trial on RTS,S involving 16,000 children is underway in 11 research centers in seven African countries
Selection of the appropriate clinical trial efficacy end points is of crucial importance and calls for standardized protocols of malaria case definition for current and future trials or studies adapted to the different levels of care where the protocols will be applied

Summary

Introduction

Every year approximately 250 million clinical malaria cases are reported [1] with about one million deaths in sub-Saharan Africa, mostly in children under five years of age [2]. The largest phase III malaria vaccine trial on RTS,S involving 16,000 children is underway in 11 research centers in seven African countries.

Results

Conclusion