Burkina Faso: GMZ2 malaria vaccine trial recruiting first patients
Recruitment of the first patients for the phase IIb clinical trial of the candidate malaria vaccine GMZ2 has started in the Burkina Faso trial site in the Banfora Health District on 29 April; 38 children were vaccinated that first day. Malaria is the principal affliction in this region. On average, children under five years old suffer from malaria twice a year. The Centre National de Recherche et de Formation sur le Paludisme (CNRFP) is conducting the trial as a member of the GMZ2 clinical trial consortium funded by EDCTP.
This is the second site to initiate volunteer recruitment. Vaccination is already underway at the trial site of the consortium in Gabon, the Medical Research Unit at Albert Schweitzer Hospital in Lambarene (MRU-ASH), since November 2010. All safety reports there have been satisfactory. They are in line with safety data obtained from previous trials of the GMZ2 vaccine at University of Tübingen among malaria naïve adults, and trials done in adults and children also by MRU-ASH. The GMZ2 vaccine is a hybrid malaria vaccine composed of merozoite surface protein (MSP3) and glutamate rich protein (GLURP). The vaccine is adjuvanted with aluminium hydroxide. Other sites that are part of this multi-centre study are in Uganda and Ghana. A total of 1870 children between 1 and 5 years of age is targeted to be vaccinated.
The GMZ2 consortium is funded by EDCTP and is composed of the African Malaria Network Trust (project coordinator and sponsor) in Tanzania, the Centre National de Recherche et de Formation sur le Paludisme, Burkina Faso; Statens Serum Institut, Denmark; the Medical Research Unit at Albert Schweitzer Hospital, Gabon; the Medical Research Council Laboratories, The Gambia; University of Tübingen, Germany; Makerere University, Uganda; Navrongo Health Research Centre, Ghana; and the London School of Hygiene and Tropical Medicine, UK.
The CNRFP multidisciplinary team consists of scientists, several post-doctoral fellows and graduate students. In the previous five years CNRFP has conducted many clinical trials with antimalarial drugs and another candidate malaria vaccine. The team has demonstrated capability to conduct clinical trials according to the international regulatory requirements. The Ministry of Health supports the centre and the National Ethics Committee reviews all research.
The consortium’s clinical trial is registered with the Pan African Clinical Trials Registry (PACTR), a public registration system for Malaria, TB and HIV/AIDS research in Africa, under number ATMR2010060002033537.
About EDCTP
The European and Developing Countries Clinical Trials Partnership (EDCTP) was created in 2003 as a European response to the global health crisis caused by the three main poverty-related diseases (PRDs) of HIV/AIDS, tuberculosis and malaria. Currently EDCTP is a partnership between 14 European Union member states plus Norway and Switzerland with 47 sub-Saharan African countries. The aim of the programme is to accelerate the development of new or improved drugs, vaccines and microbicides against HIV/AIDS, malaria and tuberculosis through promoting the integration of national programmes of EDCTP European Member States and development of a genuine partnership with African counterparts.
_________________________________
Note to the editor:
For further information, please contact:
Mr Gert Onne van de Klashorst, Communications Officer
Phone: +31 70 344 0885
Email: media[at]edctp.org