Home › AMANET announces good progress of the Phase 2 Clinical Trial of Candidate Malaria Vaccine GMZ2 in Gabon
AMANET announces good progress of the Phase 2 Clinical Trial of Candidate Malaria Vaccine GMZ2 in Gabon
10 February 2011
The African Malaria Network Trust (AMANET) and the consortium investigating the efficacy of malaria vaccine candidate GMZ2 proudly announce the good progress of the GMZ2 trial in Lambarene Gabon.
GMZ2 is a fusion protein composed of Plasmodium falciparum Glutamate Rich Protein (GLURP) and Merozoite Surface Protein 3 (MSP3). The vaccine is being tested in a double blinded trial with rabies vaccine as a control. The first vaccination was given on 8th November 2010 and to date more than 250 children at Medical Research Unit (MRU) of the Albert Schweitzer Hospital (ASH) in Lambarene, Gabon have been vaccinated. The Gabon team has successfully completed immunization of the first group of children. The safety data obtained have been reviewed by a Data and Safety Monitoring Board (DSMB) after each vaccination. All the safety reports have been satisfactory with the DSMB giving the team the green light to go ahead with vaccinations after each report.
The AMANET sponsored Phase IIb trial is recruiting children aged between 1 and 5 years and within the next months other participating centres namely the Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Burkina Faso, Makerere University, Uganda and Navrongo Health Research Centre, Ghana will also start vaccinations.
The GMZ2 vaccine consortium is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and is composed of AMANET, the Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Burkina Faso; Statens Serum Institut (SSI), Denmark; the Medical Research Unit at Albert Schweitzer Hospital (MRU-ASH), Gabon; the Medical Research Council (MRC) Laboratories, The Gambia; University of Tübingen, Germany; Makerere University, Uganda; Navrongo Health Research Centre, Ghana; and the London School of Hygiene and Tropical Medicine (LSHTM), UK.
The satisfactory safety reports 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 at MRU-ASH Hospital in Gabon in adults and children. The previous studies were funded by the European Commission – AIDCO, EDCTP and the European Malaria Vaccine Initiative (EMVI).
This trial is registered with PACTR [ATMR2010060002033537], a public registration system for Malaria, TB and HIV/AIDS research in Africa.
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