Today, the EDCTP-funded GMZ2 consortium starts volunteer enrolment for the phase IIb clinical trial of the candidate malaria vaccine GMZ2 in Uganda. This is the third trial site to initiate volunteer recruitment for this multi-country study. Vaccination is already underway at trial sites in Gabon (November 2010) and Burkina Faso (April 2011). The Uganda site is in the peri-urban area of Iganga/Mayuge, at the Iganga Hospital. Akin to most areas in Uganda, malaria is one of the major health problems in this district. A team from Makerere University (Kampala) is conducting the trial.
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. The targeted total for vaccination is 1870 children between 1 and 5 years of age. The Faculty of Medicine is the largest faculty of Makerere University, Uganda’s leading university. It is an experienced academic and research institution that has conducted research in infectious diseases, degenerative diseases, reproductive health, mental health, and others. All research work is reviewed and approved by an Institutional Ethical Review Board with oversight from the Uganda National Council of Science and Technology. Between 2006 and 2009 the Faculty strengthened its capacity to supervise and monitor research on human subjects through an EDCTP-funded project.
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 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.
More information:
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.
WHO grants Emergency Use Listing for LC16m8 mpox vaccine