Fostering Research Capacity, Networking and Project Management through Phase I-IIb Clinical Trials of Candidate Malaria Vaccine GMZ2 (GMZ2 Consortium)

GMZ2 remains with Statens Serum Institut
During 2009 EMVI became a separate legal entity in its own right registered in Germany and is now known as European Vaccine Initiative - EEIG.  EMVI, in collaboration with its partners, was successful in 2009 negotiating a five year contract with EDCTP, coordinated by AMANET, for the funding of the project entitled “Fostering Research Capacity, Networking and Project Management through Phase I-IIb Clinical Trials of Candidate Malaria Vaccine GMZ2”. As the title suggests, the project involves Phase II clinical trials of GMZ2 at several African sites. As the mandate of EMVI was primarily to develop experimental malaria vaccines up to Phase II clinical evaluation, GMZ2 will remain with Statens Serum Institut. It is the sincere hope of EVI-EEIG that Statens Serum Institut will be able to commit the resources necessary to continue the highly successful work of EMVI in the development of this promising malaria vaccine candidate, and to make it available to Developing Countries if the EDCTP project is successful.The five year project with seven consortium members, coordinated by AMANET, with a budget of €9 863 901 was submitted to EDCTP in November 2007.

The objective of GMZ2 Clinical Trials is to develop an effective malaria vaccine that is safe, and can be integrated into the expanded programme on immunisation within African countries. The four work packages involved are related to Project Management, Clinical Trials, Capacity Building and Networking. EMVI’s Director of Clinical and Regulatory Affairs Dr. Imoukhuede will act as Clinical Trial Leader.

The contract was signed January 2009, and the kick-off meeting was held in Dar es Salaam 26-27 January 2009.

In preparation for the multi-centre Phase IIb trials of the GMZ2 vaccine in Africa three GMP consistency batches of the vaccine have been manufactured at Henogen S.A., Belgium. Lyophilisation of the GMZ2 vaccine is being carried out at Synco BioPartners, The Netherlands.