The full background, aims, rationale etc. are in the proposal submitted by Michael Theisen in response to European Malaria Vaccine Initiative's (EMVI) now European Vaccine Initiative call in 2002. The proposal was recommended by the independent Scientific Advisory Committee and approved the Board in early 2003.
A contract for product development was signed in 2003 with Henogen. The manufacture of three consistency batches was initiated in 2007 also under a contract with Henogen, in anticipation of a contract signed with European and Developing Countries' Clinical Trials Partnership (EDCTP) in 2009, involving multi-centre clinical testing of GMZ2 in Africa. Coordination of the EDCTP project was taken over by Statens Serum Institut as at 30 September 2009 - please read below.
A contract for the conduct of a clinical Phase Ia clinical trial was signed in 2005 with the University of Tübingen, Institute for Tropical Medicine, sponsored by EMVI:
Assessment of the Safety and Immunogenicity of the Recombinant Lactococcus Lactis Hybrid GMZ2 [GLURP+MSP3] Malaria Vaccine formulated with Aluminum hydroxide in Healthy Adult Volunteers. A Phase I, Randomised, Open, Adjuvant Dose-selection, Single centre trial.
Assessment of the longevity of the immune responses induced by the first three vaccinations, and the ability of a further dose of the vaccine to boost immune response also took place at the University of Tübingen.
A paper has been published in Vaccine. 2009 Nov 16;27(49):6862-8. Epub 2009 Sep 13.
In 2007 and 2008, clinical development was followed up with two clinical trials at the Medical Research Unit, Albert Schweitzer Hospital Lambarene, Gabon, sponsored by the African Malaria Network Trust:
Randomised controlled trial to evaluate the Safety and Immunogenicity of recombinant lactococcus lactis hybrid GMZ 2 [GLURP + MSP 3] blood stage malaria vaccine versus rabies vaccine in healthy Gabonese adult Volunteers.
A phase I, randomized, controlled, double-blind, single centre trial to evaluate the safety and immunogenicity of 30 and 100 µg of GMZ2 in Gabonese children aged 1-5 years.
GMZ2 remains with Statens Serum Institut
During 2009 European Malaria Vaccine Initiative became a separate legal entity in its own right registered in Germany and is now known as European Vaccine Initiative - EEIG. In 2009, EMVI, in collaboration with its partners, was successful in negotiating a five year contract with the European and Developing Countries' Clinical Trials Partnership (EDCTP), coordinated by the African Malaria Network Trust, for the funding of the project entitled “Fostering Research Capacity, Networking and Project Management through Phase I-IIb Clinical Trials of Malaria Vaccine Candidate 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.