Inventor:                                       Dr Michael Theisen/Søren Jepse, Statens Serum Institut, Copenhagen, Denmark
Project Team Leader:                     Dr Babatunde Imoukhuede (EMVI)
Product Leader:                             Cedric Delsemme, Henogen
Manufacturer:                                Henogen, Belgium
Clinical Trial Principal Investigator:  Prof. Jurgen Knobloch, co-ordinator Prof. Peter Kremsner, Institute for Tropical Medicine, University of Tübingen

Clinical Development Sponsored by EMVI up to 30 September 2009

Assessment of the Safety and Immunogenicity of the Recombinant Lactococcus lactis Hybrid GMZ2 [GLURP+MSP3] a Malaria Vaccine in Healthy Adult Volunteers. A Phase 1, Double-Blind, Randomised, Dose-selection, Unicentre trial

The clinical Phase Ia trial of the GMZ2 malaria candidate vaccine took place at the University of Tübingen, Institute for Tropical Medicine, Germany from October 2006 – December 2007.

The safety profile has been shown to be acceptable and met the go-criteria for progression to Phase 1b Clinical Trials in Africa.

The final integrated Clinical and Statistical Report was completed in July 2009. A manuscript was submitted to a peer review journal also in July 2009.

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.