BRUSSELS, Belgium - A biotechnology-derived vaccine targeted at the pre-erythrocytic stage of malaria received backing from the European Union (EU) in an unusual type of research support aimed at helping the vaccine's developer, SmithKline Beecham Biologicals SA, demonstrate the feasibility of the approach.
A three-year program of trials is to be run in West Africa, following promising Phase I/II volunteer studies with the circumsporozoite protein-based antigen obtained by recombinant DNA technology. The EU said the formulation technology developed for this vaccine is highly innovative and, if successful, could be applied to immunoprophylaxis and immunotherapy of other infectious diseases, and even cancer.
This could be “a first but important step toward the final development of a widely applicable Plasmodium falciparum malaria vaccine,“ and “a breakthrough in the field of vaccine adjuvant technology,“ EU officials said.
The principal aim of the study is to assess whether the vaccine can protect against malaria in the variety of naturally occurring epidemiological conditions encountered in endemic regions and in the face of parasite antigen polymorphism.
It brings SmithKline Beecham plc - the London-based parent of SmithKline Beecham Biologicals, in Belgium - together with the U.K.'s Medical Research Council, Oxford University, the London School of Hygiene and Tropical Medicine, local authorities in the West African nation of Gambia, and EU scientific officers.
The cooperative venture is one of a new series of what the EU calls “demonstration projects.“ Typically receiving around US$2 million in EU funding, the projects are aimed at filling the gap between research and the commercial exploitation of innovations. They provide financial support so new technologies can be assessed and their advantages over current technologies proved. By showing the technical viability of new technologies and their possible economic merits under realistic conditions, the EU is trying to encourage entrepreneurs to take on their development.
Demonstration projects use available knowledge rather than aiming to generate new basic knowledge. To qualify for EU backing, the technologies - or their applications - must be novel and the projects must bring together inventors and technology users in pre-competitive - that is, pre-marketing - demonstrations.
Another of the new projects, based in Finland but with several partners in Sweden and Germany, is designed to boost the chances of developing an effective genomic HIV-1 vaccine. It aims to demonstrate that prototype genomic HIV-1 vaccines can be produced economically and that the vaccines are safe, immunogenic and have beneficial therapeutic effects. The project also will help determine the therapeutic range and protective potential of this type of vaccine.
HIV Vaccines Slow In Developing
The HIV project coordinator, Kai Krohn, of Tampere's University Institute of Medical Technology, said despite the urgent need to create an effective vaccine, overall progress has been “rather slow,“ partly because of “mediocre coordination of ongoing studies“ in different laboratories and centers.
So three European research centers with a track record in HIV vaccine development will work together - the Bavarian Nordic Research Centre; SBL Vaccine, of Stockholm; and Finnish Immunotechnology.
The new series of demonstration projects will run through 2000. Among the other studies is development of an immunotherapy for leukemia using suicide gene-transduced donor lymphocytes in the context of allogeneic bone marrow transplantation. This effort also is designed to foster a positive perception of gene therapy by providing tangible results to the public and the medical community.
Other projects include application of a protein-free medium in industrial processes with mammalian cell cultures to produce biopharmaceuticals; development of molecular marker systems for gene banks and for variety testing; and generation of common access to biotechnological resources and information. *