The BILHVAX vaccine, supported financially by the Nord-Pas de Calais region in France and the Walloon region in Belgium, was developed in partnership with Inserm, researchers from the Pasteur Institute of Lille, and Eurogentec’s scientists. The BILHVAX
vaccine was produced in Eurogentec’s GMP manufacturing unit and goes into the third clinical development phase (Bilhvax 3) in Saint-Louis in Senegal this month.
This clinical research programme is aimed to test the efficacy of the new vaccine against schistosomiasis among 250 already infected girls and boys between 6 and 9 years old.
After malaria, schistosomiasis is the second most important socioeconomically devastating parasitic disease in tropical developing countries.
This chronic parasitic disease is endemic to 80 countries, affecting an estimated 200 million people worldwide. On average, 800 million people are regularly exposed to it and its death rate is estimated at 300,000 victims per year.
Not many treatments against schistosomiasis exist. The current treatment is Praziquantel, but this drug does not protect against reinfection. Nevertheless, reinfection is generally very fast because it is caused by the massive presence of larvae in fresh water which appears essential for domestic, agricultural and recreational activities. During contact with water, the larvae enter through the skin and differentiate into worms which live in the blood stream. Once formed, the worms have a life expectancy of about fifteen years and produce up to 400 eggs/ day on average. In urinary schistosomiasis, a large amount of eggs is eliminated into urine. A remaining part of eggs is trapped in the urogenital tissues where it causes tragic damage.
All the concerned populations, the WHO and health organisations are expecting impatiently for such a vaccine.
For more than 20 years, Professor André Capron’s team has been involved in both fundamental and applied research to discover a crucial vaccine candidate able to induce antibodies inhibiting the life cycle of the parasite. The identified protein is an essential enzyme for the parasite’s reproductive process and is also endowed with vaccine properties. This molecule, glutathion S-transferase, is the sole vaccine candidate currently developed and is the subject of this clinical phase III.
Since 1995 and with the support of the European community, Eurogentec and the scientists of Lille and of Senegal have pooled their skills to determine the production methods of the recombinant parasite protein to realise the first clinical studies.
For the needs of the Phase III clinical trials, Eurogentec’s R&D laboratories have recently improved the manufacturing and quality control processes. At the end of 2008, the industrial scale up was realised and the GMP vaccine was delivered during March 2009.
Eurogentec is a biotechnology company in Liège with one of its business units specialised in the GMP production of recombinant proteins designed for therapeutic use in human medicine.
Eurogentec, in collaboration with Inserm, is proud to have been chosen once again, as the BILHVAX
vaccine producer for the clinical phase III trials in Senegal.
This vast programme for vaccine production began at the end of 2007. During last March, the first injections of the vaccine candidate have been proceeded to infected children. The investigation team is a Senegalese NGO “Espoir Pour la Santé
” which has included patients from 13 villages located in the Senegal River basin. This clinical plateform undertakes this clinical phase according to standards of good clinical practices and security and under the supervision of the Senegalese Health Ministry and Inserm.
The implementation of the last clinical assays was made possible thanks to the strong mobilization of public and private European and Senegalese partners.
This clinical research programme is supported by the International Relations department of the Walloon region at the level of 300,000 €. The Secretary of Foreign relationships, Marie-Dominique SIMONET, is pleased with this partnership between the various regions for the development of the Bilhvax
vaccine and confirms her interest in the development of health matters.
The Walloon region continues to support the Senegalese in the health sector though ongoing training of health professionals.