Malaria: New Vaccination Method goes into Clinical Trials
Malaria is still not under control despite numerous attempts. On the contrary: Resistance against the commonly used drugs is further impeding the fight against this dangerous infectious disease. This week, a promising vaccination method against malaria will be going into phase I clinical trials for efficacy and safety testing at the DZIF’s Tübingen partner site, the Institute of Tropical Medicine at the University Hospital. The method uses attenuated forms of the malaria parasite to obtain long-lasting and effective protection against the disease. The trial is a German Centre for Infection Research (DZIF) project and is being conducted at its Thematic Translational Unit "Malaria”.
Malaria is still one of the most common infectious diseases. In 2012, the World Health Organisation (WHO) estimated approximately 207 million cases of infection and approximately 627,000 deaths, 90 percent of which occur in Africa. In Africa, children under the age of five are especially affected and the mosquito-borne disease is one of the most common causes of death. Although the search for new active substances has been going on for years, no malaria vaccine has been brought to market yet. The first malaria vaccine, RTS,S, which is being developed by the DZIF partner institute, Centre de Recherches Médicales de Lambaréné (CERMEL) among others, is expected to be ready for market by mid-2015 only. The preliminary trial results indicate a moderate vaccine protection of 30 to 50 percent.
“The next step in malaria vaccine development is to find highly efficacious vaccines,” says DZIF researcher Dr Benjamin Mordmüller, leader and principal investigator of the project in Tübingen. “Up to now, the usual approaches have failed, so we have to investigate new methods which may at first glance seem astonishing,” he explains. And, after long preclinical trials, the research team from Tübingen is now bringing such a method into clinical trials. The trial starts this week, and will investigate the intravenous injection of live malaria plasmodium falciparum parasite, in short ‘PfSPZ Challenge’, with simultaneous administration of a drug for malaria prophylaxis to weaken the parasites—this results in an effective vaccine protection.
This method has been shown to fundamentally work in animal models, as well as in one clinical study that used infected mosquitos rather than the parasites alone. Until now, this has been the most effective strategy for immunisation against malaria parasites. Sanaria Inc. in Rockville, USA, produces malaria parasites for immunisation purposes which fulfil all the criteria for drug approval. The branch near Tübingen will act as the clinical sponsor and will make the vaccine component PfSPZ Challenge available. Stephen Hoffman, founder and director of Sanaria Inc. USA, confirms: "The collaboration between our branch in Germany and the ITM Tübingen has great potential to quickly develop a more efficient PfSPZ-based vaccine which could prevent and eliminate malaria.” DZIF project partners are the Bernhard Nocht Institute for Tropical Medicine in Hamburg and the Department of Infectious Diseases at the Heidelberg University Hospital, who will be investigating some of the parasitological and immunological aspects.
The efficacy will be tested on a human model of malaria infection which was developed at the University of Tübingen’s Institute of Tropical Medicine and was successfully completed as a clinical study at the DZIF. Professor Peter G. Kremsner, Director of the Tübingen Institute for Tropical Medicine and DZIF coordinator of the Thematic Translational Unit "Malaria” is happy, “The experience we have had with this and our dedication to clinically developing all current malaria vaccines is now paying off.”
The trial starts on 28 April 2014 and many people are interested in participating. “Lots of people know that malaria is a big problem,” says Markus Gmeiner, the clinical trial manager. The researchers expect first results to be available in mid-2015.
