The first injection in three volunteers is the first official step in the human trial programme in the Leiden University Medical Center (LUMC) and the Radboudumc in Nijmegen investigating a promising malaria vaccine, Sanaria® PfSPZ-GA1 Vaccine, manufactured by biotechnology firm Sanaria. The initial objective is to test whether the vaccine is safe and does not cause serious side effects.
“This phase tests whether weakened or attenuated parasites in the vaccine do not cause malaria in clinical trial volunteers”, explains Meta Roestenberg, internist-infectious disease specialist in the department of Parasitology and Infectious Diseases at the LUMC. “We are starting with a low dose and if this does not cause any problems, we will inject a higher dose in the next set of volunteers.” The volunteers will be monitored closely for signs of malaria and side effects over a period of four weeks after the injection.
Unique clinical trial
Jona Walk, researcher in the department of Medical Microbiology at the Radboudumc: “We have demonstrated the vaccine does not develop to infectious parasites in human liver cells and in experimental animals, so I am confident it will be safe in volunteers. However, this must be assessed in a clinical trial.” However, she continues, “Although vaccines based on radiation attenuated malaria parasites have been studied in multiple clinical trials, this is the first clinical trial assessing an injectable genetically modified malaria vaccine.”
Scientists involved in the development of the genetically attenuated parasite in the vaccine, Robert Sauerwein (Radboudumc), Ben van Schaijk (Radboudumc), Chris Janse (LUMC) and Shahid Khan (LUMC) explain that the difference is that the parasite in this new vaccine has been attenuated by deleting two genes instead of by irradiating the parasite.
“We are extremely excited to be working with our Dutch colleagues to initiate the first clinical trial of injectable, genetically attenuated malaria vaccine based on our platform technology-aseptic, purified, cryopreserved PfSPZ,” says B. Kim Lee Sim, executive VP of manufacturing at Sanaria.
Development of the genetically attenuated parasite by the LUMC, Radboudumc and the Sanaria team was supported by a grant by TI Pharma (the Netherlands); manufacture of PfSPZ-GA1 was supported by an SBIR grant from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health (USA). The clinical trial is supported by LUMC and Radboudumc.
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