Investigational Malaria Vaccine Found Safe and Protective
Rockville, MD - An investigational malaria vaccine has been found to be safe, to generate an immune system response, and to offer protection against malaria infection in healthy adults, according to the results of an early-stage clinical trial published in the journal Science.
The vaccine, known as PfSPZ Vaccine, was developed by scientists at Sanaria Inc., of Rockville, Md. The clinical evaluation was conducted by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and their collaborators at the Walter Reed Army Institute of Research, Silver Spring, Md., and the Naval Medical Research Center, Bethesda, Md.
The PfSPZ Vaccine is composed of live but weakened sporozoites of the species Plasmodium falciparum, the most deadly of the malaria-causing parasites.
“The global burden of malaria is extraordinary and unacceptable,” said NIAID Director Anthony S. Fauci, M.D. “Scientists and health care providers have made significant gains in characterizing, treating and preventing malaria; however, a vaccine has remained an elusive goal. We are encouraged by this important step forward.”
The Phase I trial, which took place at the NIH Clinical Center in Bethesda, received informed consent from and enrolled 57 healthy adult volunteers ages 18 to 45 years who never had malaria. Of these, 40 participants received the vaccine and 17 did not. To evaluate the vaccine’s safety, vaccinees were split into groups receiving two to six intravenous doses of PfSPZ Vaccine at increasing dosages. After vaccination, participants were monitored closely for seven days. No severe adverse effects associated with the vaccine occurred, and no malaria infections related to vaccination were observed. Continue>
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