FOR IMMEDIATE RELEASE
Thursday, Jan. 19, 2012
Researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), have begun enrolling participants in an early-stage clinical trial testing an investigational malaria vaccine composed of live but weakened malaria parasites in the immature, sporozoite stage of their life cycle. The Phase I trial is taking place on the NIH campus in Bethesda, Md.
The candidate vaccine, known as PfSPZ, was developed by scientists at Sanaria Inc., of Rockville, Md., and is intended to protect against Plasmodium falciparum, the most deadly of the malaria parasites.
Earlier human testing conducted by Sanaria found little evidence of protection against malaria from intradermal (into the skin) and subcutaneous (under the skin) administration of the candidate vaccine. However, follow-up animal studies led by scientists at NIAID’s Vaccine Research Center (VRC) suggested that an intravenous (into a vein) route might improve protection by inducing specialized immune system cells in the liver, the first site of malaria infection.
The new study, called VRC 312, is designed to test the vaccine’s safety and effectiveness among 51 healthy men and women, ages 18 to 45, who have never had malaria. Additionally, researchers will be examining immune responses to the vaccine and potential ways to measure immunity to malaria. Participants will be divided into five groups, one unvaccinated control group and four others assigned to receive different dosages of the vaccine. Vaccinated volunteers will receive at least two intravenous vaccinations at their assigned levels. Following the final vaccination, all but one of the five groups will be exposed to a drug-sensitive strain of malaria in order to learn whether the vaccine is protective. All participants will receive an initial physical exam and frequent blood tests throughout the study; vaccinated volunteers will be followed for up to 24 weeks after the final vaccination. Participants who develop malaria will receive immediate treatment at the first sign of malaria parasites in their blood and will be examined daily thereafter. The study, which is expected to be completed in the spring of 2013, is sponsored by NIAID in collaboration with Sanaria and the U.S. Military Malaria Vaccine Program.
NIH Clinical Center. Clinical trial: Experimental PfSPZ vaccine in adults without malaria. ClinicalTrials.gov Identifier: NCT01441167.
For more information on earlier research involving the PfSPZ vaccine, see the NIAID media availability and JE Epstein et al. Live attenuated malaria vaccine designed to protect through hepatic CD8+ T cell immunity. Science Express DOI: 10.1126/science1211548 (2011). Also see NIAID’s malaria portal.
NIAID Director Anthony S. Fauci, M.D.; Barney A. Graham, M.D., Ph.D., Chief of the VRC’s Clinical Trials Core Laboratory; and Robert A. Seder, M.D., Chief of the VRC’s Cellular Immunology Section, are available to discuss this study.
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Last Updated January 19, 2012
Last Reviewed January 18, 2012