NIH-supported malaria vax posts 'encouraging' PhI results


An investigational malaria vaccine with big-name support was able to protect volunteers for more than one year in a study that represents an “encouraging step forward” in eradicating malaria, said NIAID Dr. Director Anthony Fauci.

In early trial results announced this week, a vaccine dubbed PfSPZ, developed and produced by Sanaria of Rockville, MD, protected 55% of people who had no prior malaria infection more than a year after a final dose was administered. The vaccine has support from the National Institutes of Health, University of Maryland and the Walter Reed Army Institute of Research.

The Phase I trial enrolled 101 volunteers aged 18 to 45 and tested the vaccine, containing live but weakened Plasmodium falciparum sporozoites, in 59 of them.

Those participants were divided further into groups to test intravenous versus intramuscular injections, dose size and number of immunizations. All of the trial participants were exposed to mosquitos containing the malaria strain in a controlled process at the Walter Reed Army Institute of Research, the researchers said.

Together, the results show “that administering the PfSPZ Vaccine intravenously confers long-term, sterile protection in a small number of participants, which has not been achieved with other current vaccine approaches,” Dr. Robert Seder, chief of NIAID’s Cellular Immunology Section, said in a statement.

With a favorable safety profile, the team is planning to test the experimental shot at higher doses in larger trials “to see if even greater protection can be achieved,” Seder said.

The vaccine could prove to be a threat to GlaxoSmithKline's Mosquirix, the world's first approved malaria vaccine. Mosquirix received EMA approval last summer but has since experienced a setback, with the agency in October calling for pilot projects to test its efficacy in the real world instead of widespread rollouts. The vaccine is seen as far from perfect, with a four-dose regimen conferring only 40% efficacy, which wanes over time.

- here's the release

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