New Vaccine Provides Protection Against Deadliest Malaria Parasite

Evidence from a clinical trial has shown that a new vaccine protects adults against malaria infection for at least 14 months.

According to the World Health Organization (WHO), malaria caused by the Plasmodium falciparum parasite must be treated within 24 hours or it will cause severe illness, which can be fatal. WHO notes that P. falciparum is “responsible for most malaria-related deaths globally.” The most recent data on global malaria prevalence estimates that, in 2015, there were 214 million cases and 438 million deaths associated with P. falciparum parasites. In April 2016 WHO reported that there are currently “no licensed vaccines against malaria or any other human parasite.” This may soon change.

In an article published on May 9, 2016 in Nature Medicine, Sanaria Inc’s Plasmodium falciparum sporozoite (PfSPZ) Vaccine was found to be highly effective against this parasitic malaria infection in a clinical trial.

According to the National Institute of Allergy and Infectious Diseases (NIAID), the PfSPZ Vaccine, “which consists of live, weakened, purified malaria parasites that do not cause illness,” was administered to healthy adult volunteers, aged 18 to 45 years, during a Phase 1 clinical trial. The volunteers had never had malaria previously.

Of the 101 adults enrolled in the trial, 57 received the PfSPZ Vaccine; 32 served as controls, and 12 adults served as backup controls and did not receive the vaccine. Those participants that received the vaccine were divided into groups to assess the route of administration, dose, and number of immunizations in discussing both short- and long-term protection against malaria.

NIAID states that “to evaluate how well the PfSPZ Vaccine prevented malaria infection, all participants—including the control participants who were not vaccinated—were exposed at varying times to the bites of mosquitoes carrying the same P. falciparum strain from which the PfSPZ Vaccine was derived.”

Overall, the results showed that “the PfSPZ Vaccine provided malaria protection for more than one year in 55 percent of people without prior malaria infection.” In addition, the vaccinations were well-tolerated by study participants.

Sanaria reported that, with these results, the PfSPZ Vaccine may become the first vaccine providing “durable protection against infection with malaria parasites.” Clinical trials are expected to proceed in Africa, the United States, and Europe. Sanaria hopes that this may lead to the licensing of the PfSPZ Vaccine.

CEO of Sanaria, Stephen L. Hoffman, stated, “The data from this trial support the design and conduct of ongoing studies by the International PfSPZ Consortium intended to finalize an optimized vaccine regimen for phase 3 clinical trials and licensure of a PfSPZ Vaccine regimen that protects greater than 80% of recipients for at least 6 months.” He went on to note that Sanaria will not only use the PfSPZ Vaccine to protect individuals against the disease, but that through mass vaccine campaigns, the company hopes to eliminate the parasite altogether. Hoffman noted, “It’s reasonable to suggest that within three-to-four years a safe, reliable vaccine could be a commercial reality and provide medical benefit to a huge population.”

The clinical trial was funded with support from several Small Business Innovation Research (SBIR) awards from NIAID and Sanaria. Many US, European, and African institutions, some of which are involved in the International PfSPZ Consortium, granted Sanaria funding and research support, and will continue to do so.