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PATH initiating phase-1 trial for new malaria vaccine candidate

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Officials from the PATH Malaria Vaccine Initiative announced that, in partnership with Sanaria Inc., they will begin recruiting participants for a phase-1 trial of a new malaria vaccine. The FDA recently approved the vaccine candidate for phase-1 trials in humans.

The Sanaria vaccine candidate is unlike other malaria vaccine candidates; it deploys a weakened form of the whole malaria parasite harvested from irradiated mosquitoes rather than smaller portions of the parasite. Officials said this approach may represent the strongest chances yet for a successful vaccine against malaria.

In an interview, Christian Loucq, MD, director of the PATH Malaria Vaccine Initiative, said the idea of developing a vaccine against malaria using irradiated mosquitoes was first discussed in the 1960s, “however, no one had the technology until now to do this safely and effectively.”

PATH and its partners are now recruiting more than 100 people to serve as volunteers for the trial. The trial will be conducted at the U.S. Naval Medical Research Center in Bethesda, Md., and at the University of Maryland School of Medicine in Baltimore. The trial will assess safety and efficacy of the vaccine. Inoculation of the first group of participants is planned for mid-May. Loucq said the first results on efficacy will be available in the fourth quarter of 2009. The volunteers will be followed for an additional eight months.

Loucq said ensuring the safety of the particpants will be a top priority. “Blood samples will be taken from the participants daily," Loucq said. "If anyone's blood shows the presence of parasites, they will be treated immediately.”

The trial will also be used to determine optimal dosage and the best routes for administering the vaccine. “Participants will be given different dosage levels of the vaccine through intradermal and subcutaneous inoculations,” Loucq said.

Loucq said officials at PATH have focused on the Sanaria vaccine candidate because early results were encouraging. – by Jay Lewis