New malaria vaccine candidate shows promising efficacy in Phase I trial

Researchers at the Walter Reed Army Institute of Research (WRAIR) have demonstrated the safety and protective efficacy of a novel malaria vaccine candidate, FMP013/ALFQ, in a human clinical trial. The findings, https://doi.org/10.1093/infdis/jiag533on Nov. 4, 2026, in the Journal of Infectious Diseases, represent a major step toward developing next-generation tools to combat malaria.

The World Health Organization (WHO) estimated 282 million cases of malaria, resulting in 610,000 deaths (2024 data), mostly among children living in Africa. The currently approved vaccines, RTS,S/AS01, developed by GSK, and R21/Matrix-M, developed by the University of Oxford, have been approved to reduce malaria-related deaths in children living in Africa. The WHO’s Strategic Advisory Group notes the need for additional malaria control tools to achieve malaria eradication.

The FMP013/ALFQ vaccine targets the infective sporozoite stage by inducing antibodies to the Circumsporozoite Protein (CSP), thereby preventing sporozoite infection of human liver.

Malaria, caused by the parasite Plasmodium falciparum, is highly prevalent in Africa and Southeast Asia, is transmitted by infected mosquitoes and it causes a flu-like illness with chills, headache, muscle aches, nausea and diarrhea. In complicated cases, patients can develop severe anemia, seizures, coma, and death. Targeting the sporozoite stage with a vaccine can protect against malaria infection even if the person is exposed to malaria infected mosquitoes.

“FMP013/ALFQ was developed specifically to protect military personnel and travelers who are at high risk of developing serious malaria-related problems while stationed in malaria endemic regions,” said Dr. Sheetij Dutta, WRAIR’s Chief of Structural Vaccinology, Biologics Research and Development Branch and inventor of the FMP013/ALFQ vaccine. “While the two licensed vaccines contain a portion of the CSP molecule, we engineered FMP013 to contain all of the protective regions of CSP. These additional CSP epitopes can potentially lower the high antibody threshold, leading to a more durably protective vaccine.”

The vaccine also contains a novel adjuvant Army Liposomal Formulation Adjuvant (ALFQ), developed by WRAIR’s Laboratory of Antigen and Adjuvant Research, led by Dr. Gary Matyas. “This was the first time that we tested our adjuvant ALFQ against a live parasite challenge in humans,” Matyas added.

The Phase 1 trial of FMP013/ALFQ vaccine conducted by the WRAIR Clinical Trial Center, involved 29 healthy human volunteers, recruited from the Baltimore-Washington, D.C. region. The volunteers were divided into three groups.

The first group received three vaccine doses at one-month intervals; a second group received two doses at a one-month interval and a third group received a full dose after a five-month delay. The third group received a fractionated dose on the five-month delayed schedule. The vaccinated volunteers underwent malaria challenge via the bite of five Plasmodium falciparum infected mosquitoes. The novel FMP013/ALFQ vaccine was found to be well tolerated and showed significant protective efficacy against malaria infection.

While all six unvaccinated control volunteers developed malaria, 5 of 9 volunteers in the delayed full-dose group were protected during the challenge,” said COL Paul Robben, the Principal Investigator who oversaw this clinical trial at WRAIR. “The quality of antibodies developed by the group’s volunteers was superior and most likely explains why we saw the 55% protection in the delayed full-dose group.”

“It took us several decades of research to arrive at the right combination of antigen (FMP013), adjuvant (ALFQ) and the optimized vaccine schedule, to see these exciting results, said Dr. Evelina Angov, director of WRAIR’s Biologics Research & Development Branch. The team is currently seeking partnerships to catalyze the transition of FMP013/ALFQ into field trials.

Correspondence: Dr. Sheetij Dutta, Chief of Structural Vaccinology, Biologics Research and Development Branch EM: mailto:sheetij.dutta.civ@health.mil

Dr. Jasleen Shant, director of the Office of Technology Transfer Em: jasleen.shant.civ@health.mil

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