The Walter Reed Army Institute of Research (WRAIR) has conducted a first-in-human evaluation of a novel malaria vaccine candidate containing the FMP013 antigen and the ALFQ adjuvant, both developed at WRAIR. Results were published August 30 in the journal Vaccine.
For over three decades, WRAIR has been working to develop malaria vaccine candidates, testing their safety and ability to create lasting protective immune responses against malaria infection. The latest candidate, the FMP013 antigen, primes vaccinated humans to produce antibodies against the circumsporozoite protein (CSP) of the malaria parasite Plasmodium falciparum.
First-generation malaria vaccine products, such as RTS,S/AS01 (Mosquirix, GSK) provide moderate (30-50%) protection, which wanes within months. The search for improved vaccine strategies remains a priority.
“The FMP013 vaccine design broadens the host immune response to epitopes that were not included in the RTS,S vaccine and targeting these additional susceptible epitopes on CSP could be key to an improved vaccine,” said Dr. Sheetij Dutta, head of WRAIR’s Structural Vaccinology Laboratory and inventor of the FMP013 antigen.
The other important component of this vaccine is the novel adjuvant, Army Liposome Formulation containing QS-21 (ALFQ). Developed by the Military HIV Research Program (MHRP) at WRAIR, ALFQ was shown to be strongly potent as a vaccine adjuvant in preclinical studies. “ALFQ displays promising immune-enhancing effects and is also being tested with vaccines against a number of infectious diseases,” said Dr. Gary Matyas, Chief of MHRP’s Adjuvants and Formulation Section. ALFQ, which was awarded the 2020 United States Army Medical Research and Development Command Invention of the Year, is also currently being evaluated in a Phase 1 clinical trial of two HIV vaccine candidates in Thailand.
The initial clinical evaluation of FMP013/ALFQ was promising. “Both high and low dose of FMP013 antigen and the ALFQ adjuvant were found to be safe and well tolerated by adults,” according to Major Jack Hutter, the principal investigator for the clinical trial. The results of follow-on safety and efficacy testing in malaria-naïve adults are expected to be released in October of 2022.
The antigen FMP013 and the adjuvant ALFQ are both patented products owned by the U.S. Army. The vaccine product development and clinical trials were funded jointly by the United States Agency for International Development (USAID) Malaria Vaccine Development Program and the U.S. Military Infectious Diseases Research Program (MIDRP). The Congressionally Directed Medical Research Programs (CDMRP) Joint WarFighter grant partly funded the adjuvant development.