New Malaria Vaccine is Safe and Immunogenic

For adults, the combination of FMP013 antigen and ALFQ adjuvant to treat malaria, appears to be safe and immunogenic.

Highlights:

In 2020, the WHO reported 241 million malaria cases worldwide, causing 627,000 fatalities
A newly designed malaria vaccine broadens the host immune response to epitopes and is safe for adults

The malaria vaccine, FMP013 antigen and ALFQ adjuvant combination, is safe and immunogenic for adults.

Although attempts to control malaria have steadily improved over the past ten years, the COVID-19 pandemic-induced instability has caused a rise in the incidence and death due to malaria. According to the World Health Organization, there were 241 million malaria cases worldwide in 2020, causing 627,000 fatalities.

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‘The FMP013 antigen and ALFQ adjuvant vaccines for malaria in adults seem to be immune-stimulating and safe.’

Developing Potential Malaria Vaccines

Vaccines are a crucial element of the portfolio to combat these horrifying figures. Although effective, first-generation initiatives like RTS,S/AS01 (Mosquirix, GSK) only offer modest (30–50%) protection that quickly wears off.

“The search for improved vaccine strategies remains a priority,” said Col. Jason Regules, Biologics Research and Development Branch Director.

Researchers from the U.S. Army have been developing potential malaria vaccines for over three decades, evaluating their efficacy in preventing infection and safety. People vaccinated with the current FMP013 candidate are primed to make antibodies against the circumsporozoite protein (CSP) of the Plasmodium falciparum malaria parasite.

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“The 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, Chief of the Structural Vaccinology Laboratory and inventor of the FMP013 antigen.

The adjuvant Army Liposome Formulation with QS-21, or ALFQ, created at WRAIR by the Military HIV Research Program, is also included in the vaccine. “ALFQ displays promising immune-enhancing effects and is now being tested with vaccines against a number of infectious diseases,” said Dr Gary Matyas, Chief of the Adjuvants and Formulation Section.

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Preclinical research supported the use of ALFQ in this initial human study by demonstrating that it is safe and highly effective as a vaccine adjuvant.

“Both the high and low dose of FMP013 antigen and the ALFQ adjuvant was found to be safe and well tolerated by adults,” said Maj. Jack Hutter, the clinical trial principal investigator. “Both groups exhibited robust humoral and cellular immunological responses and compared favourably with historical responses reported for RTS,S/AS01.”

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Source-Medindia