NIH awards contract for acute flaccid myelitis natural history study

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has awarded the University of Alabama at Birmingham (UAB) approximately $10 million over 5 years to study acute flaccid myelitis (AFM), a rare but serious condition which causes muscle weakness and paralysis. As part of the contract, UAB will organize and implement an international, multi-site study to learn more about the incidence and distribution of AFM and to better understand how the disease develops and progresses in children.

AFM affects nerve tissue within the spinal cord. Most people with AFM developed the condition following a mild respiratory illness. Although sporadic cases of AFM have historically been reported, AFM unexpectedly re-emerged globally in epidemic form in 2014. It appears to occur primarily in children, and clusters of AFM have occurred at the same time and locations as outbreaks of enteroviruses. Although the cause of AFM is still unknown, growing epidemiological evidence suggests that enterovirus-D68 (EV-D68) could play a role. Most people who become infected with EV-D68 are asymptomatic or experience mild, cold-like symptoms. Researchers and physicians are working to understand if there is a connection between these viral outbreaks and AFM, and if so, why some children but not others experience this sudden muscle weakness and paralysis.

The Centers for Disease Control and Prevention (CDC) established an AFM Task Force in 2018 comprising physicians, scientists, and public health experts from diverse disciplines and institutions to assist in the ongoing investigation to define the cause of AFM and improve outcomes for patients with the condition. CDC experts are assisting in the design and implementation of the new NIAID-funded study, which will address knowledge gaps outlined by the AFM Task Force. This includes identifying potential risk factors and further characterizing the symptoms associated with AFM. The study also will collect clinical specimens (blood, cerebrospinal fluid, etc.) for future research.

David Kimberlin, M.D., professor of pediatrics at UAB, will be principal investigator for the new study, and Carlos Pardo-Villamizar, M.D., associate professor of neurology and pathology at Johns Hopkins University in Baltimore, will serve as co-principal investigator. The study will gradually enroll children with symptoms of AFM and follow them for one year. Household contacts of children with suspected AFM also will be enrolled and followed as comparators. The study is expected to begin enrollment by this fall, and more details about the design and sites will be available at that time.

The AFM natural history study is funded under contract HHSN272201600018C.

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