NIAID Awards $10 Million for Study of Acute Flaccid Myelitis

The National Institute of Health’s National Institute of Allergy and Infectious Diseases (NIAID) has awarded $10 million over 5 years for a natural history study on acute flaccid myelitis (AFM), with an aim of better understanding the rare polio-like virus that affects children.

The international, multicenter study will be organized by the University of Alabama at Birmingham (UAB) under principal investigator David Kimberlin, MD, professor of pediatrics at UAB. Carlos Pardo-Villamizar, MD, professor of neurology and pathology at Johns Hopkins University and director of the Johns Hopkins Hospital Transverse Myelitis Center, is co-principal investigator.

“At this moment we have indirect evidence that patients that are affected by acute flaccid myelitis may have been exposed to upper respiratory infection, and among those upper respiratory infections, enterovirus-D68 is the prime suspect,” Pardo-Villamizar said in an interview with Contagion^®. “But the evidence that we have is indirect.”

The illness occurs primarily in the late summer and early fall from August to October. Since 2014, 559 cases have been reported in 41 states, according to the US Centers for Disease Control and Prevention (CDC), which recently urged practitioners to report suspected cases rapidly.

The CDC has detected enterovirus-D68, enterovirus-A71, and coxsackievirus A16 in the spinal fluid of only 4 of the confirmed cases of AFM. Last year, the CDC established the AFM Task Force and will assist with the design and implementation of the NIAID-funded study, which aims to shed light on the incidence and distribution of the disease along with how it develops and progresses in children.

Investigators hope to collect clinical assessments and biological and respiratory samples to allow them to better characterize the disease and identify potential etiological agents.

“There are several challenges. The first is to be able to recruit patients prospectively,” Pardo-Villamizar said. “The second is we are not sure if the seasonality that we observed in the past 8 years is going to continue.”

He said the hope is to have a few research centers ready by the end of August to begin evaluating patients with AFM if they emerge. By 2020, they hope to have at least 35 research sites around the country.

Pardo-Villamizar emphasized the importance of raising awareness of the possibility of AFM among practitioners, particularly when they see children who are seeking treatment for weakness following any upper respiratory infection. The need for rapid diagnosis is underscored by a need for prompt treatment for neurological effects of the condition, including paralysis, gait disturbances, and difficulties with mobility.

“The most common misconception about acute flaccid myelitis is that this is a transitory neurological problem,” Pardo-Villamizar said. “Unfortunately, that’s a misconception because, as I mentioned before, acute flaccid myelitis is equivalent to poliomyelitis…Many children that were affected in the past several years with acute flaccid myelitis are still in rehabilitation centers, are still undergoing a lot of rehabilitation effort to improve their condition. In other words, the effects of acute flaccid myelitis may be long-term, lifelong effects.”

Pardo-Villamizar also emphasized the need for funding for such research projects and to help families affected by the condition and the need for prolonged interventions.

Once the underlying cause of the disease has been identified, the investigators will be able to work on the development of treatments and design vaccines to prevent it, he said, explaining that this process will be similar to the response to the emergence of polio.

“When the outbreak of polio emerged in the ’40s and ’50s the next major effort was to identify the virus and be able to generate proper vaccination,” Pardo-Villamizar said. “The scientific effort in the ’50s and ’60s in the United States paid back tremendously and actually helped everyone around the world to prevent more problems with polio and that is exactly what we are doing with acute flaccid myelitis right now.”