In a significant development, the National Institutes of Health (NIH) has commenced a clinical trial to evaluate the safety and efficacy of a novel monoclonal antibody designed to combat enterovirus D68 (EV-D68), a virus known to cause severe respiratory and neurological conditions like acute flaccid myelitis (AFM).
Revolutionizing Approaches to EV-D68
Scientists are dedicated to gaining a deeper insight into AFM, a condition that has seen an increase in cases in the United States, especially during late-summer months in recent years. The U.S. Centers for Disease Control and Prevention (CDC) has noted spikes in AFM instances in 2014, 2016, and 2018, highlighting the risks associated with EV-D68 and its link to periodic AFM outbreaks.
The trial, spearheaded by Dr. C. Buddy Creech at Vanderbilt University Medical Center and supported by NIH's National Institute of Allergy and Infectious Diseases (NIAID), aims to assess the safety, efficacy, and optimal dosage of the investigational monoclonal antibody EV68-228-N. This experimental antibody seeks to neutralize various EV-D68 strains identified across multiple epidemic years, offering promise for effective treatment options.
Innovative Collaborative Research
Between 2017 and 2019, experts at Vanderbilt University Medical Center isolated a potent neutralizing antibody, EV68-228, from patients recovering from EV-D68 infections. Working with institutions like Utah State University, KBio, Inc., and ZabBio, they further developed EV68-228-N for testing, underscoring the impact of collaborative research in advancing medical solutions.
The trial, listed as NCT06444048, aims to recruit 36 healthy volunteers aged 18 to 49, focusing on evaluating the safety and effectiveness of EV68-228-N administration at different dose levels. Participants will receive either a placebo or varying doses of the antibody intravenously, enabling researchers to closely monitor their responses over a 120-day period.
Advancing Insights into EV-D68
Initially discovered in California in 1962, EV-D68 has presented challenges due to its association with respiratory ailments, particularly severe cases leading to AFM. Cases of AFM in the U.S. have been on the rise since 2014, prompting heightened surveillance efforts by the CDC to track EV-D68 activity and related illnesses.
By delving into the intricacies of EV-D68 and AFM, the NIH aims to enhance scientific understanding, develop efficacious treatments, and uphold public health standards. Stay updated for more news on this groundbreaking trial that could transform the way EV-D68 is managed and pave the way for innovative medical interventions.
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