Matthew Vogt, MD, PhD, and Michelle Hernandez, MD, initiate pandemic preparedness study focused on children with NIAID Vaccine Research Center.
The Pandemic Response Repository Through Microbial and Immunological Surveillance and Epidemiology (PREMISE) initiative is enrolling children aged 10 years or younger in a study aimed at getting ahead of the next pandemic. By studying the evolving immune responses of children over time, investigators hope to guide the rapid development of diagnostic, therapeutic, and preventive tools to combat the next pandemic. Establishing a pre-emptive stockpile of tangible immunobiological countermeasures will accelerate the response to potential pandemic threats. The study is funded by NIH/NIAID through a subcontract with the Frederick National Laboratory for Cancer Research, operated by Leidos Biomedical Research (21X192QT1) in Frederick, Maryland.
PREMISE is the brainchild of NIAID Vaccine Research Center investigators Daniel Douek, MD, PhD, and Adrian McDermott, PhD. Although the PREMISE initiative is intended to be broadly applied to global pathogens, NIAID investigators chose to focus early efforts on combating future outbreaks of enterovirus D68 acute flaccid myelitis, or AFM. Enterovirus D68 is a virus on NIAID’s list of priority pathogens because it typically causes common cold symptoms but has also caused outbreaks of AFM. AFM is a syndrome of polio-like paralysis, and outbreaks that are caused by enterovirus D68 almost exclusively affect otherwise healthy children.
As an expert in the study of the human antibody response to enterovirus D68 infections, UNC Chapel Hill’s Matthew Vogt, MD, PhD, Assistant Professor of Pediatrics in the Division of Infectious Diseases and Microbiology & Immunology, was consulted during early discussions of the PREMISE concept. Vogt teamed up with Michelle Hernandez, MD, Professor of Pediatrics in the Division of Allergy/Immunology, in her role as Faculty Director of the Pediatrics Clinical Research Unit (Peds CRU) to pilot PREMISE at UNC-Chapel Hill.
As a pilot study of PREMISE, UNC-Chapel Hill investigators will prospectively collect paired blood samples from children pre- and post-enterovirus season (late summer into fall) with an option to collect a nasal swab during any respiratory illness that occurs during enterovirus season. With these samples, NIAID investigators will determine when children experience their first infection with enterovirus D68, what kind of antibodies they make in response to infection, and use the samples to make banks of human monoclonal antibodies that could be used as countermeasures in future outbreaks. Then monoclonal antibodies, just like the ones being used to combat COVID-19, will be on the shelf and ready to employ.
“PREMISE is an opportunity for UNC to pioneer yet another approach to prepare for the next inevitable pandemic,” Vogt said. “This is especially exciting because we are focusing on a pediatric disease and recruiting children, which is a population that pandemic-related clinical studies often omit in early stages. We are focusing on children from the start. Any member of the UNC or larger Triangle community with a child in our age groups is welcome to join this effort.
“We are also happy to jump in alongside other UNC pandemic preparedness efforts like the READDI initiative that focuses on development of antiviral drugs that target viruses with pandemic potential. Not to mention the countless clinical studies advancing vaccines and therapeutics for COVID-19 here at UNC for both children and adults.”
- Kids over 17 pounds and 10 years old or younger without immunodeficiencies or other severe chronic illnesses.
- There are two study visits, one year apart, where health information is collected and blood samples will be drawn.
- An optional portion has the parent filling out a brief on-line survey every two weeks from July to December, to determine if the child has a respiratory illness. Then they would collect a nasal swab for the study.
The family will receive a $50 gift card for each visit and the nasal swab, for up to $150 total.
Please contact study coordinator Sandy Grubbs, RN, for more information if interested in enrolling, at 919-445-0122 or Sandy_Grubbs@med.unc.edu. More details can also be found on UNC’s Research for Me website.