Emory University and Micron Biomedical have initiated the first clinical trial of a novel rotavirus vaccine delivered through dissolvable microarray patch technology, representing the first CDC-sponsored clinical evaluation of any drug or vaccine administered via patch technology. The Phase I trial is now enrolling participants to test CC24, an inactivated rotavirus vaccine developed by the CDC as an alternative to oral administration.
Addressing Global Health Challenge
Rotavirus infection remains a leading cause of childhood diarrheal deaths worldwide, with the greatest impact in low- and middle-income countries where existing oral vaccines demonstrate reduced effectiveness. "Rotavirus is a leading cause of diarrheal morbidity and mortality in children less than five years of age worldwide, but current oral rotavirus vaccines don't work as well in low- and middle-income countries where the burden of disease is greatest," said Dr. Christina Rostad, Pediatric Infectious Disease associate professor at Emory University and lead investigator of the trial.
Dr. Demetre Daskalakis, Director of CDC's National Center for Immunization and Respiratory Diseases, emphasized the trial's significance: "CDC recognizes the potential of this groundbreaking clinical trial, which will test the safety of both our novel vaccine, CC24, in adults and the vaccine's delivery with 'patch' technology. The trial marks significant progress in vaccine technology innovation and is a critical step toward saving more children from rotavirus illness and death."
Revolutionary Delivery Technology
Micron Biomedical's dissolvable microarray technology offers a needle-free approach that rapidly delivers vaccines through compounds pressed painlessly into the uppermost layers of skin. The thumb-sized, lightweight technology can be self-administered with the push of a button while producing no medical sharps waste. Crucially, the company formulates existing drugs to have thermostable properties, reducing or eliminating cold chain requirements.
"The availability of new vaccine administration methods, such as Micron Biomedical's dissolvable microarray patch, could offer important choices for children and adults, not just with rotavirus but also with vaccines that are currently administered by injection," said Lauren Nolan, the trial's study manager and research physician assistant at Emory Children's Center Vaccine Research Clinic. "People who are afraid of needles may be more likely to use this patch because it feels less invasive than vaccines currently administered by injection."
Clinical Trial Design
The Phase I double-blind placebo-controlled trial will assess the safety, reactogenicity, and immunogenicity of CC24 delivered via Micron Biomedical's microarray technology. The study will recruit 50 healthy adults between ages 18 and 45 years old, with data informing planned pediatric studies.
The research builds on existing work by Emory University, published in The Lancet, examining self-administered seasonal influenza vaccine via Micron Biomedical's dissolvable microarray technology, as well as studies across other disease indications including measles and rubella.
Broader Implications
Steven Damon, CEO of Micron Biomedical, highlighted the technology's potential impact: "The faster we can simplify access to life-saving vaccines and therapeutics, the more lives we can save and this clinical trial is a critical milestone both in accelerating innovations that are likely to make rotavirus vaccines more effective and accessible - and in demonstrating the growing demand for needle-free vaccines and drugs."
Micron's technology has been recognized for its potential to expand vaccine and therapeutic access in hard-to-reach settings, including developing countries and situations requiring swift delivery and administration during epidemics, pandemics, and national security applications. The company receives funding from organizations including the Gates Foundation, CDC, PATH, the Coalition for Epidemic Preparedness Innovations (CEPI), and the Biomedical Advanced Research and Development Authority (BARDA).
