The study, which was presented at the MICRONEEDLES 2023 conference in Washington, examined the safety, immunogenicity, and acceptability of the commercially available MR vaccine from the Serum Institute of India administered using the microarray technology of the US-based life science company Micron Biomedical.
In the trial, conducted in The Gambia, 45 adults, 120 toddlers (15-18 months old), and 120 infants (9-10 months old) were enrolled and were randomized to receive the MR vaccine either by Micron's microarray, which is painless or by subcutaneous (SC) injection.
Vaccination by microarray was found to be safe and well tolerated with no allergic reactions or related serious adverse events.
The immunogenicity shown was high and similar for those who received the vaccine via stickers or injection.
Over 90% of the parents of toddlers and infants enrolled in the trial who took part in an acceptability survey said that the microarray technology would be better than injections to give vaccines to children.
"This trial may help shape future approaches to reaching children and families with vaccines," said James Goodson, Senior Scientist and Epidemiologist in the Global Immunisation Division at the Centers for Disease Control and Prevention (CDC), and co-investigator for the study, in a statement.
"These are exciting results which show, for the first time, the potential for microarray patches to safely and effectively deliver vaccines to children," added Ed Clarke, Head of Infant Immunology at the Medical Research Council, The Gambia (MRCG).
In many low- and middle-income countries (LMICs), the MR vaccine coverage rate remains well below the threshold recommended by the World Health Organization (WHO) to sustain disease elimination.
The dissolvable microarray technology, in which vaccines are embedded, is designed to overcome critical logistical vaccination challenges that exist in LMICs and to increase access to life-saving vaccines.
The technology aims to significantly simplify the transport, storage, and administration of vaccines that are traditionally delivered via injection and eliminate sharp waste.
"Supporting innovations in vaccine delivery is critical to addressing ongoing health inequities," Goodson said.
"This clinical trial is an important step forward in the critical development pathway for the MR microarray patch toward licensure," he added.