Micron Biomedical has begun trialing a microneedle-based measles-rubella vaccine in children. The Atlanta-based drug delivery specialist said the phase 1/2 study is the first time a microneedle vaccine has been tested in pediatric subjects.
Investigators will assess the safety, tolerability and immunogenicity of a vaccine against measles and rubella when given using Micron’s microneedle technology or standard subcutaneous injection. The study will enroll adults and children, taking an age-de-escalation approach that will test the vaccine in progressively younger populations as data is gathered in older cohorts.
The team at the Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine that is running the study will initially enroll 45 adults aged 18 to 50 years. Beyond that, the team plans to enroll 120 toddlers aged 15 to 18 months and later 120 infants aged 9 to 10 months.
Micron’s choice of Gambia, a country in sub-Saharan Africa, as the location of the clinical trial reflects a belief that microneedle technology is particularly well suited to the administration of vaccines in that part of the world.
“Microneedle technology, such as this, is viewed as being a key component to measles control in sub-Saharan Africa and elsewhere. This reflects, amongst other things, the potential ease of delivery, reduced cold chain requirements and absence of sharps waste,” Ed Clarke, the London School of Hygiene and Tropical Medicine researcher leading the study, said in a statement.
Micron expects enrollment in the study to continue through the second half of the year, leading to the delivery of results in the first half of 2022. The readout will provide Micron with early evidence of whether its dissolving microneedle-based technology has a role to play in the vaccination of children. Micron reached this point with support from the Bill & Melinda Gates Foundation.