First-in-Human Phase 1 Evaluation of the DegradaBALL Mesoporous Silica Nanoparticle Delivery System: An mRNA SARS-CoV-2 Vaccine Study in Healthy Korean Adult Volunteers.
Sooyoun Lee, Ki Young Huh, Kyung-Sang Yu et al.
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From the abstract
mRNA vaccines require an effective delivery system for intracellular uptake, and alternative carriers with improved stability and tolerability remain of continued interest. This study evaluated the safety, tolerability, and exploratory immunogenicity of LEM-mR203, an mRNA SARS-CoV-2 receptor binding domain (RBD) booster vaccine formulated with DegradaBALL, a mesoporous silica…
Reported results
LEM-mR203 was well tolerated at both dose levels, with mild (Grade 1) injection-site reactions and infrequent solicited systemic AEs; no fever, serious AEs, or AEs of special interest were reported. Transient, asymptomatic decreases in white blood cell count occurred across active and placebo groups and resolved without sequelae.
Authors' conclusions
A single booster dose of LEM-mR203 was well tolerated, with no major safety concerns over 366 days, and with exploratory cellular responses suggesting an IFN-γ-oriented profile without Th2 skewing. Given the small sample size and high pre-existing immunity, these findings require confirmation in larger, adequately powered studies of DegradaBALL-based mRNA vaccines.