A Phase 1 clinical trial of a novel dry powder intranasal vaccine for prevention of the H5N1 influenza strain demonstrated that the product was well tolerated, and no serious adverse events occurred, according to developer Nanotherapeutics. the GelVac nasal dry powder H5N1 vaccine is delivered by a disposable single-use positive pressure intranasal inhaler that uses compressed air to aerosolize the formulation.
The company says that the study, although not intended to determine efficacy, produced initial results that show immune responses that are “encouraging and support the development of larger trials to confirm efficacy and demonstrate distinct advantages in meeting the critical needs of pandemic preparedness.”
Nanotherapeutics’ GelSite, “a novel, naturally occurring, mucoadhesive ionic carbohydrate polymer capable of forming a gel when brought into contact with nasal fluids,” is a key component of the GelVac formulation. The polymer is extracted from the aloe vera plant and, according to the company, provides an adjuvant effect at very low concentrations and for a range of different vaccine formulations. Nanotherapeutics also has GelVac nasal dry powder vaccines against norovirus and typhoid in its pipeline.
Read the Nanotherapeutics press release.
