Nanotherapeutics, Inc. announced the successful completion of a Phase 1 clinical trial of GelVac Nasal Dry-Powder H5N1 Influenza Vaccine. The trial assessed the safety of the novel intranasal dry-powder formulation vaccine for the H5N1 flu strain.
No safety issues were identified, and no serious adverse events occurred during the trial. The vaccine, which was administered intranasally by a disposable single-use inhaler, was well tolerated by the patients. GelVac incorporates the GelSite polymer, combining it with an H5N1 antigen.
Patients received two intranasal doses given 4 weeks apart. Nasal wash and serum samples were collected at several time points for exploratory endpoints of effectiveness. Although the study was not statistically powered to provide effectiveness data, initial results are encouraging and support the development of larger trials to confirm efficacy and demonstrate distinct advantages in meeting the critical needs of pandemic preparedness. The preliminary data show increased serum and mucosal IgA as well as serum HAI responses to H5N1.
The GelVac vaccine possesses distinct potential advantages, including induction of both mucosal and systemic immunity, room temperature stability, prolonged shelf life, cold-chain-free distribution, and needle-free administration that can be particularly valuable in meeting the needs for pandemic preparation and stockpiling.
GelSite polymer is a novel, naturally occurring, mucoadhesive ionic carbohydrate polymer capable of forming a gel when brought into contact with nasal fluids. Gelling occurs with the powder formulation and provides sustained antigen release within the nasal cavity for enhancement of the immune response.