![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » DELSITE PRESENTS DATA ON NASAL POWDER FLU VACCINE
DELSITE PRESENTS DATA ON NASAL POWDER FLU VACCINE
October 25, 2006
Carrington Laboratories has presented data on a nasal powder influenza vaccine that incorporates inactivated whole virion antigen in the GelVac dry powder delivery system, a unique in situ gelling powder formulation. Upon hydration by nasal fluid, the GelVac powder formulation changes from dry powder particles to wet gel particles, resulting in the formation of a gel that adheres to nasal mucus, maximizing antigen exposure through prolonged nasal residence time and sustained antigen release.
A Phase I human safety study showed that the GelVac powder without an antigen was safe and well-tolerated in humans. Preclinical studies have shown that GelVac powder vaccine is highly immunogenic in animal models, inducing a strong immune response and a strong protective effect following challenge infection. Together, these results form a critical base for further expeditious development of this novel vaccine toward clinical studies.
This vaccine provides distinct advantages in meeting the critical needs for influenza pandemic preparedness and epidemic control, including room temperature stability, broader protection, antigen sparing, ease of administration and induction of both mucosal and systemic immune responses, according to the company. The powder vaccine was found to be stable at ambient temperature for more than 18 months.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct