Stable dry powder formulation for nasal delivery of anthrax vaccine.

Journal Article (Journal Article)

There is a current biodefense interest in protection against anthrax. Here, we developed a new generation of stable and effective anthrax vaccine. We studied the immune response elicited by recombinant protective antigen (rPA) delivered intranasally with a novel mucosal adjuvant, a mast cell activator compound 48/80 (C48/80). The vaccine formulation was prepared in a powder form by spray-freeze-drying (SFD) under optimized conditions to produce particles with a target size of D(50) = 25 μm, suitable for delivery to the rabbit nasal cavity. Physicochemical properties of the powder vaccines were characterized to assess their delivery and storage potential. Structural stability of rPA was confirmed by circular dichroism and attenuated total reflectance-Fourier transform infrared spectroscopy, whereas functional stability of rPA and C48/80 was monitored by cell-based assays. Animal study was performed using a unit-dose powder device for direct nasal application. Results showed that C48/80 provided effective mucosal adjuvant activity in rabbits. Freshly prepared SFD powder vaccine formulations or powders stored for over 2 years at room temperature elicited significantly elevated serum PA-specific and lethal toxin neutralization antibody titers that were comparable to that induced by intramuscular immunization with rPA. Nasal delivery of this vaccine formulation may be a viable alternative to the currently licensed vaccine or an attractive vaccine platform for other mucosally transmitted diseases.

Full Text

Duke Authors

Cited Authors

  • Wang, SH; Kirwan, SM; Abraham, SN; Staats, HF; Hickey, AJ

Published Date

  • January 2012

Published In

Volume / Issue

  • 101 / 1

Start / End Page

  • 31 - 47

PubMed ID

  • 21905034

Pubmed Central ID

  • PMC3725471

Electronic International Standard Serial Number (EISSN)

  • 1520-6017

Digital Object Identifier (DOI)

  • 10.1002/jps.22742


  • eng

Conference Location

  • United States