Absorbable Gels for Modulated Bioavailability of Vaccines. Phase I
Abstract
The research question addressed in Phase I was: Would selected members of a novel family of absorbable copolyester gel formers be suitable as safe carriers for the development of a single-dose, controlled, release, injectable formulation of vaccines, using ricin A-chain (RAC) as a model, to provide timely, high antibody response, and prolonged immunity against respective pathogens? Available Phase I results do not only fulfill the initially sought positive response to the research question, but also provided us with the knowledge that a single-shot, absorbable subcutaneous (sc) formulation, GF-II, exhibits potentially unique in vivo performance as it comprises a microparticulate cation-exchanger. In addition to the planned sc study of Phase I, preliminary studies were conducted in mice to explore the possibility of intranasal (in) immunization. Analysis of available data gave us the incentive to propose the development of a fluid, tissue-adhering, gel-forming formulation comprising a microparticulate ion-exchanger for in vaccination. Collectively, the development of an absorbable gel-forming controlled system of RAC and potentially other vaccines is feasible and plans for a successful execution of Phase II are in place.
Document Details
- Document Type
- Technical Report
- Publication Date
- Nov 01, 1996
- Accession Number
- ADB217309
Entities
People
- Shalaby W. Shalaby