Modernized Production of Enteric Coated Live, Oral Adenovirus Vaccine

Adenoviruses are a frequent cause of epidemic acute respiratory disease (ARD) in military recruit training centers and pose a significant threat to military readiness, especially during times of large mobilization. There are no FDA-licensed treatment options available for adenovirus infections. Under the SBIR phase I, PaxVax successfully re-developed research-grade Ad4 and Ad7 capsule vaccines with comparable potency to the Teva Ad4 and Ad7 Tablet vaccines using modernized platform technologies, including a high-yield continuous cell line, serum-free medium, single-use bioreactor and purification technologies, new thermostable formulations and aqueous enteric-coating. During the SBIR Phase II, PaxVax will cGMP manufacture clinical Ad4/Ad7 vaccines with processes and assays developed under the SBIR I. PaxVax will produce Ad4/Ad7 cGMP master viral seeds (MVS) with plaque-purified and amplified pre-MVS, bulk drug substances (BDS), and final drug products (FDP), and subsequently release these products for clinical trials. The produced Ad4/Ad7 FDP will also be placed on a stability program as required to support the trials. A small clinical trial will be conducted to evaluate the safety and immunogenicity of a single dose of the PaxVax Ad4/Ad7 vaccines. A successful clinical trial will in turn advance the production processes to a commercial production stage.