Monath T.P.,Paxvax, Inc.
Vaccine | Year: 2013
This review focuses on the immunization of animals as a means of preventing human diseases (zoonoses). Three frameworks for the use of vaccines in this context are described, and examples are provided of successes and failures. Framework I vaccines are used for protection of humans and economically valuable animals, where neither plays a role in the transmission cycle. The benefit of collaborations between animal health and human health industries and regulators in developing such products is discussed, and one example (West Nile vaccine) of a single product developed for use in animals and humans is described. Framework II vaccines are indicated for domesticated animals as a means of preventing disease in both animals and humans. The agents of concern are transmitted directly or indirectly (e.g. via arthropod vectors) from animals to humans. A number of examples of the use of Framework II vaccines are provided, e.g. against brucellosis, Escherischia coli O157, rabies, Rift Valley fever, Venezuelan equine encephalitis, and Hendra virus. Framework III vaccines are used to immunize wild animals as a means of preventing transmission of disease agents to humans and domesticated animals. Examples are reservoir-targeted, oral bait rabies, Mycobacterium bovis and Lyme disease vaccines. Given the speed and lost cost of veterinary vaccine development, some interventions based on the immunization of animals could lead to rapid and relatively inexpensive advances in public health. Opportunities for vaccine-based approaches to preventing zoonotic and emerging diseases that integrate veterinary and human medicine (the One Health paradigm) are emphasized. © 2013 Elsevier Ltd. Source
Monath T.P.,Hookipa Biotech |
Monath T.P.,Paxvax, Inc. |
Vasconcelos P.F.C.,Instituto Evandro Chagas |
Vasconcelos P.F.C.,National Institute of Science and Technology for Viral Hemorrhagic Fevers |
Vasconcelos P.F.C.,Para State University
Journal of Clinical Virology | Year: 2015
Yellow fever, a mosquito-borne flavivirus disease occurs in tropical areas of South America and Africa. It is a disease of major historical importance, but remains a threat to travelers to and residents of endemic areas despite the availability of an effective vaccine for nearly 70 years. An important aspect is the receptivity of many non-endemic areas to introduction and spread of yellow fever. This paper reviews the clinical aspects, pathogenesis, and epidemiology of yellow fever, with an emphasis on recent changes in the distribution and incidence of the disease. Recent knowledge about yellow fever 17D vaccine mechanism of action and safety are discussed. © 2014 Elsevier B.V. Source
Paxvax, Inc. | Date: 2012-06-01
The present invention provides formulations comprising nanocoated biological materials (e.g., viral particles), methods for producing powders comprising nanocoated biological materials, and powders produced from such formulations and methods. Also provided are pharmaceutical compositions comprising the present formulations or dried powders, and vaccines comprising the present formulations or dried powders. The nanocoated biological materials typically display superior stability for either direct use in a formulation or in drying processes to produce a powder material, wherein the coated materials are typically more tolerant to environmental stress (e.g., chemical, thermal, and/or mechanical stress) during storage or drying processes.
Paxvax, Inc. | Date: 2012-02-24
The present invention is directed to formulations for spray-drying viral particles, methods for spray drying such compositions, and pharmaceutical compositions and vaccines comprising the present spray-dried powders. The present formulations advantageously provide for spray-drying viral particles at low temperatures, thereby producing spray-dried viral powders having viral infectivities comparable to those of powders prepared by lyophilization of comparable formulations. The methods and compositions described herein advantageously provide substantially higher throughput and production rates for the production of viral powders. Further, spray-dried viral powders incorporating enteric polymers can be produced at low temperatures.
Agency: Department of Defense | Branch: Defense Health Program | Program: SBIR | Phase: Phase II | Award Amount: 1.00M | Year: 2015
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.