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SAN DIEGO, CA, United States

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

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 Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 298.46K | Year: 2012

DESCRIPTION (provided by applicant): The 2009 H1N1 pandemic illustrates a critical weakness in our ability to respond to a pandemic threat. The ability to ramp up production of vaccine doses within the critical period from the discovery of the threat is hindered by two major supply constrictions: 1) production technology for producing influenza vaccines in eggs; and 2) the logistical considerations involved in deploying and delivering a refrigerated parenteral vaccine by trained personnel. Our Ad 4 vaccinevector encoding influenza antigens and a delivered oral dosage form addresses both of these issues. This project focuses on developing a old technique to be applied in a new way to increase the speed and scale of producing live vaccine powder in both a convention form and in a coated form. That technique utilizes spray drying to replace lyophilization as a drying method. The program also consists of enteric coating of adenovirus technology that can be incorporated in a manufacturing process suitable for drying the vector. Spray drying is unique in that the coating and drying process are achieved simultaneously. The resulting enteric coated vector platform could be used for widely different vaccine applications, and would therefore save both time and money indevelopment of vaccines against emerging diseases, bioterror threats, and pandemics. PUBLIC HEALTH RELEVANCE: Spray Drying, a simple and versatile manufacturing process to make powder products in bulk for vaccines and biologics. Spray drying process for biologics allows meeting any emergency needs at low cost per dose through economies of scale. A Spray Drying process manufacturing site can be commissioned anywhere in the world in the event of an emergency situation.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 548.82K | Year: 2012

DESCRIPTION (provided by applicant): Development of a vaccine to prevent, or reduce the rate of, HIV infections remains a high priority despite recent setbacks in the field. The lessons from failed and successful experimental programs indicate the need toapply new approaches to HIV vaccine design with the goal of inducing immune responses that are the appropriate type, quality, magnitude and active in the appropriate sites in the body. A promising approach is the use of the Adenovirus serotype 4 (Ad4) as avaccine delivery vehicle. The Ad4 virus is a component in the US Military adenovirus vaccine which was formulated for administration in an oral dosage form. Oral delivery should be advantageous for HIV vaccines because this route of administration is morelikely to induce mucosal immune responses than parenteral injection and would target the gut mucosal tissues in particular. The Ad4 vaccine vector is replication-competent in humans which should drive the induction and expansion of immune responses that are higher in quality, in terms of magnitude and effector functions, than those induced by non-replicating vectors. In Y1, multiple Ad4 vectors will be engineered to express unique antigens including: 1) HIV-1 Env clade C protein with the appropriate modifications for the purpose of inducing antibody responses broadly effective against a variety of HIV strains; and 2) GB virus type C E2 protein, which may induce synergistic antibody responses which would significantly broaden HIV-1 neutralization. In Y1-Y2,all vectors will be assessed for immunogenicity in small animals (rabbits). HIV-1 Env-specific antibody, both neutralizing and binding, will be determined. Completion of this SBIR program will provide sufficient data to determine the utility of this Ad4 vector system for inducing effective antibody and T cell responses and potentially could yield an experimental vaccine suitable for clinical development. PUBLIC HEALTH RELEVANCE: The development of a safe and protective vaccine against the Human Immunodeficiency Virus (HIV) that causes AIDS has been very difficult. The proposed research will modify an existing adenovirus vaccine, which was used safely in more than 10 million people, so that it expresses HIV proteins and induces an immunological response in animals. This vaccine will have the advantage of being taken by mouth and the advantages of a live virus vaccine, such as the polio or measles vaccines but will not have any risk of causing HIV infection.

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