U.S. Army Medical Research, Frederick, MD

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U.S. Army Medical Research, Frederick, MD

DOD Funding of Animal Cruelty 2005:
M4: Medical Biological Defense - 4

Title: Immunology and Efficacy of Recombinant Protein Vaccines andNovel Mucosal Adjuvants Delivered by Inhalation in Guinea Pigs.

Research Category: M4: Medical Biological Defense

FY: 2005 Funding (in dollars):  $40,000

Responsible Organization: U.S. ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES
Primary Contact: MRMC: U.S. Army Medical Research Institute of Infectious Diseases
City: Fort Detrick
State: MD
Zip: 21702-5011

Keywords: LABORATORY ANIMALS RPA

Objective:
The objective of the proposed experimental plan is to assess the immunogenicity and efficacy of recombinant vaccines when delivered by inhalation. An ancillary objective described in this plan is to assess the adjuvanticity and relative safety of novel mucosal adjuvants. Specific objectives follow. 1) Establish systemic and mucosal immunogenicity of inhaled rPA with an appropriate adjuvant in guinea pigs 2) Establish the efficacy of inhaled rPA with the appropriate mucosal adjuvant in guinea pigs against lethal aerosol challenge using a virulent strain of B. anthracis 3) Estab systemic and mucosal immunogenicity of inhaled F1V with an appropriate adjuvant in guinea pigs 4) Establish the efficacy of inhaled F1V with the appropriate mucosal adjuvant in guinea pigs against lethal aerosol challenge using a virulent strain of Y. pestis 5) Establish systemic and mucosal immunogenicity of inhaled recombinant ricin vaccine with an appropriate mucosal adjuvant in guinea pigs

Approach:
Vaccines have traditionally been administered by injection using a needle and syringe. There are many advantages, both practical and scientific, why alternative delivery of vaccines, specifically inhalation, may work better than injection. One of the most important considerations in vaccine administration 15 increasing the body's immune response at the point of entry, which in the case of aerosolized biowarfare agents, is the lung It has been shown in previous studies that administration of vaccine by injection, while inducing serological (bloodborne) antibodies, does not necessarily induce the type of antibodies that coat the lining of the lungs or intestines. The induction of these type of antibodies, called mucosal antibodies, are very important in the body's first defense against infectious biological agents that are delivered by inhalation. This animal protocol details experiments that will test whether delivering a vaccine along with compounds called adjuvants that act as a catalyst for the vaccine by inhalation rather than injection, will lead to mucosal immunity in the animals. Once the antibody response has been determined in the animals, they will be exposed to a lethal amount of aerosolized agent to test whether the vaccine will indeed protect the animals as well or better than groups that have been vaccinated by injection.
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Research was conducted in compliance with the Animal Welfare Act and other Federal statutes and regulations relating to the use of animals in research and was reviewed and approved by the Institute's Animal Care and Use Committee.

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Rats, mice, birds, amphibians and other animals have been excluded from coverage by the Animal Welfare Act. Therefore research facility reports do not include these animals. As a result of this situation, a blank report, or one with few animals listed, does not mean that a facility has not performed experiments on non-reportable animals. A blank form does mean that the facility in question has not used covered animals (primates, dogs, cats, rabbits, guinea pigs, hamsters, pigs, sheep, goats, etc.). Rats and mice alone are believed to comprise over 90% of the animals used in experimentation. Therefore the majority of animals used at research facilities are not even counted.

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