Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Bacterium or component thereof or substance produced by said...
Reexamination Certificate
1999-05-14
2003-02-11
Minnifield, Nita (Department: 1645)
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Bacterium or component thereof or substance produced by said...
C424S203100, C424S234100, C424S204100, C424S253100, C424S254100, C435S091500, C435S038000, C435S041000, C435S091500, C930S200000
Reexamination Certificate
active
06517844
ABSTRACT:
BACKGROUND OF THE INVENTION
The current economic pressure on agriculture to produce foods cheaper, results in labor saving animal husbandry techniques which leave large populations of poultry at risk of contracting communicable diseases, often more than one disease at a time. When this does occur, and a farm flock is infected with concurrent infections, the results are usually devastating in regard to lost animals and lost production performance. Currently utilized vaccine technology has not resulted in an effective means to control this risk of concurrent infections.
Modified live vaccines have the advantage of being able to be applied or administered in the drinking water. However, certain drawbacks do exist. First, live vaccines can cause clinical disease particularly when they are delivered to birds that are stressed from either environmental problems or concurrent infections. Second, the administration of live vaccines in drinking water requires that the birds be vaccinated in a relatively short period of time, usually 2 to 4 hours, because live vaccines can die in the drinking water system used to water the birds. Thus, this often results in a situation where all the birds in the barn are not receiving an immunizing dose of the vaccine because they may not be drinking enough water during the period of time that the vaccine is being delivered. Third, since certain live vaccines (e.g., bacterial antigens) are susceptible to antibiotics, the birds typically cannot have received any antibiotic for 3 to 5 days prior to, or after, vaccination. The problem this creates is exemplified by a producer who has just spent money to vaccinate a flock against a disease using a live vaccine, and the next day the birds are showing signs of a digestive infection which could be easily treated with antibiotics. Unfortunately, if the producer treats the birds with antibiotics, the immunizing effect of the vaccine is lost. In addition, most live vaccines must be refrigerated during storage and shipping.
Inactivated vaccines that are administered parentally have the advantage that they can be delivered while the birds are being treated with antibiotics. However, this approach also has significant drawbacks associated with it. First, the obvious expense that is associated with handling individual birds in the vaccination process results in multiplying the cost 2 to 3 times over a mass vaccination approach such as used in modified live vaccines. Second, when the birds are going through a stress period, either environmental in nature or due to a concurrent infectious disease, the handling required for injecting individual birds can result in significant exacerbation of the clinical problem. Third, the risks associated with accidental injection of the vaccines to the people administering them has long been known, with some people losing fingers from severe inflammatory responses. Generally, inactivated vaccines also require refrigeration to prevent the adjuvant system from going rancid or breaking down in some other fashion.
Therefore, there is a need for an effective poultry vaccine that can be safely administered to a population of birds without exacerbating a stressful situation into a clinical problem. There is also a need for a vaccine that can be administered with antibiotics without detrimental effect to the immune response to the vaccine antigen. There is a further need for clinically useful vaccines which do not require refrigeration during storage or transportation. These and other needs are addressed by the present invention.
SUMMARY OF THE INVENTION
The present invention is directed to vaccine compositions and methods for safe and effective immunization of large populations of animals, particularly birds, through their drinking water.
It will be noted that at several places throughout the present specification, guidance is provided through lists of examples. In each instance, the recited lists serve only as a representative group. It is not meant, however, that the lists are exclusive.
A vaccine composition according to the invention includes an inactivated bacterin and a preservative. In one embodiment, the bacterin is present in one gallon of the vaccine composition at a concentration permitting a spectrophotometric transmission reading of up 12% at 540 nanometer per 10,000 doses of the vaccine. The inactivated bacterin can be derived from
Escherichia Coli, Bordetella avium
, a combination of
Bordetella avium
and
Ornithobacterium rhinotrachaeale, Riemerella anatipestifer
and
Pasteurella multocida
. Other bacterins suitable for the invention will become apparent to one of skill in the art after reading the present patent disclosure.
The vaccine composition preferably also includes a preservative. In one embodiment, the preservative is methyl/propyl paraben. In addition, a vaccine composition of the invention can also include an antibiotic.
The invention also provides a method for immunizing poultry with a vaccine composition of the invention in the drinking water of poultry. The vaccine composition can be administered to provide a priming immunization or booster immunization to the birds.
DETAILED DESCRIPTION OF THE INVENTION
To be clinically useful, an immunization system should preferably be safe, simple to perform, cost effective and clinically effective in preventing the targeted disease. The present invention provides such an immunization system.
Oral tolerance is a theory which explains why animals do not usually develop immune responses to the food they eat. This theory fosters the notion that orally dosed antigens do not result in meaningful immune protection against an inactivated antigen that is orally administered. However, in contrast to the traditionally held notions regarding orally administered antigens, the present invention provides compositions and methods for the safe and effective administration of an inactivated vaccine through an oral administration route.
In general, the compositions of the invention can be administered to mass populations of animals through their drinking water, over a 12-24 hour period, with confidence that all animals are receiving an effective immunizing dose of the vaccine. The vaccines can be administered to young animals or adults as a primary immunizing agent, or as a booster immunizing agent as needed. Advantageously, the vaccine compositions of the invention do not require refrigeration and thus can be cost effectively stored with little concern regarding efficacy if not administered immediately upon opening.
In a preferred embodiment the methods of the invention are particularly advantageous for administration to poultry. As used herein, the term “poultry” includes chickens, turkeys, pheasant, geese, duck, etc. The methods are particularly advantageous for use with intensive management operations of mass populations of birds.
As used herein, the term “bacterin” refers to a suspension of killed or attenuated bacteria. A bacterin according to the invention can also include a component of the bacteria, for example, fragments or components isolated from the whole organism, specific antigens genetically engineered, etc. In most preferred embodiments, the bacterin is an inactivated whole organism. In addition, the term “toxoid” refers to a toxin produced by an organism. Typically, a bacterin of the invention will also contain the toxins produced by the organism. In fact, as described below, the invention provides methods for increasing the level of toxins in the bacterin for enhanced immunogenicity.
Examples of disease conditions which can effectively be controlled by the compositions and methods of the invention include respiratory diseases, gastrointestinal diseases, central nervous system disease, etc. Respiratory disease problems which can typically arise in confinement housing operations include mortality, morbidity, loss of performance (i.e., decreased rate of gain or feed conversion), and loss of wholesomeness due to chronic airsaculitis.
Typically, the infectious components of respiratory disease of turkeys include
Bordetella
Hines Ja'na
Minnifield Nita
Schwegman Lundberg Woessner & Kluth P.A.
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