Drug – bio-affecting and body treating compositions – Immunoglobulin – antiserum – antibody – or antibody fragment,... – Binds antigen or epitope whose amino acid sequence is...
Reexamination Certificate
1998-04-08
2001-04-17
Salimi, Ali R. (Department: 1648)
Drug, bio-affecting and body treating compositions
Immunoglobulin, antiserum, antibody, or antibody fragment,...
Binds antigen or epitope whose amino acid sequence is...
C424S581000, C435S345000, C530S387100, C530S350000
Reexamination Certificate
active
06217865
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a method of increasing the efficacy of an antibody in a subject. More particularly, the invention relates to blending eggs from all egg lots produced over a predetermined time period of the egg laying cycle of immunized avians, to form an antibody-containing substance. The administration of an effective amount of such a blended antibody-containing substance to a subject increases the efficacy of the antibody in the subject over that of administering a substance containing the same amount of antibody obtained from eggs collected over less than the predetermined period of time.
BACKGROUND OF THE INVENTION
The induction of an immune response in a living animal causes many things to occur within that animal, one of which is the production of antibodies. There are several characteristics of an antibody response including specificity, amount, isotype (class) and affinity of the antibodies produced. The specificity determines the ability of the antibody to distinguish one immunogen from another. The amount of antibody is a function of the number of responding B cells, their rate of antibody synthesis, and the persistence of the antibody after production. The persistence of the antibody in different tissues of the body is determined by its isotype, wherein each isotype has a different half-life in vivo. The isotypic composition of an antibody response also determines the biological functions these antibodies can perform and the sites in which they will be found. Finally, the strength of binding or affinity of the antibody to its antigen is important because the higher the affinity, the less the amount of antibody that will be necessary to eliminate the antigen.
These different characteristics of the antibodies occur at different times during the development of a mature antibody. This process is known as affinity maturation. The affinity maturation process varies not only in response to each individual immunogen, but also for every individual animal which is undergoing the immune response.
In recent years, it has been determined that avians and other animal species produce different immunoglobulins (Igs) than do mammals. In particular, mammals produce a unique series of Igs, including IgM, IgG, IgE and IgA among others. In the vertebrate classes of Amphibia, Reptilia and Aves, the primary Ig which is produced in the egg yolk is IgY. IgY is believed to be the evolutionary ancestor of IgG and IgE. Not much more, however, is known about IgY, especially with regard to its functional requirements and limitations (Warr et al.,
Immunology Today
, Vol. 16, No. 8, pp 392-298, 1995).
In the art, there is a process known as passive immunization which relates to the transfer of immunity from one species to another. For example, in a common form of passive immunization, an avian is immunized with one or more immunogens. Immunization with such immunogens induces an immune response in the avian. Antibodies to the immunogens are produced by the avian during the immune response. A large number of these antibodies become concentrated in the egg of the avian. Administration to an animal of the egg containing such antibodies, or administration of the purified antibodies themselves, causes that animal to become passively immunized to the corresponding immunogens due to the transfer of the antibodies. Such a passive immunization process is the subject of U.S. Pat. No. 4,748,018, assigned to DCV, Inc. and incorporated herein by reference.
The process of passive immunization using antibodies produced in the egg of an egg-producing animal requires, of course, the collection of antibody-containing eggs from an immunized avian. In this process, it is known in the art that the highest titers of antibodies are found in eggs produced at the early stages of the egg-laying cycle of an immunized avian. As time goes on after an immune response induction, antibody titers rise quickly, eventually peak and then fall off. The production of antibody titer in the eggs of an immunized avian has been charted to generally form a bell-shaped curve over the entire egg laying-life cycle of the avian (see R. Schade et al., ATLA, 19, pp. 403-419, 1991). Antibody titers can be somewhat maintained by revaccination. Either way, it is generally the practice in the art to collect eggs soon after vaccination or revaccination (i.e. within the first few (1-5) weeks) in order to obtain eggs having the highest antibody titers.
SUMMARY OF THE INVENTION
It is an object of this invention to increase the efficacy of one or more antibodies obtained from the egg of an avian which has been immunized against one or more immunogens The efficacy of the antibodies is increased by taking all lots of eggs produced for at least the first 30 weeks following immunization, wherein all lots of eggs contain antibodies produced in response to the immunization, and blending together these lots. The blending of eggs collected over such an extended period of time results in a more efficacious antibody when administered to a subject animal.
In particular, the invention is directed to a method for increasing efficacy of an antibody in a subject comprising:
A. inducing an immune response in an egg-producing animal with at least one immunogen;
B. collecting eggs from the egg-producing animal for a predetermined period of time following induction of said immune response;
C. processing all of the collected eggs together to form a blended mix; and
D. administering to the subject a portion of the blended mix which contains an effective titer of said antibody.
The invention is additionally directed to an antibody-containing substance comprising an effective titer of at least one antibody, said antibody comprising all antibody structures produced within an animal over a predetermined period of time following induction of an immune response in said animal.
The invention is finally directed to an antibody-containing substance comprising an effective titer of at least one antibody, said antibody-containing substance comprising an egg product obtained from a blended mix of all eggs produced over a predetermined period of time by one or more egg-producing animals which have been immunized with at least one immunogen.
DETAILED DESCRIPTION OF THE INVENTION
Definitions
The term “egg or fraction thereof” means any whole egg (table, hyperimmunized or otherwise) or any product derived therefrom.
The term “egg product” refers to any substance which is produced from one or more eggs or fractions thereof.
The term “immune-egg or fraction thereof” means one or more whole eggs or any product derived therefrom, obtained from egg producing animals which have been immunized and/or maintained in an immune state.
The term “antibody-containing substance” means any substance which contains at least one antibody produced by an immunized animal.
The term “egg-laying cycle” means the entire time span over which an egg-producing animal lays eggs prior to molting.
The term “egg lot” means a mixture of eggs which are collected from one or more egg-producing animals over a specific time-period after induction of an immune response, wherein the time-period is less than the entire egg-laying cycle.
The term “blended lot of eggs” means a mixture of more than one egg lots.
The term “blended egg product” means egg product derived from a blended lot of eggs.
The term “effective amount of egg product” means an egg product containing an effective antibody titer. In particular, the amount of antibody is effective when the egg product is administered to a subject animal.
The term “hyperimmunization” means exposure to one or more antigens such that an immune response is elevated and maintained above the natural unexposed state.
The term “genetic vaccine” refers to a nucleic acid vaccine which is generally produced by recombinant technologies and which may elicit an immune response.
The term “administer” means any method of providing a subject with a substance, including orally, intranasally, parenterally (intravenously, intramuscularly, or subcutaneously), r
DCV, Inc.
Krikelis Basil S.
Salimi Ali R.
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