Field of the Invention
This invention relates to the treatment of humans with immunodeficiency disorders, who exhibit reduced or inadequate response to vaccines. More specifically, this invention describes method of consuming a medical food to activate the immune system before, during, or after vaccination. This enables the immune system to respond better, and produce a higher antibody immunity titer than would otherwise be achieved.
Description of Related Art
Immunodeficiency disorder refers to a heterogeneous group of over 130 disorders that result from defects in immune system development and/or function. Immunodeficiency disorders are broadly described as disorders of adaptive immunity (i.e., T-cell, B-cell or combination) or of innate immunity (e.g., phagocyte and complement disorders).
The population incidence of immunodeficiency disorders is difficult to quantify because many cases are not detected or treated. The person simply functions at a lower level, and repeatedly suffers from infections.
Although the clinical manifestations of immunodeficiency disorders are highly variable, most disorders involve at least an increased susceptibility to infection.
T cells and B cells are the primary cells of the adaptive immune system. B cells mediate antibody production and, therefore, play a major role in antibody-mediated immunity. Defects relating to B-cell development and/or maturation result in antibody-deficiency disorders.
T cells govern cell-mediated immune responses. Defects occurring at any stage of T-cell development, differentiation and maturation lead to T-cell (cellular) immunodeficiency disorders. Since B-cell-mediated antibody production requires intact T-cell function, most T-cell defects lead to combined (B- and T-cell) immunodeficiency disorders.
There are two generally recognized classes of immunodeficiency disorder: primary and secondary. Within this disclosure, we are defining a third class, which is high exposure immunodeficiency disorder.
Primary immunodeficiency disorder (PID) refers to a heterogeneous group of disorders characterized by poor or absent function in one or more components of the immune system. Most PIDs result from inherited defects in immune system development and/or function; however, acquired forms have also been described. Routine vaccinations at an early age may not work for a child with PID.
Secondary immunodeficiency disorder (SID) results from other causes. Examples include viral or bacterial infections, malnutrition, or treatment with drugs that induce immunosuppression. An excess of cortisol has been cited as a contributing factor.
High exposure immunodeficiency disorder (HEID) describes a situation wherein a person with a normal immune response is subjected to a high risk environment. Examples include medical students, hospital employees, and viral testing personnel. For these people, a high response titer is advantageous.
A person with any immunodeficiency disorder is in danger because he/she is vulnerable to opportunistic pathogens. The titer (which quantifies the level of immunity achieved by vaccination) may be well below normal. In some cases, the vaccination itself might cause a problem.
The treatment of immunodeficiency disorder is complex and generally requires both supportive and definitive strategies. Antibiotics and antifungals are commonly recommended for many immunodeficiency disorders to prevent the frequency and severity of infections.
The mainstay of therapy for most B-cell (antibody-deficiency) disorders is intravenous (IV) or subcutaneous Ig replacement therapy. Many patients will require this treatment indefinitely.
Vaccines are the primary tool to enhance the immune system. Vaccines present an inactivated antigen to the immune system, which then produces the appropriate protective antibodies. Vaccines are specific to a disease, but may be given in combination injections. Because the antigen is inactive, the process is safe.
Adjuvants are often used with a vaccine to stimulate the immune system. The only approved adjuvant in the United States is aluminum, which is a neurotoxin. The aluminum is present as an aluminum salt (such as aluminum hydroxide, aluminum phosphate, or aluminum potassium sulfate).
A superior way to activate stimulate the immune system would be a natural food, rather than a neurotoxin. A food-based adjuvant works to build the immune system, rather than just stimulate it.
There is a need for a medical food that builds immune function before, during, or after vaccination. The targeted response is a higher titer for persons with immunodeficiency disorders. A medical food can improve vaccine response with or without an aluminum adjuvant.
The potential for immune enhancement by transfer factor and lactic acid generating bacteria was first cited by Ramaekers [application Ser. No. 11/237,216, filed Sep. 27, 2005, full text version, paragraph 0180, line 1-2], which states, “In high risk cattle that are not preconditioned such as the heifers in these studies, direct stimulation of the immune system with stress formula along with vaccine administration appeared to indeed enhance the level of immunity against BRD.”