Method and composition for an early vaccine to protect against both common infectious diseases and chronic immune mediated disorders or their sequelae

A method of immunizing a mammalian subject which comprises:

• (I) screening a plurality of immunization schedules, by
• (a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
• (b) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),
• where the first dose of at least one infectious disease-causing organism associated immunogen given to both groups is given sooner after birth according to the first screened immunization schedule than according to the second schedule (each such immunogen so administered to said first group being hereafter referred to as an “early” immunogen regardless of its time of administration in the second group), and
• (II) immunizing said subject according to a subject immunization schedule, according to which at least one of said early infectious disease-causing organism-associated immunogens is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

A method of immunizing a mammalian subject which comprises

• (I) (a) immunizing a first group of mammals with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule,
• (b) immunizing at least a second group of mammals with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, the first and second groups being of the same species, and
• (c) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups,
• as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),
• where the first dose of at least one infectious disease-causing organism-associated immunogen given to both groups is given sooner after birth according to the first screened immunization schedule than according to the second schedule (each such immunogen so administered to said first group being hereafter referred to as an “early” immunogen regardless of its time of administration in the second group), and
• (II) immunizing said subject according to a subject immunization schedule, according to which at least one of said early, infectious disease-causing organism-associated immunogens is administered in accordance with said lower risk screened immunization schedule, resulting in a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule.

A method of protecting a mammalian subject, by immunization, against at least one infectious disease while reducing the risk of said subject thereby developing a chronic immune mediated disorder, which comprises:

• (I) screening a plurality of immunization schedules, by
• (a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
• (b) comparing the effectiveness of said first and second screened immunization schedules in protecting against or inducing a chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the risk of developing said chronic immune mediated disorder(s),
• where the first dose of at least one infectious disease-causing organism associated immunogen given to both groups is given sooner after birth according to the first screened immunization schedule than according to the second schedule (each such immunogen so administered to said first group being hereafter referred to as an “early” immunogen regardless of its time of administration in the second group), and
• (II) immunizing said subject according to a subject immunization schedule, according to which at least one of said early infectious disease-causing organism-associated immunogens is administered in accordance with said lower risk screened immunization schedule, which administration is associated with a lower risk of development of said chronic immune-mediated disorder(s) than when said immunogen was administered according to said higher risk screened immunization schedule,
• at least one of the immunogens of (II) being protective against said infectious disease when administered according to aid third immunization schedule, said third schedule presenting a reduced risk of said subject developing a chronic immune mediated disorder relative to said second schedule.

A method of immunizing a mammalian subject which comprises:

• (I) screening a plurality of immunization schedules, by
• (a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
• (b) comparing the incidence, frequency, prevalence, or time of onset of said chronic immune-mediated disorder in the first group with that in the second group,
• where the first dose of at least one immunogen given to both groups is given (i) sooner after birth according to the first screened immunization schedule than according to the second schedule (each such immunogen so administered to said first group being hereafter referred to as an “early” immunogen regardless of its time of administration in the second group), or (ii) according to the first screened immunization schedule when the mammals of the first group are less than 42 days old (each such immunogen is administered to said first group being hereafter referred to as a “pre-42” immunogen regardless of its time of immunization in the second group);
• (II) immunizing said subject according to a subject immunization schedule, according to which at least one of said early or pre-42 immunogens is administered in accordance with said first screened immunization schedule, and is associated with a lower incidence, frequency, or prevalence, or slower onset, of a chronic immune-mediated disorder than when said immunogen was administered according to said second screened immunization schedule.

A business method for developing safer methods of protecting humans against infectious diseases by immunizing humans with one or more doses of one or more immunogens which induce protective immunity to one or more infectious diseases when administered according to one or more immunization schedules, said method comprising

• I. evaluating the association between said immunization schedule and one or more chronic immune mediated disorders by
• a) comparing the incidence, prevalence or frequency of a chronic immune mediated disorder in a group comprising humans where the majority receive an immunization schedule comprising said one or more immunogens to that in a control group comprising humans where the majority receive a different immunization schedule, or
• b) comparing the risk of said chronic immune mediated disorder associated between two or more immunization schedules,
• where the comparisons each comprise a time span of at least one year after the administration of said one or more immunogens, and
• II. determining one or more methods of immunization to allow safe immunization with said immunogenic agent reflective of the analysis from I.

A business method for developing safer methods of protecting humans against infectious diseases by immunizing humans with one or more doses of one or more immunogens which induce protective immunity to one or more infectious diseases when administered according to one or more immunization schedules, said method comprising

• (I) screening a plurality of immunization schedules, by
• (a) identifying a first group of mammals and at least a second group of mammals, said mammals being of the same species, the first group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a first screened immunization schedule, and the second group of mammals having been immunized with one or more doses of one or more infectious disease-causing organism-associated immunogens according to a second screened immunization schedule, each group of mammals having been immunized according to a different immunization schedule, and
• (b) comparing the incidence, prevalence or frequency of at least one chronic immune-mediated disorder in said first and second groups, as a result of which one of said screened immunization schedules may be identified as a lower risk screened immunization schedule and the other of said screened schedules as a higher risk screened immunization schedule with regard to the incidence or severity of said chronic immune mediated disorder(s), and
• II. selecting an immunization schedule which protects humans against such infectious disease, but would be expected to result in a reduced incidence, prevalence or frequency of said disorder relative to that observed in at least one of said groups.