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 while reducing the risk of said subject thereby developing at least one chronic immune-mediated disorder, 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 one or more of the screened immunization schedules than according to one or more of the other screened immunization schedules, each such immunogen so administered being hereafter referred to as an “early” immunogen regardless of its time of administration in the latter schedule(s),
• where at least one of said chronic immune-mediated disorders is diabetes,
• where said mammalian subject is or said mammals are humans,
• where at least one of said early immunogens is one other than BCG or pertussis immunogen, 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 to the subject at about the same dates, relative to the date of birth as it was administered to the mammals in 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 immunizing a mammalian subject while reducing the risk of said subject thereby developing at least one 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 one or more of the screened immunization schedules than according to one or more of the other screened immunization schedules, each such immunogen so administered being hereafter referred to as an “early” immunogen regardless of its time of administration in the latter schedules,
• where at least one of said chronic immune-mediated disorders is diabetes,
• where said mammalian subject is or said mammals are humans,
• where at least one of said early immunogens is one other than BCG or pertussis immunogen, 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 first administered to the subject at a date earlier, relative to the date of birth of the subject, than the relative date it was first administered to mammals in said higher risk screened immunization shedule.

A method of immunizing a mammalian subject while reducing the risk of said subject thereby developing at least one 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 one or more of the screened immunization schedules than according to one or more of the other screened immunization schedules, each such immunogen so administered being hereafter referred to as an “early” immunogen regardless of its time of administration in the latter schedules,
• where one of said chronic immune-mediated disorders is diabetes,
• where said mammalian subject is or said mammals are humans,
• where at least one of said early immunogens is one other than BCG or pertussis immunogen, and
• (II) immunizing said subject according to a subject immunization schedule, according to which, during a first period corresponding to the first 112 days after birth, at least one of said early infectious disease-causing organism-associated immunogens is administered (i) at least as often as during said first period according to said lower risk screened immunization schedule, or (ii) more often than during said first period according to said higher risk screened immunization schedule.