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

Abstract

A method of immunization, and compositions therefor, are provided for substantially preventing or reducing the symptoms of at least one infectious disease and at least one chronic immune mediated disorder. An immunogenic challenge which supplements the normal childhood immunization schedule can help ensure the proper maturation of the immune system and prevent the development of chronic immune mediated disorders, such as immune-mediated diabetes or SLE.

1 . An improved method of marketing a vaccine or vaccine kit, the method comprising selling, advertising, distributing, or marketing of a human vaccine, the improvement comprising aiding, assisting or directly informing the purchaser, practitioner, recipient or guardian of the recipient that information exists on the risk of human immunization associated with one or more vaccine immunogens where said information provides one or more comparisons comprising 
 A) the incidence, prevalence or frequency of at least one chronic immune mediated disorder in a first group comprising humans where the majority receive an immunization schedule comprising at least one said vaccine immunogen is compared relative to that in at least one other group comprising humans where the majority receive a different immunization schedule, and or    B) the risk in humans of at least one chronic immune mediated disorder associated with said immunization schedule is compared to at least one other immunization schedule of said one or more vaccine immunogens said information allows the informed to consider the risk and or risk benefit of immunization prior to immunization and allows for safer immunization.    
     
     
         2 . The method of  claim 1  where condition A. applies.  
     
     
         3 . The method of  claim 1  wherein at least one said chronic immune mediated disorder comprises diabetes mellitus and where the incidence, prevalence, frequency or risk was determined in the majority of humans after a time span of at least one year from the first difference between two immunization schedules.  
     
     
         4 . The method of  claim 1  wherein one schedule provides at least one dose of at least one immunogen at a later or earlier time from birth than the corresponding dose of the same immunogen is provided by another schedule.  
     
     
         5 . The method of  claim 1  wherein one immunization schedule provides at least one immunogen not provided by another screened schedule or fails to provide at least one immunogen provided by another screened schedule.  
     
     
         6 . The method of  claim 4  wherein said at least one immunogen is first administered in at least one schedule starting after 41 days after birth but before 180 days after birth.  
     
     
         7 . The method of  claim 5  wherein said at least one immunogen is first administered in at least one schedule starting after 41 days after birth but before 180 days after birth.  
     
     
         8 . The method of  claim 1  wherein at least one immunogen is given when said humans are less than 42 days old in at least one schedule.  
     
     
         9 . The method of  claim 4  wherein said at least one immunogen is given when said humans are less than 42 days old in at least one schedule.  
     
     
         10 . The method of  claim 5  wherein said at least one immunogen is given when said humans are less than 42 days old in at least one schedule.  
     
     
         11 . The method of  claim 1  where said comparison comprises information adjusted for at least one possible confounding variable selected from the group consisting of breast feeding, receiving antibiotics, the maternal age, family history of a chronic immune mediated disorder, maternal infections while the human was in utero, infections during the first 12 months of life, and size of the human at birth, gestational age of the human at birth, race, date of birth.  
     
     
         12 . The method of  claim 3  where said comparison comprises information adjusted for at least one possible confounding variable selected from the group consisting of breast feeding, receiving antibiotics, the maternal age, family history of a chronic immune mediated disorder, maternal infections while the human was in utero, infections during the first 12 months of life, and size of the human at birth, gestational age of the human at birth, race, date of birth.  
     
     
         13 . The method of  claim 6  where said comparison comprises information adjusted for at least one possible confounding variable selected from the group consisting of breast feeding, receiving antibiotics, the maternal age, family history of a chronic immune mediated disorder, maternal infections while the human was in utero, infections during the first 12 months of life, and size of the human at birth, gestational age of the human at birth, race, date of birth.  
     
     
         14 . The method of  claim 7  where said comparison comprises information adjusted for at least one possible confounding variable selected from the group consisting of breast feeding, receiving antibiotics, the maternal age, family history of a chronic immune mediated disorder, maternal infections while the human was in utero, infections during the first 12 months of life, and size of the human at birth, gestational age of the human at birth, race, date of birth.  
     
     
         15 . The method of  claim 9  where said comparison comprises information adjusted for at least one possible confounding variable selected from the group consisting of breast feeding, receiving antibiotics, the maternal age, family history of a chronic immune mediated disorder, maternal infections while the human was in utero, infections during the first 12 months of life, and size of the human at birth, gestational age of the human at birth, race, date of birth.  
     
     
         16 . The method of  claim 10  where said comparison comprises information adjusted for at least one possible confounding variable selected from the group consisting of breast feeding, receiving antibiotics, the maternal age, family history of a chronic immune mediated disorder, maternal infections while the human was in utero, infections during the first 12 months of life, and size of the human at birth, gestational age of the human at birth, race, date of birth.  
     
     
         17 . The method of  claim 1  where said comparison comprises information adjusted for the possible confounding effect from exposure to one or more vaccine immunogens.  
     
     
         18 . The method of  claim 3  where said comparison comprises information adjusted for the possible confounding effect from exposure to one or more vaccine immunogens.  
     
     
         19 . The method of  claim 6  where said comparison comprises information adjusted for the possible confounding effect from exposure to one or more vaccine immunogens.  
     
     
         20 . The method of  claim 7  where said comparison comprises information adjusted for the possible confounding effect from exposure to one or more vaccine immunogens.  
     
     
         21 . The method of  claim 9  where said comparison comprises information adjusted for the possible confounding effect from exposure to one or more vaccine immunogens.  
     
     
         22 . The method of  claim 10  where said comparison comprises information adjusted for the possible confounding effect from exposure to one or more vaccine immunogens.  
     
     
         23 . The method of  claim 4  where said disorder comprises at least one conventional organ specific autoimmune disorder and at least one of the following comprising at least one rheumatic disease/connective tissue disease, at least one autoimmune cytopenia, asthma.  
     
     
         24 . The method of  claim 2  wherein at least one said chronic immune mediated disorder comprises diabetes mellitus and where the incidence, prevalence, frequency or risk was determined in the majority of humans after a time span of at least one year from the first difference between two immunization schedules.  
     
     
         25 . The method of  claim 4  wherein at least one said chronic immune mediated disorder comprises diabetes mellitus and where the incidence, prevalence, frequency or risk was determined in the majority of humans after a time span of at least one year from the first difference between two immunization schedules.  
     
     
         26 . The method of  claim 5  wherein at least one said chronic immune mediated disorder comprises diabetes mellitus and where the incidence, prevalence, frequency or risk was determined in the majority of humans after a time span of at least one year from the first difference between two immunization schedules.  
     
     
         27 . The method of  claim 6  wherein at least one said chronic immune mediated disorder comprises diabetes mellitus and where the incidence, prevalence, frequency or risk was determined in the majority of humans after a time span of at least one year from the first difference between two immunization schedules.  
     
     
         28 . The method of  claim 7  wherein at least one said chronic immune mediated disorder comprises diabetes mellitus and where the incidence, prevalence, frequency or risk was determined in the majority of humans after a time span of at least one year from the first difference between two immunization schedules.  
     
     
         29 . The method of  claim 8  wherein at least one said chronic immune mediated disorder comprises diabetes mellitus and where the incidence, prevalence, frequency or risk was determined in the majority of humans after a time span of at least one year from the first difference between two immunization schedules.  
     
     
         30 . The method of  claim 9  wherein at least one said chronic immune mediated disorder comprises diabetes mellitus and where the incidence, prevalence, frequency or risk was determined in the majority of humans after a time span of at least one year from the first difference between two immunization schedules.  
     
     
         31 . The method of  claim 10  wherein at least one said chronic immune mediated disorder comprises diabetes mellitus and where the incidence, prevalence, frequency or risk was determined in the majority of humans after a time span of at least one year from the first difference between two immunization schedules.  
     
     
         32 . The method of  claim 1  where said disorder comprises at least one conventional organ specific autoimmune disorder and at least one of the following comprising at least one rheumatic disease/connective tissue disease, at least one autoimmune cytopenia, asthma.  
     
     
         33 . The method of  claim 6  where said disorder comprises at least one conventional organ specific autoimmune disorder and at least one of the following comprising at least one rheumatic disease/connective tissue disease, at least one autoimmune cytopenia, asthma.  
     
     
         34 . The method of  claim 9  where said disorder comprises at least one conventional organ specific autoimmune disorder and at least one of the following comprising at least one rheumatic disease/connective tissue disease, at least one autoimmune cytopenia, asthma.  
     
     
         35 . The method of  claim 12  where said disorder comprises at least one conventional organ specific autoimmune disorder and at least one of the following comprising at least one rheumatic disease/connective tissue disease, at least one autoimmune cytopenia, asthma.  
     
     
         36 . The method of  claim 1  wherein at least one immunogen is other than a live vaccine.  
     
     
         37 . The method of  claim 25  wherein at least one immunogen is other than a live vaccine.  
     
     
         38 . The method of  claim 30  wherein at least one immunogen is other than a live vaccine.  
     
     
         39 . The method according to  claim 3  wherein said at least one immunogen is other than a measles, mumps, rubella, BCG, or smallpox or pertussis immunogen.  
     
     
         40 . The method according to  claim 25  wherein said at least one immunogen is other than a measles, mumps, rubella, BCG, or smallpox or pertussis immunogen.  
     
     
         41 . The method according to  claim 30  wherein said at least one immunogen is other than a measles, mumps, rubella, BCG, or smallpox or pertussis immunogen.  
     
     
         42 . The method of  claim 1  where said at least one immunogen comprises at least one of the following, BCG, measles, mumps, rubella, diphtheria, pertussis,  Hemophilus influenza , tetanus, hepatitis B, polio, anthrax, plague, encephalitis, meningococcal, meningitis,  pneumococcus , typhus, typhoid fever,  streptococcus, staphylococcus, neisseria , lyme, cytomegalovirus (CMV), respiratory syncytial virus, Epstein Barr virus, herpes, influenza, parainfluenza, rotavirus, adenovirus, hepatitis A, NonA NonB hepatitis, varicella, rabies, yellow fever, smallpox, Japanese encephalitis, flavivirus, dengue, toxoplasmosis, cocidiomycosis, schistosomiasis, and malaria immunogens.  
     
     
         43 . The method of  claim 25  where said at least one immunogen comprises at least one of the following, BCG, measles, mumps, rubella, diphtheria, pertussis,  Hemophilus influenza , tetanus, hepatitis B, polio, anthrax, plague, encephalitis, meningococcal, meningitis,  pneumococcus , typhus, typhoid fever,  streptococcus, staphylococcus, neisseria , lyme, cytomegalovirus (CMV), respiratory syncytial virus, Epstein Barr virus, herpes, influenza, parainfluenza, rotavirus, adenovirus, hepatitis A, NonA NonB hepatitis, varicella, rabies, yellow fever, smallpox, Japanese encephalitis, flavivirus, dengue, toxoplasmosis, cocidiomycosis, schistosomiasis, and malaria immunogens.  
     
     
         44 . The method of  claim 30  where said at least one immunogen comprises at least one of the following, BCG, measles, mumps, rubella, diphtheria, pertussis,  Hemophilus influenza , tetanus, hepatitis B, polio, anthrax, plague, encephalitis, meningococcal, meningitis,  pneumococcus , typhus, typhoid fever,  streptococcus, staphylococcus, neisseria , lyme, cytomegalovirus (CMV), respiratory syncytial virus, Epstein Barr virus, herpes, influenza, parainfluenza, rotavirus, adenovirus, hepatitis A, NonA NonB hepatitis, varicella, rabies, yellow fever, smallpox, Japanese encephalitis, flavivirus, dengue, toxoplasmosis, cocidiomycosis, schistosomiasis, and malaria immunogens.  
     
     
         45 . The method according to  claim 1  where the difference in the incidence, prevalence, frequency, or risk is statistically significant.