United States Patent:  6,099,853

Assignee:  Protein Express (Cincinnati, OH)

Filed:  September 4, 1997

This invention is directed to a suppository-based vaccine delivery system for immunizing against urogenital infectious disease in humans and a method for treating same. More particularly, this invention is directed to a suppository-based vaccine delivery system for the prophylaxis against urogenital infectious diseases, such as urinary tract infections. The suppository-based vaccine delivery system is comprised of a vaccine comprised of inactivated bacteria which originate from cultures of 8 to 14 uropathogenic bacteria strains of the species: Escherichia coli, Klebsiella pnieumoniae, Proteus mirabilis, Proteus morganii, and Streptococcus faecalis; and polyethylene glycol suppository base; wherein the suppository is adapted to be inserted into a bodily orifice of a human so as to allow the suppository to be in contact with tissue of the bodily orifice to facilitate transfer of suppository material therethrough.

SUMMARY OF THE INVENTION

According to the present invention, there is provided a intravaginally administered suppository-based vaccine delivery system for prophylaxis against urogenital infectious diseases, such as urinary tract infections.

Further according to the present invention, there is provided a suppository-based vaccine delivery system for the prophylaxis against urogenital infectious diseases, such as urinary tract infections wherein the vaccine is in contact with the vaginal mucous membrane for a sufficient period of time to enhance the immune response.

Still further according to the present invention, there is provided a suppository-based vaccine delivery system for the prophylaxis against urogenital infectious diseases, such as urinary tract infections, wherein the vaccine is easily administered, does not require the patient to lie in a supine position for an extended period of time after receiving the vaccination, and is suitably administered by the patient for primary and routine booster requirements.

Still further according to the present invention, there is provided a suppository-based vaccine delivery system for prophylaxis against urogenital infectious diseases, such as urinary tract infections in humans, said suppository comprising: a vaccine comprised of inactivated bacteria which originate from cultures of 8 to 14 uropathogenic bacteria strains isolated from the urine of persons suffering from a urinary tract infection of the species: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus morganii, and Streptococcus faecalis, and are present in an amount of about 50 million to about 5 billion germs of each strain per suppository, wherein one-half to three-quarters of the strains used belong to Escherichia coli species; and polyethylene glycol suppository base; wherein the suppository is adapted to be inserted vaginally so as to allow the suppository to be in contact with vaginal mucous membrane to facilitate transfer of suppository material therethrough.

An advantage of the present invention is the provision of a suppository-based vaccine delivery system for the prophylaxis against urogenital infectious diseases, such as urinary tract infections, wherein the vaccine is in contact with the vaginal mucous membrane for a sufficient period of time to enhance the immune response.

Another advantage of the present invention is the provision of a suppository-based vaccine delivery system for the prophylaxis against urogenital infectious diseases, such as urinary tract infections, wherein the vaccine is easily administered, and does not require the patient to be in a supine position for an extended period of time after receiving the vaccination.

Another advantage of the present invention is the provision of a suppository-based vaccine delivery system wherein the vaccine is suitably administered by the patient.

Another advantage of the present invention is the provision of a suppository-based vaccine delivery system wherein the administration of the vaccine is relatively painless.

Yet another advantage of the present invention is the provision of a suppository-based vaccine delivery system wherein sIgA--specific stimulation from mucosal vaccination allows immune responses to specifically keep bacterial colonization from occurring, instead of fighting the infection once it has colonized.

Yet another advantage of the present invention is the provision of a suppository-based vaccine delivery system wherein the patient may self-administer booster vaccinations periodically.

Claim 1 of 28 Claims

1. A suppository-based vaccine delivery system for enhancing resistance to urogenital disease in humans, said suppository comprising:

(a) a vaccine comprised of inactivated bacteria which originate from cultures of 8 to 14 uropathogenic bacteria strains of the species: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Proteus morganii, and Streptococcus faecalis, and are present in an amount of about 50 million to about 5 billion germs of each strain per milliliter, wherein one-half to three-quarters of the strains used belong to Escherichia coli species; and

(b) polyethylene glycol suppository base,

wherein the suppository is adapted to be inserted into a bodily orifice of a human so as to allow the suppository to be in contact with tissue of the bodily orifice to facilitate transfer of suppository material therethrough.

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