United States Patent:   6,045,786

Assignee:  Johns Hopkins University (Baltimore, MD)

Filed:  February 1, 1993

Certain antibody molecules are so stable and so potent at immobilizing sperm as well as the pathogens for sexually transmitted diseases (STDs) that they make possible new prophylactic contraceptive methods: (a) for men, a skin lotion containing antibodies against sperm and against STD pathogens to be applied to the penis and external genitals during sexual activity, thereby delivering prophylactically effective doses of antibodies to virtually all areas of skin and epithelia across which most STDs, including AIDS, are usually transmitted, and, during vaginal intercourse, the penis will deliver a contraceptively reliable dose of the antibodies to the cervical region of the vagina; and (b) for women, intrauterine devices (IUDs) and intravaginal devices (IVDs) that release antibodies into the uterus or into the vagina to provide continuous protection against pregnancy and STDs for periods of months to years.

SUMMARY OF THE INVENTION

Each embodiment of this invention includes a selection of one or more antibodies that best suits the desires of an individual user. For protection against the exchange of sperm (contraception) one or more antibodies that immobilize sperm in mucus are included. Similarly, for each toxin or STD pathogen for which protection is desired, one or more antibodies are included that will immobilize that toxin or STD pathogen in mucus. In each embodiment, enough of each antibody is included to deliver a dose sufficient to exert the desired immobilizing effect(s).

In one embodiment, suitable for men, the selection of antibodies desired by the user is incorporated in a pharmaceutically acceptable lotion to be applied, during sexual activity, to the external genitals and to any other area of skin or epithelium where protection against sperm, toxins, and/or STD pathogens is desired: The lotion can be directly applied by hand to all areas of skin in need of protection and indirectly by the penis and fingers to all internal mucus epithelial surfaces that may require protection (e.g., vagina, mouth, rectum).

In another embodiment, suitable for women, the selection of antibodies is incorporated in a sustained release device for insertion, and retention, in the vagina, an Intra-Vaginal Device, IVD, for the sustained release of the selection of antibodies desired by the user: such an IVD can readily be inserted, and removed by the user without the assistance of trained personnel.

In another embodiment suitable for women, the selection of antibodies is incorporated in a sustained release device for insertion and retention in the uterus, an Intra-Uterine Device, IUD, for the sustained release of the selection of antibodies desired by the user.

In another embodiment of the invention, the selection of antibodies desired by the user can be included in any of several existing contraceptive methods to enhance their contraceptive reliability and/or to add to them prophylactic efficacy against STDs and toxins e.g. sustained release devices for delivering the selection of antibodies can be incorporated in IUDs, IVDs, and cervical caps, including those devices that release hormones (e.g., progestins and estrogens) as active ingredients.

In another embodiment of the invention, the selection of antibodies desired by the user can be included in any of several detergent-based, or detergent-enhanced, prophylactic contraceptives similar to those now available, (e.g., vaginal suppositories, jellies, creams, tablets, and foams; diaphragm plus jelly, the "sponge", and detergent-coated condoms) to extend the duration of protection and to enhance protection against STD pathogens, especially detergent-resistant toxins and STD pathogens.

In yet another embodiment of this invention, existing detergent-based or detergent-enhanced topical and barrier contraceptives (e.g., vaginal suppositories, jellies, creams, tablets, and foams; diaphragm plus jelly, the "sponge", and condoms) can be converted to detergent-free methods for individuals who are highly irritated by detergents by substituting an appropriate selection of contraceptive and/or prophylactic antibodies for the detergent.

Claim 1 of 8 Claims

1. A method of prophylaxis in a female mammal which comprises continuously introducing into the vaginal cavity or uterus of said female mammal, over a prolonged period of time at a controlled rate a prophylactically effective amount of at least one pan semen antibody capable of binding, directly or indirectly, to cells and pathogens in semen, thereby trapping said cells and pathogens in semen, including sexually transmitted disease pathogens and cells infected with sexually transmitted disease pathogens, in mucus secretions present in said vaginal cavity or uterus;

by means of a biologically compatible prolonged released carrier therefor,

wherein said at least one pan semen antibody is contacted with and binds, directly or indirectly, to said cells and pathogens in semen and thereby effects said trapping.

____________________________________________
If you want to learn more about this patent, please go directly to the U.S. Patent and Trademark Office Web site to access the full patent.