Local delivery of antibodies to the reproductive tract can block sperm and sexually transmitted pathogens to prevent pregnancy or infection. Recent advances in monoclonal antibody technology make it possible to produce large quantities of inexpensive antibodies. This design directed proposal will develop and test formulations for topical antibody delivery to the vagina. We will examine unique vaginal formulations that provide a range of the duration of protection; an immediate acting formulation, a slower acting solid dosage form, and a controlled release vaginal ring that lasts for up to one month will be investigated. Product concepts will be evaluated for efficacy in an animal model of HSV vaginal transmission. PROPOSED COMMERCIAL APPLICATION: There is a significant market in the U.S. (>$600 million) and the world (>$1.5 billion) for a safe and effective microbicide that prevent STDs. Successful commercialization of vaginal microbicides could save the U.S. a significant amount of the $17 billion spent annually on medical costs for the treatment of STDs.
Public Health Relevance Statement: Project Terms: laboratory mouse; biotechnology; antiviral agent; topical drug application; drug design /synthesis /production; hybrid antibody; monoclonal antibody; antiviral antibody; disease /disorder model; genital herpes; Alphaherpesvirinae
