A Prebiotic Hydrogel to Prevent Cervical Cancer by Optimizing the Vaginal Ecology and Reducing Oncogenic Biological Risk Factors in Women Across Global Health Care Access

Abstract

PURPOSE Persistent oncogenic, high-risk human papillomavirus (hrHPV) is a leading cause of cervical cancer and driven by vaginal dysbiosis and mucosal irritation. There is a high need for a product to optimize vaginal ecology and decrease biological risk factors of hrHPV persistence and cervical cancer. METHODS A prebiotic hydrogel (PreBioGyn) was designed for cervical cancer prevention to support the cervicovaginal ecology and anti-viral function. PreBioGyn was compared to over-the-counter (OTC) acidifying vaginal gels RepHresh and Trimosan for impact on: (1) in-vitro growth of L. crispatus—a Lactobacillus essential for the healthy vaginal biome; (2) inhibition of P. bivia—a pathobiont characteristic of vaginal dysbiosis and directly linked to hrHPV reactivation and cervical cancer spread; (3) mucosal irritation potential measured as daily mucus production by slugs (Arion lusitanicus) after 5-day intermittent product exposure; and (4) osmolality and mucoadhesion essential for compatibility with the cervicovaginal mucosal barrier (ability of gel to interdigitate with mucins in vivo). RESULTS Exposure to PreBioGyn for 24 hours completely suppressed P. bivia while sustaining L. crispatus growth which was recovered at 100 ± 1%. Trimosan was bactericidal to L. crispatus within 4 hours incubation and RepHresh within 24 hours of incubation. The mucosal irritation potential of PreBioGyn equaled negative controls, whereas the OTC acidifying-gels resulted in greater irritation potential with > 2-fold mucus production versus the control ( P < .05). The PreBioGyn formula was iso-osmotic to the human vagina (280 mOsmo/kg), while RepHresh was hyper- (1,400 mOsmo/kg) and Trimosan - hypoosmotic (81 mOsmo/kg). The mucoadhesion index of PreBioGyn (10 ± 2.0) was higher ( P < .05) than that of RepHresh (1 ± 0.2) and Trimosan (1 ± 0.3). CONCLUSION Our results provide preclinical evidence for the biocompatibility and safety of the Pre-BioGyn gel. The prebiotic PreBioGyn vaginal gel improved microbiota parameters essential for cervical cancer prevention, compared to leading OTC acidifying-gels. PreBioGyn may offer a simple, affordable user-directed cervical cancer prevention intervention.