imiquimod + 9-valent HPV vaccine

The combination of imiquimod and the 9-valent human papillomavirus (HPV) vaccine is a therapeutic intervention utilizing a "prime and pull" strategy for treating high-grade cervical intraepithelial neoplasia (CIN 2/3). Developed and evaluated by researchers at Yale University, this approach involves systemically "priming" the immune system with the 9-valent HPV vaccine (Gardasil 9) to generate a T-cell response against oncogenic HPV types. Subsequently, imiquimod, a small molecule Toll-like receptor 7 (TLR7) agonist, is applied locally as a vaginal suppository to "pull" or recruit these vaccine-induced T cells to the site of the cervical lesion. This strategy aims to induce regression of pre-neoplastic lesions to a lower grade (CIN 1 or less) without the need for surgical excision. Results from a Phase II trial (NCT02864147) published in 2024 showed high regression rates, although the combination did not meet its prespecified statistical efficacy endpoint compared to surveillance in that specific study population.

Brand names

Gardasil 9Gardasil9Gardasil-9Aldara

Other names

9vHPV + imiquimodPrime and Pull strategy9-valent human papillomavirus vaccine + imiquimod