Off-Label HPV Vaccination in a 67-Year-Old Woman with Recurrent HPV Infection

Human Papillomavirus (HPV) is a highly prevalent sexually transmitted infection associated with malignancies of the cervix, vulva, and vagina. While prophylactic vaccination with Gardasil®9 is FDA-approved through age 45, no clinical trials have evaluated its use in older adults who remain sexually active and at risk for HPV-related cancers. We describe the case of a woman who presented with recurrent high-risk HPV and received the three-dose Gardasil®9 series off-label at the age of 67. Following vaccination, her cervical cytology was negative for HPV and subsequent colposcopy did not demonstrate any evidence of intraepithelial lesion or malignancy. As this is a single case report, this temporal association cannot establish that vaccination caused viral clearance. Nonetheless, this case raises important questions regarding age-based HPV vaccination limits. Immunosenescence in older populations may impair viral clearance and could increase cumulative risk of progression from dysplasia to malignancy. Vaccination may therefore serve both prophylactic and potentially therapeutic roles; however, this must be evaluated in further controlled studies. This case highlights the need for further research into HPV vaccination in patients over the age of 45 years with or without history of HPV infection.