Sex: F
Vaccine: HPV9
Symptoms: Condition aggravated, Conjunctivitis bacterial, Nausea, Off label use, Optical coherence tomography abnormal
Clinical narrative: presumed conjunctival papilloma treated with off-label use of the HPVvaccine (Gardasil 9); Literature Report.  This literature marketed report has been received from the authors of a published literature article, entitled as stated above, and refers to a 55-year-old female immunocompromised patient with human immunodeficiency virus (HIV) infection, receiving highly active antiretroviral therapy without acquired immunodeficiency syndrome (AIDS) (CD4+ T-cell count, 471 cells), presented for examination. A pedunculated, floppy, conjunctival lesion with multiple vessel loops was noted in the inferior fornix of the left eye, consistent with conjunctival papilloma. A left corneal scar was noted, from prior herpetic keratitis. Visual acuity was 20/25 in the right eye and 20/60 in the left. The fundus was unremarkable. She was prescribed oral cimetidine, 800 mg 3 times daily, and topical 5-fluorouracil, 1%, 4 times daily for 2-week intervals with 2-week suspension periods. She was not able to tolerate cimetidine owing to nausea and developed bacterial conjunctivitis after 2 cycles of 5-fluorouracil. Therefore, all medications were discontinued. The patient refused excision, and 5-fluorouracil injections were started. Minimal change in lesion size was observed after 4 injections (25 mg/0.5 mL, 2 weeks apart). Slitlamp image of the left eye demonstrated a lesion in the inferotemporal fornix, which extended to the lower palpebral conjunctiva. An anterior segment optical coherence tomography (AS-OCT) image showed thickened hyperreflective epithelium with corrugated surface. A mushroom-like appearance of the lesion was noted. As the patient was still deferring surgery, off-label use of the HPV vaccine was discussed as a therapeutic modality, and the patient agreed. On unknown dates, 10 weeks after the last 5-fluorouracil injection, the patient was administered 2 doses, 6 weeks apart, of intramuscular hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # and expiration date were not reported), in the right arm (off label use). After the first injection, a substantial reduction in the size of the lesion was noted. One month after the second injection, the lesion had completely resolved. Slitlamp image of the left eye showed complete clinical resolution of the lesion after receiving 2 intramuscular doses of systemic hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 6 weeks apart. The AS-OCT image showed a normalized, nonthickened conjunctival epithelium following treatment with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No adverse effects following the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) were observed.  The authors discussed that since they did not have biopsy confirmation of the treated lesion, this study demonstrated resolution of a presumed conjunctival papilloma treated with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in an immunocompromised woman. The highly active antiretroviral therapy administered did not vary and the 5-fluorouracil treatment did not have any apparent effect, but these might have had a role in the resolution of the papilloma independent of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). Furthermore, without histologic confirmation, the distinction from conjunctival intraepithelial neoplasia was not clear, but the HPV vaccine has also been associated with a reduction in benign and malignant skin lesions. The authors summarized that this case report suggested that the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) may be an alternative treatment for conjunctival papilloma.  A copy of the published article is attached as further documentation of the patient's experience.