Background/Purpose: Cervical neoplasia is increased in women with SLE presumably due to cervical infection with oncogenic Human Papillomavirus (HPV) types which persist in an immunosuppressed host. Vaccinating women with SLE against HPV is thus an important part of health prevention in this population.  Gardasil® immunizes against the HPV types that cause the majority of cervical cancer (types 16 and 18) and genital warts (types 6 and 11), and has been shown to be protective against these HPV-related diseases.

Methods: For this ongoing trial, twenty women ages 18-50 years with a history of mild to moderate SLE and minimally active or inactive SLE disease received Gardasil® at the standard dosing schedule (0, 2 months, 6 months). This study was approved by the Human Investigation Committee at Wayne State University and the U.S.  Food and Drug Administration. Patients were excluded if they had active disease (SELENA-SLEDAI >2), a history of severe disease, deep venous thrombosis, were on >400 mg/day of hydroxychloroquine, were on  >15 mg/day of prednisone, or had active infections. To date, 20 patients have completed the second vaccine shot. Patients were monitored for adverse events (AE), SLE flare, and generation of thrombogenic antibodies and thrombosis.

 Results: The women in the study were predominantly African-American (75%), mean age 39 years with mean age at diagnosis of SLE at 29.8 years. All patients met American College of Rheumatology (ACR) criteria for SLE; 25% had a history of smoking, 95% had 4 or more sexual partners, 35% had a history of sexually transmitted diseases, and only 21% used condoms on a regular basis. History of abnormal pap smears occurred in 40%, ranging from ASCUS (atypical glandular cells of undetermined significance) to CIN 3 (cervical intraepithelial neoplasia grade 3). Most of our patients had multiple comorbidities in addition to SLE. Vaccine site reactions (VSRs) occurred in 50%, 90% being mild, with the most common reaction being pain. This compares favorably to data from the current prescribing label showing frequency of VSRs in normal women to be 83.9% for Gardasil® vs. 75.4% for controls. For the non-vaccine site adverse events (nvAE), 90% of our cohort experienced at least one nvAE; there were 105 nvAEs reported from 18 patients and 90% of these nvAEs were mild.  There was one serious AE related to underlying osteoarthritis and cervical disc disease. The most common nvAEs reported were musculoskeletal (n=28) followed by cardiopulmonary (n=25), headache (n=21), and dermatologic (n=19). None of the nvAEs were related to vaccine or SLE. There was no flare of SLE, thrombosis, or generation of thrombogenic antibodies in any patient.

Conclusion: Preliminary data from our study shows that Gardasil® vaccine is safe to use in women with SLE. Vaccine site reactions are not increased in SLE patients. Other than vaccine site reactions, there were no related short term adverse events.  Gardasil® vaccine administration did not result in any lupus flare or thrombosis.  Women with SLE should be immunized with Gardasil® vaccine as part of their health prevention program, particularly since this population is at increased risk for HPV-related cervical dysplasia.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/safety-of-gardasil-vaccine-in-systemic-lupus-erythematosus/