Objectives To evaluate the immunogenicity and safety of GARDASIL, a quadrivalent human papillomavirus (HPV) vaccine, in patients with systemic lupus erythematosus (SLE).
Methods Women with SLE aged 18–35 years who had stable disease were recruited to receive GARDASIL vaccination and an equal number of age-matched healthy women were also vaccinated. Seroconversion rates of antibodies to HPV serotypes 6, 11, 16 and 18 at months 7 and 12 and adverse events (AEs) were compared between patients and controls. The rate of disease flares in SLE participants was compared with matched SLE controls.
Results 50 patients with SLE and 50 healthy controls were studied. The mean age and disease duration of the patients was 25.8±3.9 years and 6.6±4.5 years, respectively. At month 12 the seroconversion rates of anti-HPV serotypes 6, 11, 16 and 18 in patients and controls were 82%, 89%, 95%, 76% and 98%, 98%, 98%, 80%, respectively. In patients with SLE there were no significant changes in the titres of anti-dsDNA, complements, anti-C1q and SLE Disease Activity Index scores from baseline to months 2, 7 and 12. There was one mild/moderate SLE flare at months 0–2, two mild/moderate flares at months 3–6 and six mild/moderate and two severe flares at months 7–12. Disease flares in patients with SLE occurred at a similar frequency to that of 50 matched SLE controls (0.22/patient/year vs 0.20/patient/year, p=0.81). Injection site reaction was the commonest AE (5%), and the incidence of AEs was comparable between patients with SLE and controls.
Conclusions The quadrivalent HPV vaccine is well tolerated and reasonably effective in patients with stable SLE and does not induce an increase in lupus activity or flares.
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Funding Merck, Sharp & Dohme (MSD) Ltd Asia.
Competing interests This investigator-initiated study supported by MSD (Asia) provided the investigators with samples of GARDASIL for the participants and performed assays of the anti-HPV antibodies at the central Merck laboratory in the USA. MSD was not involved in the design and conduct of the study. The principal investigator is independent of the sponsoring drug company in the data analysis. He has full access to all of the data and takes responsibility for the integrity of the data and the accuracy of the data analysis. None of the authors has any financial interests in the sponsoring drug company.
Patient consent Obtained.
Ethics approval The protocol was approved by the Research and Ethics Committee of Tuen Mun Hospital and registered in the US ClinicalTrials.gov (number NCT00911521).
Provenance and peer review Not commissioned; externally peer reviewed.