Arthritis & Rheumatism, Volume 62,
November 2010 Abstract Supplement
Abstracts of the American College of
Rheumatology/Association of Rheumatology Health Professionals
Annual Scientific Meeting
Atlanta, Georgia November 6-11, 2010.
Immunogenicity of the Quadrivalent Recombinant HPV Vaccine in Female Systemic Lupus Erythematosus Patients Aged 9 to 26 Years.
Soybilgic2, Arzu, Onel1, Karen, Utset1, Tammy O., Alexander1, Kenneth A., Wagner-Weiner1, Linda
Women with SLE have higher rates of persistent HPV infections than healthy women. HPV vaccine is safe and effective in healthy females aged 926 years. There are no data on the immunogenicity of HPV vaccine in females with SLE.
To evaluate immunogenicity of recombinant quadrivalent HPV vaccine in female SLE patients aged 926 years.
Prospective, open-label, pre-post intervention study. All patients met ACR Criteria for SLE. Exclusion criteria: disease exacerbation within past 30 days resulting in >=6 points increase in SLEDAI, increase in corticosteroid dose, initiation of new immunosuppressive medication or hospitalization; rituximab in the past 6 months; current cyclophosphamide treatment; previous HPV vaccination; pregnancy. HPV vaccine was given at months 0, 2, 6. Patients were monitored by physical examination, SLEDAI, lupus laboratories at months 0, 2, 4, 6 and 7. Each patient's SLEDAIs and laboratory profile in the year prior to vaccine administration were used as controls for that patient. Antiphospholipid, anti-ENA, HPV antibodies were measured at months 0 and 7. Primary outcome measures were change in SLEDAI and mean geometric HPV antibody titers. The secondary outcome measure was induction of autoantibodies.
26 patients, ages 12 to 26 years, were enrolled. 24 and 19 patients received two and three doses of HPV vaccine, respectively. Seven patients dropped out of the study: 2 pregnancies, 1 non-compliant, 2 moved out-of-state, 2 secondary to increased arthralgias. 19 patients completed the study.
Type-specific immunoassays with type-specific standards were used to assess immunogenicity to each vaccine HPV type. These assays measured antibodies against neutralizing epitopes for each HPV type. The immunogenicity analyses were conducted in a per-protocol immunogenicity (PPI) patient population. This population consisted of individuals who were seronegative to the relevant HPV type(s) at enrollment, received all three vaccinations, and did not deviate from the study protocol in ways that could interfere with the effects of the vaccine.
Immunogenicity was measured by (1)the percentage of individuals who were seropositive for antibodies against the relevant vaccine HPV type, and (2) the Geometric Mean Titer (GMT) (reported as Mmu/ml). GMTs were measured at month-7 because across all populations in previous clinical trials anti-HPV antibody titers peaked at month-7. HPV Antibody was determined by test kits, and cutoff values for seropositivity were titers at or above 20, 16, 20 and 24 mMU/mL for HPV 6, 11, 16 and 18 respectively.
Of the 19 patients who completed the study,16 had samples available at month-7 for analysis. Seropositivity rates after three doses of the vaccine were 90.9%, 100%, 100%, and 92.3%, and GMT were 641.4, 587.1, 28.44, 422.0 mMu/ml for HPV 6,11,16 and 18 respectively. One patient who received rituximab after the first vaccine dose had no antibody response at month 7.
The recombinant quadrivalent HPV vaccine was immunogenic in females aged 926. Only one patient who received rituximab after the first vaccine dose had no antibody response. Limitation of our study was the relatively small sample size.
To cite this abstract, please use the following information:
Soybilgic, Arzu, Onel, Karen, Utset, Tammy O., Alexander, Kenneth A., Wagner-Weiner, Linda; Immunogenicity of the Quadrivalent Recombinant HPV Vaccine in Female Systemic Lupus Erythematosus Patients Aged 9 to 26 Years. [abstract]. Arthritis Rheum 2010;62 Suppl 10 :464