Cervical neoplasia is increased in women with SLE most likely due to cervical infection with human papilloma virus (HPV). 70% of cervical cancer is caused by HPV types 16 and 18. Gardasil vaccine prevents cervical infection with HPV types 16 and 18. Thus lupus patients (who are susceptible to cervical cancer) may benefit from getting Gardasil vaccine which can prevent cervical cancer. Vaccines are generally safe and efficacious in SLE but no studies have been done on the use of this vaccine in SLE. The investigators hypothesize that Gardasil vaccine is safe and effective in SLE. This study will look at vaccine safety in patients with mild to moderate and minimally active or inactive SLE and measure how well they make protective antibodies after receiving the vaccine. In other words this will check how well the vaccine works in SLE.
To gather safety information and adverse events on the use of Gardasil® in mild to moderate and minimally active or inactive SLE. To gather information on SLE disease activity flares after vaccination with Gardasil®. To gather information on the immunogenicity or development of protective anti HPV antibodies SLE after vaccination with Gardasil®.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
37
0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6
DCaTS-Clinical Research Center
Detroit, Michigan, United States
Frequency of Participants With Adverse Events
Frequency of participants with Vaccine site reactions, Frequency of participants with Non Vaccine Adverse Events,
Time frame: 1,61,66,181,186,211,330 days
Number of Non Vaccine Adverse Events
the number of non vaccine adverse events
Time frame: 1,61,66,181,186,211,330 days
Seroconversion by HPV Serotypes (HPV 6, HPV 11, HPV 16, HPV 18)as Assessed by Geometric Mean Antibody Titer
1\. The percentage of HPV naive women who seroconverted by HPV serotypes was measured using Geometric Mean Titers for HPV serotypes HPV 6, HPV 11, HPV 16, HPV 18
Time frame: Baseline (prevaccine) neutralizing anti HPV antibody titers at visit 1 and anti HPV antibody titers at 1 month post 3rd vaccine shot which is at 7 months in the study.
SLE Disease Activity Flares
SELENA-SLEDAI measurements \> or = to 2 The SELENA/SLEDAI is a validated instrument which is used to score disease activity and define flares with the SELENA-SLEDAI score range being 0-105, with 0 indicating inactive disease.The SELENA/SLEDAI instrument consists of 24 items, each with a definition of activity; there are 16 clinical items and 8 laboratory items. Although there are no set standards, inactive or minimal disease is generally reflected by a SELENA/SLEDAI score of less than or equal to 2 while more than minimally active disease is reflected by a score of \>2.
Time frame: 1,61,66,181,186,211,330 days
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