Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study
NCT ID: NCT00911521
Last Updated: 2011-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2009-10-31
2011-06-30
Brief Summary
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Detailed Description
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Systemic lupus erythematosus (SLE) is a disease that predominantly affects women of the childbearing age. Patients with SLE are at risk of persistent HPV infection. This is because of the immunosuppressive state induced by various treatments. The prevalence of abnormal Pap smears and cervical squamous intraepithelial neoplasia (CIN) in SLE patients is higher than that in age-matched healthy women. Thus, prevention of HPV infection is important in patients with SLE to reduce the incidence of CIN lesions and hence invasive cervical cancers in the long run.
The quadrivalent HPV vaccine, GARDASIL is effective in reducing the occurrence of high-grade CIN lesions and anogenital disease elated to HPV-16 and HPV-18 infection. Vaccination of young women aged 16 to 23 years resulted in seroconversion rates of more than 99% for all the HPV types (6,11,16,18) and was well tolerated. There has been very little information regarding the efficacy of the quadrivalent HPV vaccine in immunocompromised hosts. The objectives of the current study are to evaluate the immunogenicity and safety of the quadrivalent HPV vaccine in a group of patients with SLE in terms of antibody conversion. Comparison will be made with an equal number of age-matched healthy women.
Conditions
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Study Design
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PARALLEL
PREVENTION
NONE
Study Groups
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Vaccine arm
subjects receiving vaccination
human papillomavirus vaccination (Gardasil)
3 doses of the human papillomavirus vaccines to be given at baseline, month 2 and month 6
Interventions
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human papillomavirus vaccination (Gardasil)
3 doses of the human papillomavirus vaccines to be given at baseline, month 2 and month 6
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Female patients aged ≤ 35 years
* Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
* Having received a stable dose of prednisolone and/or other immunosuppressive agents within 3 months of study entry
* Able to give written informed consent
Controls
* Women aged ≤ 35 years, matched those of SLE patients recruited
* No known chronic medical diseases
* Not receiving any long-term medications including herbs
Exclusion Criteria
35 Years
FEMALE
Yes
Sponsors
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Tuen Mun Hospital
OTHER_GOV
Responsible Party
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Chi Chiu Mok
Consultant
Principal Investigators
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Chi Chiu Mok, MD, FRCP
Role: PRINCIPAL_INVESTIGATOR
Tuen Mun Hospital, Hong Kong, China
Locations
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Department of Medicine, Tuen Mun Hospital
Hong Kong, , China
Countries
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References
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Mok CC, Ho LY, To CH. Long-term immunogenicity of a quadrivalent human papillomavirus vaccine in systemic lupus erythematosus. Vaccine. 2018 May 31;36(23):3301-3307. doi: 10.1016/j.vaccine.2018.04.056. Epub 2018 Apr 24.
Other Identifiers
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NTWC/CREC/704/09
Identifier Type: -
Identifier Source: org_study_id