Status:
COMPLETED
Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study
Lead Sponsor:
Tuen Mun Hospital
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
Up to 35 years
Phase:
PHASE4
Brief Summary
The purpose of this trial is to study the effect of Human Papillomavirus (HPV) vaccination on the elevation of antibody titer to 4 serotypes of HPV in patients with systemic lupus erythematous and com...
Detailed Description
Genital infection with human papillomavirus (HPV) is one of the most common sexually transmitted infections in Hong Kong. Most cases of HPV infection are asymptomatic. However, in some individuals, es...
Eligibility Criteria
Inclusion
- SLE patients
- 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
- History of allergy to HPV vaccines
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00911521
Start Date
October 1 2009
End Date
June 1 2011
Last Update
October 12 2011
Active Locations (1)
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1
Department of Medicine, Tuen Mun Hospital
Hong Kong, China, 000