Immunogenicity and Safety of a Quadrivalent Human Papillomavirus (HPV) Vaccine in Patients With SLE: a Controlled Study
1 other identifier
interventional
100
1 country
1
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 compare the antibody response with an equal number of age-matched healthy women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2009
CompletedFirst Posted
Study publicly available on registry
June 2, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedOctober 12, 2011
October 1, 2011
1.4 years
May 28, 2009
October 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
antibody titers against 4 strains of human papillomavirus
baseline, month 7 and month 12
Study Arms (1)
Vaccine arm
ACTIVE COMPARATORsubjects receiving vaccination
Interventions
3 doses of the human papillomavirus vaccines to be given at baseline, month 2 and month 6
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- History of allergy to HPV vaccines
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine, Tuen Mun Hospital
Hong Kong, 000, China
Related Publications (1)
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.
PMID: 29699792DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chi Chiu Mok, MD, FRCP
Tuen Mun Hospital, Hong Kong, China
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
May 28, 2009
First Posted
June 2, 2009
Study Start
October 1, 2009
Primary Completion
March 1, 2011
Study Completion
June 1, 2011
Last Updated
October 12, 2011
Record last verified: 2011-10