Long-term Immunogenicity of a HPV Vaccine in SLE
1 other identifier
observational
84
1 country
1
Brief Summary
To study the 5-year immunogenicity against a quadrivalent HPV vaccine in patients with SLE and healthy controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2015
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
June 17, 2015
CompletedFirst Posted
Study publicly available on registry
June 22, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedOctober 19, 2016
October 1, 2016
10 months
June 17, 2015
October 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neutralizing antibodies to HPV serotypes 6,11,16 and 18
proportion of subjects in each arm who remains sero-converted for each HPV serotype at 5 years after vaccination
5 years
Secondary Outcomes (1)
Neutralizing antibodies to HPV serotypes 6,11,16 and 18
5 years
Study Arms (2)
SLE patients
SLE patients who received HPV vaccination
Control subjects
Healthy subjects who received HPV vaccination
Interventions
Eligibility Criteria
SLE patients 1. Female patients aged 18-35 years 2. Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE 3. Having participated in the investigators' original HPV study in 2010 4. Able to give written informed consent Controls 1. Women aged 18-35 years, matched those of SLE patients recruited 2. No known chronic medical diseases 3. Having participated in our HPV study in 2010
You may qualify if:
- SLE patients
- Female patients aged 18-35 years
- Fulfilling the American College of Rheumatology (ACR) criteria for the classification of SLE
- Having participated in the investigators' original HPV study in 2010
- Able to give written informed consent
- Controls
- Women aged 18-35 years, matched those of SLE patients recruited
- No known chronic medical diseases
- Having participated in our HPV study in 2010
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
Biospecimen
serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CC Mok, MD
Tuen Mun Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- consultant
Study Record Dates
First Submitted
June 17, 2015
First Posted
June 22, 2015
Study Start
July 1, 2015
Primary Completion
May 1, 2016
Study Completion
October 1, 2016
Last Updated
October 19, 2016
Record last verified: 2016-10