A study of booster-dose influenza vaccination responses compared to standard-dose in lupus patients: an open labelled, randomized controlled study
- Conditions
- Immune responses to influenza vaccination in lupus patients receiving high and low immunosuppressive agentlupushigh dose influenza vaccineseroprotectionseroconversion
- Registration Number
- TCTR20230610003
- Lead Sponsor
- Mahidol university
- Brief Summary
In conclusion, booster dose influenza vaccination may increase seroconversion in some strains (H1N1 and B/Victoria), especially in patients who received high levels of immunosuppression. However, there were no clinical differences in the incidence of influenza infection between the SD and BD regimens. Further studies on a larger scale are necessary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 109
1. Lupus patients diagnosed by the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE Classification criteria, 2. Under the care of rheumatologists at the rheumatology clinic of Ramathibodi Hospital
1. Pregnancy, 2. Active cancer, 3. Positive HIV status, 4. Prior history of organ transplant, 5. Receipt of influenza vaccine or prior history of an influenza infection within six months, 6. Evidence of CMV infection within three months, 7. Known history of severe allergic reaction to influenza vaccine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method seroprotection, seroconversion 4-12 weeks after vaccination Hemagglutination inhibition assay
- Secondary Outcome Measures
Name Time Method Incidence of influenza infection within 6 months after end of the intervention Questionnaire interview,Adverse events after vaccination within 72 hours after vaccination Common Terminology Criteria for Adverse Events (CTCAE) version 5