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A study of booster-dose influenza vaccination responses compared to standard-dose in lupus patients: an open labelled, randomized controlled study

A study of booster-dose influenza vaccination responses compared to standard-dose in lupus patients: an open labeled, randomized controlled study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20230610003
Enrollment
128
Registered
2023-06-10
Start date
2021-05-27
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune responses to influenza vaccination in lupus patients receiving high and low immunosuppressive agent lupus high dose influenza vaccine seroprotection seroconversion

Interventions

Booster dose quadrivalent inactivated influenza vaccine (two seperated standard dose injection 4-12 weeks apart) administered intramuscular route in both high and low immnosuppressive lupus patients,S
Booster dose influenza vaccination,Standard dose influenza vaccination

Sponsors

Mahidol university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
seroprotection, seroconversion 4-12 weeks after vaccination Hemagglutination inhibition assay

Secondary

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactSasicha Yingyounyong

Faculty of Medicine Ramathibodi Hospital, Mahidol University

sasicha.yyy@gmail.com022011301

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026