Status:
COMPLETED
Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases
Lead Sponsor:
Mahidol University
Conditions:
Bullous Dermatoses
Psoriasis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This is a randomised controlled trial conducted to prove that the immunological performance of intradermal tozinameran (i.e., Pfizer-BioNTech COVID-19 vaccine) is no worse than the standard intramuscu...
Detailed Description
The standard intramuscular tozinameran is widely used as a COVID-19 vaccine booster dose, although the fractionated-dose intradermal route of the vaccine has emerged as a dose-sparing and cost-effecti...
Eligibility Criteria
Inclusion
- Aged equal to or more than 18 years
- Diagnosed with psoriasis or autoimmune bullous diseases
- Completed two-doses of the primary vaccine series and the third booster dose lasted for more than three months
- Agree to receive the fourth COVID-19 vaccine dose as tozinameran
Exclusion
- History of previous COVID-19 infection
- Positive result of COVID-19 rapid antigen test (tested upon recruitment prior to vaccination)
- Uncontrolled disease activity
- Non-dermatologic immune-mediated diseases
- Congenital or acquired immunodeficiency syndrome
- Cancer
- Pregnant women
- Allergy to components of tozinameran
- Inability to give written informed consent to participate in the study
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT05406908
Start Date
June 15 2022
End Date
May 1 2023
Last Update
March 25 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dermatology outpatient clinic, Somdech Phra Debaratana Medical Center, Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, Thailand, 10400