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Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Aged equal to or more than 18 years. 2. Diagnosed with psoriasis or autoimmune bullous diseases. 3. Completed two-doses of the primary vaccine series and the third booster dose lasted for more than three months. 4. Agree to receive the fourth COVID-19 vaccine dose as tozinameran.
Exclusion Criteria:1. History of previous COVID-19 infection. 2. Positive result of COVID-19 rapid antigen test (tested upon recruitment prior to vaccination) 3. Uncontrolled disease activity. 4. Non-dermatologic immune-mediated diseases. 5. Congenital or acquired immunodeficiency syndrome. 6. Cancer. 7. Pregnant women. 8. Allergy to components of tozinameran. 9. Inability to give written informed consent to participate in the study
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Chutima Seree-aphinan, MD|
|Principal Investigator Affiliation||Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Bullous Dermatoses, Psoriasis, COVID-19 Vaccines|
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-effective alternative. However, before implementing the intradermal vaccine in patients with immune-mediated dermatologic diseases, its immunogenicity should be confirmed, as many of them use long-term immunosuppressive medications, which may alter their immune responses to the vaccine. This prospective open-labelled single-blinded randomised-controlled parallel-grouped non-inferiority trial aims to determine non-inferiority in the immunogenicity of fractionated-dose intradermal tozinameran in comparison with the standard intramuscular tozinameran as the fourth COVID-19 vaccine dose in patients with immune-mediated dermatologic diseases and compare vaccine-related adverse effects between the two.
Experimental: fractionated-dose intradermal tozinameran
10 micrograms (0.1 mL) of tozinameran administered intradermally to the deltoid area of the non-dominant arm with a sterile 30-gauge needle.
Active Comparator: standard intramuscular tozinameran
30 micrograms (0.3 mL) of tozinameran administered intramuscularly to the deltoid area of the non-dominant arm with a sterile 25-gauge needle.
Biological: - tozinameran
Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty)
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If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.