| Trial registration number
|
TCTR20220524004 |
Full text link
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
https://www.thaiclinicaltrials.org/show/TCTR20220524004
|
First author
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Chutima Sereeaphinan
|
Contact
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
czircons@gmail.com
|
Registration date
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2022-05-24
|
Recruitment status
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Not recruiting
|
Study design
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
RCT
|
Allocation
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Randomized
|
Design
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Parallel
|
Masking
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Open label
|
Center
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
single-center
|
Study aim
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Prevention
|
Inclusion criteria
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
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
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
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
|
Number of arms
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2
|
Funding
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Faculty of Medicine Ramathibodi Hospital
|
Inclusion age min
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
18
|
Inclusion age max
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
100
|
Countries
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Thailand
|
Type of patients
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
High risk patients
|
Severity scale
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
N/A
|
Total sample size
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
160
|
primary outcome
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Humoral immune response Week 0; 4; 12; 24 Anti-SARS-CoV-2 S1 RBD IgG ;Cellular immune response Week 0;12;24 IFN-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA)
|
Notes
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
|
Phase
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Phase 4
|
Arms
Last imported at : June 2, 2022, 8 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
[{"arm_notes": "intradermal", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "intramuscular", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]
|