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| ID | Type | Description | Link |
|---|---|---|---|
| TCTR20220524004 | Registry Identifier | Thai Clinical Trials Registry |
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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 intramuscular route in patients with immune-mediated dermatologic diseases. The side effects profile and disease activity post-vaccination will also be assessed.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fractionated-dose intradermal tozinameran | Experimental | 10 micrograms (0.1 mL) of tozinameran administered intradermally to the deltoid area of the non-dominant arm with a sterile 30-gauge needle. |
|
| standard intramuscular tozinameran | Active Comparator | 30 micrograms (0.3 mL) of tozinameran administered intramuscularly to the deltoid area of the non-dominant arm with a sterile 25-gauge needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tozinameran | Biological | Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline level of humoral immunity at Week 4 | Anti-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 Receptor-binding domain (RBD) Immunoglobulin G (IgG) | Week 4 |
| Change from baseline level of cellular immunity at Week 12 | Interferon-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA) | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in the level of SARS-CoV-2 specific humoral immunity between 4- and 12- weeks post-vaccination | Anti-SARS-CoV-2 S1 RBD IgG | Week 4, 12 |
| The difference in the level of SARS-CoV-2 specific humoral immunity between 12- and 24- weeks post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chutima Seree-aphinan, MD | Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology outpatient clinic, Somdech Phra Debaratana Medical Center, Ramathibodi Hospital, Mahidol University | Ratchathewi | Bangkok | 10400 | Thailand |
Deidentified participant data and study protocol are available from the principle investigators.
available without end date
upon reasonable requests made via email.
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| ID | Term |
|---|---|
| D012872 | Skin Diseases, Vesiculobullous |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017444 | Skin Diseases, Papulosquamous |
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| ID | Term |
|---|---|
| D000090982 | BNT162 Vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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Anti-SARS-CoV-2 S1 RBD IgG |
| Week 12, 24 |
| The difference in the level of SARS-CoV-2 specific cellular immunity between 12- and 24 weeks post-vaccination | IGRA-derived interferon-gamma level | Week 12,24 |
| Vaccine-related adverse reactions | The percentages of participants who have local or systemic vaccine-related adverse reactions | Week 0,1,2,3,4,8,12,24 |
| The changes in the disease activity of psoriasis patients | Psoriasis Area Severity Index (PASI) | Week 0,1,2,3,4,8,12,24 |
| The changes in the disease activity of autoimmune bullous disease patients | Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) | Week 0,1,2,3,4,8,12,24 |
| The changes in the disease activity of pemphigus patients | Pemphigus Disease Area Index (PDAI) | Week 0,1,2,3,4,8,12,24 |
| The changes in the disease activity of bullous pemphigoid patients | Bullous Pemphigoid Disease Area Index (BPDAI) | Week 0,1,2,3,4,8,12,24 |
| Disease control | The percentages of participants who required an adjustment of systemic treatment for disease control | Week 4,12,24 |
| COVID-19 | The percentages of participants who are diagnosed with COVID-19 post-vaccination | Any time points during the study period (i.e., up to Week 24) |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |