Bullous Dermatoses, COVID-19 Vaccines, Psoriasis
Conditions
Keywords
COVID-19 Vaccine, immunogenicity, autoimmune bullous diseases, psoriasis
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 intramuscular route in patients with immune-mediated dermatologic diseases. The side effects profile and disease activity post-vaccination will also be assessed.
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-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.
Interventions
BIOLOGICALtozinameran
Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty)
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline level of humoral immunity at Week 4 | Week 4 | Anti-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 Receptor-binding domain (RBD) Immunoglobulin G (IgG) |
| Change from baseline level of cellular immunity at Week 12 | Week 12 | Interferon-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference in the level of SARS-CoV-2 specific cellular immunity between 12- and 24 weeks post-vaccination | Week 12,24 | IGRA-derived interferon-gamma level |
| Vaccine-related adverse reactions | Week 0,1,2,3,4,8,12,24 | The percentages of participants who have local or systemic vaccine-related adverse reactions |
| The changes in the disease activity of psoriasis patients | Week 0,1,2,3,4,8,12,24 | Psoriasis Area Severity Index (PASI) |
| The changes in the disease activity of autoimmune bullous disease patients | Week 0,1,2,3,4,8,12,24 | Autoimmune Bullous Skin Disorder Intensity Score (ABSIS) |
| The difference in the level of SARS-CoV-2 specific humoral immunity between 4- and 12- weeks post-vaccination | Week 4, 12 | Anti-SARS-CoV-2 S1 RBD IgG |
| The changes in the disease activity of bullous pemphigoid patients | Week 0,1,2,3,4,8,12,24 | Bullous Pemphigoid Disease Area Index (BPDAI) |
| Disease control | Week 4,12,24 | The percentages of participants who required an adjustment of systemic treatment for disease control |
| COVID-19 | Any time points during the study period (i.e., up to Week 24) | The percentages of participants who are diagnosed with COVID-19 post-vaccination |
| The changes in the disease activity of pemphigus patients | Week 0,1,2,3,4,8,12,24 | Pemphigus Disease Area Index (PDAI) |
| The difference in the level of SARS-CoV-2 specific humoral immunity between 12- and 24- weeks post-vaccination | Week 12, 24 | Anti-SARS-CoV-2 S1 RBD IgG |
Countries
Thailand
Outcome results
None listed