Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Immunogenicity and Reactogenicity of Fractionated-dose Intradermal vs Standard Intramuscular Tozinameran as the Fourth Coronavirus Disease 2019 (COVID-19) Vaccine Dose in Patients With Immune-mediated Dermatologic Diseases: a Single-blinded Randomised-controlled Parallel-grouped Non-inferiority Trial

Conditions
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Psoriasis, Bullous Dermatoses, COVID-19 Vaccines

Intervention / Treatment
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* Biological: tozinameran


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fractionated-dose intradermal tozinameran<br>10 micrograms (0.1 mL) of tozinameran administered intradermally to the deltoid area of the non-dominant arm with a sterile 30-gauge needle. | Biological: tozinameran<br>* Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty)<br>|
| Active Comparator: standard intramuscular tozinameran<br>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<br>* Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 Vaccine, immunogenicity, autoimmune bullous diseases, psoriasis