Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

Mahidol University109 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

109

Conditions

Bullous Dermatoses Psoriasis COVID-19 Vaccines

Interventions

tozinameranBIOLOGICAL

Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Dermatology outpatient clinic, Somdech Phra Debaratana Medical Center, Ramathibodi Hospital, Mahidol University

Ratchathewi, Bangkok, Thailand

Outcomes

Primary Outcomes

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)

Time frame: Week 4

Change from baseline level of cellular immunity at Week 12

Interferon-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA)

Time frame: Week 12

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Week 12,24

Vaccine-related adverse reactions

The percentages of participants who have local or systemic vaccine-related adverse reactions

Time frame: Week 0,1,2,3,4,8,12,24

The changes in the disease activity of psoriasis patients

Psoriasis Area Severity Index (PASI)

Time frame: Week 0,1,2,3,4,8,12,24

The changes in the disease activity of autoimmune bullous disease patients

Data from ClinicalTrials.gov

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