Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

Phase 4

Completed

• Conditions: Bullous Dermatoses; Psoriasis; COVID-19 Vaccines
• Interventions: Biological: tozinameran

• Registration Number: NCT05406908
• Lead Sponsor: Mahidol University

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.

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-06-01
• Study First Posted: 2022-06-07
• Study Start: 2022-06-15
• Primary Completion: 2023-03-20
• Study Completion: 2023-05-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-22
• Last Update Posted: 2024-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fractionated-dose intradermal tozinameran	tozinameran	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	tozinameran	30 micrograms (0.3 mL) of tozinameran administered intramuscularly to the deltoid area of the non-dominant arm with a sterile 25-gauge needle.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 bullous pemphigoid patients	Week 0,1,2,3,4,8,12,24	Bullous Pemphigoid Disease Area Index (BPDAI)
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
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 changes in the disease activity of pemphigus patients	Week 0,1,2,3,4,8,12,24	Pemphigus Disease Area Index (PDAI)
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

Trial Locations

Locations (1)

Dermatology outpatient clinic, Somdech Phra Debaratana Medical Center, Ramathibodi Hospital, Mahidol University; 🇹🇭 Ratchathewi, Bangkok, Thailand