Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

Sponsor

Mahidol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05406908

Collaborator

(none)

160

Enrollment

Location

Arms

10.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bullous Dermatoses Psoriasis COVID-19 Vaccines	Biological: tozinameran	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Dec 5, 2022

Anticipated Study Completion Date :

May 5, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: fractionated-dose intradermal 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.	Biological: tozinameran Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty)
Active Comparator: standard intramuscular 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.	Biological: tozinameran Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty)

Arm

Intervention/Treatment

Experimental: fractionated-dose intradermal 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.

Biological: tozinameran

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

Active Comparator: standard intramuscular 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.

Biological: tozinameran

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

Outcome Measures

Primary Outcome Measures

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

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
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 changes in the disease activity of pemphigus patients [Week 0,1,2,3,4,8,12,24]
Pemphigus Disease Area Index (PDAI)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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