Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05406908
• Other study ID #: MURA2022/238
• Secondary ID: TCTR20220524004
• Status: Completed
• Phase: Phase 4
• Start date: June 15, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2024
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 1, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bullous Dermatoses
• COVID-19
• COVID-19 Vaccines
• Psoriasis
• Skin Diseases

Intervention

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

Locations

Country	Name	City	State
Thailand	Dermatology outpatient clinic, Somdech Phra Debaratana Medical Center, Ramathibodi Hospital, Mahidol University	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The changes in the disease activity of psoriasis patients	Psoriasis Area Severity Index (PASI)	Week 0,1,2,3,4,8,12,24
Secondary	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
Secondary	The changes in the disease activity of pemphigus patients	Pemphigus Disease Area Index (PDAI)	Week 0,1,2,3,4,8,12,24
Secondary	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
Secondary	Disease control	The percentages of participants who required an adjustment of systemic treatment for disease control	Week 4,12,24
Secondary	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)