Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

NCT05406908 | Completed Phase 4 DMC

• 2 other identifiers: MURA2022/238TCTR20220524004
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Bullous Dermatoses; Psoriasis; COVID-19 Vaccines

Keywords

COVID-19 Vaccine; immunogenicity; autoimmune bullous diseases; psoriasis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• The difference in the level of SARS-CoV-2 specific humoral immunity between 4- and 12- weeks post-vaccination

  Week 4, 12

• The difference in the level of SARS-CoV-2 specific humoral immunity between 12- and 24- weeks post-vaccination

  Week 12, 24

• The difference in the level of SARS-CoV-2 specific cellular immunity between 12- and 24 weeks post-vaccination

  Week 12,24

• Vaccine-related adverse reactions

  Week 0,1,2,3,4,8,12,24

• The changes in the disease activity of psoriasis patients

  Week 0,1,2,3,4,8,12,24

Study Arms (2)

fractionated-dose intradermal tozinameran

EXPERIMENTAL

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

standard intramuscular tozinameran

ACTIVE COMPARATOR

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

Interventions

tozinameran BIOLOGICAL

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

fractionated-dose intradermal tozinameran; standard intramuscular tozinameran

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

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

Ratchathewi, Bangkok, 10400, Thailand

Location

MeSH Terms

Conditions

Skin Diseases, Vesiculobullous; Psoriasis

Interventions

BNT162 Vaccine

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Chutima Seree-aphinan, MD

  Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 7, 2022
• Study Start: June 15, 2022
• Primary Completion: March 20, 2023
• Study Completion: May 1, 2023
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: available without end date
• Access Criteria: upon reasonable requests made via email.

Locations

TH (1)