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Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

Primary Purpose

Bullous Dermatoses, Psoriasis, COVID-19 Vaccines

Status
Active
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
tozinameran
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bullous Dermatoses focused on measuring COVID-19 Vaccine, immunogenicity, autoimmune bullous diseases, psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fractionated-dose intradermal tozinameran

standard intramuscular tozinameran

Arm Description

10 micrograms (0.1 mL) of tozinameran administered intradermally to the deltoid area of the non-dominant arm with a sterile 30-gauge needle.

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

Outcomes

Primary Outcome Measures

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)
Change from baseline level of cellular immunity at 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
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
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
IGRA-derived interferon-gamma level
Vaccine-related adverse reactions
The percentages of participants who have local or systemic vaccine-related adverse reactions
The changes in the disease activity of psoriasis patients
Psoriasis Area Severity Index (PASI)
The changes in the disease activity of autoimmune bullous disease patients
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
The changes in the disease activity of pemphigus patients
Pemphigus Disease Area Index (PDAI)
The changes in the disease activity of bullous pemphigoid patients
Bullous Pemphigoid Disease Area Index (BPDAI)
Disease control
The percentages of participants who required an adjustment of systemic treatment for disease control
COVID-19
The percentages of participants who are diagnosed with COVID-19 post-vaccination

Full Information

First Posted
May 27, 2022
Last Updated
March 17, 2023
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT05406908
Brief Title
Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
March 20, 2023 (Anticipated)
Study Completion Date
May 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bullous Dermatoses, Psoriasis, COVID-19 Vaccines
Keywords
COVID-19 Vaccine, immunogenicity, autoimmune bullous diseases, psoriasis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fractionated-dose intradermal tozinameran
Arm Type
Experimental
Arm Description
10 micrograms (0.1 mL) of tozinameran administered intradermally to the deltoid area of the non-dominant arm with a sterile 30-gauge needle.
Arm Title
standard intramuscular tozinameran
Arm Type
Active Comparator
Arm Description
30 micrograms (0.3 mL) of tozinameran administered intramuscularly to the deltoid area of the non-dominant arm with a sterile 25-gauge needle.
Intervention Type
Biological
Intervention Name(s)
tozinameran
Intervention Description
Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty)
Primary Outcome Measure Information:
Title
Change from baseline level of humoral immunity at Week 4
Description
Anti-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 Receptor-binding domain (RBD) Immunoglobulin G (IgG)
Time Frame
Week 4
Title
Change from baseline level of cellular immunity at Week 12
Description
Interferon-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA)
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
The difference in the level of SARS-CoV-2 specific humoral immunity between 4- and 12- weeks post-vaccination
Description
Anti-SARS-CoV-2 S1 RBD IgG
Time Frame
Week 4, 12
Title
The difference in the level of SARS-CoV-2 specific humoral immunity between 12- and 24- weeks post-vaccination
Description
Anti-SARS-CoV-2 S1 RBD IgG
Time Frame
Week 12, 24
Title
The difference in the level of SARS-CoV-2 specific cellular immunity between 12- and 24 weeks post-vaccination
Description
IGRA-derived interferon-gamma level
Time Frame
Week 12,24
Title
Vaccine-related adverse reactions
Description
The percentages of participants who have local or systemic vaccine-related adverse reactions
Time Frame
Week 0,1,2,3,4,8,12,24
Title
The changes in the disease activity of psoriasis patients
Description
Psoriasis Area Severity Index (PASI)
Time Frame
Week 0,1,2,3,4,8,12,24
Title
The changes in the disease activity of autoimmune bullous disease patients
Description
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
Time Frame
Week 0,1,2,3,4,8,12,24
Title
The changes in the disease activity of pemphigus patients
Description
Pemphigus Disease Area Index (PDAI)
Time Frame
Week 0,1,2,3,4,8,12,24
Title
The changes in the disease activity of bullous pemphigoid patients
Description
Bullous Pemphigoid Disease Area Index (BPDAI)
Time Frame
Week 0,1,2,3,4,8,12,24
Title
Disease control
Description
The percentages of participants who required an adjustment of systemic treatment for disease control
Time Frame
Week 4,12,24
Title
COVID-19
Description
The percentages of participants who are diagnosed with COVID-19 post-vaccination
Time Frame
Any time points during the study period (i.e., up to Week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chutima Seree-aphinan, MD
Organizational Affiliation
Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology outpatient clinic, Somdech Phra Debaratana Medical Center, Ramathibodi Hospital, Mahidol University
City
Ratchathewi
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data and study protocol are available from the principle investigators.
IPD Sharing Time Frame
available without end date
IPD Sharing Access Criteria
upon reasonable requests made via email.

Learn more about this trial

Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

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