Clinical trial NCT05406908: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bullous Dermatoses
Psoriasis
COVID-19 Vaccines
Keywords: COVID-19 Vaccine
immunogenicity
autoimmune bullous diseases
psoriasis
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline level of humoral immunity at Week 4
timeFrame: Week 4
measure: Change from baseline level of cellular immunity at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: The difference in the level of SARS-CoV-2 specific humoral immunity between 4- and 12- weeks post-vaccination
timeFrame: Week 4, 12
measure: The difference in the level of SARS-CoV-2 specific humoral immunity between 12- and 24- weeks post-vaccination
timeFrame: Week 12, 24
measure: The difference in the level of SARS-CoV-2 specific cellular immunity between 12- and 24 weeks post-vaccination
timeFrame: Week 12,24
measure: Vaccine-related adverse reactions
timeFrame: Week 0,1,2,3,4,8,12,24
measure: The changes in the disease activity of psoriasis patients
timeFrame: Week 0,1,2,3,4,8,12,24
measure: The changes in the disease activity of autoimmune bullous disease patients
timeFrame: Week 0,1,2,3,4,8,12,24
measure: The changes in the disease activity of pemphigus patients
timeFrame: Week 0,1,2,3,4,8,12,24
measure: The changes in the disease activity of bullous pemphigoid patients
timeFrame: Week 0,1,2,3,4,8,12,24
measure: Disease control
timeFrame: Week 4,12,24
measure: COVID-19
timeFrame: Any time points during the study period (i.e., up to Week 24)
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Dermatology outpatient clinic, Somdech Phra Debaratana Medical Center, Ramathibodi Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital
name: Chutima Seree-aphinan, MD
role: PRINCIPAL_INVESTIGATOR
References: