Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05406908
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mahidol University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Chutima Seree-aphinan, MD
Principal Investigator Affiliation Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Thailand
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Bullous Dermatoses, Psoriasis, COVID-19 Vaccines
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

Biological: - tozinameran

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

Contact a Trial Team

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International Sites

Ratchathewi, Bangkok, Thailand

Status

Recruiting

Address

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

Ratchathewi, Bangkok, 10400

Site Contact

Chutima Seree-aphinan, MD

[email protected]

(66) 22011211

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