Trials / Completed
CompletedNCT05406908
Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 109 (actual)
- Sponsor
- Mahidol University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | tozinameran | Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty) |
Timeline
- Start date
- 2022-06-15
- Primary completion
- 2023-03-20
- Completion
- 2023-05-01
- First posted
- 2022-06-07
- Last updated
- 2024-03-25
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT05406908. Inclusion in this directory is not an endorsement.