Intradermal COVID-19 vaccine for immune-mediated dermatologic disease patient

Phase 4

Completed

• Conditions: psoriasisautoimmune bullous diseases COVID-19 vaccine' s immunogenicity COVID-19 vaccine' s reactogenicity; psoriasis; bullous dermatosis; COVID-19 Vaccines; BNT162 Vaccine

• Registration Number: TCTR20220524004
• Lead Sponsor: Faculty of Medicine Ramathibodi Hospital

Brief Summary

The intradermal BNT162b2 vaccine is a viable booster option for IMDD patients troubled by post-vaccination fever; its role in mitigating the risk of flare-ups remains unclear.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-24
• Study Completion: 2023-02-28
• Results First Posted: 2024-03-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Humoral immune response Week 0, 4, 12, 24 Anti-SARS-CoV-2 S1 RBD IgG ,Cellular immune response Week 0,12,24 IFN-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA)