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

Immunogenicity and reactogenicity of fractionated-dose intradermal vs standard intramuscular tozinameran as the fourth COVID-19 vaccine dose in patients with immune-mediated dermatologic diseases: a single-blinded randomised-controlled parallel-grouped non-inferiority trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20220524004

Enrollment

118

Registered

2022-05-24

Start date

2022-05-06

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriasis autoimmune bullous diseases COVID-19 vaccine&#039

Interventions

10 micrograms (0.1 mL) of tozinameran will be administered intradermally to the deltoid area with a sterile 30G inch needle.,30 micrograms (0.3 mL) of tozinameran will be administered intramuscularly

Experimental Biological/Vaccine,Active Comparator Biological/Vaccine

fractionated-dose intradermal tozinameran,standard intramuscular tozinameran

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
The difference in the SARS-CoV-2 IgG levels between 4- and 12- weeks post-vaccination Week 4, 12 Anti-SARS-CoV-2 S1 RBD IgG,The difference in the SARS-CoV-2 IgG levels between 12- and 24- weeks post-vaccination Week 12, 24 Anti-SARS-CoV-2 S1 RBD IgG,The difference in the IGRA-derived IFN-gamma levels between 12- and 24 weeks post-vaccination Week 12,24 IFN-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA),Vaccine-related adverse reactions Week 0,1,2,3,4,8,12,24 The percentages of participants who have local or systemic vaccine-related adverse reactions,The changes in the disease activity of immune-mediated dermatologic diseases Week 0,1,2,3,4,8,12,24 Psoriasis Area Severity Index (PASI), Autoimmune Bullous Skin Disorder Intensity Score (ABSIS), Pemphigus Disease Area Index (PDAI), Bullous Pemphigoid Disease Area Index (BPDAI),Disease control Week 4,12,24 adjustment of systemic treatment,COVID-19 Any (up to Week 24) The percentages of participants who are diagnosed with COVID-19 post-vaccination	—

Measure

Time frame

The difference in the SARS-CoV-2 IgG levels between 4- and 12- weeks post-vaccination Week 4, 12 Anti-SARS-CoV-2 S1 RBD IgG,The difference in the SARS-CoV-2 IgG levels between 12- and 24- weeks post-vaccination Week 12, 24 Anti-SARS-CoV-2 S1 RBD IgG,The difference in the IGRA-derived IFN-gamma levels between 12- and 24 weeks post-vaccination Week 12,24 IFN-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA),Vaccine-related adverse reactions Week 0,1,2,3,4,8,12,24 The percentages of participants who have local or systemic vaccine-related adverse reactions,The changes in the disease activity of immune-mediated dermatologic diseases Week 0,1,2,3,4,8,12,24 Psoriasis Area Severity Index (PASI), Autoimmune Bullous Skin Disorder Intensity Score (ABSIS), Pemphigus Disease Area Index (PDAI), Bullous Pemphigoid Disease Area Index (BPDAI),Disease control Week 4,12,24 adjustment of systemic treatment,COVID-19 Any (up to Week 24) The percentages of participants who are diagnosed with COVID-19 post-vaccination

—

Countries

Thailand

Contacts

Public ContactChutima Sereeaphinan

Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi hospital, Mahidol University

czircons@gmail.com0817622887

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026