Bullous DermatosesPhase 4NCT05406908
Intradermal Tozinameran for Patients With Immune-mediated Dermatologic Diseases
A Phase 4 study testing tozinameran in people with Bullous Dermatoses and Psoriasis, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bullous Dermatoses, Psoriasis, COVID-19 Vaccines
- What is being tested?
- tozinameran
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jun 2022to 1 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged equal to or more than 18 years
- Diagnosed with psoriasis or autoimmune bullous diseases
- Completed two-doses of the primary vaccine series and the third booster dose lasted for more than three months
- Agree to receive the fourth COVID-19 vaccine dose as tozinameran
Who cannot join
- History of previous COVID-19 infection
- Positive result of COVID-19 rapid antigen test (tested upon recruitment prior to vaccination)
- Uncontrolled disease activity
- Non-dermatologic immune-mediated diseases
- Congenital or acquired immunodeficiency syndrome
- Cancer
Show all 9Show fewer
- Pregnant women
- Allergy to components of tozinameran
- Inability to give written informed consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Dermatology outpatient clinic, Somdech Phra Debaratana Medical Center, Ramathibodi Hospital, Mahidol University
Ratchathewi, Bangkok, 10400
About this study
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
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.
Read the 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
- Bullous Dermatoses, Psoriasis, COVID-19 Vaccines
- Being tested
- tozinameran
- Keywords
- COVID-19 Vaccine, immunogenicity, autoimmune bullous diseases, psoriasis
- Medical subject headings
- Skin Diseases, Vesiculobullous, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tozinameranBiological
Pfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty)
| Study group | Role | What they receive |
|---|---|---|
| fractionated-dose intradermal tozinameran | Experimental | 10 micrograms (0.1 mL) of tozinameran administered intradermally to the deltoid area of the non-dominant arm with a sterile 30-gauge needle. Receives: Biological: tozinameran |
| standard intramuscular tozinameran | Active comparator | 30 micrograms (0.3 mL) of tozinameran administered intramuscularly to the deltoid area of the non-dominant arm with a sterile 25-gauge needle. Receives: Biological: tozinameran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline level of humoral immunity at Week 4
Anti-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 Receptor-binding domain (RBD) Immunoglobulin G (IgG)
Measured: Week 4
Change from baseline level of cellular immunity at Week 12
Interferon-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA)
Measured: Week 12
Secondary outcomes (10)
The difference in the level of SARS-CoV-2 specific humoral immunity between 4- and 12- weeks post-vaccination
Anti-SARS-CoV-2 S1 RBD IgG
Measured: Week 4, 12
The difference in the level of SARS-CoV-2 specific humoral immunity between 12- and 24- weeks post-vaccination
Anti-SARS-CoV-2 S1 RBD IgG
Measured: Week 12, 24
The difference in the level of SARS-CoV-2 specific cellular immunity between 12- and 24 weeks post-vaccination
IGRA-derived interferon-gamma level
Measured: Week 12,24
Vaccine-related adverse reactions
The percentages of participants who have local or systemic vaccine-related adverse reactions
Measured: Week 0,1,2,3,4,8,12,24
The changes in the disease activity of psoriasis patients
Psoriasis Area Severity Index (PASI)
Measured: Week 0,1,2,3,4,8,12,24
The changes in the disease activity of autoimmune bullous disease patients
Autoimmune Bullous Skin Disorder Intensity Score (ABSIS)
Measured: Week 0,1,2,3,4,8,12,24
The changes in the disease activity of pemphigus patients
Pemphigus Disease Area Index (PDAI)
Measured: Week 0,1,2,3,4,8,12,24
The changes in the disease activity of bullous pemphigoid patients
Bullous Pemphigoid Disease Area Index (BPDAI)
Measured: Week 0,1,2,3,4,8,12,24
Disease control
The percentages of participants who required an adjustment of systemic treatment for disease control
Measured: Week 4,12,24
COVID-19
The percentages of participants who are diagnosed with COVID-19 post-vaccination
Measured: Any time points during the study period (i.e., up to Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start15 Jun 2022
- Primary completion20 Mar 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous DermatosesStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chutima Seree-aphinan, Mahidol University
- Investigators
- Chutima Seree-aphinan, MD, Principal investigator, Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406908
- Sponsor's protocol ID
- MURA2022/238
- Other IDs
- TCTR20220524004
- Status last verified
- Mar 2024
- First submitted
- 27 May 2022
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data and study protocol are available from the principle investigators.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05406908
- Acronym / sponsor ID
- MURA2022/238
- Conditions
- Bullous Dermatoses, Psoriasis, COVID-19 Vaccines
- Keywords
- COVID-19 Vaccine, immunogenicity, autoimmune bullous diseases, psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fractionated-dose intradermal tozinameran | Experimental | Biological: tozinameran10 micrograms (0.1 mL) of tozinameran administered intradermally to the deltoid area of the non-dominant arm with a sterile 30-gauge needle. |
| standard intramuscular tozinameran | Active comparator | Biological: tozinameran30 micrograms (0.3 mL) of tozinameran administered intramuscularly to the deltoid area of the non-dominant arm with a sterile 25-gauge needle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged equal to or more than 18 years
- Diagnosed with psoriasis or autoimmune bullous diseases
- Completed two-doses of the primary vaccine series and the third booster dose lasted for more than three months
- Agree to receive the fourth COVID-19 vaccine dose as tozinameran
Key exclusion criteria (9 listed)
- History of previous COVID-19 infection
- Positive result of COVID-19 rapid antigen test (tested upon recruitment prior to vaccination)
- Uncontrolled disease activity
- Non-dermatologic immune-mediated diseases
- Congenital or acquired immunodeficiency syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tozinameranPfizer-BioNTech COVID-19 vaccine (Trade name: Comirnaty) | Biological | fractionated-dose intradermal tozinameran, standard intramuscular tozinameran |
Primary outcome
Change from baseline level of humoral immunity at Week 4
Time frame: Week 4
Anti-Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) S1 Receptor-binding domain (RBD) Immunoglobulin G (IgG)
Change from baseline level of cellular immunity at Week 12
Time frame: Week 12
Interferon-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA)
10 secondary outcomes
The difference in the level of SARS-CoV-2 specific humoral immunity between 4- and 12- weeks post-vaccination
Time frame: Week 4, 12
The difference in the level of SARS-CoV-2 specific humoral immunity between 12- and 24- weeks post-vaccination
Time frame: Week 12, 24
The difference in the level of SARS-CoV-2 specific cellular immunity between 12- and 24 weeks post-vaccination
Time frame: Week 12,24
Vaccine-related adverse reactions
Time frame: Week 0,1,2,3,4,8,12,24
The changes in the disease activity of psoriasis patients
Time frame: Week 0,1,2,3,4,8,12,24
The changes in the disease activity of autoimmune bullous disease patients
Time frame: Week 0,1,2,3,4,8,12,24
The changes in the disease activity of pemphigus patients
Time frame: Week 0,1,2,3,4,8,12,24
The changes in the disease activity of bullous pemphigoid patients
Time frame: Week 0,1,2,3,4,8,12,24
Disease control
Time frame: Week 4,12,24
COVID-19
Time frame: Any time points during the study period (i.e., up to Week 24)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: Yes. Deidentified participant data and study protocol are available from the principle investigators.
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Active, not recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chutima Seree-aphinan, MD principal investigator
Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tozinameran in people with Bullous Dermatoses and Psoriasis, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline level of humoral immunity at Week 4 (time frame: Week 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2024.