immune-mediated dermatologic diseases COVID-19 vaccines Immunogenicity COVID-19 Vaccines immune-mediated dermatologic diseases psoriasis autoimmune bullous diseases
Conditions
Interventions
The participants who received the third dose of COVID-19 vaccine at 30-120 days post-primary series.,The participants who did not receive the third dose of COVID-19 vaccine within 30-120 days post-pri
Other,Other
Participants receiving additional primary dose,Participants not receiving additional primary dose
Sponsors
Faculty of Medicine Ramathibodi Hospital, Mahidol University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants of a real-world observational study of immunogenicity and safety of COVID-19 vaccines among patients with immune-mediated dermatologic diseases (TCTR20220317008) who had been assessed for SARS-CoV-2-specific immunity one-month post-vaccination. 2. Diagnosed with and currently receiving treatment for immune-mediated dermatologic diseases (IMDD) 3. Received weakly immunogenic primary COVID-19 vaccine series (i.e., whole-virion inactivated vaccines) or did not achieve a high-level SARS-CoV-2 specific immunity after receiving highly immunogenic primary COVID-19 vaccine series (i.e., homologous ChAdOx1-S[recombinant] and the heterologous vaccines). *The high-level immunity was defined as the neutralising antibody level (measured by the surrogate viral neutralisation test [sVNT]) at least at the delta-variant cut-off (>= 60%) or the presence of cellular immunity demonstrated by interferon-gamma release assay (IGRA).
Exclusion criteria
Exclusion criteria: Per the original cohort study (TCTR20220317008)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Breakthrough COVID-19 6 months post-primary series Days from the last dose of the primary series to the date of breakthrough COVID-19,Disease flare-ups 6 months post-primary series The percentages of participants with physician-diagnosed disease flare-ups,Immunological performance of the additional dose 1 month post-additional dose Changes from baseline seroconversion and IGRA positive rates | — |
Secondary
| Measure | Time frame |
|---|---|
| Strength of SARS-CoV-2 specific humoral immunity after the third dose 1 months after the third dose Anti-SARS-CoV-2 S1 receptor binding domain IgG level in participants who seroconverted after the third dose,Strength of SARS-CoV-2 specific cellular immunity after the third dose 1 month after the third dose Interferon-gamma level from SARS-CoV-2 IGRA in participants with positive IGRA after the third dose,Reactogenicity of the additional dose 6 months post-primary series the percentages of participants reported vaccine-related side effects | — |
Countries
Thailand
Contacts
Public ContactChutima Sereeaphinan
Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Ramathibodi Hospital, Mahidol University
Outcome results
None listed