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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Change from baseline level of humoral immunity at Week 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •Pregnant women
- •Allergy to components of tozinameran
- •Inability to give written informed consent to participate in the study
结局指标
主要结局
Change from baseline level of humoral immunity at Week 4
时间窗: 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
时间窗: Week 12
Interferon-gamma level from SARS-CoV-2 interferon-gamma release assay (IGRA)
次要结局
- The difference in the level of SARS-CoV-2 specific humoral immunity between 4- and 12- weeks post-vaccination(Week 4, 12)
- The difference in the level of SARS-CoV-2 specific humoral immunity between 12- and 24- weeks post-vaccination(Week 12, 24)
- Disease control(Week 4,12,24)
- COVID-19(Any time points during the study period (i.e., up to Week 24))
- The difference in the level of SARS-CoV-2 specific cellular immunity between 12- and 24 weeks post-vaccination(Week 12,24)
- The changes in the disease activity of psoriasis patients(Week 0,1,2,3,4,8,12,24)
- The changes in the disease activity of autoimmune bullous disease patients(Week 0,1,2,3,4,8,12,24)
- The changes in the disease activity of pemphigus patients(Week 0,1,2,3,4,8,12,24)
- The changes in the disease activity of bullous pemphigoid patients(Week 0,1,2,3,4,8,12,24)
- Vaccine-related adverse reactions(Week 0,1,2,3,4,8,12,24)
研究者
Chutima Seree-aphinan
Dr.
Mahidol University