NCT06224270招募中4 期
Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Adults With Inflammatory Bowel Disease on Biologic Immunosuppressive Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 264
- 试验地点
- 6
- 主要终点
- Geometric Mean Concentrations of Anti-gE Antibodies
研究概览
简要总结
This multi-center study will evaluate the safety and immune response to recombinant zoster vaccine (RZV) series in 264 patients with inflammatory bowel disease (IBD) on immunosuppressive therapy recruited from 6 study sites who can expect to be on study for up to 14 months.
详细描述
Study Visits:
-
Visit 1 (V1) - day 1 - blood draw, RZV dose 1
-
Follow up (FU) 1 - between days 7-15
-
FU 2 - between days 22-29
-
Visit 2 (V2) - between days 30-90 - RZV dose 2
-
FU 3 - V2 + 7-14 days
-
Visit 3 (V3) - V2 + 21-50 days - blood draw
-
Visit 4 (V4) - V2 + approximately 360 days - blood draw
Primary Objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between the ages of 19 and 85 years with a diagnosis of IBD based on standard clinical and histological criteria.
- •Can provide appropriate written informed consent.
- •Patient has a history of ulcerative colitis or Crohn's disease diagnosed by standard clinical, radiographic, endoscopic, and histopathologic criteria.
- •Patient is receiving one of the following treatments for their IBD:
- •Anti-TNF therapy (infliximab, adalimumab, certolizumab, or golimumab)
- •On anti-TNF monotherapy
- •Or anti-TNF therapy in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6-Mercaptopurine (6MP) 0.5mg/kg
- •Non-TNF therapy
- •On ustekinumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
- •On vedolizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
- •On Risankizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
- •On mirikizumab monotherapy or in combination with either 10mg of methotrexate or azathioprine at least 1.0mg/kg or 6MP 0.5mg/kg
- •Janus Kinase Inhibitor
- •On tofacitinib at least 5mg PO twice per day (BID)
- •On upadactinib at least 15mg PO BID
- •Patient has been on stable biologic or JAK treatment for IBD for at least two months.
- •Patient is in stable clinical remission
- •o No recent corticosteroid prescription within the past two months.
- •Female participant of non-childbearing potential (pre-menarche, current tubal ligation, hysterectomy, oophorectomy or post-menopause) and childbearing potential (if they had: practiced adequate contraception (include IUD or equivalent, hormonal contraceptive (e.g. pill, patch, ring, implant or an injection used consistently and that has reached full effect prior to the first dose of vaccine), hysterectomy and/or a bilateral tubal ligation or bilateral oophorectomy) for 1 month prior to vaccination and agrees to continue adequate contraception during the primary treatment period, and for 2 months after completion of the vaccination series). Non-pregnant females with a negative pregnancy test who are willing to practice adequate contraception during the primary treatment period, and for 2 months after completion of the vaccination series).
排除标准
- •Patient cannot or will not provide written informed consent.
- •Patient has been taking any dose of oral or intravenous steroids for more than 3 days within 2 months prior to immunization.
- •Any confirmed or suspected HIV, primary immunodeficiency disease, disseminated or untreated malignancy, or systemic infection.
- •Previous vaccination against HZ or varicella within the 12M preceding the first dose of RZV.
- •Occurrence of varicella or HZ per clinical history, within the 12M preceding the first dose of RZV.
- •Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to the use of induction and/or maintenance immunosuppressive therapies.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
- •Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
- •Any condition which, in the judgment of the investigator, would make intramuscular injection unsafe.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) before Month 3 (i.e. 2 months after last dose of study V2).
研究组 & 干预措施
Adults with IBD
Experimental
干预措施: Adjuvanted Recombinant Zoster Vaccine (RZV) (Biological)
结局指标
主要结局
Geometric Mean Concentrations of Anti-gE Antibodies
时间窗: Visit 3 (between 50 and 140 days on study)
Anti-gE antibody concentrations expressed as geometric mean concentrations (GMCs) at V3, following 2 doses of RZV, in patients on non-TNF biologic therapy compared to those on anti-TNF biologic therapy.
次要结局
- Number of Participants with Unsolicited Adverse Events(up to 30 days after Visit 1, up to 30 days after Visit 2)
- Number of Participants Reporting Potential Immune-Mediated Diseases (pIMDs)(up to 14 months)
- Vaccine response rate (VRR)(Visit 3 (between 50 and 140 days on study))
- Geometric Mean Concentrations of Anti-gE Antibodies(Visit 1 (day 1), Visit 3 (between 50 and 140 days on study), Visit 4 (approximately 360 days))
- Number of Participants Reporting Complications from HZ(up to 14 months)
- Number of Participants reporting disease flares of IBD(baseline, Visit 1 (day 1), Follow-Up 2 (up to 29 days), Visit 2 (up to 90 days), Visit 3 (up to 140 days on study), Visit 4 (up to 360 days))
- Seropositivity rate(Visit 1 (day 1), Visit 3 (between 50 and 140 days on study), Visit 4 (approximately 360 days))
- Number of Participants with Solicited Adverse Events (AEs)(Up to 7 days after Visit 1, up to 7 days after Visit 2)
- Number of Participants with Serious Adverse Events (SAEs)(up to 14 months)
- Number of Herpes Zoster Events(up to 14 months)
研究者
研究点 (6)
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