Booster Vaccine Strategy to Improve Serologic Responses to Influenza Vaccination in Children With Rheumatic Diseases and Inflammatory Bowel Disease Who Are Receiving Immunosuppressive Therapies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Influenza hemagglutination inhibition (HAI) titer
研究概览
简要总结
This proposed study will assess the immunogenicity, safety, and clinical efficacy of an influenza vaccine booster dose strategy in patients with autoimmune diseases who are receiving immunosuppressive therapies. Investigators will compare serologic responses to single versus a booster dose of influenza vaccine in patients with inflammatory bowel disease (IBD- Crohn's Disease or Ulcerative Colitis) or rheumatologic diseases who are receiving immunosuppressive therapies. Subjects will be randomized to receive either one or two doses of influenza vaccination in year #1. In year# 2, all participants will be given two doses of influenza vaccine. Serologic responses will be measured pre and 4-6 weeks post vaccination. This study will also assess the immunogenicity and safety of a booster vaccine strategy in the prevention of influenza-like illness (ILI). Investigators anticipate that booster dose strategy will improve both clinical and serologic responses in this vulnerable population.
详细描述
Patients receiving immunosuppressive therapies for rheumatologic diseases and inflammatory bowel disease (IBD) are at increased risk of serious infections, including influenza. Infections can also trigger flares of the underlying disease. Although newer biologic treatments are improving disease outcomes, these medications reduce vaccine responses, placing patients at high risk for vaccine-preventable illnesses. In a case-cohort study by Flannery et al. looking at influenza vaccine effectiveness from 2010-2014, only one in four children who died of laboratory-confirmed influenza were vaccinated, while a high prevalence (53%) had an underlying condition that put them at risk for severe influenza-related complications. Yearly influenza vaccination is recommended for all patients with rheumatologic diseases and IBD. However, these recommendations are based on studies that did not include patients receiving newer biologic therapies. Recent studies in organ transplant recipients, a group known to have suboptimal vaccine responses, have suggested a booster influenza vaccine strategy as a way of enhancing vaccine responses.
SPECIFIC AIMS:
The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies.
Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 3-22 years
- •Rheumatologic condition (JIA, Uveitis, SLE and other rheumatologic disorders) or inflammatory bowel disease (Crohn's disease or ulcerative colitis) and who are receiving immunosuppressive therapies as follows:
- •TNF inhibitors [etanercept (Enbrel), adalimumab (Humira®), infliximab (Remicade®)]
- •anti IL -1 [anakinra (Kineret®) or canakinumab (Ilaris®)]
- •IL-6 tocilizumab (Actemra®)
- •anti IL-12/23 ustekinumab (Stelara®)
- •anti CTLA-4 [abatacept (Orencia®)]
- •vedolizumab (Entyvio®)
- •azathioprine (Imuran®)
- •6 mercaptopurine (Purinethol®)
- •Cyclosporine
- •Leflunomide
- •Mycophenolate
- •methotrexate (Otrexup® or Rasuvo®)
排除标准
- •Prior allergic reaction to any vaccine components
- •Other contraindication to influenza vaccination
- •Severe egg allergy
- •Pregnancy
- •Prior Guillain-Barre syndrome
- •Therapy with oral corticosteroids ≥2 mg/mg/day within 4 weeks of study entry
- •Prior rituximab
- •Prior cyclophosphamide
- •Prior IVIG within 8 weeks
- •Acute febrile illness at time of study evaluation
- •No prior history of two doses of influenza in the past for ages 3-8 years
研究组 & 干预措施
Group 2 - Standard - Year 2
Group 2 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2
干预措施: Influenza vaccine (Biological)
Group 1 - Booster - Year 1
Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 1
干预措施: Influenza vaccine (Biological)
Group 2 - Standard - Year 1
Group 2 subjects will be receive the standard single dose of influenza vaccine in year 1
干预措施: Influenza vaccine (Biological)
Group 1 - Booster - Year 2
Group 1 subjects will receive a second booster dose of injectable influenza vaccine 4 weeks after initial vaccination in year 2
干预措施: Influenza vaccine (Biological)
结局指标
主要结局
Influenza hemagglutination inhibition (HAI) titer
时间窗: 4 weeks post vaccination
immunological vaccine response
Influenza Hemagglutination Inhibition (HAI) Titer
时间窗: 4-6 weeks post final influenza vaccination dose (if participants received a booster, this was after the booster dose) in Year 1 and Year 2
immunological vaccine response
次要结局
- Clinical efficacy of vaccine(through study completion, an average of 2 years)
- Number of Participants With Decreased Influenza Rates Per Strain(through study completion, an average of 2 years)
研究者
Christy Beneri
Assistant Professor of Pediatrics
Stony Brook University