Randomized Trial of High Dose vs. Standard Dose Influenza Vaccine in Inflammatory Bowel Disease Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
研究概览
简要总结
Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC). A recent epidemiological investigation estimates that nearly 4 million people worldwide are affected and approximately 1.4 million of these cases occur in the United States. IBD can lead to debilitating symptoms, hospitalizations, decreased quality of life, frequent procedures and/or surgery. Treatment options consist of immunosuppressive therapy, such as systemic corticosteroids, immunomodulators (thiopurines and methotrexate) and/or biologics, such as tumor necrosis factor alpha (TNF) agents or an integrin inhibitor, vedolizumab. They can achieve clinical remission and decrease the risk of complications, but also increase the risk for opportunistic infections, including influenza.
Multiple studies have shown lower influenza vaccine responses in patients with IBD compared to healthy individuals; IBD patients treated with TNF agents or combination therapy (TNF inhibitors and immunomodulators) are very likely to mount a poor immune response. Influenza serum antibody concentration correlates with protection from infection following vaccination. Therefore, increasing influenza antibody responses in patients with IBD would appear to be critical to improving protection from influenza. A high dose (HD) influenza vaccine containing four times more hemagglutinin was licensed based on its ability to induce higher antibody concentrations compared to standard dose (SD) in adults 65 years or older.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CASES Specific Aim #1 Inclusion Criteria
- •A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic and histopathologic criteria.
- •Ages 18-64
- •Currently taking anti-TNF therapy (infliximab, golilumab, adalimumab, or certolizumab) for at least 3 months
排除标准
- •Received season's influenza vaccine
- •Allergy to eggs or influenza vaccine
- •Currently use of systemic steroids in the past 3 months
- •Specific Aim #2 Inclusion criteria
- •A history of chronic (greater than 3 month) ulcerative colitis or Crohn's disease diagnosed and documented by the standard clinical, radiographic, endoscopic and histopathologic criteria.
- •Ages 18-64
- •Currently on vedolizumab therapy
- •Exclusion Criteria
- •Received season's influenza vaccine
- •Allergy to eggs or influenza vaccine
- •Currently use of systemic steroids in the past 3 months
- •Control group Inclusion criteria
- •Age 18-64
- •Willing to participate in study
- •Control group Exclusion criteria
- •Currently on immunosuppressive therapy
- •Has a chronic health condition that may have an impact on vaccine antibody concentrations as deemed by the investigators, including chronic liver disease, celiac disease, history of solid organ or bone marrow transplantation.
- •Older than age 65 years
- •Unconfirmed Measles, Mumps, and Rubella (MMR) vaccination status
- •Patients in whom venipuncture are not feasible due to poor tolerability or lack of easy access.
研究组 & 干预措施
High dose influenza vaccine (HDIV)
This arm will be a double blind randomized controlled trial of High dose influenza vaccine (HDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
干预措施: High dose influenza vaccine (HDIV) (Biological)
Control Group
A group of 20 healthy individuals without IBD, other chronic diseases, or immunosuppressive therapy will be enrolled. All healthy individuals will receive standard dose influenza vaccine SDIV.
干预措施: Standard dose Influenza vaccine (SDIV) (Biological)
Vedolizumab Group + standard dose influenza vaccine (SDIV)
A group of 20 patients who are currently on vedolizumab. All individuals in this group will receive SDIV
干预措施: Standard dose Influenza vaccine (SDIV) (Biological)
Standard dose influenza vaccine (SDIV)
This arm will be a double blind randomized controlled trial of standard dose influenza vaccine (SDIV) for IBD patients on TNF monotherapy.
40 patients will be enrolled and randomized in a 5:3 fashion to HDIV or SDIV. Randomization will generated by a random number generator and investigator will be blinded to randomization scheme.
干预措施: Standard dose Influenza vaccine (SDIV) (Biological)
结局指标
主要结局
Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine
时间窗: Pre-immunization and 2-4 weeks post immunization
Influenza vaccine antibody concentration will be measured in immunosuppressed IBD patients who receive high dose and standard of care dose influenza vaccine. Higher antibody concentrations are associated with better protection from infection.
次要结局
- Response Rate Against Influenza Vaccine in Patients With Inflammatory Bowel Disease: Number of Participants Positive for Seroconversion(4 weeks)
- Seroprotection: Number of Participants With Antibody Concentration at Least 1:40 at Week 4 Postimmunization(4 weeks)
- Measure Antibody Concentrations in Immunosuppressed IBD Patients Who Receive High Dose and Standard of Care Dose Influenza Vaccine(6 months post-immunization)
- Seroprotection: Number of Participants With Antibody Titer of 160 at Week 4 Post-immunization(4 weeks)