Duration of Immune Response to Influenza Vaccination in Patients With Rheumatoid Arthritis Receiving Treatment With Biologic Agents
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Initial Immune response
研究概览
简要总结
The main objective is to evaluate the strength and duration of immune response after influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with biological agents as compared to a group healthy controls who do not have RA. Influenza vaccine titers will be drawn 3 times: at Baseline(prior to vaccination), 4-6 weeks post vaccination, and 5-6 months post vaccination. Influenza vaccination will be done at the baseline visit after the baseline blood draw.
详细描述
Aims:
- Evaluate the strength and duration of immune response after influenza vaccination in patients with Rheumatoid Arthritis (RA) receiving treatment with biological agents.
- Evaluate for predictors of immune response such as age, gender, disease duration, type of the biological agent(s) used, duration of the treatment, and type of treatment in the past.
- Assess the efficacy of vaccine response in this population by recording proportion of patients who contracted influenza illness despite vaccination. The result of the study may provide more information regarding which situations inadequate immune response by strength or duration would most likely to be expected. This may help lay some groundwork for future studies looking at the use of booster vaccinations in this population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria (RA Patients)
- •Patients with RA receiving treatment with an Anti-T Cell or Anti-TNF biological agent
- •Age 40-75
- •Inclusion Criteria (Healthy Controls):
- •Age 40-75
排除标准
- •Exclusion criteria (RA Patients)
- •Known hypersensitivity/allergy influenza vaccine
- •Chronic debilitating conditions (such as end-stage Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), liver disease, Chronic Kidney Disease (CKD) )
- •Active malignancy at time of vaccination
- •Pregnancy and lactation
- •Known HIV
- •Active infection at time of vaccination
- •Recent acute illness (within 1 month prior to vaccination)
- •Exclusion Criteria(Healthy Controls):
- •Known autoimmune conditions
- •Chronic use of immunosuppressant treatments
- •Known hypersensitivity/allergy influenza vaccine
- •Chronic debilitating conditions (such as end-stage COPD, CHF, liver disease, CKD)
- •Active malignancy at time of vaccination
- •Pregnancy and lactation
- •Known HIV
- •Active infection at time of vaccination
- •Recent acute illness (within 1 month prior to vaccination)
结局指标
主要结局
Initial Immune response
时间窗: 4-6 weeks post vaccination
proportion of subjects with at least a 4-fold increase in titer at 4-6 weeks postvaccination to this year's influenza vaccine antigens;
Total proportion of seroconversion
时间窗: 6 months post vaccination
proportion of subjects with a persistent level of antibodies for influenza at the end of influenza period
次要结局
- Occurrence of influenza infection(6 months post vaccination)
- Occurrence of flu-like illnesses(6 months post vaccination)
研究者
Donald A Raddatz
Attending Physician, Department of Medicine - Rheumatology
Bassett Healthcare