Seasonal Influenza Vaccine, Quadrivalent Versus Trivalent in Patients With Advanced Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hemagglutination inhibiting antibodies (HI) against the components of viral antigens
研究概览
简要总结
To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of GOLD Stage C and D COPD vs. those patients without COPD.
详细描述
Primary Objectives:
To evaluate the magnitude of the humoral immune responses to quadrivalent vs trivalent influenza vaccines in adults between the age of 50 and 64 years with a prior diagnosis of GOLD Stage C and D COPD (vs. those patients without COPD).
To demonstrate immunogenicity by measuring hemagglutination inhibiting antibodies (HI) against the components of viral antigens using seroconversion (≥4 fold increase over baseline titers) and sero-protection (HI titer of ≥40 against the vaccine components).
Secondary Objective:
To assess the degree of antibody response of COPD patients based on severity of disease as measured by FEV1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for patients with COPD will be:
- •Signed informed consent prior to initiation of study-mandated vaccination.
- •Patients with spirometric data in the preceding 18 months confirming the diagnosis of COPD.
- •Patients meeting GOLD Classification of Stage C or Stage D COPD.
- •Patients 50 years old - 64 years old.
- •Inclusion criteria for Healthy participants will be:
- •Signed informed consent prior to initiation of study-mandated vaccination.
- •No active symptoms of lung disease.
- •FEV1/FVC in the normal range > 70% age predicted value.
- •No history of tobacco use/abuse.
- •No prior history of alpha-1 antitrypsin deficiency.
- •Patients 50 years old - 64 years old.
排除标准
- •Severe allergy to eggs.
- •Severe reaction to past doses of influenza vaccine.
- •Guillian-Barre syndrome.
- •Currently recieving dialysis.
- •Current, active, treatment for cancer.
- •History of transplant (allograft).
- •Dementia or Alzheimer's disease diagnosis.
- •Prior diagnosis of HIV or AIDS.
- •Moderate to severe pulmonary hypertension.
- •Serum AST/ALT > 3x the upper limit of normal.
- •Patients with exacerbations or respiratory infection during the 4 weeks preceding the onset of the study.
- •Active pregnancy.
- •Systemic immunomodulating medications.
结局指标
主要结局
Hemagglutination inhibiting antibodies (HI) against the components of viral antigens
时间窗: 3 months
The investigators will be measuring hemagglutination inhibiting antibodies (HI) against the components of viral antigens using seroconversion (≥4 fold increase over baseline titers) and sero-protection (HI titer of ≥40 against the vaccine components)
次要结局
未报告次要终点
研究者
David Baratz, M.D.
Medical Doctor
Banner Health