Using Live Vaccines to Induce Beneficial Innate Immune Training and Reduce Systemic Inflammation in COPD Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Innate immune training.
研究概览
简要总结
A randomized, single-blinded clinical pilot study to assess whether vaccination with live attenuated vaccines can induce trained immunity and cause beneficial changes in patients with COPD.
详细描述
Single-blinded 1:1:1 block randomized controlled trial (with varying block sizes of 3-6), stratified by sex. A total of 60 participants will be recruited and randomly assigned with 20 in each treatment arm. Separated by three months, the participants will receive two doses of one of the following three treatments:
- MMR vaccine (M-M-R VaxPro)
- BCG vaccine (Danish strain 1331)
- Saline (placebo)
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specialist verified and spirometry-confirmed COPD
- •Age > 40 years.
- •Negative HIV-test.
- •Able to give informed consent.
排除标准
- •Acute febrile illness.
- •Known allergy to BCG or MMR vaccines or serious adverse effects at previous vaccination.
- •Allergy to MMR vaccine components, neomycin, or egg proteins.
- •Known prior, active, or latent infection with mycobacterium tuberculosis.
- •Pregnancy or breastfeeding.
- •Vaccination with a live vaccine within the last 4 weeks.
- •Being severely immunocompromised (HIV-1 infection, organ- or bone marrow transplantation, chemotherapy, primary immune defect, anti-cytokine therapy, immunosuppressant treatment).
- •Oral or intravenous corticosteroid at dose of ≥10 mg/day with duration over 3 months.
- •Active solid or non-solid malignancy or lymphoma, excluding basal cell carcinoma within 2 years.
- •Treatment with immunoglobulins within the last 3 months or expected treatment with immunoglobulins for the duration of the trial.
研究组 & 干预措施
BCG vaccine
Intradermal BCG vaccine (0.1 ml) + subcutaneous saline at inclusion and after 3 months.
干预措施: BCG vaccine (Danish strain 1331) (Drug)
MMR vaccine
Subcutaneous MMR vaccine (0.5ml) + intradermal saline at inclusion and after 3 months.
干预措施: MMR Vaccine (Drug)
Placebo
Subcutaneous saline + intradermal saline at inclusion and after 3 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Innate immune training.
时间窗: From inclusion to 4 months post-inclusion.
Innate immune training, detected as fold-changes in cytokine production capacity of innate immune cells for cytokines such as IL-1β, IL-6, IL-10, TNF-α and IFN-γ, following pro-inflammatory stimulation from inclusion to 4 months post-inclusion.
次要结局
未报告次要终点
研究者
Josefin Eklöf
MD, PhD
Chronic Obstructive Pulmonary Disease Trial Network, Denmark