Randomized Double-blind Placebo-controlled Multicenter Clinical Trial of Bacterial Polyvalent Vaccine (BACTEK®), Administered Sublingually in COPD Patients, to Evaluate Efficacy, Safety, and Immunomodulatory Response.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 7
- 主要终点
- Number of COPD Exacerbations.
研究概览
简要总结
The goal of this clinical trial is to learn whether the bacterial vaccine MV130 helps reduce the number of exacerbations in adults with moderate to severe COPD. It will also assess the safety and immune effects of MV130. The main questions it aims to answer is: Does MV130 lower the number and severity of COPD flare-ups? Other questions include: Does it reduce the use of healthcare resources and improve quality of life?
Researchers will compare MV130 to a placebo (a similar spray without the active substance; bacterial species) to see how well it works. Participants will use either MV130 or placebo daily under the tongue for 12 months, attend regular clinic visits, and be followed for an additional 6 months to monitor health outcomes and side effects.
详细描述
This was a randomized, double-blind, placebo-controlled, prospective, parallel, multicenter clinical trial designed to evaluate the efficacy, safety, and immunomodulatory effects of a sublingually administered bacterial polyvalent vaccine (BACTEK®, also known as MV130) in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The study was conducted by Inmunotek, S.L., and included seven sHospitals across Spain. A total of 198 participants were enrolled and randomized equally into two groups to receive either MV130 or placebo over a period of 12 months, followed by a 6-month observation phase, totaling 18 months of participation per participant.
The investigational product, MV130, consisted of a glycerinated suspension containing six inactivated non-lysate bacterial species: Streptococcus pneumoniae, Staphylococcus epidermidis, Staphylococcus aureus, Klebsiella pneumoniae, Moraxella catarrhalis, and Haemophilus influenzae. The product was administered sublingually at a dosage of two sprays (0.2 mL total) per day. The placebo formulation was identical in appearance and composition, excluding the active bacterial components. All study participants received their first dose under supervision at the clinical site and were trained for home administration.
Eligible participants were between 35 and 85 years old, with a diagnosis of moderate or severe COPD according to GOLD guidelines, a history of recurrent exacerbations (≥3 moderate or ≥2 with at least one hospitalization in the past year), and a smoking history of at least 10 pack-years. Subjects were excluded if they had very severe COPD, a history of recent exacerbations or systemic corticosteroid use, concurrent immunodeficiency or serious comorbid conditions, or if they were pregnant, breastfeeding, or unwilling to use contraception during the study.
The primary efficacy endpoint was the total number of COPD exacerbations during the full 18-month period. Secondary endpoints included the severity of exacerbations, time to first exacerbation, healthcare resource usage (hospitalizations, emergency room visits, unscheduled consultations), medication use, health-related quality of life (assessed using the CAT questionnaire), and a pharmacoeconomic evaluation based on healthcare expenditures. In a subset of participants, immunological parameters were also assessed to explore the immunomodulatory response. Safety analysis included all randomized participants.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent.
- •Both sexes.
- •Age between 35 and
- •Must be capable of complying with the dosing regimen.
- •Diagnosis of moderate or severe COPD according to GOLD criteria.
- •Experienced at least three moderate exacerbations (i.e., those requiring treatment with antibiotics, systemic corticosteroids, or both, as prescribed by their general practitioner or pulmonologist in the standard consultation and/or the Emergency Department of their Clinic) or two exacerbations with at least one requiring hospitalization due to a COPD exacerbation and the other one a moderate exacerbation occurred within the last year.
- •Not changed their medication for the maintenance treatment of COPD within the past 6 months.
- •Consumption of 10 or more packs of cigarettes/year. Participants may be or not active smokers.
- •Live in the Autonomous Community of Madrid throughout the study period.
- •Women of childbearing age women of must use an approved contraceptive method and obtain a negative result in the urine pregnancy test performed during the screening visit.
排除标准
- •Participants outside allowed age range.
- •Participants unable to cooperate and/or have a severe psychiatric disorder.
- •Women who are pregnant, breastfeeding, expect to become pregnant during the study (including assisted reproduction), or who refuse to use contraceptives during the study (including barrier methods). Women who become pregnant during the clinical trial will have to discontinue their participation in it.
- •Participants who has participated in a study or clinical trial with an investigational product in the last 3 months before inclusion.
- •Participants diagnosed with asthma based on the guidelines of the American Thoracic Society and the European Respiratory Society. If the investigators are unable to differentiate between COPD and asthma after applying the criteria listed in the following table, a bronchodilator test with inhaled salbutamol must be performed, excluding those subjects with FEV1 changes >400 ml.
- •Participants with a diagnosis other than COPD that causes them to have an unstable condition or a life expectancy <3 years.
- •Participants who had an exacerbation within 4 weeks before starting the trial.
- •Participants with moderate COPD who required treatment with inhaled corticosteroids in the last 4 weeks.
- •Participants with moderate COPD who received systemic corticosteroids (orally, intramuscularly, or intravenously) in the last 4 weeks.
- •Participants diagnosed with a Primary or Secondary Immunodeficiency within the 12 months preceding their inclusion in the clinical trial or the trial's baseline visit.
- •Participants diagnosed with chronic lymphoproliferative disease.
- •Participants diagnosed with chronic infectious disease.
- •Participants with chronic heart disease, arrhythmias, or episodes of arrhythmia secondary to the administration of bronchodilators.
- •Participants diagnosed with COPD and chronic colonization by Pseudomonas aeruginosa.
- •Participants with COPD and bronchiectasis diagnosed by CT imaging before the age of
- •Participants diagnosed with very severe COPD according to the GOLD classification.
- •Participants requiring home oxygen therapy or non-invasive mechanical ventilation.
- •Participants with a history of hypersensitivity to any of the vaccine's components.
- •Participants receiving immunosuppressive treatment with: azathioprine, methotrexate, ciclosporin, cyclophosphamide, tacrolimus, antimalarial drugs, or gold salts.
- •Participants who have been treated with monoclonal antibodies such as rituximab or TNF-alpha inhibitors in the last 6 months.
- •Participants receiving chronic treatment with azithromycin or inhaled antibiotics (tobramycin or colistin).
研究组 & 干预措施
Active - MV130
The participants will receive daily dose of MV130 during 12 months sublingually.
干预措施: MV130 (Biological)
Placebo
The participants will receive daily dose of placebo during 12 months sublingually.
干预措施: Placebo (Biological)
结局指标
主要结局
Number of COPD Exacerbations.
时间窗: 18 months
Comparison in the number of COPD exacerbations in the two study groups in the 18-month study period.
次要结局
- Change in the Rate of COPD Exacerbations.(18 months)
- Time Elapsed Between Start of Treatment and First COPD Exacerbation.(18 months)
- Change in Severity of COPD Exacerbations.(18 months)
- Use of Drugs (Antibiotics, Corticosteroids, Etc).(18 months)
- Number of Hospitalizations Due to a COPD Exacerbation.(18 months)
- Number of Visits to the Emergency Room.(18 months)
- Days of Hospitalization Due to a COPD Exacerbation.(18 months)
- Number of Unscheduled Medical Consultations Due to COPD(18 months.)
- Health Related Quality of Life.(18 months)
- Healthcare Resource Utilization During COPD Exacerbations(18 months)
- Adverse Events and Overall Tolerability (Adverse Reactions).(18 months)