A Study to Test if the Vaccine is Working Well in Chronic Obstructive Pulmonary Disease (COPD) Patients Aged 40 to 80 Years Old to Reduce Episodes of Worsening Symptoms and to Gather Further Information on Safety and Immune Response.

Completed · Phase 2 · Has a placebo group

Conditions studied: Respiratory Disorders

In brief

The purpose of this study is to test if the vaccine is working well in COPD patients aged 40 to 80 years old to reduce episodes of worsening symptoms ("exacerbations") and to gather further information on safety and immune response. In the current study, COPD patients with a history of acute exacerbations will receive 2 doses of the investigational vaccine or placebo intramuscularly according to a 0, 2 month vaccination schedule, in addition to standard care. The effect of vaccination against two pathogens known to cause exacerbations (Non-typeable Haemophilus influenza \[NTHi\] and Moraxella catarrhalis \[Mcat\]) will be evaluated at pre-defined timepoints (scheduled study visits). In addition to the scheduled study visits, additional study visit(s) and/ or phone contact(s) will take place for each acute exacerbation of COPD occurring from first vaccination up to study conclusion.

Key facts

Study ID

NCT03281876

Run by

GlaxoSmithKline

People needed

606

Starts

2017-11-27

Expected to finish

2020-03-26

Last updated by the study team

2021-01-11

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written informed consent obtained from the subject prior to performing any study specific procedure.
• A male or female between, and including, 40 and 80 years of age at the time of the first vaccination.
• Confirmed diagnosis of COPD with forced expiratory volume in 1 second (FEV1) over forced vital capacity (FVC) ratio (FEV1/FVC) < 0.7, AND FEV1 < 80% predicted (GOLD 2, 3 and 4).
• Current or former smoker with a cigarette smoking history of ≥ 10 pack-years.
• Stable COPD patient* with documented history** of at least 1 moderate or severe AECOPD within the 12 months before Screening.
• Patient for whom the last episode of AECOPD is resolved for at least 30 days at the time of first vaccination.
• A documented history of a COPD exacerbation is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence. Subject verbal reports are not acceptable.
• Capable of complying with the daily electronic Diary Card completion throughout the study period, according to investigator's judgement at Visit 1.
• Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

You may not qualify if…

• Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.
• Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe.
• Administration of immunoglobulins or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
• Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine, with the exception of any influenza or pneumococcal vaccine which may be administered ≥15 days preceding or following any study vaccine dose.
• Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
• Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose (e.g. methotrexate).
• Administration of systemic corticosteroids within the 30 days before first vaccination.
• Subjects who received systemic corticosteroids within this period may be enrolled at a later date if enrolment is still open.
• Inhaled and topical steroids are allowed.
• Administration of systemic antibiotics within the 30 days before first vaccination.
• Subjects who received systemic antibiotics within this period may be enrolled at a later date if enrolment is still open.
• Chronic use of antibiotics for prevention of AECOPD (e.g. azithromycin).
• Acute disease and/or fever at the time of first vaccination. Fever is defined as temperature ≥37.5°C. The preferred location for measuring temperature in this study will be the oral cavity or the axilla.
• Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
• Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3L/min (Oxygen use ≤3L/min flow is not exclusionary).
• Planned lung transplantation.
• Lung resection: Subjects with planned lung volume reduction surgery during the study or within the 12 months prior to first vaccination.
• Diagnosis of α-1 antitrypsin deficiency as the underlying cause of COPD.
• Diagnosed with a respiratory disorder other than COPD at time of enrolment (such as sarcoidosis, active tuberculosis, clinically significant bronchiectasis, clinically significant lung fibrosis, clinically significant pulmonary embolism, clinically significant pneumothorax, current diagnosis of asthma in the opinion of the investigator), or chest X-ray/ CT scan revealing evidence of clinically significant abnormalities not believed to be due to the presence of COPD. Subjects with allergic rhinitis do not need to be excluded and may be enrolled at the discretion of the investigator.
• History of immune-mediated disease other than COPD. If the subject has any condition on the non-exhaustive list of potential immune-mediated diseases defined in the protocol, they must be excluded unless the aetiology is clearly documented to be non-immune mediated.
• Previous vaccination with any vaccine containing NTHi and/ or Mcat antigens.
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines and/ or the bronchodilator used for spirometry assessment during the study.
• Contraindication for spirometry testing.
• Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded:

Where it is running

• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Phoenix, Arizona, United States
• GSK Investigational Site — Palm Springs, California, United States
• GSK Investigational Site — Clearwater, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Jacksonville, Florida, United States
• GSK Investigational Site — Council Bluffs, Iowa, United States
• GSK Investigational Site — Wichita, Kansas, United States
• GSK Investigational Site — Missoula, Montana, United States
• GSK Investigational Site — Neptune City, New Jersey, United States
• GSK Investigational Site — Charlotte, North Carolina, United States
• GSK Investigational Site — Mooresville, North Carolina, United States
• GSK Investigational Site — Winston-Salem, North Carolina, United States
• GSK Investigational Site — Columbus, Ohio, United States
• GSK Investigational Site — Corvallis, Oregon, United States
• GSK Investigational Site — Medford, Oregon, United States
• GSK Investigational Site — Erie, Pennsylvania, United States
• GSK Investigational Site — Gaffney, South Carolina, United States
• GSK Investigational Site — Mt. Pleasant, South Carolina, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Union, South Carolina, United States
• GSK Investigational Site — Abingdon, Virginia, United States
• GSK Investigational Site — Richmond, Virginia, United States
• GSK Investigational Site — Wenatchee, Washington, United States
• GSK Investigational Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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