A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithkline (GSK) Biologicals' Investigational Vaccine GSK2838504A When Administered to Chronic Obstructive Pulmonary Disease (COPD) Patients With Persistent Airflow Obstruction.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Respiratory Disorders

Treatments: Biological: NTHi-10-AS01E; Drug: NaCl Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02075541

200157

2013-003062-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of this Phase II study is to assess the safety, reactogenicity and immunogenicity of the investigational Non-typeable Haemophilus influenzae (NTHi) vaccine in patients with moderate and severe persistent airflow obstruction.

Enrollment: 145 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.

• A male or female between, and including, 40 and 80 years of age at the time of the first vaccination.

• Written informed consent obtained from the subject.

• 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% and ≥ 30% predicted.

• 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 acute exacerbation of COPD within the 12 months before Screening.

• Regular sputum producer.

• Capable to comply 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.

• 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.

Exclusion criteria

• 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.

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.

• 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.

• Previous vaccination with any vaccine containing NTHi antigens.

• 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.

• Chronic administration of non-steroid immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

• History of immune-mediated disease other than COPD.

• Administration of systemic corticosteroids within the 30 days before Screening.

• Administration of systemic antibiotics within the 30 days before Screening.

• Chronic use of antibiotics for prevention of acute exacerbations of COPD (AECOPD).

• Receiving oxygen therapy.

• Planned lung transplantation.

• Planned/ underwent lung resection surgery.

• Diagnosis of α-1 antitrypsin deficiency as the underlying cause of COPD.

• Diagnosed with a respiratory disorder other than COPD, 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 can be enrolled.

• 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.

• Clinically significant abnormality in haematology or biochemistry parameter.

• Acute cardiac insufficiency.

• Malignancies within the previous 5 years or lymphoproliferative disorder.

• Any known disease or condition likely to cause death during the study period.

• Acute disease and/ or fever at the time of Screening.

  • Fever is defined as oral or axillary temperature ≥ 37.5°C. The preferred route for recording temperature in this study will be oral.
  • Subjects with acute disease and/ or fever at the time of Screening may be enrolled at a later date if enrolment is still open. Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

• Pregnant or lactating female.

• Current alcoholism and/or drug abuse.

• Other condition which the investigator judges may put the safety of the subject at risk through study participation or which may interfere with the study findings.

• Planned move to a location that will complicate participation in the trial through study end.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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145 participants in 2 patient groups, including a placebo group

10-AS01E group

Experimental group

Description:

Subjects in this group will receive the investigational NTHi vaccine.

Treatment:

Biological: NTHi-10-AS01E

Control group

Placebo Comparator group

Description:

Subjects in this group will receive placebo.

Treatment:

Drug: NaCl Placebo