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.

Phase 2CompletedNCT02075541

GlaxoSmithKline145 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

145

Conditions

Respiratory Disorders

Interventions

NTHi-10-AS01EBIOLOGICAL

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

NaCl PlaceboDRUG

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (14)

GSK Investigational Site

Eskilstuna, Sweden

GSK Investigational Site

Gothenburg, Sweden

GSK Investigational Site

Örebro, Sweden

Outcomes

Primary Outcomes

Number of Subjects With Any Solicited Local Adverse Events (AEs).

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Time frame: During a 7-day follow-up period (from Day 0 to Day 6) after first dose.

Number of Subjects With Any Solicited Local AEs.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Time frame: During a 7-day follow-up period (from Day 60 to Day 66) after second dose.

Number of Subjects With Any Solicited General AEs.

Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever \[defined as oral temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.

Time frame: During a 7-day follow-up period (from Day 0 to Day 6) following the first dose.

Number of Subjects With Any Solicited General AEs

Assessed solicited general symptoms are fatigue, gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), headache, fever (defined as oral temperature equal to or above 37.5 °C). Any = occurrence of the symptom regardless of intensity grade.

Time frame: During a 7-day follow-up period (from Day 60 to Day 66) following the second dose.

Number of Subjects With Any Unsolicited AEs.

Assessed unsolicited AEs covered any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination.

Data from ClinicalTrials.gov

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GSK Investigational Site

Llanelli, Carmarthenshire, United Kingdom

GSK Investigational Site

Leicester, Leicestershire, United Kingdom

GSK Investigational Site

Stoke-on-Trent, Staffordshire, United Kingdom

GSK Investigational Site

Bradford, United Kingdom

GSK Investigational Site

Dundee, United Kingdom

GSK Investigational Site

Edinburgh, United Kingdom

GSK Investigational Site

Liverpool, United Kingdom

...and 4 more locations

Time frame: During the 30-day follow-up period (from Day 0 to Day 29) following the first dose.

Number of Subjects With Any Unsolicited AEs

Time frame: During the 30-day follow-up period (from Day 60 to Day 89) following the second dose.