Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: NTHi-Mcat 10-10-3.3
Product Code: GSK3277511A
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: -
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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. • Current or former smoker with a cigarette smoking history of = 10 pack-years. • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (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. • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone =20 mg/day, or equivalent. Inhaled and topical steroids are allowed. • Administration of long-acting immune-modifying drugs at any time 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 and ending 30 days after the last dose of vaccine administration, 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. • Previous vaccination with any vaccine containing NTHi and/or Mcat antigens. • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. • History of or current autoimmune disease. • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. •Acute disease and/or fever at the time of enrolment. - 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. • Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period. • Pregnant or lactating female. • Current alcoholism and/or drug abuse. • Female planning to become pregnant or planning to discontinue contraceptive precautions. • Diagnosed with a respiratory disorder. • Has significant disease, in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration. • Malignancies within previous 5 years or lymphoproliferative disorders. • Any other condition that the investigator judges may interfere with study findings.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1-2: During the 7-day follow-up period (Days 1-7) after each vaccination. 3: During the 30-day follow-up period (Days 1-30) after each vaccination. 4-5: From first vaccination (Day 1) up to and including Visit 9, at Day 541. ; Secondary Objective: • To evaluate the long term safety profile. • To evaluate the humoral immunogenicity of the NTHi-Mcat investigational vaccine. • To evaluate the cellular immunogenicity of the NTHi-Mcat investigational vaccine. ; Primary end point(s): 1. Number of subjects reported with each solicited local adverse event (AE) (any and grade 3) within each vaccination schedule. 2. Number of subjects reported with each solicited general adverse event (AE) (any and grade 3) within each vaccination schedule. 3. Number of subjects reported with any unsolicited adverse event (AE) within each vaccination schedule. 4. Number of subjects reported with any serious adverse event (SAE) within each vaccination schedule. 5. Number of subjects reported with any Potential Immune-mediated diseases (pIMDs) within each vaccination schedule. ;Main Objective: To evaluate the safety and reactogenicity profile of the NTHi-Mcat vaccine administered according to two vaccination schedules | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of subjects reported with any serious adverse event (SAE) within each vaccination schedule. 2. Number of subjects reported with any Potential Immune-mediated diseases (pIMDs) within each vaccination schedule. 3. Anti–Protein D (PD) antibody concentrations, as measured by ELISA, within each vaccination schedule. 4. Anti–Protein E (PE) antibody concentrations, as measured by ELISA, within each vaccination schedule. 5. Anti–type IV pili subunit (PilA) antibody concentrations, as measured by ELISA, within each vaccination schedule. 6. Anti–ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, as measured by ELISA, within each vaccination schedule. 7. Number of seropositive subjects for anti-PD antibody, as measured by ELISA, within each vaccination schedule. 8. Number of seropositive subjects for anti-PE antibody, as measured by ELISA, within each vaccination schedule. 9. Number of seropositive subjects for anti-PilA antibody, as measured by ELISA, within each vaccination schedule. 10. Number of seropositive subjects for anti-UspA2 antibody, as measured by ELISA, within each vaccination schedule. 11. NTHi-specific and Mcat-specific cell-mediated immune responses as measured by flow cytometry Intracellular Cytokine Staining (ICS) (frequency of specific CD4+ T-cells), in a sub-cohort of subjects and within each vaccination schedule. 12. NTHi-specific and Mcat-specific cell-mediated immune responses as measured by flow cytometry Intracellular Cytokine Staining (ICS) (frequency of specific CD8+ T-cells), in a sub-cohort of subjects and within each vaccination schedule. ; Timepoint(s) of evaluation of this end point: 1-2: From Visit 9 (Day 541) up to and including Visit 10 (Day 721). | — |
Countries
Canada, Germany, United Kingdom
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed