A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults

Phase 1CompletedNCT03201211

GlaxoSmithKline81 enrolled

Overview

The purpose of this long-term follow-up of a Phase I study is to evaluate the kinetics of the antibody response to NTHi-Mcat antigens and long-term safety, in subjects aged between 50-71 years at the time of enrolment in the NTHi-Mcat-001 study. These subjects were previously exposed to two adjuvanted formulations of the NTHi-Mcat vaccine administered according to a 0, 2 months schedule in the NTHi-Mcat-001 (201281) study. The subjects that had received saline placebo controls will also be included in this follow-up study to make comparisons with the investigational vaccines. No vaccinations will be administered in this trial.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Respiratory Disorders

Interventions

GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.BIOLOGICAL

2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.BIOLOGICAL

PlaceboDRUG

Eligibility

Sex: ALLMin age: 51 YearsMax age: 73 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who previously participated in STEP 2 of study NTHi-Mcat-001 (201281), and performed the last study visit (Month 14) and received the 2 study vaccinations. * Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. return for follow-up visits). And subjects' Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol. * Written informed consent obtained from the subject/ LAR(s) of the subject prior to performance of any study specific procedure. Exclusion Criteria: * Use of any investigational or non-registered product (drug or vaccine) during the period starting 30 days before the first follow-up study visit (Month 19 to Month 20), or planned use during the study period. * Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since the end of the NTHi-Mcat-001 study. 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 (e.g. infliximab). * 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 (pharmaceutical product or device). * Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first follow-up visit or planned administration during the study period. * Current alcoholism and/or drug abuse. * Has significant disease (including significant neurological or psychological disorders), in the opinion of the investigator, likely to interfere with the study and/or likely to cause death within the study duration. * Any other condition that the investigator judges may interfere with study findings.

Locations (3)

GSK Investigational Site

Ghent, Belgium

GSK Investigational Site

Leuven, Belgium

GSK Investigational Site

Wilrijk, Belgium

Outcomes

Primary Outcomes

Anti-Protein D (PD) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Adjusted geometric mean concentration (GMC) and their 95% confidence interval (CI) was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PD assay was 153 ELISA unit per millilitre (EU/mL).

Time frame: At Month 20

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate. The cut-off value of the ELISA anti-PD assay was 153 EU/mL.

Time frame: At Month 26

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 32

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 38

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 44

Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 50

Anti-Protein E (PE) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 20

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 26

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 32

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 38

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 44

Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Time frame: At Month 50

Anti-type IV Pili Subunit (PilA) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.

Time frame: At Month 20

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.

Time frame: At Month 26

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.

Time frame: At Month 32

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.

Time frame: At Month 38

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.

Time frame: At Month 44

Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine

Adjusted GMC and their 95% CI was calculated. GMCs were estimated using an ANCOVA model including treatment group as fixed effect and Month 0 antibody concentration from NTHi Mcat-001 as covariate.The cut-off value of the ELISA anti-PilA assay was 7 EU/mL.

Time frame: At Month 50

Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine