Clinical trial NCT03201211: A Long Term Follow-up Study up to 4 Years After Study Vaccination to Assess Immunogenicity and Safety of the Investigational Vaccine in Adults
Official title: A Long-term Follow-up Study of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Disorders
Keywords: Safety
Immunogenicity
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-06-28
Enrollment: 81
Sex: ALL
Minimum age (years): 51
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anti-Protein D (PD) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 20
measure: Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 26
measure: Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 32
measure: Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 38
measure: Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 44
measure: Anti-PD Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 50
measure: Anti-Protein E (PE) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 20
measure: Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 26
measure: Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 32
measure: Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 38
measure: Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 44
measure: Anti-PE Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 50
measure: Anti-type IV Pili Subunit (PilA) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 20
measure: Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 26
measure: Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 32
measure: Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 38
measure: Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 44
measure: Anti-PilA Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 50
measure: Anti-ubiquitous Surface Protein A2 of Moraxella Catarrhalis (UspA2) Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 20
measure: Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 26
measure: Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 32
measure: Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 38
measure: Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 44
measure: Anti-UspA2 Antibody Concentrations, Measured as Component of the NTHi Mcat Investigational Vaccine
timeFrame: At Month 50
Secondary outcomes:
measure: Number of Subjects Reported With Any Serious Adverse Event (SAE)
timeFrame: From first visit (Month 20) up to study conclusion (Month 50)
measure: Number of Subjects Reported With Any Potential Immune-mediated Disease (pIMD)
timeFrame: From first visit (Month 20) up to study conclusion (Month 50)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: Wilrijk
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: