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

NCT ID: NCT03201211

Last Updated: 2021-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-22
• Study Completion Date: 2020-03-19

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.

Conditions

Respiratory Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

10-10-10-AS

Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, PE-PilA and UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: BIOLOGICAL

A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.

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

Intervention Type: 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.

10-10-3-AS

Subjects who received two doses of the AS01E adjuvanted GSK Biologicals' NTHi-Mcat investigational vaccine, containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2, and administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974), and were enrolled in the study.

Group Type: EXPERIMENTAL

Blood sampling

Intervention Type: BIOLOGICAL

A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.

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

Intervention Type: 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.

PLACEBO

Subjects who received two doses of placebo (saline solution), administered at Month 0 and Month 2 in NTHi-Mcat-001 study (NCT02547974) and were enrolled in the study.

Group Type: PLACEBO_COMPARATOR

Blood sampling

Intervention Type: BIOLOGICAL

A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.

Placebo

Intervention Type: DRUG

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.

Interventions

Blood sampling

A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.

Intervention Type: BIOLOGICAL

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

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.

Intervention Type: BIOLOGICAL

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

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.

Intervention Type: BIOLOGICAL

Placebo

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 51 Years
• Maximum Eligible Age: 73 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Ghent, , Belgium

GSK Investigational Site

Leuven, , Belgium

GSK Investigational Site

Wilrijk, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-004248-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

204913

Identifier Type: -

Identifier Source: org_study_id