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

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ClinicalTrials.gov Identifier: NCT03201211
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Respiratory Disorders Biological: Blood sampling Biological: Formulation 1 : NTHi-Mcat high dose adjuvanted vaccine GSK3277513A Biological: Formulation 2 : NTHi-Mcat low dose adjuvanted vaccine GSK3339036A Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Long-term Follow-up Study of the Investigational GSK Biologicals' GSK3277511A Vaccine in Adults
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : March 19, 2020
Actual Study Completion Date : March 19, 2020

Arm Intervention/treatment
Experimental: Group A
Subjects who received two doses of formulation 1 of the NTHi-Mcat investigational vaccine during STEP 2 of NTHi -Mcat-001 (201281 - NCT02547974) study and for whom blood sampling was taken at each planned visit during the NTHI Mcat-006 study, for antibody determination and assay validation/development.
Biological: 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.

Biological: Formulation 1 : NTHi-Mcat high dose adjuvanted vaccine GSK3277513A
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.

Experimental: Group B
Subjects who received two doses of formulation 2 of the NTHi-Mcat investigational vaccine during STEP 2 of NTHi -Mcat-001 (201281 - NCT02547974) study and for whom blood sampling was taken at each planned visit during the NTHI Mcat-006 study, for antibody determination and assay validation/development.
Biological: 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.

Biological: Formulation 2 : NTHi-Mcat low dose adjuvanted vaccine GSK3339036A
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 Comparator: Group C
Subjects who received placebo during STEP 2 of NTHi -Mcat-001 (201281 - NCT02547974) study and for whom blood sampling was taken at each planned visit during the NTHI Mcat-006 study, for antibody determination and assay validation/development
Biological: 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.

Drug: 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.




Primary Outcome Measures :
  1. Anti-Protein D (PD) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 20 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations),. The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PD assay is 153 EU/mL (ELISA unit per millilitre).

  2. Anti-Protein D (PD) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 26 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations),. The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PD assay is 153 EU/mL (ELISA unit per millilitre).

  3. Anti-Protein D (PD) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 32 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PD assay is 153 EU/mL (ELISA unit per millilitre).

  4. Anti-Protein D (PD) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 38 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PD assay is 153 EU/mL (ELISA unit per millilitre).

  5. Anti-Protein D (PD) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 44 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PD assay is 153 EU/mL (ELISA unit per millilitre).

  6. Anti-Protein D (PD) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 50 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PD assay is 153 EU/mL (ELISA unit per millilitre).

  7. Anti-Protein E (PE) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 20 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PE assay is 8 EU/mL (ELISA unit per millilitre).

  8. Anti-Protein E (PE) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 26 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PE assay is 8 EU/mL (ELISA unit per millilitre).

  9. Anti-Protein E (PE) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 32 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PE assay is 8 EU/mL (ELISA unit per millilitre).

  10. Anti-Protein E (PE) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 38 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations).The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PE assay is 8 EU/mL (ELISA unit per millilitre).

  11. Anti-Protein E (PE) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 44 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PE assay is 8 EU/mL (ELISA unit per millilitre).

  12. Anti-Protein E (PE) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 50 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PE assay is 8 EU/mL (ELISA unit per millilitre).

  13. Anti-type IV pili subunit (PilA) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 20 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PilA assay is 7 EU/mL (ELISA unit per millilitre).

  14. Anti-type IV pili subunit (PilA) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 26 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PilA assay is 7 EU/mL (ELISA unit per millilitre).

  15. Anti-type IV pili subunit (PilA) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 32 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PilA assay is 7 EU/mL (ELISA unit per millilitre).

  16. Anti-type IV pili subunit (PilA) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 38 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PilA assay is 7 EU/mL (ELISA unit per millilitre).

  17. Anti-type IV pili subunit (PilA) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 44 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PilA assay is 7 EU/mL (ELISA unit per millilitre).

  18. Anti-type IV pili subunit (PilA) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 50 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-PilA assay is 7 EU/mL (ELISA unit per millilitre).

  19. Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 20 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-UspA2 assay is 18 EU/mL (ELISA unit per millilitre).

  20. Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 26 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-UspA2 assay is 18 EU/mL (ELISA unit per millilitre).

  21. Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 32 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-UspA2 assay is 18 EU/mL (ELISA unit per millilitre).

  22. Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 38 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-UspA2 assay is 18 EU/mL (ELISA unit per millilitre).

  23. Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 44 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations). The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-UspA2 assay is 18 EU/mL (ELISA unit per millilitre).

  24. Anti-ubiquitous surface protein A2 of Moraxella catarrhalis (UspA2) antibody concentrations, measured as component of the NTHi Mcat investigational vaccine. [ Time Frame: At Month 50 ]
    Geometric Mean Concentrations (GMC) and their 95% CI will be calculated (the GMCs are computed by taking the anti-log of the mean of the log concentration transformations) The cut-off value of the enzyme-linked immunosorbent assay (ELISA) anti-UspA2 assay is 18 EU/mL (ELISA unit per millilitre).


Secondary Outcome Measures :
  1. Number of subjects reported with any serious adverse event (SAE). [ Time Frame: From first visit (Month 20) up to study conclusion (Month 50) ]
    A Serious Adverse Event is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity.

  2. Number of subjects reported with any potential immune-mediated disease (pIMD). [ Time Frame: From first visit (Month 20) up to study conclusion (Month 50) ]
    Potential immune-mediated diseases (pIMDs) are a subset of Adverse Events that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   51 Years to 73 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201211


Locations
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Belgium
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, 3000
GSK Investigational Site
Wilrijk, Belgium, 2610
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT03201211    
Other Study ID Numbers: 204913
2016-004248-13 ( EudraCT Number )
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlaxoSmithKline:
Safety
Immunogenicity
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs