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Respiratory DisordersPhase 1NCT01678677

A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers

A Phase 1 study testing NTHI vaccine GSK2838500A (formulation 1), NTHI vaccine GSK2838501A (formulation 2) and NTHI vaccine GSK2838502A (formulation 3) in people with Respiratory Disorders, run by GlaxoSmithKline at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8 different formulations of investigational NTHI vaccine in current and former smokers, 50-70 years of age. Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Respiratory Disorders
What is being tested?
NTHI vaccine GSK2838500A (formulation 1), NTHI vaccine GSK2838501A (formulation 2) and NTHI vaccine GSK2838502A (formulation 3)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
272 participants
Where
3 sitesBelgium
Study dates
31 Aug 2012to 30 Jan 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • A male or female between, and including, 50 and 70 years of age at the time of the first vaccination.
  • Written informed consent obtained from the subject.
  • Subjects without medical history, clinical finding or laboratory finding which in the opinion of the investigator could pose a safety concern or interfere with the protocol.
  • Current or former smokers.
  • A smoking history of at least 10 pack-years.
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  • Female subjects of non-childbearing potential may be enrolled in the study.
  • 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.

Who cannot join

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • 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.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of vaccine, with the exception of any influenza vaccine which may be administered ≥ 15 days preceding or following any study vaccine dose.
  • Previous vaccination with any vaccine containing NTHi-antigens.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Topical steroids are allowed.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
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  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of or current autoimmune disease.
  • Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) < 80% of predicted normal value.
  • Diagnosed with a respiratory disorder. Please note that subjects with mild pulmonary obstruction can be enrolled.
  • Laboratory evidence of clinically significant haematological abnormalities at Screening.
  • Acute disease and/or fever at the time of enrolment.
  • Current alcoholism and/or drug abuse.
  • 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.
  • History of or current condition preventing intramuscular injection as bleeding or coagulation disorder.
  • Has contraindication for spirometry testing.
  • Malignancies within previous 5 years and lymphoproliferative disorders.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • Any other condition that the investigator judges may interfere with study findings.

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites

  • GSK Investigational Site

    Antwerp, 2060

  • GSK Investigational Site

    Ghent, 9000

  • GSK Investigational Site

    Wilrijk, 2610

Other trials in Belgium

About this study

Official title: An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Non-typeable Haemophilus Influenzae (NTHi) Investigational Vaccine (GSK2838497A) in Current and Former Smokers

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of 8 different formulations of investigational NTHI vaccine in current and former smokers, 50-70 years of age.

Read the detailed description

This Protocol Posting has been updated following Protocol Amendment 1, dated 10 October 2012, leading to a change in an inclusion criterion.

Being tested
NTHI vaccine GSK2838500A (formulation 1), NTHI vaccine GSK2838501A (formulation 2), NTHI vaccine GSK2838502A (formulation 3), NTHI vaccine GSK2838503A (formulation 4), NTHI vaccine GSK2838504A (formulation 5)
Keywords
non-typeable Haemophilus influenzae, immunogenicity, reactogenicity, safety
Medical subject headings
Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NTHI vaccine GSK2838500A (formulation 1)Biological

    Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

  • NTHI vaccine GSK2838501A (formulation 2)Biological

    Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

  • NTHI vaccine GSK2838502A (formulation 3)Biological

    Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

  • NTHI vaccine GSK2838503A (formulation 4)Biological

    Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

  • NTHI vaccine GSK2838504A (formulation 5)Biological

    Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

  • NTHI vaccine GSK2838505A (formulation 6)Biological

    Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

  • NTHI vaccine GSK2838508A (formulation 7)Biological

    Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

  • NTHI vaccine GSK2838509A (formulation 8)Biological

    Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

  • Placebo comparatorDrug

    Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Study groups in NCT01678677
Study groupRoleWhat they receive
Group AExperimentalSubjects in this group will receive formulation 1 of NTHi vaccine.
Receives: Biological: NTHI vaccine GSK2838500A (formulation 1)
Group BExperimentalSubjects in this group will receive formulation 2 of NTHi vaccine.
Receives: Biological: NTHI vaccine GSK2838501A (formulation 2)
Group CExperimentalSubjects in this group will receive formulation 3 of NTHi vaccine.
Receives: Biological: NTHI vaccine GSK2838502A (formulation 3)
Group DExperimentalSubjects in this group will receive formulation 4 of NTHi vaccine.
Receives: Biological: NTHI vaccine GSK2838503A (formulation 4)
Group EExperimentalSubjects in this group will receive formulation 5 of NTHi vaccine and a placebo.
Receives: Biological: NTHI vaccine GSK2838504A (formulation 5)
Group FExperimentalSubjects in this group will receive formulation 6 of NTHi vaccine and a placebo.
Receives: Biological: NTHI vaccine GSK2838505A (formulation 6)
Group GExperimentalSubjects in this group will receive formulation 7 of NTHi vaccine and a placebo.
Receives: Biological: NTHI vaccine GSK2838508A (formulation 7)
Group HExperimentalSubjects in this group will receive formulation 8 of NTHi vaccine and a placebo.
Receives: Biological: NTHI vaccine GSK2838509A (formulation 8)
Group Placebo 1Placebo comparatorSubjects in this group will receive placebo.
Receives: Drug: Placebo comparator
Group Placebo 2Placebo comparatorSubjects in this group will receive placebo.
Receives: Drug: Placebo comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of each solicited local and general adverse event (AE), in all subjects, in all groups.

    Measured: During a 7-day follow-up period (from day 0 to day 6) after each vaccination.

  2. Occurrence of any unsolicited AE, in all subjects, in all groups.

    Measured: During a 30-day follow-up period (from day 0 to day 29) after each vaccination.

  3. Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.

    Measured: Prior to each vaccination.

  4. Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.

    Measured: 7 days after each vaccination.

  5. Occurrence of haematological and biochemical laboratory abnormalities, in all subjects, in all groups.

    Measured: At study conclusion (Day 420).

  6. Occurrence of any serious adverse event (SAE), in all subjects, in all groups.

    Measured: From first vaccination (Day 0) to study conclusion (Day 420).

  7. Occurrence of any potential immune-mediated disease (pIMD) in all subjects, in all groups.

    Measured: From first vaccination (Day 0) to study conclusion (Day 420).

Secondary outcomes (2)

  1. Humoral immune response to the components of the NTHi vaccine formulations, in all subjects, in all groups, in terms of antibody concentrations.

    Measured: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).

  2. Cell-mediated immune (CMI) responses to components of the NTHi vaccine formulations, in a sub-cohort of subjects, in all groups.

    Measured: Prior to each vaccination, 30 days after each vaccination, and at study conclusion (Day 420).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2012 (estimated)
  2. Study start31 Aug 2012
  3. Primary completion30 Jan 2014
  4. Study completion30 Jan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01678677
Sponsor's protocol ID
116647
Status last verified
May 2017
First submitted
23 Aug 2012
Last updated
15 May 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NTHI vaccine GSK2838500A (formulation 1), NTHI vaccine GSK2838501A (formulation 2) and NTHI vaccine GSK2838502A (formulation 3) in people with Respiratory Disorders, run by GlaxoSmithKline at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of each solicited local and general adverse event (AE), in all subjects, in all groups. (time frame: During a 7-day follow-up period (from day 0 to day 6) after each vaccination.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01678677.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2017.

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