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Infections, Respiratory Syncytial VirusPhase 1NCT01905215

Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccines

A Phase 1 study testing RSV vaccine GSK3003892A (formulation 1), RSV vaccine GSK3003893A (formulation 2) and RSV vaccine GSK3003895A (formulation 3) in people with Infections, Respiratory Syncytial Virus, run by GlaxoSmithKline at 3 sites in Canada.

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 first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men. Read more about this study

Who is it for?
Ages 18 to 44 years, men onlyHealthy volunteers can take part
Conditions the study is for
Infections, Respiratory Syncytial Virus
What is being tested?
RSV vaccine GSK3003892A (formulation 1), RSV vaccine GSK3003893A (formulation 2) and RSV vaccine GSK3003895A (formulation 3)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
128 participants
Where
3 sitesCanada
Study dates
22 Jul 2013to 16 Mar 2015
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 18 to 44 years
  • Men only
  • Healthy volunteers accepted
  • 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.
  • Written informed consent obtained from the subject.
  • A male between, and including, 18 and 44 years of age at the time of vaccination.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.

Who cannot join

  • Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the 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 within the period starting 30 days before and ending 30 days after vaccination, with the exception of any licensed influenza vaccine which may be administered ≥ 15 days before or after vaccination.
  • Previous vaccination against RSV.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the vaccine dose. Inhaled and topical steroids are allowed.
  • Administration of long-acting immune-modifying drugs at any time during the study period.
Show all 23Show fewer
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the dose of study vaccine or planned administration during the study period.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of or current autoimmune disease.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
  • Hypersensitivity to latex.
  • Any clinically significant hematological (hemoglobin level, white blood cell [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine) abnormality as per the opinion of the investigator, based on the local laboratory normal ranges.
  • Subjects with hematological/ biochemical values out of normal range which are expected to be temporary may be re-screened at a later date.
  • Any acute or chronic, clinically significant disease, as determined by physical examination or laboratory screening tests.
  • Malignancies within previous 5 years (excluding non-melanoma skin cancer) and lymphoproliferative disorders.
  • Current alcoholism and/or drug abuse.
  • Acute disease and/or fever at the time of Screening.
  • Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study will be oral.
  • Subjects with a minor illness (such as mild diarrhea) without fever may be enrolled at the discretion of the investigator.
  • Subjects with acute disease and/ or fever at the time of Screening may be re screened at a later date.
  • Planned move to a location that will prohibit participating in the trial until study end.
  • Any other condition that the investigator judges may interfere with study procedures (e.g. drawing blood) or findings (e.g. immune response).

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • GSK Investigational Site

    Brampton, Ontario, L6T 0G1

  • GSK Investigational Site

    Halifax, Nova Scotia, B3K 6R8

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

About this study

Official title: An Observer-blind Study to Evaluate the Safety, Reactogenicity and Immunogenicity of GSK Biologicals' Respiratory Syncytial Virus (RSV) Investigational Vaccine (GSK3003891A) in Healthy Men

The purpose of this first time in human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of several formulations of Respiratory Syncytial Virus (RSV) investigational vaccines in healthy men.

Read the detailed description

This protocol posting has been updated following protocol amendment 3 to amend the respective exclusion criterion as to only exclude subjects with clinically significant hematological/ biochemical abnormalities as per opinion of the investigator.

Being tested
RSV vaccine GSK3003892A (formulation 1), RSV vaccine GSK3003893A (formulation 2), RSV vaccine GSK3003895A (formulation 3), RSV vaccine GSK3003896A (formulation 4), RSV vaccine GSK3003898A (formulation 5)
Keywords
Immunogenicity, Respiratory Syncytial Virus, Reactogenicity, Vaccination, Safety
Medical subject headings
Respiratory Syncytial Virus Infections

What participants receive

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

  • RSV vaccine GSK3003892A (formulation 1)Biological

    Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

  • RSV vaccine GSK3003893A (formulation 2)Biological

    Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

  • RSV vaccine GSK3003895A (formulation 3)Biological

    Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

  • RSV vaccine GSK3003896A (formulation 4)Biological

    Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

  • RSV vaccine GSK3003898A (formulation 5)Biological

    Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

  • RSV vaccine GSK3003899A (formulation 6)Biological

    Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

  • Placebo comparatorDrug

    Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

Study groups in NCT01905215
Study groupRoleWhat they receive
Group AExperimentalSubjects in this group will receive a single dose of formulation 1 of RSV vaccine
Receives: Biological: RSV vaccine GSK3003892A (formulation 1)
Group BExperimentalSubjects in this group will receive a single dose of formulation 2 of RSV vaccine
Receives: Biological: RSV vaccine GSK3003893A (formulation 2)
Group CExperimentalSubjects in this group will receive a single dose of formulation 3 of RSV vaccine
Receives: Biological: RSV vaccine GSK3003895A (formulation 3)
Group DExperimentalSubjects in this group will receive a single dose of formulation 4 of RSV vaccine
Receives: Biological: RSV vaccine GSK3003896A (formulation 4)
Group EExperimentalSubjects in this group will receive a single dose of formulation 5 of RSV vaccine
Receives: Biological: RSV vaccine GSK3003898A (formulation 5)
Group FExperimentalSubjects in this group will receive a single dose of formulation 6 of RSV vaccine
Receives: Biological: RSV vaccine GSK3003899A (formulation 6)
Group Placebo 1Placebo comparatorSubjects in this group will receive a single dose of placebo
Receives: Drug: Placebo comparator
Group Placebo 2Placebo comparatorSubjects in this group will receive a single dose of 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)

    Measured: During the 7 days (Days 0-6) follow-up period after vaccination

  2. Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality

    Measured: At Day 0

  3. Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality

    Measured: At Day 7

  4. Occurrence of any hematological (hemoglobin level, white blood cells [WBC], lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality

    Measured: At Day 30

  5. Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (alanine amino-transferase [ALT], aspartate amino-transferase [AST] and creatinine) laboratory abnormality

    Measured: At Day 60

  6. Occurrence of any unsolicited AE

    Measured: During a 30-day (Days 0-29) follow-up period after vaccination

  7. Occurrence of any Serious Adverse Events (SAEs)

    Measured: From Day 0 to Day 60

Secondary outcomes (4)

  1. Humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups

    Measured: At pre-vaccination (Day 0) and post-vaccination (Day 7, Day 30 and Day 60)

  2. Persistence of the humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups

    Measured: At Day 180 and Day 360

  3. Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality

    Measured: At Day 180 and Day 360

  4. Occurrence of any SAE

    Measured: From Day 60 to the study conclusion (i.e. Day 360)

Timeline

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

  1. First posted23 Jul 2013 (estimated)
  2. Study start22 Jul 2013
  3. Primary completion9 Apr 2014
  4. Study completion16 Mar 2015

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
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01905215
Sponsor's protocol ID
116969
Status last verified
May 2017
First submitted
11 Jul 2013
Last updated
30 May 2017
Results posted
No

Publications

  • Steff AM, Cadieux-Dion C, de Lannoy G, Prato MK, Czeszak X, Andre B, Ingels DC, Louckx M, Dewe W, Picciolato M, Maleux K, Fissette L, Dieussaert I. Hamster neogenin, a host-cell protein contained in a respiratory syncytial virus candidate vaccine, induces antibody responses in rabbits but not in clinical trial participants. Hum Vaccin Immunother. 2020 Jun 2;16(6):1327-1337. doi: 10.1080/21645515.2019.1693749. Epub 2020 Jan 17.

    PubMed 31951765

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RSV vaccine GSK3003892A (formulation 1), RSV vaccine GSK3003893A (formulation 2) and RSV vaccine GSK3003895A (formulation 3) in people with Infections, Respiratory Syncytial Virus, run by GlaxoSmithKline at 3 sites in Canada.

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 4 inclusion and 23 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 30 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 Canada. 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) (time frame: During the 7 days (Days 0-6) follow-up period after 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 NCT01905215, which also lists 1 linked publication.

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 30 May 2017.

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