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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01905215
First received: July 11, 2013
Last updated: February 20, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Infections, Respiratory Syncytial Virus
Biological: RSV vaccine GSK3003892A (formulation 1)
Biological: RSV vaccine GSK3003893A (formulation 2)
Biological: RSV vaccine GSK3003895A (formulation 3)
Biological: RSV vaccine GSK3003896A (formulation 4)
Biological: RSV vaccine GSK3003898A (formulation 5)
Biological: RSV vaccine GSK3003899A (formulation 6)
Drug: Placebo comparator
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of each solicited local and general adverse event (AE) [ Time Frame: During the 7 days (Days 0-6) follow-up period after vaccination ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At Day 0 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At Day 7 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At Day 30 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At Day 60 ] [ Designated as safety issue: No ]
  • Occurrence of any unsolicited AE [ Time Frame: During a 30-day (Days 0-29) follow-up period after vaccination ] [ Designated as safety issue: No ]
  • Occurrence of any Serious Adverse Events (SAEs) [ Time Frame: From Day 0 to Day 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups [ Time Frame: At pre-vaccination (Day 0) and post-vaccination (Day 7, Day 30 and Day 60) ] [ Designated as safety issue: No ]
  • Persistence of the humoral immune response in terms of neutralizing antibody titers to the investigational RSV vaccines, in all subjects, in all groups [ Time Frame: At Day 180 and Day 360 ] [ Designated as safety issue: No ]
  • Occurrence of any hematological (hemoglobin level, WBC, lymphocyte, neutrophil, eosinophil and platelet count) and biochemical (ALT, AST and creatinine) laboratory abnormality [ Time Frame: At Day 180 and Day 360 ] [ Designated as safety issue: No ]
  • Occurrence of any SAE [ Time Frame: From Day 60 to the study conclusion (i.e. Day 360) ] [ Designated as safety issue: No ]

Enrollment: 128
Study Start Date: July 2013
Estimated Study Completion Date: March 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Subjects in this group will receive a single dose of formulation 1 of RSV vaccine
Biological: RSV vaccine GSK3003892A (formulation 1)
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Experimental: Group B
Subjects in this group will receive a single dose of formulation 2 of RSV vaccine
Biological: RSV vaccine GSK3003893A (formulation 2)
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Experimental: Group C
Subjects in this group will receive a single dose of formulation 3 of RSV vaccine
Biological: RSV vaccine GSK3003895A (formulation 3)
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Experimental: Group D
Subjects in this group will receive a single dose of formulation 4 of RSV vaccine
Biological: RSV vaccine GSK3003896A (formulation 4)
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Experimental: Group E
Subjects in this group will receive a single dose of formulation 5 of RSV vaccine
Biological: RSV vaccine GSK3003898A (formulation 5)
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Experimental: Group F
Subjects in this group will receive a single dose of formulation 6 of RSV vaccine
Biological: RSV vaccine GSK3003899A (formulation 6)
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Placebo Comparator: Group Placebo 1
Subjects in this group will receive a single dose of placebo
Drug: Placebo comparator
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
Placebo Comparator: Group Placebo 2
Subjects in this group will receive a single dose of placebo
Drug: Placebo comparator
Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule

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.

  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01905215

Locations
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
GSK Investigational Site
Brampton, Ontario, Canada, L6T 0G1
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01905215     History of Changes
Other Study ID Numbers: 116969
Study First Received: July 11, 2013
Last Updated: February 20, 2014
Health Authority: Canada: Health Canada

Keywords provided by GlaxoSmithKline:
Immunogenicity
Respiratory Syncytial Virus
Reactogenicity
Vaccination
Safety

Additional relevant MeSH terms:
Virus Diseases
Respiratory Tract Infections
Respiratory Syncytial Virus Infections
Infection
Respiratory Tract Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections

ClinicalTrials.gov processed this record on September 29, 2014