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

NCT ID: NCT01905215

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-22
• Study Completion Date: 2015-03-16

Brief 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.

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.

Conditions

Infections, Respiratory Syncytial Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group A

Subjects in this group will receive a single dose of formulation 1 of RSV vaccine

Group Type: EXPERIMENTAL

RSV vaccine GSK3003892A (formulation 1)

Intervention Type: BIOLOGICAL

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

Group B

Subjects in this group will receive a single dose of formulation 2 of RSV vaccine

Group Type: EXPERIMENTAL

RSV vaccine GSK3003893A (formulation 2)

Intervention Type: BIOLOGICAL

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

Group C

Subjects in this group will receive a single dose of formulation 3 of RSV vaccine

Group Type: EXPERIMENTAL

RSV vaccine GSK3003895A (formulation 3)

Intervention Type: BIOLOGICAL

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

Group D

Subjects in this group will receive a single dose of formulation 4 of RSV vaccine

Group Type: EXPERIMENTAL

RSV vaccine GSK3003896A (formulation 4)

Intervention Type: BIOLOGICAL

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

Group E

Subjects in this group will receive a single dose of formulation 5 of RSV vaccine

Group Type: EXPERIMENTAL

RSV vaccine GSK3003898A (formulation 5)

Intervention Type: BIOLOGICAL

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

Group F

Subjects in this group will receive a single dose of formulation 6 of RSV vaccine

Group Type: EXPERIMENTAL

RSV vaccine GSK3003899A (formulation 6)

Intervention Type: BIOLOGICAL

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

Group Placebo 1

Subjects in this group will receive a single dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

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

Group Placebo 2

Subjects in this group will receive a single dose of placebo

Group Type: PLACEBO_COMPARATOR

Placebo comparator

Intervention Type: DRUG

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

Interventions

RSV vaccine GSK3003892A (formulation 1)

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: BIOLOGICAL

Placebo comparator

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

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: MALE
• 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

Halifax, Nova Scotia, Canada

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 31951765 (View on PubMed)

Other Identifiers

116969

Identifier Type: -

Identifier Source: org_study_id