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

NCT01905215 | Completed Phase 1

• 1 other identifier: 116969
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

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.

Conditions

Infections, Respiratory Syncytial Virus

Keywords

Immunogenicity; Respiratory Syncytial Virus; Reactogenicity; Vaccination; Safety

Outcome Measures

Primary Outcomes (7)

• Occurrence of each solicited local and general adverse event (AE)

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

• 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

  At Day 0

• 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

  At Day 7

• 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

  At Day 30

• 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

  At Day 60

• Occurrence of any unsolicited AE

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

• Occurrence of any Serious Adverse Events (SAEs)

  From Day 0 to Day 60

Secondary Outcomes (4)

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

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

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

  At Day 180 and Day 360

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

  At Day 180 and Day 360

• Occurrence of any SAE

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

Study Arms (8)

Group A

EXPERIMENTAL

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

Biological: RSV vaccine GSK3003892A (formulation 1)

Group B

EXPERIMENTAL

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

Biological: RSV vaccine GSK3003893A (formulation 2)

Group C

EXPERIMENTAL

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

Biological: RSV vaccine GSK3003895A (formulation 3)

Group D

EXPERIMENTAL

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

Biological: RSV vaccine GSK3003896A (formulation 4)

Group E

EXPERIMENTAL

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

Biological: RSV vaccine GSK3003898A (formulation 5)

Group F

EXPERIMENTAL

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

Biological: RSV vaccine GSK3003899A (formulation 6)

Group Placebo 1

PLACEBO COMPARATOR

Subjects in this group will receive a single dose of placebo

Drug: Placebo comparator

Group Placebo 2

PLACEBO COMPARATOR

Subjects in this group will receive a single dose of placebo

Drug: Placebo comparator

Interventions

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

Group A

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

Group B

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

Group C

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

Group D

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

Group E

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

Group F

Placebo comparator DRUG

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

Group Placebo 1; Group Placebo 2

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Halifax, Nova Scotia, B3K 6R8, Canada

Location

GSK Investigational Site

Brampton, Ontario, L6T 0G1, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9W 4L6, Canada

Location

Related Publications (1)

• 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.

  PMID: 31951765 DERIVED

Related Links

• Results for study 116969 can be found on the GSK Clinical Study Register

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 23, 2013
• Study Start: July 22, 2013
• Primary Completion: April 9, 2014
• Study Completion: March 16, 2015
• Last Updated: May 30, 2017

Record last verified: 2017-05

Locations

CA (3)