A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults

NCT04090658 | Completed Phase 1 Results

• 1 other identifier: 209699
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 doses of GSK Biologicals' RSV candidate vaccine adjuvanted with AS01B for the prevention of lower respiratory tract diseases caused by RSV in ethnic Japanese adults 60-80 years of age.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (11)

• Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination

  Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling is scored with a diameter larger than (\>) 20 millimeters (mm).

  During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination administered at Day 1

• Number of Subjects With Solicited Local AEs After Second Dose of Vaccination

  Assessed solicited local AEs at injection site are pain, erythema and swelling. Any erythema/swelling was scored with a diameter larger than (\>) 20 millimeters (mm).

  During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination administered at Day 61

• Number of Subjects With Solicited General AEs After First Dose of Vaccination

  Assessed solicited general AEs solicited were: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms (including nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering.

  During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after first dose of vaccination administered at Day 1

• Number of Subjects With Solicited General AEs After Second Dose of Vaccination

  Assessed solicited general AEs solicited are: arthralgia; fatigue; fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity); gastrointestinal symptoms including (nausea, vomiting, diarrhea and/or abdominal pain); headache; myalgia and shivering.

  During a 7-day follow-up period (i.e. on the day of vaccination and 6 subsequent days) after second dose of vaccination administered at Day 61

• Number of Subjects With Unsolicited AEs After Any Vaccination

  An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE.

  During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination (across doses)

• Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose When Compared to Day 1

  Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 1 (pre-vaccination dose 1=baseline) and Day 8 hematological and biochemical laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Ranges level being classified as below, within or above the normal ranges.

  At 7 days after the first vaccine dose (i.e. at Day 8 versus Day 1)

• Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After Second Vaccine Dose When Compared to Day 61

  Assessed hematological laboratory parameters include basophils, eosinophils, erythrocytes, hemoglobin, lymphocytes, monocytes, neutrophils, platelets, white blood cells. Biochemical laboratory parameters include alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], creatinine, urea nitrogen and uric acid. Categories reported when comparing Day 61 (pre-vaccination dose 2=baseline) and Day 68 hematological and biochemical laboratory results are defined as follows: \<parameter\>-\<range at baseline\>-\<range at timing\> (e.g. ALT-Within-Within). Ranges level being classified as below, within or above the normal ranges.

  At 7 days after the second vaccine dose (i.e at Day 68 versus Day 61)

• Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination

  A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.

  During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first vaccination

• Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination

  A Grade 3 AE is any AE assessed as severe, i.e. which prevents normal, everyday activities. In adults, such an AE would, for example, prevent attendance at work and would necessitate the administration of corrective therapy.

  During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second vaccination

• Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination

  A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.

  From Day 1 up to 30 days after the second vaccination (Day 91)

• Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination

  pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology

  From Day 1 up to 30 days after the second vaccination (Day 91)

Secondary Outcomes (5)

• Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV- Serotype A

  At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)

• Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations

  At pre-vaccination (Day 1), 30 days post-Dose 1 (Day 31), on the day of second vaccination (Day 61) and 30 days post-Dose 2 (Day 91)

• Number of Subjects With Any SAEs, up the End of Follow-up Study Period (Month 14)

  From Day 1 up to the end of follow-up period (Month 14)

• Number of Subjects Reporting pIMDs up to the End of Follow-up Study Period (Month 14)

  From Day 1 up to the end of follow-up period (Month 14)

• Number of Subjects With Respiratory Tract Infection (RTI) Episodes Reported During RTI Surveillance

  During the RSV seasons from Day 1 to Month 14

Study Arms (2)

RSV_PreF3_AS01B Group

EXPERIMENTAL

Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.

Biological: RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B

Placebo Group

PLACEBO COMPARATOR

Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.

Drug: Placebo

Interventions

RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B BIOLOGICAL

Subjects aged 60 to 80 years received 2 doses of the investigational adjuvanted RSV\_PreF3 vaccine (GSK3844766A), at Day 1 and Day 61, by intramuscular (IM) injection into the deltoid region of the non-dominant arm preferably.

RSV_PreF3_AS01B Group

Placebo DRUG

Subjects aged 60 to 80 years received 2 doses of placebo as control, at Day 1 and Day 61, by IM injection into the deltoid region of the non-dominant arm preferably.

Placebo Group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 prior to performance of any study specific procedure.
• A male or female between, and including, 60 and 80 years of age at the time of the first vaccination.
• Subjects with residence status allowing free mixing with general community or in an assisted-living facility that provides minimal assistance, such that the subject is primarily responsible for self-care and activities of daily living, may be enrolled.
• Japanese ethnic origin (defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese).
• Subject satisfying screening requirements.

You may not qualify if:

• Medical conditions
• Any medical condition that in the judgment of the investigator would make IM injection unsafe.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
• Hypersensitivity to latex.
• Serious or unstable chronic illness. Patients with chronic stable conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study.
• Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
• History of any neurological disorders or seizures.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by the investigator based on medical history, physical examination or laboratory screening tests.
• Hepatomegaly, right upper quadrant abdominal pain or tenderness.
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study.
• Lymphoproliferative disorder and malignancy within 5 years.
• At screening: Hematology parameters (complete blood cell count \[red blood cells, WBC\], white blood cells differential count \[lymphocytes, neutrophils and eosinophils\], platelets count or hemoglobin level) and/or biochemistry parameters (creatinine, blood urea nitrogen or liver enzymes \[ALT or AST\]) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.
• Prior/Concomitant therapy
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the first dose of study vaccine (Day -29 to Day 1), or planned use during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Fukuoka, 812-0025, Japan

Location

Related Publications (1)

• Kotb S, Haranaka M, Folschweiller N, Nakanwagi P, Verheust C, De Schrevel N, David MP, Mesaros N, Hulstrom V. Safety and immunogenicity of a respiratory syncytial virus prefusion F protein (RSVPreF3) candidate vaccine in older Japanese adults: A phase I, randomized, observer-blind clinical trial. Respir Investig. 2023 Mar;61(2):261-269. doi: 10.1016/j.resinv.2022.11.003. Epub 2023 Jan 12.

  PMID: 36641341 DERIVED

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: September 25, 2019
• Primary Completion: January 10, 2020
• Study Completion: December 11, 2020
• Last Updated: February 25, 2022
• Results First Posted: February 25, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

JP (1)