Clinical trial NCT04090658: A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
Official title: Phase I, Observer-blind, Safety, Reactogenicity and Immunogenicity Study of GSK's Respiratory Syncytial Virus (RSV) Vaccine GSK3844766A in Japanese Subjects Aged 60-80 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2019-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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 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.

Exclusion Criteria:

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.
* Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration, with the exception of inactivated and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after each study vaccination.
* Previous vaccination with an RSV vaccine.
* Known previous administration of a vaccine containing MPL, QS-21 and/or MF59.
* Planned administration of GSK's Herpes Zoster vaccine marketed as Shingrix or an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine \[HZ/su\] within 180 days after the second dose of the study vaccine.
* Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 6 months prior to the first vaccine dose. For corticosteroids, this will mean prednisone (≥ 20 mg/day, or equivalent). Inhaled and topical steroids are allowed.
* Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
* Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first dose of study vaccine or planned administration during the study period.

Prior/Concurrent clinical study experience

• 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 (pharmaceutical product or device).

Other exclusions

* History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
* Body mass index greater than 40 kg/m\^2.
* Planned move to a location that will prohibit participating in the trial until study end.
* Bedridden subjects.

Primary outcomes:
measure: Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination
timeFrame: 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
measure: Number of Subjects With Solicited Local AEs After Second Dose of Vaccination
timeFrame: 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
measure: Number of Subjects With Solicited General AEs After First Dose of Vaccination
timeFrame: 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
measure: Number of Subjects With Solicited General AEs After Second Dose of Vaccination
timeFrame: 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
measure: Number of Subjects With Unsolicited AEs After Any Vaccination
timeFrame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination (across doses)
measure: 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
timeFrame: At 7 days after the first vaccine dose (i.e. at Day 8 versus Day 1)
measure: 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
timeFrame: At 7 days after the second vaccine dose (i.e at Day 68 versus Day 61)
measure: Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination
timeFrame: During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first vaccination
measure: Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination
timeFrame: During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second vaccination
measure: Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination
timeFrame: From Day 1 up to 30 days after the second vaccination (Day 91)
measure: Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination
timeFrame: From Day 1 up to 30 days after the second vaccination (Day 91)
Secondary outcomes:
measure: Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of Neutralizing Antibody Titers Against RSV- Serotype A
timeFrame: 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)
measure: Humoral Immune Response With Respect to Components of the Investigational Vaccine in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations
timeFrame: 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)
measure: Number of Subjects With Any SAEs, up the End of Follow-up Study Period (Month 14)
timeFrame: From Day 1 up to the end of follow-up period (Month 14)
measure: Number of Subjects Reporting pIMDs up to the End of Follow-up Study Period (Month 14)
timeFrame: From Day 1 up to the end of follow-up period (Month 14)
measure: Number of Subjects With Respiratory Tract Infection (RTI) Episodes Reported During RTI Surveillance
timeFrame: During the RSV seasons from Day 1 to Month 14
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: