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
Overview
- Phase
- Phase 1
- Intervention
- RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B
- Conditions
- Respiratory Syncytial Virus Infections
- Sponsor
- GlaxoSmithKline
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
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.
Arms & Interventions
RSV_PreF3_AS01B Group
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.
Intervention: RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B
Placebo Group
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Subjects With Solicited Local Adverse Events (AEs) After First Dose of Vaccination
Time Frame: 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
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).
Number of Subjects With Solicited Local AEs After Second Dose of Vaccination
Time Frame: 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
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).
Number of Subjects With Solicited General AEs After First Dose of Vaccination
Time Frame: 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
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.
Number of Subjects With Solicited General AEs After Second Dose of Vaccination
Time Frame: 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
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.
Number of Subjects With Unsolicited AEs After Any Vaccination
Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination (across doses)
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.
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
Time Frame: At 7 days after the first vaccine dose (i.e. at Day 8 versus 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.
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
Time Frame: At 7 days after the second vaccine dose (i.e at Day 68 versus 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.
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After First Dose of Vaccination
Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination at Day 1, and 29 subsequent days) after first 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.
Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination
Time Frame: During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) after second 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.
Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination
Time Frame: From Day 1 up to 30 days after the second vaccination (Day 91)
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.
Number of Subjects With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days After the Second Vaccination
Time Frame: From Day 1 up to 30 days after the second vaccination (Day 91)
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
Secondary Outcomes
- 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)