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RSV Vaccine unadjuvanted low dose

Phase 1

Respiratory Syncytial Virus Infections | Monoclonal antibody | Respiratory |GSK plc|Last Updated: Aug 5, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,053
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03814590A Study to Assess the Safety, Reactogenicity and Immune Response of GlaxoSmithKline (GSK) Biologicals' Investigational Respiratory Syncytial Virus (RSV) Vaccine (GSK3844766A) in Older AdultsPHASE1 COMPLETED 1,053Jan 21, 2019Nov 30, 2020Aug 5, 202221 United States, Belgium
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Study Endpoints
Primary Endpoints
Number of Subjects With Any Solicited Local Symptoms After First Vaccination Dose
During a 7-day follow-up period after first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)

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

Number of Subjects With Any Solicited Local Symptoms After Second Vaccination Dose
During a 7-day follow-up period after second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)

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

Number of Subjects With Any Solicited General Symptom After First Vaccination Dose
During a 7-day follow-up period after the first vaccination dose (i.e., on the day of vaccination [at Day 1] and 6 subsequent days)

Assessed solicited general symptoms include arthralgia, fatigue, fever \[defined as temperature equal to or above 38.0 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], headache, myalgia and shivering.

Number of Subjects With Any Solicited General Symptom After Second Vaccination Dose
During a 7-day follow-up period after the second vaccination dose (i.e., on the day of vaccination [at Day 61] and 6 subsequent days)

Assessed solicited general symptoms include arthralgia, fatigue, fever \[defined as temperature equal to or above 38.0 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhea and/or abdominal pain\], headache, myalgia and shivering.

Number of Subjects With Any Unsolicited Adverse Events (AEs) After Any Vaccination Dose
During a 30-day follow-up period (i.e., on the day of vaccination and 29 subsequent days) after any vaccination dose (across doses)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and/or any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Number of Subjects Presenting Change From Baseline in Hematology and Biochemistry With Respect of Normal Laboratory Ranges, After First Vaccine Dose (Part A Groups)
At baseline and at 7 days after the first vaccine dose (Day 8)

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 unknown, 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 First Vaccine Dose (Part B Groups)
At baseline and at 7 days after the first vaccine dose (Day 8)

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 unknown, 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 (Part A Groups)
At baseline and at 7 days after the second vaccine dose (Day 68)

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 unknown, 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 (Part B Groups)
At baseline and at 7 days after the second vaccine dose (Day 68)

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

Number of Subjects With Any Grade 3 Non-serious AEs (Solicited and Unsolicited) After Second Dose of Vaccination
During a 30-day follow-up period (i.e., on the day of vaccination at Day 61, and 29 subsequent days) 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.

Number of Subjects With Any Serious Adverse Events (SAEs) up to 30 Days After the Second Vaccination
From first vaccination (Day 1) up to 30 days post 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 (Part B Groups)
From first vaccination (Day 1) up to 30 days post 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 Endpoints
Number of Subjects With Any SAEs, up the End of Follow-up Period (Month 14) - Part B Groups
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 Period (Month 14) - Part B Groups
From Day 1 up to the end of follow-up period (Month 14)
Number of Subjects With at Least One RSV-confirmed Respiratory Tract Infection (RTI) Episode Post-vaccination Reported During RTI Surveillance - Part B Groups
During the RSV season (from October 2019 to March 2020)
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group Low Dose_PLAIN_AEXPERIMENTALSubjects in Part A, aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Medium Dose_PLAIN_AEXPERIMENTALSubjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group High Dose_PLAIN_AEXPERIMENTALSubjects in Part A aged 18-40 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Placebo_APLACEBO_COMPARATORSubjects in Part A aged 18-40 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Low Dose_PLAIN_BEXPERIMENTALSubjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted low dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Low Dose_AS01E_BEXPERIMENTALSubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Low Dose_AS01B_BEXPERIMENTALSubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Medium Dose_PLAIN_BEXPERIMENTALSubjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted medium dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Medium Dose_AS01E_BEXPERIMENTALSubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Medium Dose_AS01B_BEXPERIMENTALSubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group High Dose_PLAIN_BEXPERIMENTALSubjects in Part B aged 60-80 years, receiving 2 doses of RSV Vaccine (GSK3844766A) unadjuvanted high dose, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group High Dose_AS01E_BEXPERIMENTALSubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group High Dose_AS01B_BEXPERIMENTALSubjects in Part B aged 60-80 years, receiving 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01B, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Group Placebo_BPLACEBO_COMPARATORSubjects in Part B aged 60-80 years, receiving 2 doses of placebo (saline solution) control, on a 0, 2 Months schedule, by IM injection into the deltoid region of the arm.
Interventions
NameTypeDescription
RSV Vaccine (GSK3844766A) unadjuvanted low doseBIOLOGICALTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01EBIOLOGICALTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01BBIOLOGICALTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
RSV Vaccine (GSK3844766A) unadjuvanted medium doseBIOLOGICALTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01EBIOLOGICALTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01BBIOLOGICALTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) unadjuvanted high doseBIOLOGICALTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01EBIOLOGICALTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm
RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01BBIOLOGICALTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
Placebo (Saline solution)DRUGTwo doses administered intramuscularly at Days 1 and 61 in the deltoid region of the arm.
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Eligibility Criteria
Age Range18 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites21

Inclusion Criteria: For all subjects: * 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 performing any study specific procedure. For Part A: • A male or female between, and ...

Countries:United StatesBelgium
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