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A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults (RSV-OA=ADJ-020)

Primary Purpose

Respiratory Syncytial Viruses, Respiratory Syncytial Virus Infections

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
RSVPreF3 OA investigational vaccine
HZ/su vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Syncytial Viruses focused on measuring Respiratory syncytial virus, Infection, Vaccine, Older adult, Immunogenicity, Safety

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: A male or female participant ≥50 YOA at the time of the first study intervention administration. Female participants of non-childbearing potential may be enrolled in the study. Female participants of childbearing potential may be enrolled in the study, if the participant: has practiced adequate contraception from 1 month prior to study intervention administration. has a negative pregnancy test on the day of and prior to study intervention administration. has agreed to continue effective contraception until the end of the study. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed informed consent obtained from the participant prior to any study specific procedure being performed. Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable. Exclusion Criteria: Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions. Any confirmed or suspected autoimmune disorders, immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to any vaccine component. History of Guillain-Barré syndrome. Any history of dementia or any medical condition that moderately or severely impairs cognition. Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. Clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of herpes zoster. History of previous vaccination with any licensed or investigational recombinant adjuvanted zoster vaccine (HZ/su vaccine; Shingrix) before the study start or planned receipt through study participation. History of previous vaccination with any licensed or investigational live herpes zoster vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation. Previous vaccination with licensed or investigational RSV vaccine. Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions, or their planned use during the study period. Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. o In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided COVID-19 vaccine use is in line with local governmental recommendations. Planned or actual administration of adjuvanted quadrivalent influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. Administration of long-acting immune-modifying drugs during the period starting 180 days before the administration of first dose of study interventions or planned administration at any time during the study period (e.g., infliximab). Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the administration of first dose of study interventions or planned administration during the study period. Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune modifying drugs during the period starting 90 days prior to the first study intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled, topical or intra-articular steroids are allowed. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product (IMP) (drug or invasive medical device). History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. Bedridden participants. Planned move during the study conduct that prohibits participation until study end. Participation of any study personnel or their immediate dependents, family, or household members.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational SiteRecruiting
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RSV+ HZ/su Co-administration Group

RSV+HZ/su Control Group

Arm Description

Participants will be administered first dose of HZ/su vaccine and the RSVPreF3 OA investigational vaccine together on Day 1. A second dose of the HZ/su vaccine will be administered at Day 61.

Participants will be administered first dose HZ/su vaccine on Day 1, followed by the RSVPreF3 OA investigational vaccine on Day 31, and then second dose of HZ/su vaccine on Day 61.

Outcomes

Primary Outcome Measures

Anti-gE antibody concentrations expressed as group geometric mean concentration (GMC) ratio
Concentration of RSV-A neutralizing titers expressed as group geometric mean titer (GMT) ratio
Concentration of RSV-B neutralizing titers expressed as group GMT ratio

Secondary Outcome Measures

Anti-gE antibody concentrations expressed as seropositivity rate
Anti-gE antibody concentrations expressed as GMC
Anti-gE antibody concentrations expressed as mean geometric increase (MGI)
Vaccine response rate at 1-month postsecond dose of HZ/su vaccine
Concentration of RSV-A neutralizing titers expressed as GMT
Concentration of RSV-A neutralizing titers expressed as MGI
Concentration of RSV-B neutralizing titers expressed as GMT
Concentration of RSV-B neutralizing titers expressed as MGI
Percentage of participants reporting solicited administration site events (AE)
The solicited administration site AEs are erythema, pain and swelling.
Percentage of participants reporting solicited systemic events
The solicited systemic events are arthralgia, fatigue, fever, headache, myalgia, shivering/chills and gastrointestinal symptoms.
Percentage of participants reporting unsolicited Adverse Events (AEs)
Percentage of participants reporting serious adverse events (SAEs)
Percentage of participants reporting potential immune mediated disorders (pIMDs)

Full Information

First Posted
July 21, 2023
Last Updated
August 25, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05966090
Brief Title
A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults
Acronym
RSV-OA=ADJ-020
Official Title
A Phase III, Open-label, Randomized, Controlled, Multi-country Study to Evaluate the Immune Response, Safety and Reactogenicity of RSVPreF3 OA Investigational Vaccine When Co-administered With Herpes Zoster Recombinant Subunit (HZ/su) Vaccine in Adults Aged 50 Years and Older
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
April 12, 2024 (Anticipated)
Study Completion Date
September 13, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To assess the ability of RSVPreF3 OA investigational vaccine to generate an immune response when given in combination with HZ/su vaccine and its safety in older adults, aged >=50 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Viruses, Respiratory Syncytial Virus Infections
Keywords
Respiratory syncytial virus, Infection, Vaccine, Older adult, Immunogenicity, Safety

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The laboratory in charge of sample testing will be blinded to the study intervention assignment.
Allocation
Randomized
Enrollment
530 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RSV+ HZ/su Co-administration Group
Arm Type
Experimental
Arm Description
Participants will be administered first dose of HZ/su vaccine and the RSVPreF3 OA investigational vaccine together on Day 1. A second dose of the HZ/su vaccine will be administered at Day 61.
Arm Title
RSV+HZ/su Control Group
Arm Type
Active Comparator
Arm Description
Participants will be administered first dose HZ/su vaccine on Day 1, followed by the RSVPreF3 OA investigational vaccine on Day 31, and then second dose of HZ/su vaccine on Day 61.
Intervention Type
Biological
Intervention Name(s)
RSVPreF3 OA investigational vaccine
Other Intervention Name(s)
Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine
Intervention Description
One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).
Intervention Type
Biological
Intervention Name(s)
HZ/su vaccine
Other Intervention Name(s)
Herpes Zoster recombinant subunit vaccine, Shingrix
Intervention Description
Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.
Primary Outcome Measure Information:
Title
Anti-gE antibody concentrations expressed as group geometric mean concentration (GMC) ratio
Time Frame
1-month after the second dose of HZ/su vaccine (at day 91)
Title
Concentration of RSV-A neutralizing titers expressed as group geometric mean titer (GMT) ratio
Time Frame
1-month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-administration group and at Day 61 for the Control group)
Title
Concentration of RSV-B neutralizing titers expressed as group GMT ratio
Time Frame
1-month after the RSVPreF3 OA investigational vaccine dose (at Day 31 for the Co-administration group and at Day 61 for the Control group)
Secondary Outcome Measure Information:
Title
Anti-gE antibody concentrations expressed as seropositivity rate
Time Frame
At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)
Title
Anti-gE antibody concentrations expressed as GMC
Time Frame
At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)
Title
Anti-gE antibody concentrations expressed as mean geometric increase (MGI)
Time Frame
At 1-month after the second dose of HZ/su vaccine (at Day 91) versus pre-vaccination (Day 1)
Title
Vaccine response rate at 1-month postsecond dose of HZ/su vaccine
Time Frame
At 1-month after the second dose of HZ/su vaccine (at Day 91)
Title
Concentration of RSV-A neutralizing titers expressed as GMT
Time Frame
At pre-vaccination and at 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 1 and Day 31 for the Co-administration group and at Day 31 and Day 61 for the Control group)
Title
Concentration of RSV-A neutralizing titers expressed as MGI
Time Frame
At 1-month after the RSVPreF3 OA investigational vaccine administration versus pre-vaccination (at Day 31 versus Day 1 for the Co-administration group and at Day 61 versus Day 31 for the Control group)
Title
Concentration of RSV-B neutralizing titers expressed as GMT
Time Frame
At pre-vaccination and at 1-month after the RSVPreF3 OA investigational vaccine dose (at Day 1 and Day 31 for the Co-administration group and at Day 31 and Day 61 for the Control group)
Title
Concentration of RSV-B neutralizing titers expressed as MGI
Time Frame
At 1-month after the RSVPreF3 OA investigational vaccine administration versus pre-vaccination (at Day 31 versus Day 1 for the Co-administration group and at Day 61 versus Day 31 for the Control group)
Title
Percentage of participants reporting solicited administration site events (AE)
Description
The solicited administration site AEs are erythema, pain and swelling.
Time Frame
During the 7 days after each vaccine administration (i.e., the day of vaccination and 6 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)
Title
Percentage of participants reporting solicited systemic events
Description
The solicited systemic events are arthralgia, fatigue, fever, headache, myalgia, shivering/chills and gastrointestinal symptoms.
Time Frame
During the 7 days after each vaccine administration (i.e., the day of vaccination and 6 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)
Title
Percentage of participants reporting unsolicited Adverse Events (AEs)
Time Frame
During the 30 days after each vaccine administration (i.e., the day of vaccination and 29 subsequent days, vaccines administered at Day 1, Day 31 and Day 61)
Title
Percentage of participants reporting serious adverse events (SAEs)
Time Frame
From Day 1 up to study end (6 months after last vaccination administered at Day 61)
Title
Percentage of participants reporting potential immune mediated disorders (pIMDs)
Time Frame
From Day 1 up to study end (6 months after last vaccination administered at Day 61)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: A male or female participant ≥50 YOA at the time of the first study intervention administration. Female participants of non-childbearing potential may be enrolled in the study. Female participants of childbearing potential may be enrolled in the study, if the participant: has practiced adequate contraception from 1 month prior to study intervention administration. has a negative pregnancy test on the day of and prior to study intervention administration. has agreed to continue effective contraception until the end of the study. Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. Written or witnessed informed consent obtained from the participant prior to any study specific procedure being performed. Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable. Exclusion Criteria: Pregnant or lactating female. Female planning to become pregnant or planning to discontinue contraceptive precautions. Any confirmed or suspected autoimmune disorders, immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions, in particular any history of severe allergic reaction to any vaccine component. History of Guillain-Barré syndrome. Any history of dementia or any medical condition that moderately or severely impairs cognition. Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol. Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. Clinically suspected or polymerase chain reaction (PCR)-confirmed ongoing episode of herpes zoster. History of previous vaccination with any licensed or investigational recombinant adjuvanted zoster vaccine (HZ/su vaccine; Shingrix) before the study start or planned receipt through study participation. History of previous vaccination with any licensed or investigational live herpes zoster vaccine (Zostavax) in the last 2 years from enrollment, or planned receipt through study participation. Previous vaccination with licensed or investigational RSV vaccine. Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study interventions during the period beginning 30 days before the first dose of study interventions, or their planned use during the study period. Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. o In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after each study intervention administration provided COVID-19 vaccine use is in line with local governmental recommendations. Planned or actual administration of adjuvanted quadrivalent influenza vaccine not foreseen by the study protocol in the period starting 30 days before the first study intervention administration and ending 30 days after the last study intervention administration. Administration of long-acting immune-modifying drugs during the period starting 180 days before the administration of first dose of study interventions or planned administration at any time during the study period (e.g., infliximab). Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the administration of first dose of study interventions or planned administration during the study period. Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune modifying drugs during the period starting 90 days prior to the first study intervention dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled, topical or intra-articular steroids are allowed. Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non investigational vaccine/product (IMP) (drug or invasive medical device). History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. Bedridden participants. Planned move during the study conduct that prohibits participation until study end. Participation of any study personnel or their immediate dependents, family, or household members.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Facility Information:
Facility Name
GSK Investigational Site
City
Daphne
State/Province
Alabama
ZIP/Postal Code
36526
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85281
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Corte Madera
State/Province
California
ZIP/Postal Code
94925
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80918
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Versailles
State/Province
Kentucky
ZIP/Postal Code
40383
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Individual Site Status
Recruiting
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78244
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1H 1B1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M9V 4B4
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Levis
State/Province
Quebec
ZIP/Postal Code
G6W 0M5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK investigational Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1L 0H8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4T3
Country
Canada
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2QW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
GSK Investigational Site
City
Newcastle upon Tyne
State/Province
Tyne & Wear
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
IPD Sharing Time Frame
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
IPD Sharing Access Criteria
Anonymized IPD is shared with researchers whose proposals are approved by an 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 may be granted, when justified, for up to 6 months.
IPD Sharing URL
https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Learn more about this trial

A Study on Safety and Immune Response of Investigational RSV OA Vaccine in Combination With Herpes Zoster Vaccine in Healthy Adults

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