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)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Syncytial Virus Infections; Respiratory Syncytial Viruses
• Intervention / Treatment: Biological: RSVPreF3 OA investigational vaccine; Biological: HZ/su vaccine

• Study Type: Interventional
• Enrollment (Actual): 530
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1N 4V3
    • GSK Investigational Site
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • GSK Investigational Site
    • Guelph, Ontario, Canada, N1H 1B1
      • GSK Investigational Site
    • Sarnia, Ontario, Canada, N7T 4X3
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M3H 5S4
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M4G 3E8
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M9V 4B4
      • GSK Investigational Site
  • Quebec
    • Levis, Quebec, Canada, G6W 0M5
      • GSK Investigational Site
    • Mirabel, Quebec, Canada, J7J 2K8
      • GSK Investigational Site
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • GSK Investigational Site
• United States
  • Alabama
    • Daphne, Alabama, United States, 36526
      • GSK Investigational Site
  • Arizona
    • Tempe, Arizona, United States, 85281
      • GSK Investigational Site
  • California
    • Corte Madera, California, United States, 94925
      • GSK Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80012
      • GSK Investigational Site
  • Florida
    • North Miami Beach, Florida, United States, 33162
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • GSK Investigational Site
  • Georgia
    • Columbus, Georgia, United States, 31904-8946
      • GSK Investigational Site
  • Kentucky
    • Versailles, Kentucky, United States, 40383
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • GSK Investigational Site
  • Texas
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSV+ HZ/su Co-administration Group; 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.	Biological: RSVPreF3 OA investigational vaccine; One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).; Other Names: Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine; Biological: HZ/su vaccine; Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.; Other Names: Herpes Zoster recombinant subunit vaccine, Shingrix
Active Comparator: RSV+HZ/su Control Group; 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.	Biological: RSVPreF3 OA investigational vaccine; One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).; Other Names: Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine; Biological: HZ/su vaccine; Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.; Other Names: Herpes Zoster recombinant subunit vaccine, Shingrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anti-gE antibody concentrations expressed as group geometric mean concentration (GMC) ratio	1-month after the second dose of HZ/su vaccine (at day 91)
Concentration of RSV-A neutralizing titers expressed as group geometric mean titer (GMT) ratio	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)
Concentration of RSV-B neutralizing titers expressed as group GMT ratio	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 Measures

Outcome Measure	Measure Description	Time Frame
Anti-gE antibody concentrations expressed as seropositivity rate		At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)
Anti-gE antibody concentrations expressed as GMC		At pre-vaccination (Day 1) and 1-month after the second dose of HZ/su vaccine (at Day 91)
Anti-gE antibody concentrations expressed as mean geometric increase (MGI)		At 1-month after the second dose of HZ/su vaccine (at Day 91) versus pre-vaccination (Day 1)
Vaccine response rate at 1-month postsecond dose of HZ/su vaccine		At 1-month after the second dose of HZ/su vaccine (at Day 91)
Percentage of participants reporting solicited administration site events (AE)	The solicited administration site AEs are erythema, pain and swelling.	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)
Percentage of participants reporting solicited systemic events	The solicited systemic events are arthralgia, fatigue, fever, headache, myalgia, shivering/chills and gastrointestinal symptoms.	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)
Percentage of participants reporting unsolicited Adverse Events (AEs)		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)
Percentage of participants reporting serious adverse events (SAEs)		From Day 1 up to study end (6 months after last vaccination administered at Day 61)
Percentage of participants reporting potential immune mediated disorders (pIMDs)		From Day 1 up to study end (6 months after last vaccination administered at Day 61)
Concentration of RSV-A neutralizing titers expressed as GMT		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)
Concentration of RSV-A neutralizing titers expressed as MGI		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)
Concentration of RSV-B neutralizing titers expressed as GMT		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)
Concentration of RSV-B neutralizing titers expressed as MGI		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)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Estimated): February 13, 2024
• Study Completion (Estimated): July 16, 2024

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Safety; Infection; Vaccine; Immunogenicity; Respiratory syncytial virus; Older adult
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; DNA Virus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Herpesviridae Infections; Varicella Zoster Virus Infection; Pneumovirus Infections; Herpes Zoster; Respiratory Syncytial Virus Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: 219331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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 Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• 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