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)

• ClinicalTrials.gov Identifier: NCT05966090
• Recruitment Status: Active, not recruiting
• First Posted: July 28, 2023
• Last Update Posted: November 14, 2023
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

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.

Condition or disease	Intervention/treatment	Phase
Respiratory Syncytial Viruses; Respiratory Syncytial Virus Infections	Biological: RSVPreF3 OA investigational vaccine; Biological: HZ/su vaccine	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 530 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: The laboratory in charge of sample testing will be blinded to the study intervention assignment.
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: July 28, 2023
• Estimated Primary Completion Date: February 13, 2024
• Estimated Study Completion Date: July 16, 2024

Arms and Interventions

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 Name: 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 Name: 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 Name: 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 Name: Herpes Zoster recombinant subunit vaccine, Shingrix

Outcome Measures

Primary Outcome Measures :

1. 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) ]
2. 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) ]
3. 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 Measures :

1. 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) ]
2. 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) ]
3. 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) ]
4. 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) ]
5. 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) ]
6. 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) ]
7. 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) ]
8. 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) ]
9. Percentage of participants reporting solicited administration site events (AE) [ 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) ]
   The solicited administration site AEs are erythema, pain and swelling.
10. Percentage of participants reporting solicited systemic events [ 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) ]
    The solicited systemic events are arthralgia, fatigue, fever, headache, myalgia, shivering/chills and gastrointestinal symptoms.
11. 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) ]
12. 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) ]
13. 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) ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Alabama

GSK Investigational Site

Daphne, Alabama, United States, 36526

United States, Arizona

GSK Investigational Site

Tempe, Arizona, United States, 85281

United States, California

GSK Investigational Site

Corte Madera, California, United States, 94925

United States, Colorado

GSK Investigational Site

Aurora, Colorado, United States, 80012

United States, Florida

GSK Investigational Site

North Miami Beach, Florida, United States, 33162

GSK Investigational Site

West Palm Beach, Florida, United States, 33409

United States, Georgia

GSK Investigational Site

Columbus, Georgia, United States, 31904-8946

United States, Kentucky

GSK Investigational Site

Versailles, Kentucky, United States, 40383

United States, Louisiana

GSK Investigational Site

New Orleans, Louisiana, United States, 70115

United States, Texas

GSK Investigational Site

Fort Worth, Texas, United States, 76104

GSK Investigational Site

San Antonio, Texas, United States, 78229

Canada, Ontario

GSK Investigational Site

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

Canada, Quebec

GSK Investigational Site

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

Canada

GSK Investigational Site

Quebec, Canada, G1N 4V3

Sponsors and Collaborators

GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT05966090
• Other Study ID Numbers: 219331
• First Posted: July 28, 2023
• Last Update Posted: November 14, 2023
• Last Verified: November 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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/
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• 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.
• 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.
• URL: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

• 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

Keywords provided by GlaxoSmithKline:

Respiratory syncytial virus; Infection; Vaccine; Older adult; Immunogenicity; Safety

Additional relevant MeSH terms:

Herpes Zoster; Respiratory Syncytial Virus Infections; Infections; Virus Diseases; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Vaccines; Immunologic Factors; Physiological Effects of Drugs