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

NCT05966090 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 219331
• Study Type: interventional
• Target: 530
• Locations: 2 countries
• Sites: 31

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.

Conditions

Respiratory Syncytial Viruses; Respiratory Syncytial Virus Infections

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Adjusted Geometric Mean Concentration (GMC) of Anti-glycoprotein E (gE) Antibodies at 1 Month Post-second Dose of HZ/su Vaccination

  Anti-gE antibodies were measured with enzyme linked immunosorbent assay (ELISA) and the results were expressed as GMC, in milli international units per milliliter (mIU/mL).

  At 1 month post-second dose of HZ/su vaccination (Day 91)

• Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination

  Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

  At Day 31 for Co-administration Group and at Day 61 for Control Group

• Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination

  Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. The ED60 was defined as the dose that produced an effect in 60% of the population.

  At Day 31 for Co-administration Group and at Day 61 for Control Group

Secondary Outcomes (13)

• Percentage of Participants With Seropositivity at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination

  Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)

• GMC of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination

  Pre-vaccination (Day 1) and 1 month post-second dose of HZ/su vaccination (Day 91)

• Mean Geometric Increase (MGI) of Anti-glycoprotein Antibodies at Pre-vaccination and 1 Month Post-second Dose of HZ/su Vaccination

  At 1 month post-second dose of HZ/su vaccination (Day 91) compared to Pre-vaccination (Day 1)

• Vaccine Response Rate (VRR) at 1 Month Post-second Dose of HZ/su Vaccination

  At 1 month post-second dose of HZ/su vaccination (Day 91)

• GMT of RSV-A Neutralizing Titers (ED60) at Pre-vaccination and 1 Month After the RSVPreF3 OA Vaccination

  At pre-vaccination (Day 1) and Day 31 for Co-administration Group and at pre-vaccination (Day 1) and Day 61 for Control Group

Study Arms (2)

Co-administration Group

EXPERIMENTAL

Participants received both herpes zoster recombinant subunit (HZ/su) vaccine and respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine on Day 1 followed by second dose of HZ/su vaccine on Day 61.

Biological: RSVPreF3 OA investigational vaccine; Biological: HZ/su vaccine

Control Group

ACTIVE COMPARATOR

Participants received HZ/su vaccine on Day 1 and RSVPreF3 OA vaccine on Day 31 followed by second dose of HZ/su vaccine on Day 61.

Biological: RSVPreF3 OA investigational vaccine; Biological: HZ/su vaccine

Interventions

RSVPreF3 OA investigational vaccine BIOLOGICAL

One dose of RSVPreF3 OA investigational vaccine given intramuscularly on Day 1 (Coadministration group) or Day 31 (Control group).

Also known as: Respiratory Syncytial Virus PreFusion protein 3 Older Adults vaccine

Co-administration Group; Control Group

HZ/su vaccine BIOLOGICAL

Two doses of HZ/su vaccine given intramuscularly on Day 1 and Day 61.

Also known as: Herpes Zoster recombinant subunit vaccine, Shingrix

Co-administration Group; Control Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (31)

GSK Investigational Site

Daphne, Alabama, 36526, United States

Location

GSK Investigational Site

Tempe, Arizona, 85281, United States

Location

GSK Investigational Site

Corte Madera, California, 94925, United States

Location

GSK Investigational Site

Aurora, Colorado, 80012, United States

Location

GSK Investigational Site

North Miami Beach, Florida, 33162, United States

Location

GSK Investigational Site

West Palm Beach, Florida, 33409, United States

Location

GSK Investigational Site

Columbus, Georgia, 31904-8946, United States

Location

GSK Investigational Site

Versailles, Kentucky, 40383, United States

Location

GSK Investigational Site

New Orleans, Louisiana, 70115, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76104, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Brampton, Ontario, L6T 0G1, Canada

Location

GSK Investigational Site

Guelph, Ontario, N1H 1B1, Canada

Location

GSK Investigational Site

Toronto, Ontario, M4G 3E8, Canada

Location

GSK Investigational Site

Toronto, Ontario, M9V 4B4, Canada

Location

GSK Investigational Site

Québec, Quebec, G1N 4V3, Canada

Location

GSK Investigational Site

Québec, Quebec, G6W 0M5, Canada

Location

GSK Investigational Site

Québec, Quebec, H9R 4S3, Canada

Location

GSK Investigational Site

Québec, Quebec, J7J 2K8, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1L 0H8, Canada

Location

GSK Investigational Site

Brampton, L6T 0G1, Canada

Location

GSK Investigational Site

Guelph, N1H 1B1, Canada

Location

GSK Investigational Site

Québec, G1N 4V3, Canada

Location

GSK Investigational Site

Québec, G6W 0M5, Canada

Location

GSK Investigational Site

Québec, H9R 4S3, Canada

Location

GSK Investigational Site

Québec, J7J 2K8, Canada

Location

GSK Investigational Site

Sarnia, N7T 4X3, Canada

Location

GSK Investigational Site

Sherbrooke, J1L 0H8, Canada

Location

GSK Investigational Site

Toronto, M3H 5S4, Canada

Location

GSK Investigational Site

Toronto, M4G 3E8, Canada

Location

GSK Investigational Site

Toronto, M9V 4B4, Canada

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections; Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: July 28, 2023
• Primary Completion: February 19, 2024
• Study Completion: July 29, 2024
• Last Updated: April 1, 2025
• Results First Posted: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

CA (20); US (11)