Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

NCT04732871 | Active Not Recruiting Phase 3 Results FDA Drug

• 2 other identifiers: 2124962024-512291-34
• Study Type: interventional
• Target: 1,720
• Locations: 5 countries
• Sites: 45

Brief Summary

The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory syncytial virus; Vaccine; Safety; Reactogenicity; Immunogenicity

Outcome Measures

Primary Outcomes (8)

• Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1

  RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

  At Day 1

• Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31

  RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

  At Day 31

• Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6

  RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

  At Month 6

• Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12

  RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

  At Month 12

• Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1

  RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

  At Day 1

• Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31

  RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

  At Day 31

• Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6

  RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

  At Month 6

• Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12

  RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

  At Month 12

Secondary Outcomes (58)

• Humoral Immune Response in Terms of RSVPreF3 Immunoglobulin G (IgG) Antibody Geometric Mean Concentrations (GMCs) at Day 1

  At Day 1

• Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Day 31

  At Day 31

• Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 6

  At Month 6

• Humoral Immune Response in Terms of RSVPreF3 IgG Antibody GMCs at Month 12

  At Month 12

• Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 18

  At Month 18

Study Arms (3)

RSV_annual Group

EXPERIMENTAL

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and are followed up until Month 60.

Biological: RSVPreF3 OA investigational vaccine

RSV_Flexible revaccination Group

EXPERIMENTAL

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 24 months post-Dose 1 and at 48 months post-Dose 1, respectively and are followed up until Month 60.

Biological: RSVPreF3 OA investigational vaccine

RSV_1dose Group

EXPERIMENTAL

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until Month 36. At Month 36, participants in this group will be re-randomized in 2 groups: RSV\_1dose\_M36 (which will receive 1 additional revaccination dose at Month 36 and will be followed up until Month 60) and RSV\_1dose\_Flexible (which will receive 1 additional revaccination dose at Month 60, and will be followed up until study end at Month 72).

Biological: RSVPreF3 OA investigational vaccine

Interventions

RSVPreF3 OA investigational vaccine BIOLOGICAL

RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

RSV_1dose Group; RSV_Flexible revaccination Group; RSV_annual Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants).
• 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 performance of any study specific procedure.
• Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

You may not qualify if:

• Medical conditions
• Any confirmed or suspected 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 vaccine.
• Hypersensitivity to latex.
• Serious or unstable chronic illness.
• Recurrent or un-controlled neurological disorders or seizures. Participants with medically-controlled active or 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.
• Any history of dementia or any medical condition that moderately or severely impairs cognition.
• Prior/Concomitant therapy
• Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or 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 each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination.
• Previous vaccination with an RSV vaccine.
• Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (45)

GSK Investigational Site

Mobile, Alabama, 36608, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85020, United States

Location

GSK Investigational Site

Riverside, California, 92503, United States

Location

GSK Investigational Site

San Diego, California, 92103, United States

Location

GSK Investigational Site

Coral Gables, Florida, 33134, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33912, United States

Location

GSK Investigational Site

Sarasota, Florida, 34243, United States

Location

GSK Investigational Site

The Villages, Florida, 32162, United States

Location

GSK Investigational Site

Evansville, Indiana, 47714, United States

Location

GSK Investigational Site

Wichita, Kansas, 67226, United States

Location

GSK Investigational Site

Richfield, Minnesota, 55423, United States

Location

GSK Investigational Site

Kansas City, Missouri, 64114, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Mt. Pleasant, South Carolina, 29464, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

San Antonio, Texas, 78229, United States

Location

GSK Investigational Site

Norfolk, Virginia, 23502, United States

Location

GSK Investigational Site

Wenatchee, Washington, 98801, United States

Location

GSK Investigational Site

Espoo, 02230, Finland

Location

GSK Investigational Site

Helsinki, 00100, Finland

Location

GSK Investigational Site

Helsinki, 00930, Finland

Location

GSK Investigational Site

Jarvenpaa, 04400, Finland

Location

GSK Investigational Site

Kokkola, 67100, Finland

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Pori, 28100, Finland

Location

GSK Investigational Site

Seinäjoki, 60100, Finland

Location

GSK Investigational Site

Tampere, 33100, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Essen, 45355, Germany

Location

GSK Investigational Site

Essen, 45359, Germany

Location

GSK Investigational Site

Goch, 47574, Germany

Location

GSK Investigational Site

Hamburg, 22143, Germany

Location

GSK Investigational Site

Mainz, 55116, Germany

Location

GSK Investigational Site

München, 80339, Germany

Location

GSK Investigational Site

Wallerfing, 94574, Germany

Location

GSK Investigational Site

Würzburg, 97074, Germany

Location

GSK Investigational Site

Fukuoka, 812-0025, Japan

Location

GSK Investigational Site

Kumamoto, 861-4157, Japan

Location

GSK Investigational Site

Changhua, 500, Taiwan

Location

GSK Investigational Site

Taichung, 40447, Taiwan

Location

GSK Investigational Site

Taichung, 407, Taiwan

Location

GSK Investigational Site

Taipei, 100, Taiwan

Location

GSK Investigational Site

Taipei, 104, Taiwan

Location

GSK Investigational Site

Taipei, 112, Taiwan

Location

GSK Investigational Site

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• Schwarz TF, Hwang SJ, Ylisastigui P, Liu CS, Takazawa K, Yono M, Ervin JE, Andrews CP, Fogarty C, Eckermann T, Collete D, de Heusch M, De Schrevel N, Salaun B, Lambert A, Marechal C, Olivier A, Nakanwagi P, Lievens M, Hulstrom V. Immunogenicity and Safety Following 1 Dose of AS01E-Adjuvanted Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults: A Phase 3 Trial. J Infect Dis. 2024 Jul 25;230(1):e102-e110. doi: 10.1093/infdis/jiad546.

  PMID: 39052726 BACKGROUND

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

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

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
• Masking Details: Open-label study. Both investigator and participant know the identity of the intervention assigned.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 1, 2021
• Study Start: February 15, 2021
• Primary Completion: June 6, 2022
• Study Completion (Estimated): February 19, 2027
• Last Updated: March 20, 2026
• Results First Posted: December 21, 2023

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.

Locations

DE (8); US (18); JP (2); FI (10); TW (7)