A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above

NCT05921903 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2199002023-503951-81-00
• Study Type: interventional
• Target: 386
• Locations: 8 countries
• Sites: 46

Brief Summary

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory syncytial virus; Vaccine; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (2)

• RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group

  MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).

  At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

• RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group

  MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).

  At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

Secondary Outcomes (26)

• RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups

  At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)

• RSV-A and RSV-B Serum Neutralizing Titers Expressed as GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups

  At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)

• RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups

  At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)

• RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups

  At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

• RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups

  At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)

Study Arms (3)

RSV_IC_1 group

EXPERIMENTAL

Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).

Biological: RSVPreF3 OA Investigational Vaccine

RSV_IC_2 group

EXPERIMENTAL

IC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).

Biological: RSVPreF3 OA Investigational Vaccine

RSV_HA group

ACTIVE COMPARATOR

Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).

Biological: RSVPreF3 OA Investigational Vaccine

Interventions

RSVPreF3 OA Investigational Vaccine BIOLOGICAL

0.5 mililiter dose was administered intramuscularly as 1 dose to RSV\_IC\_1 and RSV\_HA groups, and 2 doses to RSV\_IC\_2 group.

RSV_HA group; RSV_IC_1 group; RSV_IC_2 group

Eligibility Criteria

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

You may qualify if:

• Participants and/or participant's parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
• Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
• Female participants of nonchildbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.
• 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 and agreed to continue adequate contraception until study end for this study, and has a negative pregnancy test on the day of and prior to study intervention administration.
• A male or female, \>=18 YoA at the time of signing the Informed consent form (ICF) or Informed assent form (IAF).
• Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than legal age of consent, or written informed consent obtained from the participant if the participant has achieved legal age of consent.
• Participant who has received an ABO compatible allogeneic renal or lung transplant (allograft) more than 12 months (365 days) prior to the first study intervention administration.
• Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.
• Participant with stable renal function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history.
• Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator.
• A male or female, \>=50 YoA at the time of signing the ICF.
• Healthy participants as established by medical history and clinical examination before entering the study.
• 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:

• Medical conditions:
• History of any reaction/ hypersensitivity likely to be exacerbated by any component of the study intervention.
• Acute or chronic clinically significant cardiovascular or hepatic functional abnormality as determined by physical examination or laboratory screening tests.
• Recurrent/uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study if their condition will allow them to comply with the requirements of the protocol, with the help of a caregiver if needed.
• Any history of dementia or any medical condition that moderately or severely impairs cognition.
• Any condition which would make IM injection unsafe.
• Significant underlying illness that would prevent completion of the study).
• Acute disease and/or fever at the time of study intervention administration (\>=38°C /100.4°F, oral or axillary). Participants with a minor illness without fever may be enrolled at the discretion of the investigator.
• Bedridden participants.
• Prior/Concomitant therapy:
• Use of any other investigational or non-registered product (drug, vaccine, or medical device) up to 30 days before the first dose administration (Day -30 to Day 1), or their planned use during the study period (up to Visit 6).
• Previous vaccination with the study antigen (RSV), including investigational RSV vaccines.
• Unexpected vaccine administration during a study should not occur 30 days prior to the first dose or 30 days after the last dose. For COVID-19 and inactivated/subunit/split influenza vaccines, this window is shortened to 14 days.
• Prior/Concurrent clinical study experience:
• Concurrently participating in another active clinical study

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (46)

GSK Investigational Site

Phoenix, Arizona, 85013, United States

Location

GSK Investigational Site

Chicago, Illinois, 60612, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40536, United States

Location

GSK Investigational Site

Minneapolis, Minnesota, 55455, United States

Location

GSK Investigational Site

St Louis, Missouri, 63110, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68198-2456, United States

Location

GSK Investigational Site

New York, New York, 10032, United States

Location

GSK Investigational Site

New York, New York, 10065, United States

Location

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

Location

GSK Investigational Site

Temple, Texas, 76502, United States

Location

GSK Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

GSK Investigational Site

Birtinya, Queensland, 4556, Australia

Location

GSK Investigational Site

Herston, Queensland, 4029, Australia

Location

GSK Investigational Site

Adelaide, South Australia, 5000, Australia

Location

GSK Investigational Site

Edmonton, Alberta, T6G 2B7, Canada

Location

GSK Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

Location

GSK Investigational Site

London, Ontario, N6A 5A5, Canada

Location

GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1J 2G2, Canada

Location

GSK Investigational Site

Giessen, 35392, Germany

Location

GSK Investigational Site

Milan, 20122, Italy

Location

GSK Investigational Site

Milan, 20132, Italy

Location

GSK Investigational Site

Palermo, 90127, Italy

Location

GSK Investigational Site

Pavia, 27100, Italy

Location

GSK Investigational Site

Siena, 53100, Italy

Location

GSK Investigational Site

Aichi, 466-8650, Japan

Location

GSK Investigational Site

Aichi, 470-1192, Japan

Location

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Hyōgo, 662-0918, Japan

Location

GSK Investigational Site

Kumamoto, 861-8520, Japan

Location

GSK Investigational Site

Okayama, 700-8558, Japan

Location

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

GSK Investigational Site

Tokyo, 193-0998, Japan

Location

GSK Investigational Site

Seoul, 03722, South Korea

Location

GSK Investigational Site

Seoul, 110-774, South Korea

Location

GSK Investigational Site

Seoul, 138-736, South Korea

Location

GSK Investigational Site

A Coruña, 15006, Spain

Location

GSK Investigational Site

Barcelona, 08036, Spain

Location

GSK Investigational Site

Barcelona, 08907, Spain

Location

GSK Investigational Site

Córdoba, 14004, Spain

Location

GSK Investigational Site

Madrid, 28007, Spain

Location

GSK Investigational Site

Madrid, 28034, Spain

Location

GSK Investigational Site

Madrid, 28040, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28222, Spain

Location

GSK Investigational Site

Santander, 39011, Spain

Location

Related Publications (1)

• Vyse A, Hockey C, Wright H, Ellsbury G. Could more adults than just those aged 75-79 years potentially benefit from vaccination against RSV: insights from UK data. J Pharm Policy Pract. 2025 Nov 4;18(1):2576618. doi: 10.1080/20523211.2025.2576618. eCollection 2025.

  PMID: 41199924 DERIVED

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 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is an open label study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: July 28, 2023
• Primary Completion: June 25, 2024
• Study Completion: May 16, 2025
• Last Updated: August 8, 2025
• Results First Posted: July 16, 2025

Record last verified: 2025-08

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

ES (10); DE (1); JP (8); AU (4); KR (3); CA (5); US (10); IT (5)