A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

NCT07092865 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2240832024-519730-23-00
• Study Type: interventional
• Target: 184
• Locations: 8 countries
• Sites: 37

Brief Summary

This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.

Conditions

Respiratory Syncytial Virus Infections

Keywords

Respiratory Syncytial Virus (RSV); Adjuvated RSVPreF3 vaccine; Solid organ transplant (SOT); Kidney SOT; Lung SOT; Immunocompromised (IC) patients; Humoral immune response; Safety; Reactogenicity

Outcome Measures

Primary Outcomes (8)

• RSV-A neutralizing titers expressed as Geometric mean titers (GMTs)

  RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60). GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  At Visit 1 (Day 1) of the current study

• RSV-B neutralizing titers expressed as GMTs

  RSV-B neutralizing titers are given as group GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  At Visit 1 (Day 1) of the current study

• RSV-A neutralizing titers expressed as Mean geometric increase (MGI)

  MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).

  At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study

• RSV-B neutralizing titers expressed as MGI

  MGI is defined as the geometric mean of the within participant ratios of two timepoints (ie., ratio of titers observed at Visit 1 over titers observed 30 days post last dose in the RSV OA=ADJ-023 parent study).

  At Visit 1 (Day 1) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study

• RSV-A neutralizing titers expressed as GMTs

  RSV-A neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  At Visit 2 (Day 31) of the current study

• RSV-B neutralizing titers expressed as GMTs

  RSV-B neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  At Visit 2 (Day 31) of the current study

• RSV-A neutralizing titers expressed as GMTs

  RSV-A neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  At Visit 3 (Day 180) of the current study

• RSV-B neutralizing titers expressed as GMTs

  RSV-B neutralizing titers are given as GMTs and are expressed as ED60. GMT is calculated by taking the anti-log of the mean of the log titer transformations.

  At Visit 3 (Day 180) of the current study

Secondary Outcomes (13)

• GMT ratio of RSV-A neutralizing titers

  At Visit 1 (Day 1) of the current study

• GMT ratio of RSV-B neutralizing titers

  At Visit 1 (Day 1) of the current study

• RSV-A neutralizing titers expressed as MGI

  At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]

• RSV-B neutralizing titers expressed as MGI

  At Visit 2 (Day 31) over Visit 1 (Day 1) and at Visit 3 (Day 180) over Visit 1 (Day 1) [each visit of the current study]

• RSV-A neutralizing titers expressed as MGI

  At Visit 2 (Day 31) of the current study over 30 days post last dose in the RSV OA=ADJ-023 study

Study Arms (1)

IC Revaccination Group

EXPERIMENTAL

Lung or kidney transplant recipients undergoing chronic immunosuppressive therapy who received 1 and 2 doses of the adjuvanted RSVPreF3 vaccine (IC\_1 and IC\_2 groups respectively) in the RSV OA=ADJ-023 parent study will receive a revaccination dose of adjuvanted RSVPreF3 vaccine at Visit 1 (Day 1) in the current study.

Biological: Adjuvanted RSVPreF3 vaccine

Interventions

Adjuvanted RSVPreF3 vaccine BIOLOGICAL

1 dose of adjuvanted RSVPreF3 vaccine administered intramuscularly at Visit 1 (Day 1).

IC Revaccination Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for participants in IC\_1 and Visit 4 for participants in IC\_2 group), who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available.
• Participants who, can and will comply with the requirements of the protocol (e.g., completion of the paper diary cards (as applicable), return for follow-up visits, ability to access and utilize a phone or other electronic communications, have regular contact to allow evaluation during the study).
• Written or witnessed informed consent obtained from the participant 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 1 month after study intervention, and
• has a negative pregnancy test on the day of and prior to study intervention administration.
• Participant who has received an ABO compatible allogeneic kidney or lung transplant (allograft) more than 12 months (365 days) prior to the study intervention administration.
• Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.
• Participant with stable kidney 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.

You may not qualify if:

• Medical conditions
• Any history of dementia or any medical condition that moderately or severely impairs cognition.
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival up to study end).
• History of any reaction or 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 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.
• Any condition which, in the judgment of the investigator, would make IM injection unsafe.
• Any other clinical condition that might pose additional risk to the participant due to participation in the clinical study.
• Prior/Concomitant therapy
• Vaccination with RSV-antigen containing vaccine after 1 or 2 doses received in the RSV OA=ADJ-023 study.
• Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention administration during the period beginning 30 days before the study intervention administration (Day -30 to Day 1), or their planned use during the study period (up to Month 12).
• Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study intervention administration and ending 30 days after the study intervention administration\*. In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after study intervention administration.
• If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by the public health authorities outside the routine immunization program, the time period of 30 days described above can be reduced, if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified.
• Prior/Concurrent clinical study experience
• 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 intervention (drug/invasive medical device).

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (37)

GSK Investigational Site

Lexington, Kentucky, 40536, United States

RECRUITING

GSK Investigational Site

St Louis, Missouri, 63110, United States

RECRUITING

GSK Investigational Site

St Louis, Missouri, 63110, United States

RECRUITING

GSK Investigational Site

Omaha, Nebraska, 68198, United States

RECRUITING

GSK Investigational Site

New York, New York, 10065, United States

RECRUITING

GSK Investigational Site

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

GSK Investigational Site

Temple, Texas, 76502, United States

RECRUITING

GSK Investigational Site

Camperdown, New South Wales, 2050, Australia

RECRUITING

GSK Investigational Site

Birtinya, Queensland, 4556, Australia

RECRUITING

GSK Investigational Site

Herston, Queensland, 4029, Australia

RECRUITING

GSK Investigational Site

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

GSK Investigational Site

Vancouver, British Columbia, V5Z 1M9, Canada

RECRUITING

GSK Investigational Site

London, Ontario, N6A 5A5, Canada

RECRUITING

GSK Investigational Site

Toronto, Ontario, M5G 2N2, Canada

RECRUITING

GSK Investigational Site

Giessen, 35392, Germany

RECRUITING

GSK Investigational Site

Milan, 20122, Italy

RECRUITING

GSK Investigational Site

Milan, 20132, Italy

RECRUITING

GSK Investigational Site

Pavia, 27100, Italy

RECRUITING

GSK Investigational Site

Siena, 53100, Italy

RECRUITING

GSK Investigational Site

Aichi, 466-8650, Japan

RECRUITING

GSK Investigational Site

Aichi, 470-1192, Japan

RECRUITING

GSK Investigational Site

Fukuoka, 814-0180, Japan

RECRUITING

GSK Investigational Site

Hyōgo, 662-0918, Japan

RECRUITING

GSK Investigational Site

Kumamoto, 861-8520, Japan

RECRUITING

GSK Investigational Site

Okayama, 700-8558, Japan

RECRUITING

GSK Investigational Site

Tokyo, 193-0998, Japan

RECRUITING

GSK Investigational Site

Seoul, 03722, South Korea

RECRUITING

GSK Investigational Site

Seoul, 110-774, South Korea

RECRUITING

GSK Investigational Site

A Coruña, 15006, Spain

RECRUITING

GSK Investigational Site

Barcelona, 8036, Spain

RECRUITING

GSK Investigational Site

Barcelona, 8907, Spain

RECRUITING

GSK Investigational Site

Córdoba, 14004, Spain

RECRUITING

GSK Investigational Site

Madrid, 28007, Spain

RECRUITING

GSK Investigational Site

Madrid, 28034, Spain

RECRUITING

GSK Investigational Site

Madrid, 28040, Spain

RECRUITING

GSK Investigational Site

Madrid, 28041, Spain

RECRUITING

GSK Investigational Site

Santander, 39011, Spain

RECRUITING

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

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

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: July 30, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): January 12, 2027
• Study Completion (Estimated): July 16, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

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 asset(s) with development terminated 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

AU (3); KR (2); ES (9); JP (7); CA (4); US (7); DE (1); IT (4)