Evaluation of Immune Response Persistence and Safety of Adjuvanted RSVPreF3 Vaccine in Lung and Kidney Transplant Recipients
- Trial ID
- 2024-519730-23-00
- Protocol
- 224083
- Sponsor
- GlaxoSmithKline Biologicals
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the persistence of the humoral immune response against Respiratory Syncytial Virus (RSV) types A and B in patients undergoing solid organ transplant of the lung or kidney. This assessment follows a one or two-dose primary schedule of the adjuvanted RSVPreF3 vaccine for up to 24 months post-final dose. Additionally, the study aims to evaluate the humoral immune response against RSV-A and RSV-B following a single dose of the vaccine administered as revaccination in this patient population. 5, 7
Secondary objectives include:
- Further assessment of the persistence of the humoral immune response against RSV-A and RSV-B up to 24 months after the last dose of the primary schedule.
- Evaluation of the humoral immune response following the single revaccination dose.
- Evaluation of safety and reactogenicity associated with the single dose of the adjuvanted RSVPreF3 vaccine.
Participants
This study involves 138 participants who have undergone an allogeneic kidney transplant or lung transplant. The study population consists of patients experiencing respiratory syncytial virus infections and is composed of both male and female individuals. The participants include those of non-childbearing potential or females of childbearing potential who adhere to specific contraception requirements. Selection is limited to individuals from the Per Protocol Set of a previous study who received one or two doses of an adjuvanted vaccine. Inclusion requires the receipt of an ABO compatible allograft more than 12 months prior to the intervention and the administration of maintenance immunosuppressive therapy. For kidney transplant recipients, stable kidney function is required, while lung transplant recipients must demonstrate stable lung function based on FEV1 levels.
Plans and Procedures
This Phase 2b, non-randomized, controlled, open-label, extension study is designed to evaluate the persistence of the humoral immune response against Respiratory Syncytial Virus (RSV) in kidney and lung transplant recipients. The research methodology focuses on assessing immunogenicity and safety following revaccination with the adjuvanted RSVPreF3 vaccine. The study includes participants who previously received either one or two doses in a parent study. Following screening and enrollment, participants receive a single dose of the vaccine at Visit 1. Subsequent follow-up visits, including Visit 2 and Visit 3, are conducted to monitor serum neutralizing titers and adverse events. The assessment of safety includes monitoring for solicited administration site events, systemic events, unsolicited adverse events, and serious adverse events. The study duration involves monitoring participants for up to 12 months after revaccination, with an overall estimated end date of July 5, 2027. Participant involvement may be subject to early termination based on investigator discretion regarding protocol compliance or medical stability.
Treatment
The experimental treatment consists of Arexvy, a recombinant, adjuvanted Respiratory Syncytial Virus (RSV) vaccine. The active substance is respiratory syncytial virus glycoprotein F, which is recombinant and stabilized in the pre-fusion conformation, adjuvanted with AS01E. This medication is provided as a suspension for injection and is administered via intramuscular route at a dosage of 120 µg.
Efficacy
The assessment of efficacy focuses on the persistence of the humoral immune response against Respiratory Syncytial Virus (RSV) types A and B. The primary endpoints include RSV-A and RSV-B serum neutralizing titers, which are expressed as geometric mean titers (GMT) at Visit 1 for the IC-1 and IC-2 groups. Additionally, titers are expressed as geometric mean increments (MGI) at Visit 1 for the current study over a period of 30 days following the last dose administered in the parent study for the IC-1 and IC-2 groups. Further evaluations of GMT in the IC-1 and IC-2 groups are conducted at Visit 2 and Visit 3.
Secondary efficacy parameters include:
- The group GMT ratio of IC-2 over IC-1 at Visit 1 for RSV-A and RSV-B serum neutralizing titers.
- The MGI of RSV-A and RSV-B serum neutralizing titers at Visit 2 and Visit 3 relative to Visit 1 in the IC-1 and IC-2 groups.
- The MGI of RSV-A and RSV-B serum neutralizing titers at Visit 2 in the RSV-031 study over 30 days post the last dose in the parent study for the IC-1 and IC-2 groups.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participants of the RSV OA=ADJ-023 study from the Per Protocol Set, who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available. • Participants who, in the opinion of the investigator, 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 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. Refer to Protocol Section 10.4.1 for definitions of women of childbearing potential, menarche and 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. Refer to Protocol Section 10.4.2 for definition of adequate contraception. • 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.
- For kidney transplant patients - 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.
- For lung transplant patients - 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.
Exclusion Criteria
- •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 •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. •Any condition which, in the judgment of the investigator, would make IM injection unsafe. •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the clinical study. •Vaccination with RSV-antigen containing vaccine after 1 or 2 doses received in the parent 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 •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. •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 •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. •Any study personnel or their immediate dependents, family, or household members. •Planned move during the study period that will prohibit participating in the study until study end. •Pregnant or lactating female participant. •Female participant planning to become pregnant or planning to discontinue contraceptive precautions. •More than one organ transplanted (i.e., kidney-liver or kidney-other organ(s) transplanted). Dual organ is allowed (double kidney or double lung). •History of events that, in the opinion of the investigator, may put the participant at increased risk for chronic allograft dysfunction. •Participant with an episode of allograft rejection within 3 months (90 days) prior to Visit 1. •Histologic evidence of chronic allograft injury. •Active treatment for acute rejection. •Current diagnosis of malignancy (except non-melanoma skin cancer that does not require systemic therapy). •Any autoimmune conditions or pIMDs that in the opinion of the investigator may put the participant at increased risk. •Any confirmed or suspected HIV infection or primary immunodeficiency disease or ongoing CMV infection with a viremia > 200 IU/mL •Use of anti-CD20 or other B-cell monoclonal antibody agents for the prevention of allograft rejection within 9 months prior to Visit 1. •Use of investigational and non-registered immunosuppressants •Evidence or suspicion of noncompliance or nonadherence to immunosuppressive therapy •Any clinically significant hematologic and/or biochemical laboratory abnormality
- •Previous allograft loss secondary to recurrent primary kidney disease •Evidence of significant proteinuria/albuminuria
- •Diagnosis of acute pulmonary infection within the 2 weeks •Chronic lung allograft dysfunction
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Germany | Not Yet Recruiting | 14 Nov 2025 | 8 |
 Italy | Recruiting | 14 Nov 2025 | 18 |
 Spain | Not Recruiting | 14 Nov 2025 | 45 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
Arexvy powder and suspension for suspension for injection Respiratory Syncytial Virus (RSV) vaccinerecombinant, adjuvanted | Test | POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION | INTRAMUSCULAR USE | 120 | 1 | PRD10447046 |