A study evaluating 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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

GlaxoSmithKline Biologicals

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Virus Diseases [C02]

Trial duration

10 Nov 2025 → ongoing

Decision date (initial)

2025-09-16

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

To evaluate the persistence of humoral immune response against RSV-A and RSV-B in kidney and lung solid organ transplant patients following 1 and 2 dose primary schedule of adjuvanted RSVPreF3 vaccine up to 24 months post last dose in the parent study. To evaluate the humoral immune response against RSV-A and RSV-B following revaccination of kidney and lung solid organ transplant patients from the parent study with a single dose of adjuvanted RSVPreF3 vaccine at Visit 1 in the current study.

Secondary objectives 3

1. To further evaluate persistence of the humoral immune response against RSV-A and RSV-B following 1 and 2 dose primary schedule of adjuvanted RSVPreF3 vaccine up to 24 months post last dose in the parent study.
2. To evaluate the humoral immune response against RSV-A and RSV-B following revaccination of kidney and lung SOT patients from the parent study with a single dose of adjuvanted RSVPreF3 vaccine at Visit 1 in the current study.
3. To evaluate the safety and reactogenicity of the single revaccination dose of the adjuvanted RSVPreF3 vaccine in kidney and lung SOT patients

Conditions and MedDRA coding

Respiratory Syncytial Virus Infections

Study design 1 period

Regulatory references

Plan to share IPD

Yes

IPD plan description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gskstudyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. • 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.
2. • 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.
3. • 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 3

1. •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
2. •Previous allograft loss secondary to recurrent primary kidney disease •Evidence of significant proteinuria/albuminuria
3. •Diagnosis of acute pulmonary infection within the 2 weeks •Chronic lung allograft dysfunction

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. •RSV-A and RSV-B serum neutralizing titers expressed as GMT at Visit 1 in IC-1 and IC-2 groups. •RSV-A and RSV-B serum neutralizing titers expressed as MGI at Visit 1 in the current study over 30 days post last dose in the parent study in IC-1 and IC-2 groups. •RSV-A and RSV-B serum neutralizing titers expressed as GMT in IC-1 and IC-2 groups at Visit 2 and Visit 3.

Secondary endpoints 5

1. •RSV-A and RSV-B serum neutralizing titers expressed as group GMT ratio IC-2 over IC-1 at Visit 1.
2. •RSV-A and RSV-B serum neutralizing titers expressed as MGI at Visit 2 and Visit 3 over Visit 1 in IC-1 and IC-2 groups.
3. •RSV-A and RSV-B serum neutralizing titers expressed as MGI at Visit 2 in the RSV-031 study over 30 days post last dose in the parent study in IC-1 and IC-2 groups.
4. Percentage of participants reporting: - each solicited administration site event with onset within 7 days after receiving the re-vaccination dose - each solicited systemic event with onset within 7 days after receiving the re-vaccination dose • unsolicited AEs within 30 days after receiving the re-vaccination dose • any SAEs after receiving the re-vaccination dose up to Visit 3 (Month 6) • related SAEs after receiving the re-vaccination dose up to study end (Month 12)
5. Percentage of participants reporting: -fatal SAEs after receiving the re-vaccination dose of the adjuvanted RSVPreF3 vaccine up to study end (Month 12) -AESIs (AEs specific to kidney and lung SOT patients and pIMDs) after receiving the re-vaccination dose up to study end (Month 12)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

GlaxoSmithKline Biologicals

Sponsor organisation

GlaxoSmithKline Biologicals

Address

Rue De L'Institut 89

City

Rixensart

Postcode

1330

Country

Belgium

Scientific contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Public contact point

Organisation

GlaxoSmithKline Biologicals

Contact name

EU GSK Clinical Trials Call Center

Third parties 10

Locations

3 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 40 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications