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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05921903




Registration number
NCT05921903
Ethics application status
Date submitted
16/06/2023
Date registered
27/06/2023

Titles & IDs
Public title
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
Scientific title
A Phase 2b, Randomized, Controlled, Open-label Study to Evaluate the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults (>=18 Years of Age) When Administered to Lung and Renal Transplant Recipients Comparing 1 Versus 2 Doses and Compared to Healthy Controls (>=50 Years of Age) Receiving 1 Dose
Secondary ID [1] 0 0
2023-503951-81-00
Secondary ID [2] 0 0
219900
Universal Trial Number (UTN)
Trial acronym
RSV OA=ADJ-023
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Syncytial Virus Infections 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - RSVPreF3 OA Investigational Vaccine

Experimental: RSV_IC_1 group - Immunocompromised (IC) patients receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).

Experimental: RSV_IC_2 group - Immunocompromised (IC) patients receiving 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).

Active comparator: RSV_HA group - Healthy participants receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).


Treatment: Other: RSVPreF3 OA Investigational Vaccine
The investigational vaccine will be administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group).
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
RSV-A serum neutralizing titers expressed as mean geometric increase (MGI) post Dose 2 over post-Dose 1
Timepoint [1] 0 0
At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60)
Primary outcome [2] 0 0
RSV-B serum neutralizing titers expressed as MGI post-Dose 2 over post-Dose 1
Timepoint [2] 0 0
At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60)
Secondary outcome [1] 0 0
RSV-A serum neutralizing titers expressed as Geometric Mean Titers
Timepoint [1] 0 0
At Visit 2 in a subset of participants (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Secondary outcome [2] 0 0
RSV-B serum neutralizing titers expressed as Geometric Mean Titers
Timepoint [2] 0 0
At Visit 2 in a subset of participants (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Secondary outcome [3] 0 0
RSV-A serum neutralizing titers expressed as group geometric mean titers (GMT) ratio
Timepoint [3] 0 0
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Secondary outcome [4] 0 0
RSV-B serum neutralizing titers expressed as group geometric mean titers (GMT) ratio
Timepoint [4] 0 0
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Secondary outcome [5] 0 0
RSV-A serum neutralizing titers expressed as mean geometric increase (MGI)
Timepoint [5] 0 0
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Secondary outcome [6] 0 0
RSV-B serum neutralizing titers expressed as mean geometric increase (MGI)
Timepoint [6] 0 0
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Secondary outcome [7] 0 0
Cell Mediated Immunity (CMI) response in a subset of participants
Timepoint [7] 0 0
At Day 1 (dose 1), at Visit 2 (7-14 days post-dose 1), Visit 3 (30-60 days post dose-1, dose 2 for the RSV_IC_2 group), Visit 4 (Visit 3+30-42 days), Visit 5 (180-210 days post last-dose) and at Visit 6 (350-380 days post last dose)
Secondary outcome [8] 0 0
Percentage of participants with solicited administration site events
Timepoint [8] 0 0
Within 7 days post-study intervention administration (i.e., the day of vaccination and 6 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Secondary outcome [9] 0 0
Percentage of participants with solicited systemic events
Timepoint [9] 0 0
Within 7 days post-study intervention administration (i.e., the day of vaccination and 6 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Secondary outcome [10] 0 0
Percentage of participants with unsolicited adverse events (AEs)
Timepoint [10] 0 0
Within 30 days post-study intervention administration (i.e., the day of vaccination and 29 subsequent days, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Secondary outcome [11] 0 0
Percentage of participants with any serious adverse events (SAEs) after study intervention, SAEs related to study intervention and fatal SAEs
Timepoint [11] 0 0
From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Secondary outcome [12] 0 0
Percentage of participants with any potential immune-mediated disease (pIMDs) after study intervention and pIMDs related to study intervention
Timepoint [12] 0 0
From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)
Secondary outcome [13] 0 0
Percentage of participants with any AESIs
Timepoint [13] 0 0
From Day 1 up to study end (Day 350-380 post last dose, vaccine administered on Day 1 for all groups and Day 30-60 for RSV_IC_2)

Eligibility
Key inclusion criteria
* 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.

Specific inclusion criteria for renal/lung transplant patients:

* 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.

Specific inclusion criteria for renal transplant (RTx) patients:

• 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.

Specific inclusion criteria for lung transplant (LTx) 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.

Specific inclusion criteria for healthy participants:

* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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

Other exclusion criteria:

* Pregnant or lactating female participant.
* Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
* History of chronic alcohol consumption and/or drug abuse
* Participation of any study personnel or their immediate dependents.
* Planned move during the study period that will prohibit participating in the study until study end.

Specific exclusion criteria for renal/lung transplant patients:

* More than one organ transplanted. Dual organ is allowed.
* History of events that may put the participant at increased risk for chronic allograft dysfunction.
* Participant with an episode of allograft rejection over the previous 90 days prior to the first study intervention administration.
* 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 may put the participant at increased risk.
* Any confirmed or suspected HIV infection, 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 274 days of first dose of study.
* Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are in process of approval, approved in other countries and locally available.
* Evidence/high suspicion of noncompliance/nonadherence to use of induction and/or maintenance immunosuppressive therapies.
* Any clinically significant hematologic and/or biochemical laboratory abnormality.

Specific exclusion criteria for RTx patients:

* Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason is not recurrent primary kidney disease.
* Evidence of significant proteinuria/albuminuria.

Specific exclusion criteria for LTx patients:

* At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks.
* Patients with diagnosis of chronic lung allograft dysfunction (decrement of >=20% in FEV1 compared to post-transplant baseline FEV1).

Specific exclusion criteria for healthy participants:

* Any confirmed/suspected immunosuppressive/immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
* Unstable serious chronic illness.
* Chronic administration of immune-modifying drugs (>14 days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the end of the study.

* Up to 3 months prior to the study intervention administration:
* For corticosteroids -prednisone equivalent =20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed.
* Administration of immunoglobulins and/or any blood products or plasma derivatives.
* Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
5/06/2025
Actual
Sample size
Target
Accrual to date
Final
387
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Birtinya
Recruitment hospital [3] 0 0
GSK Investigational Site - Herston
Recruitment hospital [4] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4556 - Birtinya
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
Nebraska
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Germany
State/province [15] 0 0
Hessen
Country [16] 0 0
Germany
State/province [16] 0 0
Nordrhein-Westfalen
Country [17] 0 0
Germany
State/province [17] 0 0
Rheinland-Pfalz
Country [18] 0 0
Italy
State/province [18] 0 0
Lombardia
Country [19] 0 0
Italy
State/province [19] 0 0
Sicilia
Country [20] 0 0
Italy
State/province [20] 0 0
Toscana
Country [21] 0 0
Japan
State/province [21] 0 0
Aichi
Country [22] 0 0
Japan
State/province [22] 0 0
Fukuoka
Country [23] 0 0
Japan
State/province [23] 0 0
Hyogo
Country [24] 0 0
Japan
State/province [24] 0 0
Kumamoto
Country [25] 0 0
Japan
State/province [25] 0 0
Okayama
Country [26] 0 0
Japan
State/province [26] 0 0
Tokyo
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Seoul
Country [28] 0 0
Spain
State/province [28] 0 0
Madrid
Country [29] 0 0
Spain
State/province [29] 0 0
A Coruna
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Córdoba
Country [32] 0 0
Spain
State/province [32] 0 0
Santander

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.gsk.com/en-gb/innovation/trials/data-transparency/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05921903