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A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 50 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

  • 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. The aim of the study is to prevent severe Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD).

NCT_ID: NCT05921903

Clinical Trial Link

Brief Summaries

Sequence: 30521137
Description 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. The aim of the study is to prevent severe Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD).

Studies

Study First Submitted Date 2023-06-16
Study First Posted Date 2023-06-27
Last Update Posted Date 2023-06-27
Start Month Year July 31, 2023
Primary Completion Month Year September 9, 2024
Verification Month Year June 2023
Verification Date 2023-06-30
Last Update Posted Date 2023-06-27

Facilities

Sequence: 198477541 Sequence: 198477542 Sequence: 198477543 Sequence: 198477544 Sequence: 198477545 Sequence: 198477546 Sequence: 198477547 Sequence: 198477548 Sequence: 198477549 Sequence: 198477550 Sequence: 198477551 Sequence: 198477552 Sequence: 198477553 Sequence: 198477554 Sequence: 198477555 Sequence: 198477556 Sequence: 198477557 Sequence: 198477558 Sequence: 198477559 Sequence: 198477560 Sequence: 198477561 Sequence: 198477562 Sequence: 198477563 Sequence: 198477564 Sequence: 198477565 Sequence: 198477566 Sequence: 198477567 Sequence: 198477568 Sequence: 198477569 Sequence: 198477570 Sequence: 198477571 Sequence: 198477572 Sequence: 198477573 Sequence: 198477574 Sequence: 198477575 Sequence: 198477576 Sequence: 198477577 Sequence: 198477578 Sequence: 198477579 Sequence: 198477580 Sequence: 198477581 Sequence: 198477582 Sequence: 198477583 Sequence: 198477584 Sequence: 198477585 Sequence: 198477586 Sequence: 198477587 Sequence: 198477588 Sequence: 198477589 Sequence: 198477590 Sequence: 198477591 Sequence: 198477592 Sequence: 198477593
Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK Investigational Site Name GSK investigational Site
City Phoenix City Chicago City Iowa City City Lexington City Minneapolis City Saint Louis City Omaha City New York City New York City Pittsburgh City Dallas City Birtinya City Herston City Woolloongabba City Adelaide City Nedlands City Edmonton City Vancouver City London City Toronto City Montreal City Sherbrooke City Heidelberg City Giessen City Kaiserslautern City Milano City Milano City Pavia City Palermo City Siena City Aichi City Aichi City Fukuoka City Hyogo City Kumamoto City Kyoto City Okayama City Tokyo City Tokyo City Seoul City Seoul City Seoul City Santander City Barcelona City A Coruna City Majadahonda City Barcelona City Córdoba City Madrid City Madrid City Madrid City Madrid City Sevilla
State Arizona State Illinois State Iowa State Kentucky State Minnesota State Missouri State Nebraska State New York State New York State Pennsylvania State Texas State Queensland State Queensland State Queensland State South Australia State Western Australia State Alberta State British Columbia State Ontario State Ontario State Quebec State Quebec State Baden-Wuerttemberg State Hessen State Rheinland-Pfalz State Lombardia State Lombardia State Lombardia State Sicilia State Toscana State Korea State Korea State Korea State Cantabria State Catalonia State Coruna State Madrid
Zip 85013 Zip 60612 Zip 52242 Zip 40536 Zip 55455 Zip 63110 Zip 68198 Zip 10032 Zip 10065 Zip 15213 Zip 76502 Zip 4556 Zip 4029 Zip 4102 Zip 5000 Zip 6009 Zip T6G 2B7 Zip V5Z 1M9 Zip N6A 5A5 Zip M5G 2N2 Zip H2X 3H9 Zip J1J 2G2 Zip 69120 Zip 35392 Zip 67655 Zip 20122 Zip 20132 Zip 27100 Zip 90127 Zip 53100 Zip 466-8650 Zip 470-1192 Zip 814-0180 Zip 662-0918 Zip 861-8520 Zip 606-8507 Zip 700-8558 Zip 160-0017 Zip 193-0998 Zip 03722 Zip 110-774 Zip 138-736 Zip 39011 Zip 08907 Zip 15006 Zip 28222 Zip 08036 Zip 14004 Zip 28007 Zip 28034 Zip 28040 Zip 28041 Zip 41013
Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country United States Country Australia Country Australia Country Australia Country Australia Country Australia Country Canada Country Canada Country Canada Country Canada Country Canada Country Canada Country Germany Country Germany Country Germany Country Italy Country Italy Country Italy Country Italy Country Italy Country Japan Country Japan Country Japan Country Japan Country Japan Country Japan Country Japan Country Japan Country Japan Country Korea, Republic of Country Korea, Republic of Country Korea, Republic of Country Spain Country Spain Country Spain Country Spain Country Spain Country Spain Country Spain Country Spain Country Spain Country Spain Country Spain

Conditions

Sequence: 51750754
Name Respiratory Syncytial Virus Infections
Downcase Name respiratory syncytial virus infections

Id Information

Sequence: 39823073 Sequence: 39823074
Id Source org_study_id Id Source secondary_id
Id Value 219900 Id Value 2023-503951-81-00
Id Type Other Identifier
Id Type Description EU CT number

Countries

Sequence: 42222259 Sequence: 42222260 Sequence: 42222261 Sequence: 42222262 Sequence: 42222263 Sequence: 42222264 Sequence: 42222265 Sequence: 42222266
Name United States Name Australia Name Canada Name Germany Name Italy Name Japan Name Korea, Republic of Name Spain
Removed False Removed False Removed False Removed False Removed False Removed False Removed False Removed False

Design Groups

Sequence: 55172032 Sequence: 55172033 Sequence: 55172034
Group Type Experimental Group Type Experimental Group Type Active Comparator
Title RSV_IC_1 group Title RSV_IC_2 group Title RSV_HA group
Description Immunocompromised (IC) patients receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1). Description Immunocompromised (IC) patients receiving 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days). Description Healthy participants receiving 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).

Interventions

Sequence: 52072421
Intervention Type Biological
Name RSVPreF3 OA Investigational Vaccine
Description 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).

Keywords

Sequence: 79178900 Sequence: 79178901 Sequence: 79178902 Sequence: 79178903
Name Respiratory syncytial virus Name Vaccine Name Immunogenicity Name Safety
Downcase Name respiratory syncytial virus Downcase Name vaccine Downcase Name immunogenicity Downcase Name safety

Design Outcomes

Sequence: 176020149 Sequence: 176020150 Sequence: 176020151 Sequence: 176020152 Sequence: 176020153 Sequence: 176020154 Sequence: 176020155 Sequence: 176020156 Sequence: 176020157 Sequence: 176020158 Sequence: 176020159 Sequence: 176020160
Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure RSV-A serum neutralizing titers expressed as mean geometric increase (MGI) post Dose 2 over post-Dose 1 Measure RSV-B serum neutralizing titers expressed as MGI post-Dose 2 over post-Dose 1 Measure RSV-A serum neutralizing titers expressed as geometric mean titers (GMT) Measure RSV-B serum neutralizing titers expressed as geometric mean titers (GMT) Measure Cell Mediated Immunity (CMI) response in a subset of participants Measure Percentage of participants with solicited administration site events Measure Percentage of participants with solicited administration site events and solicited systemic events Measure Percentage of participants with unsolicited adverse events (AEs) Measure Percentage of participants with serious adverse events (SAEs) Measure Percentage of participants with any serious adverse events (SAEs), SAEs related to study intervention and fatal SAEs Measure Percentage of participants with any potential immune-mediated disease (pIMDs) and pIMDs related to study intervention Measure Percentage of participants with any AESIs
Time Frame At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60) Time Frame At Visit 4 (Visit 3 + 30-42 days) versus Visit 3 (Day 30-60) Time Frame 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) Time Frame 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) Time Frame 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) Time Frame 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) Time Frame 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) Time Frame 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) Time Frame 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) Time Frame 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) Time Frame 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) Time Frame 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)
Description The analysis is performed on the renal and lung SOT patients in the 2-dose group. Description The analysis is performed on the renal and lung SOT patients in the 2-dose group. Description RSV-A serum neutralizing titers expressed as group GMT ratio RSV_HA group over RSV_IC group (pooled RSV_IC_1 and RSV_IC_2 groups) is assessed at Visit 2 (in a subset of participants) and Visit 3, and RSV_IC_2 over RSV_IC_1, RSV_HA over RSV_IC_1, and RSV_HA over RSV_IC_2) at Visit 4, Visit 5 and Visit 6. Description RSV-B serum neutralizing titers expressed as group GMT ratio RSV_HA group over RSV_IC group (pooled RSV_IC_1 and RSV_IC_2 groups) is assessed at Visit 2 (in a subset of participants) and Visit 3, and RSV_IC_2 over RSV_IC_1, RSV_HA over RSV_IC_1, and RSV_HA over RSV_IC_2) at Visit 4, Visit 5 and Visit 6. Description CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD4+ and/or CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-α, IFN-γ, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from 1-dose group and 2-dose group) and healthy participants. Description Assessed solicited administration site events included pain, redness and swelling, at the injection site. Description Assessed solicited systemic events included fever, myalgia, arthralgia, headache, and fatigue. Description An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Description A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Description A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Description Potential immune-mediated diseases (pIMDs) are a subset of AEs of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Description AESIs are AEs of special interest. Along with pIMDs, they include also the acute rejection (specific to renal and lung SOT patients) and Atrial fibrillation (AF).

Browse Conditions

Sequence: 191792689 Sequence: 191792690 Sequence: 191792691 Sequence: 191792692 Sequence: 191792693 Sequence: 191792694 Sequence: 191792695
Mesh Term Respiratory Syncytial Virus Infections Mesh Term Virus Diseases Mesh Term Infections Mesh Term Pneumovirus Infections Mesh Term Paramyxoviridae Infections Mesh Term Mononegavirales Infections Mesh Term RNA Virus Infections
Downcase Mesh Term respiratory syncytial virus infections Downcase Mesh Term virus diseases Downcase Mesh Term infections Downcase Mesh Term pneumovirus infections Downcase Mesh Term paramyxoviridae infections Downcase Mesh Term mononegavirales infections Downcase Mesh Term rna virus infections
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 47928674
Agency Class INDUSTRY
Lead Or Collaborator lead
Name GlaxoSmithKline

Central Contacts

Sequence: 11924074 Sequence: 11924075
Contact Type primary Contact Type backup
Name US GSK Clinical Trials Call Center Name EU GSK Clinical Trials Call Center
Phone 877-379-3718 Phone +44 (0) 20 89904466
Email GSKClinicalSupportHD@gsk.com Email GSKClinicalSupportHD@gsk.com
Role Contact Role Contact

Design Group Interventions

Sequence: 67639068 Sequence: 67639069 Sequence: 67639070
Design Group Id 55172034 Design Group Id 55172032 Design Group Id 55172033
Intervention Id 52072421 Intervention Id 52072421 Intervention Id 52072421

Eligibilities

Sequence: 30519918
Gender All
Minimum Age 50 Years
Maximum Age N/A
Healthy Volunteers Accepts Healthy Volunteers
Criteria Inclusion Criteria: Participants 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 prior to performance of any study-specific procedure. A male or female, ≥50 YoA at the time of signing the Informed consent form (ICF). 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: 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: 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. 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. 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). However, 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 (double kidney or double lung). 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 renal transplant (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 lung transplant (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% or more 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.
Adult True
Child False
Older Adult True

Calculated Values

Sequence: 254077522
Number Of Facilities 53
Registered In Calendar Year 2023
Were Results Reported False
Has Us Facility True
Has Single Facility False
Minimum Age Num 50
Minimum Age Unit Years
Number Of Primary Outcomes To Measure 2
Number Of Secondary Outcomes To Measure 10

Designs

Sequence: 30268937
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Prevention
Time Perspective
Masking None (Open Label)
Masking Description This study is an open label study. Potential bias will be reduced by central randomization.

Responsible Parties

Sequence: 28649089
Responsible Party Type Sponsor

Ipd Information Types

Sequence: 3310748 Sequence: 3310749 Sequence: 3310750 Sequence: 3310751
Name Study Protocol Name Statistical Analysis Plan (SAP) Name Informed Consent Form (ICF) Name Clinical Study Report (CSR)

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