BridgeMD
Tests treatment safety and results for Respiratory Syncytial Virus Infections
Official title 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
ClinicalTrials.gov ID: NCT07092865
What this study is testing
What is Adjuvanted RSVPreF3 vaccine?
Adjuvanted RSVPreF3 vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for respiratory syncytial virus infections.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)...
- Participants who, can and will comply with the requirements of the protocol (e.g., completion of the paper diary cards (as applicable), return for...
- 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...
- Female participants of childbearing potential may be enrolled in the study if the participant:
You likely can't join 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...
- 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...
- Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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. Specific for kidney transplant (KTx) 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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 (e.g., rituximab) as induction, maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days)...
- Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are non-registered and:
- available locally through compassionate use programs,
- submitted for and pending local/country registration,
- approved and registered for use in other countries with well-documented SmPC or Prescribing Information. The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication...
- Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and/or maintenance immunosuppressive therapies.
- Any clinically significant (based on the Investigator's clinical judgement) hematologic (hemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, platelet red blood cell count and erythrocyte mean...
- Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason for a previous allograft loss is not recurrent primary kidney disease.
- Evidence of significant proteinuria/albuminuria in the opinion of the investigator. Specific exclusion criteria for LTx patients:
- At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks, based on the following: clinical, radiological, and/or physiological deterioration; OR isolation of...
- Patients with diagnosis of chronic lung allograft dysfunction, defined as a decrement of 20% or more in FEV1 compared to post-transplant baseline FEV1.
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
- St Louis, Missouri, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Temple, Texas, United States
- Camperdown, New South Wales, Australia
- Birtinya, Queensland, Australia
- Herston, Queensland, Australia
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Giessen, Germany
- Milan, Italy
- Pavia, Italy
- Siena, Italy
- Aichi, Japan
- Fukuoka, Japan
- Hyōgo, Japan
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States; St Louis, Missouri, United States; Omaha, Nebraska, United States; New York, New York, United States; Pittsburgh, Pennsylvania, United States; Temple, Texas, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.