Authorised Therapeutic exploratory (Phase II) Respiratory Syncytial Virus Infections

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

EU CTIS ID: 2024-519730-23-00

What this study is testing

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.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • • 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.

You likely can't join if

  • •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

The study team makes the final eligibility decision.

Where it's taking place

  • Korea, Republic of
  • Japan
  • United States
  • Canada
  • Australia

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Korea, Republic of; Japan; United States; Canada; Australia. 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 EU CTIS; the study team decides eligibility.