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

JRCT ID: jRCT2031230191

Registered date:29/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Respiratory Syncytial Virus Infections
• Date of first enrollment: 07/08/2023
• Target sample size: 375
• Countries of recruitment: Australia,Japan,Canada,Japan,Spain,Japan,Germany,Japan,Italy,Japan,Republic of Korea,Japan,United State,Japan
• Study type: Interventional
• Intervention(s): The RSVPreF3 OA 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

Outcome(s)

Primary Outcome

RSV-A and RSV-B serum neutralizing titers expressed as mean geometric increase (MGI) post
Dose 2 over post-Dose 1

Secondary Outcome

-RSV-A serum neutralizing titers expressed as geometric mean titers (GMT)
-RSV-B serum neutralizing titers expressed as geometric mean titers (GMT)
-Cell Mediated Immunity (CMI) response in a subset of participants
-Percentage of participants with solicited administration site events
-Percentage of participants with solicited administration site events and solicited systemic events
-Percentage of participants with unsolicited adverse events (AEs)
-Percentage of participants with serious adverse events (SAEs)
-Percentage of participants with any serious adverse events (SAEs), SAEs related to study intervention and fatal SAEs
-Percentage of participants with any potential immune-mediated disease (pIMDs) and pIMDs related to study intervention
-Percentage of participants with any AESIs

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.
-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).
-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 healthy participants:
-A male or female, >-50 YoA at the time of signing the Informed consent form (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.

Exclude 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 Celsius). 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 up to 30 days before the first dose administration, or their planned use during the study period.
- 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.
- 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.
- Active treatment for acute rejection.
- 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.

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.

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.

Related Information

• Primary Sponsor: Okawa Yasutoshi
• Secondary ID(s): Nil known