jRCT2031230191Active, not recruitingNot Applicable
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
GlaxoSmithKline K.K.0 sites375 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 375
- Primary Endpoint
- RSV-A serum neutralizing titers
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention Purpose
- Masking
- Open(masking Not Used)
Eligibility Criteria
- Ages
- 18age old over to No limit (—)
- Sex
- All
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.
- •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.
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 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.
Outcomes
Primary Outcomes
RSV-A serum neutralizing titers
expressed as mean geometric increase (MGI) post Dose 2 over post-Dose 1
RSV-B serum neutralizing titers
expressed as mean geometric increase (MGI) post Dose 2 over post-Dose 1
Secondary Outcomes
- RSV-A serum neutralizing titers
- RSV-B serum neutralizing titers
- Cell Mediated Immunity (CMI) response
Investigators
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