NCT07895394 Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
| NCT ID | NCT07895394 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Seoul National University Hospital |
| Condition | Vaccination |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-10 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 80 participants in total. It began in 2026-10 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to compare the immunogenicity and safety of respiratory syncytial virus (RSV) vaccination between lung transplant recipients and immunocompetent adults and to provide evidence to guide RSV vaccination in lung transplant recipients.
Eligibility Criteria
Inclusion Criteria (for lung transplant recipient) : * Adults aged 19 years or older who voluntarily provide written informed consent to participate in the study * Recipients of a lung transplant who are receiving immunosuppressive therapy to prevent allograft rejection. Inclusion Criteria (for control) : * Adults aged 60 years or older who voluntarily provide written informed consent to participate in the study. * Individuals who do not have medical conditions associated with immunocompromise (e.g., malignancy, bone marrow transplantation, solid organ transplantation, HIV infection, or dialysis) and have not received ongoing chemotherapy, radiation therapy, immunosuppressive therapy, or immunomodulatory therapy within 6 months before vaccination. Exclusion Criteria: Participants will be excluded if they meet any of the following criteria * Previous receipt of any RSV vaccine. * RSV infection diagnosed within the past 12 months. * History of a severe allergic reaction to any component of the RSV vaccine. * Moderate or severe acute illness at the time of screening. * Pregnancy, planned pregnancy, or breastfeeding. * Any underlying medical condition for which intramuscular injection is contraindicated. * Any other condition that, in the investigator's judgment, may make the participant unsuitable for evaluation of immune responses.
Contact & Investigator
Nam Joong Kim, M.D., PhD.
PRINCIPAL INVESTIGATOR
Seoul National University Hospital
Frequently Asked Questions
Who can join the NCT07895394 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Vaccination. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07895394 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07895394 currently recruiting?
Yes, NCT07895394 is actively recruiting participants. Contact the research team at heaven229@naver.com for enrollment information.
Where is the NCT07895394 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07895394 clinical trial?
NCT07895394 is sponsored by Seoul National University Hospital. The principal investigator is Nam Joong Kim, M.D., PhD. at Seoul National University Hospital. The trial plans to enroll 80 participants.