RSV vaccine safety and immune response in lung transplant patients vs. healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial compares immunogenicity and safety of a single RSVPreF3 vaccine dose between lung transplant recipients on immunosuppression and immunocompetent adults. Participants will be followed for 30 days post-vaccination for adverse events and will have immune responses measured before vaccination, at 1 month, and at 12 months. The study aims to provide evidence to guide RSV vaccination in lung transplant recipients. It is conducted at Seoul National University Hospital with a prospective, interventional design. Outcomes focus on relative immune response and safety signals between the two groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Seoul National University Hospital
  Seoul, Jongno-Gu, South Korea Recruiting

Study contacts

• Principal investigator: Nam Joong Kim, M.D., PhD. — Seoul National University Hospital
• Study coordinator: Chan Mi Lee, M.D., PhD.
• Email: heaven229@naver.com
• Phone: 82-2-2072-1473

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• RSV vaccine in children at high risk to see if it is safe and makes a strong immune response

  This study tests whether the RSVpreF vaccine is safe and helps the immune system in children aged 5 to under 18 who are at high risk for RSV illness, including those who are immunocompromised.

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• Revaccination with RSVpreF in Immunocompromised Adults

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• Vaccine candidates for RSV and hMPV in older adults

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• RSVpreF vaccine in adults: safety and immune response in India

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• Sleep and Teens’ Immune Response to a Meningococcal Vaccine

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.