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RecruitingNCT07895394Updated Oct 26, 2026

Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients

A Phase 4 interventional study of RSVPreF3 vaccination in Vaccination, Respiratory Syncytial Virus (RSV) and Lung Transplant Recipient, sponsored by Seoul National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Prevention

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the detailed description
  • Lung transplant recipients and immunocompetent adults who are willing to receive a respiratory syncytial virus (RSV) vaccine will be recruited at the study hospital.
  • Participants will receive a single intramuscular dose of the RSV vaccine (RSVPreF3, Arexvy®)
  • Participants will be contacted by telephone on Day 7 and at the Day 30 follow-up visit after vaccination to assess adverse events.
  • Immunogenicity will be evaluated before vaccination and at 1 month and 12 months after vaccination, and safety will be monitored throughout the study period.
  • Changes in immune responses from pre-vaccination levels will be compared between lung transplant recipients and immunocompetent adults.
02

Conditions studied

  • Vaccination
  • Respiratory Syncytial Virus (RSV)
  • Lung Transplant Recipient

Keywords

  • Vaccination
  • Respiratory syncytial virus (RSV)
  • Lung Transplant Recipient
  • Immunogenicity
  • Safety
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,898 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Browse Seoul National University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Lung transplant recipient

    Lung transplant recipients aged ≥19 years receiving immunosuppressive therapy (n=60)

    Biological: RSVPreF3 vaccination

  • Active comparator
    Control

    Immunocompetent adults aged ≥60 years (n=20)

    Biological: RSVPreF3 vaccination

Interventions

  • BiologicalRSVPreF3 vaccination

    One dose of RSVPreF3 (Arexvy®) vaccine

06

What researchers measure

Primary outcomes

  1. Humoral immune response (neutralizing antibody)

    Geometric mean fold rise (GMFR) in RSV-A neutralizing antibody titers from pre-vaccination to 1 month after vaccination, compared between lung transplant recipients and immunocompetent adults.

    Time frame: 1 month after vaccination

Secondary outcomes

  1. Humoral immune response (neutralizing antibody)

    Geometric mean titers (GMTs) in RSV-A neutralizing antibody titers

    Time frame: Prevaccination, 1 month and 12 months after vaccination

  2. Humoral immune response (neutralizing antibody)

    Geometric mean titers (GMTs) in RSV-B neutralizing antibody titers

    Time frame: Prevaccination, 1 month and 12 months after vaccination

  3. Humoral immune response (neutralizing antibody)

    Geometric mean fold rises (GMFRs) in RSV-A neutralizing antibody titers from pre-vaccination levels.

    Time frame: 1 month, 12 months after vaccination

  4. Humoral immune response (neutralizing antibody)

    Geometric mean fold rises (GMFRs) in RSV-B neutralizing antibody titers from pre-vaccination levels.

    Time frame: 1 month, 12 months after vaccination

  5. Humoral immune response (RSV specific antibody)

    Geometric mean concentrations (GMCs) in RSVPreF3-specific IgG

    Time frame: Prevaccination, 1 month and 12 months after vaccination

  6. Humoral immune response (RSV specific antibody)

    Geometric mean concentrations (GMCs) in pan-RSV-specific IgG

    Time frame: Prevaccination, 1 month and 12 months after vaccination

  7. Humoral immune response (RSV specific antibody)

    Geometric mean fold rises (GMFRs) in RSVPreF3-specific IgG from pre-vaccination levels.

    Time frame: 1 month, 12 months after vaccination

  8. Humoral immune response (RSV specific antibody)

    Geometric mean fold rises (GMFRs) in pan-RSV-specific IgG from pre-vaccination levels.

    Time frame: 1 month, 12 months after vaccination

  9. Humoral immune response (serologic response rate)

    Proportion of participants with a ≥4-fold increase in antibody levels from pre-vaccination levels

    Time frame: 1 month, 12 months after vaccination

  10. Cell mediated immunity

    Frequency of RSV F-specific CD4+ and CD8+ T cells following stimulation with RSV F peptide pools, measured by flow cytometry.

    Time frame: 1 month, 12 months after vaccination

  11. Safety (solicited adverse events)

    Proportion of participants experiencing solicited local and systemic adverse events following vaccination.

    Time frame: 7 days, 30 days after vaccination

  12. Safety (unsolicited adverse events, serious adverse events)

    Proportion of participants experiencing unsolicited adverse events or serious adverse events following vaccination.

    Time frame: Up to 12 months after vaccination

07

Study locations

1 of 1 sites recruiting
  • Seoul National University Hospital
    Seoul, Jongno-Gu 03080, South Korea
    Recruiting
08

References and documents

Publications

  • Tan CS, Anjan S, Ariza-Heredia EJ, Magana F, Minniear TD, Kaur D, Falck-Ytter Y, Baden L. IDSA 2025 Guidelines on the Use of Vaccines for the Prevention of Seasonal RSV Infections in Immunocompromised Patients. Clin Infect Dis. 2026 Aug 24;82(Suppl 3):i123-i128. doi: 10.1093/cid/ciag117. PubMed 41766598 ↗
  • Mayer EF, Falsey AR, Wolfe CR, Herc E, Burns F, Kabbani D, Kumar D, Mannan A, She F, Lan L, McGrath S, Kapoor A, Priddy F. Respiratory Syncytial Virus Vaccination in Solid Organ Transplant Recipients: Interim Findings From a Phase 3 Trial of mRNA-1345. Clin Infect Dis. 2026 May 20;82(5):e1112-e1121. doi: 10.1093/cid/ciag108. PubMed 41711453 ↗
  • Levy L, Yahav D, Benzimra M, Bezalel Y, Hoffman T, Shirin N, Sinai T, Jurkowicz M, Deri O, Matalon N, Saute M, Lustig Y, Nachum E, Peled M, Nemet I, Mandelboim M. Neutralizing Antibody Response to the AreXvy Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients: Assessment Against Reference and Seasonal Strains. Vaccines (Basel). 2025 Apr 11;13(4):398. doi: 10.3390/vaccines13040398. PubMed 40333311 ↗
  • Walsh EE, Perez Marc G, Zareba AM, Falsey AR, Jiang Q, Patton M, Polack FP, Llapur C, Doreski PA, Ilangovan K, Ramet M, Fukushima Y, Hussen N, Bont LJ, Cardona J, DeHaan E, Castillo Villa G, Ingilizova M, Eiras D, Mikati T, Shah RN, Schneider K, Cooper D, Koury K, Lino MM, Anderson AS, Jansen KU, Swanson KA, Gurtman A, Gruber WC, Schmoele-Thoma B; RENOIR Clinical Trial Group. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults. N Engl J Med. 2023 Apr 20;388(16):1465-1477. doi: 10.1056/NEJMoa2213836. Epub 2023 Apr 5. PubMed 37018468 ↗
  • Ferguson M, Schwarz TF, Nunez SA, Rodriguez-Garcia J, Mital M, Zala C, Schmitt B, Toursarkissian N, Mazarro DO, Grosskopf J, Voors-Pette C, Mehta H, Hailemariam HA, de Heusch M, Salaun B, Damaso S, David MP, Descamps D, Hill J, Vandermeulen C, Hulstrom V; RSV OA=ADJ-018 Study Group. Noninferior Immunogenicity and Consistent Safety of Respiratory Syncytial Virus Prefusion F Protein Vaccine in Adults 50-59 Years Compared to >/=60 Years of Age. Clin Infect Dis. 2024 Oct 15;79(4):1074-1084. doi: 10.1093/cid/ciae364. PubMed 39099093 ↗
  • Britton A, Roper LE, Kotton CN, Hutton DW, Fleming-Dutra KE, Godfrey M, Ortega-Sanchez IR, Broder KR, Talbot HK, Long SS, Havers FP, Melgar M. Use of Respiratory Syncytial Virus Vaccines in Adults Aged >/=60 Years: Updated Recommendations of the Advisory Committee on Immunization Practices - United States, 2024. MMWR Morb Mortal Wkly Rep. 2024 Aug 15;73(32):696-702. doi: 10.15585/mmwr.mm7332e1. PubMed 39146277 ↗
  • Melgar M, Britton A, Roper LE, Talbot HK, Long SS, Kotton CN, Havers FP. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023. MMWR Morb Mortal Wkly Rep. 2023 Jul 21;72(29):793-801. doi: 10.15585/mmwr.mm7229a4. PubMed 37471262 ↗
  • Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, Schwarz TF, van Zyl-Smit RN, Campora L, Dezutter N, de Schrevel N, Fissette L, David MP, Van der Wielen M, Kostanyan L, Hulstrom V; AReSVi-006 Study Group. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. doi: 10.1056/NEJMoa2209604. PubMed 36791160 ↗
  • Tseng HF, Sy LS, Ackerson B, Solano Z, Slezak J, Luo Y, Fischetti CA, Shinde V. Severe Morbidity and Short- and Mid- to Long-term Mortality in Older Adults Hospitalized with Respiratory Syncytial Virus Infection. J Infect Dis. 2020 Sep 14;222(8):1298-1310. doi: 10.1093/infdis/jiaa361. PubMed 32591787 ↗
  • Na SH, Jo HJ, Park JJ, Seo Y, Lee J, Bae J, Lee M, Lee CM, Kang CK, Choe PG, Park WB, Kim NJ. Comparison of clinical characteristics and outcomes in hospitalized adult patients infected with respiratory syncytial virus and influenza virus. Infect Dis (Lond). 2025 Feb;57(2):159-166. doi: 10.1080/23744235.2024.2402914. Epub 2024 Sep 16. PubMed 39283316 ↗
  • de Zwart A, Riezebos-Brilman A, Lunter G, Vonk J, Glanville AR, Gottlieb J, Permpalung N, Kerstjens H, Alffenaar JW, Verschuuren E. Respiratory Syncytial Virus, Human Metapneumovirus, and Parainfluenza Virus Infections in Lung Transplant Recipients: A Systematic Review of Outcomes and Treatment Strategies. Clin Infect Dis. 2022 Jul 6;74(12):2252-2260. doi: 10.1093/cid/ciab969. PubMed 35022697 ↗
  • Havers FP, Whitaker M, Melgar M, Chatwani B, Chai SJ, Alden NB, Meek J, Openo KP, Ryan PA, Kim S, Lynfield R, Shaw YP, Barney G, Tesini BL, Sutton M, Talbot HK, Olsen KP, Patton ME; RSV-NET Surveillance Team. Characteristics and Outcomes Among Adults Aged >/=60 Years Hospitalized with Laboratory-Confirmed Respiratory Syncytial Virus - RSV-NET, 12 States, July 2022-June 2023. MMWR Morb Mortal Wkly Rep. 2023 Oct 6;72(40):1075-1082. doi: 10.15585/mmwr.mm7240a1. PubMed 37796742 ↗
  • Tin Tin Htar M, Yerramalla MS, Moisi JC, Swerdlow DL. The burden of respiratory syncytial virus in adults: a systematic review and meta-analysis. Epidemiol Infect. 2020 Feb 13;148:e48. doi: 10.1017/S0950268820000400. PubMed 32052719 ↗
  • Solidoro P, Curtoni A, Minuto S, Shbaklo N, De Rosa FG, Bondi A, Sidoti F, Patrucco F, Zanotto E, Corcione S, Boffini M, Marro M, Costa C, Rinaldo RF. Impact of RSV Infection in Transplant and Immunocompromised Population: Incidence and Co-Infections: Retrospective Analysis of a Single Centre. J Clin Med. 2025 Jul 7;14(13):4803. doi: 10.3390/jcm14134803. PubMed 40649177 ↗
  • Mahan LD, Points A, Mohanka MR, Bollineni S, Joerns J, Kaza V, La Hoz RM, Gao A, Zhang S, Torres F, Banga A. Characteristics and outcomes among lung transplant patients with respiratory syncytial virus infection. Transpl Infect Dis. 2021 Aug;23(4):e13661. doi: 10.1111/tid.13661. Epub 2021 Jun 22. PubMed 34159688 ↗

Individual participant data

Plan to share: No — We are not planning to share IPDs publically, but de-identified individual participant data for all outcome measures could be shared with other researchers under their request.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07895394
Lead sponsor
Seoul National University Hospital
Responsible party
Nam Joong Kim (Professor, Seoul National University Hospital) — Principal investigator
First posted
Oct 26, 2026
Start date
Oct 2026 (estimated)
Primary completion
Oct 2027 (estimated)
Completion
Oct 2028 (estimated)
Last update
Oct 26, 2026

Study contacts

Chan Mi Lee, M.D., PhD.
Contact
heaven229@naver.com
82-2-2072-1473
Young Hoon Hwang, M.D.
Contact
hyh0307@gmail.com
82-2-2072-2228
Nam Joong Kim, M.D., PhD.
principal investigator · Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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