VaccinationPhase 4NCT07895394
Immunogenicity and Safety of Respiratory Syncytial Virus Vaccine in Lung Transplant Recipients
A Phase 4 study testing RSVPreF3 vaccination in people with Vaccination and Respiratory Syncytial Virus (RSV), run by Seoul National University Hospital at 1 site in South Korea.
Trial 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 more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Vaccination, Respiratory Syncytial Virus (RSV), Lung Transplant Recipient
- What is being tested?
- RSVPreF3 vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2026to Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-Gu, 03080
Nam Joong Kim, M.D., PhD., 82-2-2072-0835, njkmd@snu.ac.kr
About this study
Official title: Analysis of Vaccine-induced Immune Responses and Optimization of Protective Immunity Against Respiratory Syncytial Virus in Lung Transplant Recipients
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.
- Being tested
- RSVPreF3 vaccination
- Keywords
- Vaccination, Respiratory syncytial virus (RSV), Lung Transplant Recipient, Immunogenicity, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RSVPreF3 vaccinationBiological
One dose of RSVPreF3 (Arexvy®) vaccine
| Study group | Role | What they receive |
|---|---|---|
| Lung transplant recipient | Experimental | Lung transplant recipients aged ≥19 years receiving immunosuppressive therapy (n=60) Receives: Biological: RSVPreF3 vaccination |
| Control | Active comparator | Immunocompetent adults aged ≥60 years (n=20) Receives: Biological: RSVPreF3 vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after vaccination
Secondary outcomes (12)
Humoral immune response (neutralizing antibody)
Geometric mean titers (GMTs) in RSV-A neutralizing antibody titers
Measured: Prevaccination, 1 month and 12 months after vaccination
Humoral immune response (neutralizing antibody)
Geometric mean titers (GMTs) in RSV-B neutralizing antibody titers
Measured: Prevaccination, 1 month and 12 months after vaccination
Humoral immune response (neutralizing antibody)
Geometric mean fold rises (GMFRs) in RSV-A neutralizing antibody titers from pre-vaccination levels.
Measured: 1 month, 12 months after vaccination
Humoral immune response (neutralizing antibody)
Geometric mean fold rises (GMFRs) in RSV-B neutralizing antibody titers from pre-vaccination levels.
Measured: 1 month, 12 months after vaccination
Humoral immune response (RSV specific antibody)
Geometric mean concentrations (GMCs) in RSVPreF3-specific IgG
Measured: Prevaccination, 1 month and 12 months after vaccination
Humoral immune response (RSV specific antibody)
Geometric mean concentrations (GMCs) in pan-RSV-specific IgG
Measured: Prevaccination, 1 month and 12 months after vaccination
Humoral immune response (RSV specific antibody)
Geometric mean fold rises (GMFRs) in RSVPreF3-specific IgG from pre-vaccination levels.
Measured: 1 month, 12 months after vaccination
Humoral immune response (RSV specific antibody)
Geometric mean fold rises (GMFRs) in pan-RSV-specific IgG from pre-vaccination levels.
Measured: 1 month, 12 months after vaccination
Humoral immune response (serologic response rate)
Proportion of participants with a ≥4-fold increase in antibody levels from pre-vaccination levels
Measured: 1 month, 12 months after vaccination
Cell mediated immunity
Frequency of RSV F-specific CD4+ and CD8+ T cells following stimulation with RSV F peptide pools, measured by flow cytometry.
Measured: 1 month, 12 months after vaccination
Safety (solicited adverse events)
Proportion of participants experiencing solicited local and systemic adverse events following vaccination.
Measured: 7 days, 30 days after vaccination
Safety (unsolicited adverse events, serious adverse events)
Proportion of participants experiencing unsolicited adverse events or serious adverse events following vaccination.
Measured: Up to 12 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for VaccinationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nam Joong Kim, Seoul National University Hospital
- Investigators
- Nam Joong Kim, M.D., PhD., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895394
- Sponsor's protocol ID
- 2608-187-1775
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 41766598Mayer 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 41711453Levy 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 40333311Walsh 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 37018468Ferguson 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 39099093Britton 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 39146277Melgar 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 37471262Papi 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 36791160Tseng 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 32591787Na 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 39283316de 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 35022697Havers 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 37796742Tin 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 32052719Solidoro 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 40649177Mahan 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Vaccine-induced Immune Responses and Optimization of Protective Immunity Against Respiratory Syncytial Virus in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT07895394
- Acronym / sponsor ID
- 2608-187-1775
- Keywords
- Vaccination, Respiratory syncytial virus (RSV), Lung Transplant Recipient, Immunogenicity, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lung transplant recipient | Experimental | Biological: RSVPreF3 vaccinationLung transplant recipients aged ≥19 years receiving immunosuppressive therapy (n=60) |
| Control | Active comparator | Biological: RSVPreF3 vaccinationImmunocompetent adults aged ≥60 years (n=20) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RSVPreF3 vaccinationOne dose of RSVPreF3 (Arexvy®) vaccine | Biological | Control, Lung transplant recipient |
Primary outcome
Humoral immune response (neutralizing antibody)
Time frame: 1 month after vaccination
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.
12 secondary outcomes
Humoral immune response (neutralizing antibody)
Time frame: Prevaccination, 1 month and 12 months after vaccination
Humoral immune response (neutralizing antibody)
Time frame: Prevaccination, 1 month and 12 months after vaccination
Humoral immune response (neutralizing antibody)
Time frame: 1 month, 12 months after vaccination
Humoral immune response (neutralizing antibody)
Time frame: 1 month, 12 months after vaccination
Humoral immune response (RSV specific antibody)
Time frame: Prevaccination, 1 month and 12 months after vaccination
Humoral immune response (RSV specific antibody)
Time frame: Prevaccination, 1 month and 12 months after vaccination
Humoral immune response (RSV specific antibody)
Time frame: 1 month, 12 months after vaccination
Humoral immune response (RSV specific antibody)
Time frame: 1 month, 12 months after vaccination
Humoral immune response (serologic response rate)
Time frame: 1 month, 12 months after vaccination
Cell mediated immunity
Time frame: 1 month, 12 months after vaccination
Safety (solicited adverse events)
Time frame: 7 days, 30 days after vaccination
Safety (unsolicited adverse events, serious adverse events)
Time frame: Up to 12 months after vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 41766598Tan 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.
- Background: PubMed 41711453Mayer 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.
- Background: PubMed 40333311Levy 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.
- Background: PubMed 37018468Walsh 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.
- Background: PubMed 39099093Ferguson 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.
- Background: PubMed 39146277Britton 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.
- Background: PubMed 37471262Melgar 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.
- Background: PubMed 36791160Papi 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.
- Background: PubMed 32591787Tseng 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.
- Background: PubMed 39283316Na 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.
- Background: PubMed 35022697de 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.
- Background: PubMed 37796742Havers 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nam Joong Kim, M.D., PhD. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RSVPreF3 vaccination in people with Vaccination and Respiratory Syncytial Virus (RSV), run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chan Mi Lee, M.D., PhD. (82-2-2072-1473, heaven229@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immune response (neutralizing antibody) (time frame: 1 month after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07895394, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.