{
  "abstract": "Background\n\nRespiratory syncytial virus (RSV) poses substantial health risks to elderly adults and adults with certain underlying conditions. In a multi-country phase 3 trial (AReSVi-006), the adjuvanted RSVPreF3 vaccine has shown high efficacy against RSV disease. This post-hoc sub-analysis assessed immunogenicity, immunopersistence up to 24 months, and safety of a single dose of the adjuvanted RSVPreF3 vaccine in the Korean cohort.Materials and methods\n\nIn the global, randomized, observer-blind, placebo-controlled phase 3 trial (NCT04886596), adults ≥60 years of age were randomized 1:1 to receive a single intramuscular dose of the adjuvanted RSVPreF3 vaccine or placebo. The Korean cohort (12 sites) included 719 participants. Immunogenicity and reactogenicity were evaluated in a subset of participants. Safety data included solicited adverse events (AEs) within four days, unsolicited AEs up to 30 days, and serious adverse events (SAEs)/potential immune-mediated diseases up to six months post-vaccination.Results\n\nIn the Korean cohort, 360 participants received the adjuvanted RSVPreF3 vaccine and 359 received placebo; 91 were included in the solicited safety set and 87 in the per-protocol immunogenicity set. By Day 31, neutralizing titers had increased robustly in the RSVPreF3 group with a mean geometric increase (MGI) versus baseline of 7.7 (RSV-A) and 7.2 (RSV-B); RSVPreF3-binding IgG concentrations showed an MGI of 13.4 in the RSVPreF3 group. Reactogenicity was mostly mild; solicited administration-site AEs occurred in 58.7% (predominantly pain) and solicited systemic AEs in 60.9% (predominantly fatigue) of participants in the RSVPreF3 group; no vaccine-related SAEs were reported. RSV-A and RSV-B neutralizing titers and RSVPreF3-binding IgG concentrations remained above baseline until 24 months post-vaccination, with an MGI of 2.2 (RSV-A), 1.3 (RSV-B), and 2.7 (RSVPreF3-binding IgG).Conclusion\n\nIn Korean adults aged ≥60 years, a single dose of the adjuvanted RSVPreF3 vaccine elicited a robust immune response, which persisted for up to 24 months post-vaccination, with an acceptable safety profile.Trial registration\n\nClinicalTrials.gov Identifier: NCT04886596.",
  "abstract_shown": true,
  "affiliations": [
    "GSK, Seoul, Korea.",
    "GSK Asia House, Singapore.",
    "GSK, Bangalore, India.",
    "GSK, Siena, Italy.",
    "GSK, Wavre, Belgium.",
    "Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. symonlee@catholic.ac.kr."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Seong-Beom Park",
      "orcid": "0000-0002-8482-9195"
    },
    {
      "affs": [
        1
      ],
      "name": "Suryaprakash Mishra",
      "orcid": "0009-0004-4882-5033"
    },
    {
      "affs": [
        0
      ],
      "name": "Sang-Kyu Shin",
      "orcid": "0000-0003-3122-8879"
    },
    {
      "affs": [
        2
      ],
      "name": "Stebin Xavier",
      "orcid": "0000-0002-7055-7790"
    },
    {
      "affs": [
        3
      ],
      "name": "Giulia Zigon",
      "orcid": "0000-0002-9123-4026"
    },
    {
      "affs": [
        4
      ],
      "name": "Manuel Zocco",
      "orcid": "0009-0009-9777-1170"
    },
    {
      "affs": [
        4
      ],
      "name": "Marie Van Der Wielen",
      "orcid": "0009-0006-3808-8767"
    },
    {
      "affs": [
        5
      ],
      "name": "Dong-Gun Lee",
      "orcid": "0000-0003-4655-0641"
    },
    {
      "name": "AReSVi-006 study group"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/bgvhg3cbq2vvs.bib",
  "cited_by": 0,
  "doi": "10.3947/ic.2026.0016",
  "fulltext_url": "https://europepmc.org/articles/PMC13655466",
  "id": "bgvhg3cbq2vvs",
  "issns": [
    "2093-2340",
    "2092-6448"
  ],
  "landing_url": "https://europepmc.org/article/MED/42847629",
  "language": "eng",
  "licence": "CC-BY-NC",
  "licence_label": "CC BY-NC",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2713|Respiratory viral infections research"
    ]
  ],
  "openalex": "W7170090464",
  "pdf_url": "https://europepmc.org/articles/PMC13655466?pdf=render",
  "pmcid": "PMC13655466",
  "pmid": "42847629",
  "published": "2026-09-01",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/bgvhg3cbq2vvs.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:18:10Z",
      "native_id": "MED:42847629",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42847629"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2713|Respiratory viral infections research",
      "subfield": "epidemiology-public-health"
    }
  ],
  "title": "Long-term Immunogenicity and Safety Profile of the Adjuvanted RSVPreF3 Vaccine in Korean Older Adults: A Sub-analysis of a Phase 3 Trial.",
  "title_text": "Long-term Immunogenicity and Safety Profile of the Adjuvanted RSVPreF3 Vaccine in Korean Older Adults: A Sub-analysis of a Phase 3 Trial.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:18:10Z",
  "url": "https://research.draconitic.com/paper/bgvhg3cbq2vvs",
  "venue": "Infection & chemotherapy",
  "versions": []
}