Long-term Immunogenicity and Safety Profile of the Adjuvanted RSVPreF3 Vaccine in Korean Older Adults: A Sub-analysis of a Phase 3 Trial.
6 affiliations
- 1GSK, Seoul, Korea.
- 2GSK Asia House, Singapore.
- 3GSK, Bangalore, India.
- 4GSK, Siena, Italy.
- 5GSK, Wavre, Belgium.
- 6Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea. [email protected].
Abstract
Background
Respiratory 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
In 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
In 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
In 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
ClinicalTrials.gov Identifier: NCT04886596.
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BibTeX
@article{park2026longterm,
title = {{Long-term Immunogenicity and Safety Profile of the Adjuvanted RSVPreF3 Vaccine in Korean Older Adults: A Sub-analysis of a Phase 3 Trial.}},
author = {Seong-Beom Park and Suryaprakash Mishra and Sang-Kyu Shin and Stebin Xavier and Giulia Zigon and Manuel Zocco and Marie Van Der Wielen and Dong-Gun Lee and AReSVi-006 study group},
journal = {Infection \& chemotherapy},
year = {2026},
month = sep,
doi = {10.3947/ic.2026.0016},
url = {https://europepmc.org/article/MED/42847629},
note = {CC BY-NC},
}
RIS
TY - JOUR
TI - Long-term Immunogenicity and Safety Profile of the Adjuvanted RSVPreF3 Vaccine in Korean Older Adults: A Sub-analysis of a Phase 3 Trial.
AU - Seong-Beom Park
AU - Suryaprakash Mishra
AU - Sang-Kyu Shin
AU - Stebin Xavier
AU - Giulia Zigon
AU - Manuel Zocco
AU - Marie Van Der Wielen
AU - Dong-Gun Lee
AU - AReSVi-006 study group
PY - 2026
DA - 2026/09/01
JO - Infection & chemotherapy
DO - 10.3947/ic.2026.0016
UR - https://europepmc.org/article/MED/42847629
AB - Background Respiratory 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 In 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 In 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 In 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 ClinicalTrials.gov Identifier: NCT04886596.
SN - 2093-2340
SN - 2092-6448
ER -