Efficacy of a Novel Nanoparticle RSV Vaccine in Preventing Infection in Older Adults: Phase III Clinical Trial

Trends in Immunotherapy

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Efficacy of a Novel Nanoparticle RSV Vaccine in Preventing Infection in Older Adults: Phase III Clinical Trial

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https://doi.org/10.54963/ti.v9i4.1004
Tashbolotovich, T. K., Qasim, S. A., Jasim, I. K., Al-Ani, O. A. S., Kareem, F. A., & Abdirasulovna, A. Z. (2025). Efficacy of a Novel Nanoparticle RSV Vaccine in Preventing Infection in Older Adults: Phase III Clinical Trial. Trends in Immunotherapy, 9(4), 58–72. https://doi.org/10.54963/ti.v9i4.1004
Volume 9 Issue 4 (December 2025): In Progress
Copyright (c) 2025 Turdubaev Kursanbek Tashbolotovich, Suha Adel Qasim, Ihsan Khudhair Jasim, Omar Abdulwahid Salih Al-Ani, Faris Abdul Kareem, Abdirasulova Zhainagul Abdirasulovna
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Authors

  • Turdubaev Kursanbek Tashbolotovich

    Department of Pediatrics 1, Medical Faculty, Osh State University, Osh 723500, Kyrgyzstan
  • Suha Adel Qasim

    Department of Medical Laboratory Analysis, Al Mansour University College, Baghdad 10067, Iraq
  • Ihsan Khudhair Jasim

    Department of Medical Laboratory Analysis, Al-Turath University, Baghdad 10013, Iraq
  • Omar Abdulwahid Salih Al-Ani

    Department of Medical Laboratory Analysis, Al-Rafidain University College Baghdad 10064, Iraq
  • Faris Abdul Kareem

    Department of Medical Laboratory Analysis, Madenat Alelem University College, Baghdad 10006, Iraq
  • Abdirasulova Zhainagul Abdirasulovna

    Department of Clinical Disciplines 2, International Medical Faculty, Osh State University, Osh 723500, Kyrgyzstan

Received: 10 February 2025; Revised: 30 June 2025; Accepted: 16 July 2025; Published: 29 October 2025

In this susceptible population, respiratory syncytial virus (RSV) can cause severe lower respiratory tract illness (LRTI), which can result in substantial morbidity and mortality. Adults who have RSV infection face a substantial burden. In this study, a Phase III, randomized, double-blind, placebo-controlled trial evaluated the effectiveness of a liposome-encapsulated perfusion F protein nanoparticle-based RSV vaccine (Nano-RSV) in preventing RSV infection. Adults who were enrolled and 60 years of age or older were given either Nano-RSV or a placebo. The incidence of laboratory-confirmed RSV LRTI exhibiting three or more symptoms (cough, fever, and shortness of breath) was the main outcome. Severity of symptoms and hospitalization rates for RSV LRTI were secondary endpoints. When compared to a placebo, the Nano-RSV vaccine dramatically lowered the risk of RSV LRTI (vaccine efficacy: 82.6%, 95% CI: 74.1–90.2%). RSV LRTI-related hospitalization rates were likewise markedly lower in the immunization group. The safety profile of the Nano-RSV vaccine was comparable to that of a placebo, and it was well-tolerated. These results imply that Nano-RSV may prove to be a secure and reliable prophylactic against RSV infection and its sequelae in the elderly.

Keywords:

RSV Vaccine Liposome-Encapsulated Perfusion F Protein Nanoparticle Vaccine Phase III Clinical Trial LRTI RSV Infection

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