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<p>Annual vaccination is an effective strategy for preventing severe disease caused by seasonal influenza. Quadrivalent influenza vaccines (QIVs) protect against two strains of influenza A and two strains of influenza B, thereby enhancing the host antiviral neutralizing antibody response and inducing CD4<sup>+</sup> and CD8<sup>+</sup> T cell responses. Here, we report findings from a randomized, double-blind, active-controlled phase 3 clinical trial (NCT05431725) that includes 334 healthy adults aged 18–64 years and evaluates the humoral and cellular antiviral immune responses induced by two inactivated QIVs, Sinovac-QIV and Vaxigrip-Tetra™. The primary endpoint of the study is the specific antibody responses measured by hemagglutination inhibition (HAI) assays 28 days post-vaccination, while the secondary endpoint is virus-specific T cell responses. Both QIVs elicit significant increases in antibody titers 28 days after vaccination; Sinovac-QIV induces 9–10-fold increases in geometric mean titers, while Vaxigrip-Tetra™ elicits 7–8-fold increases (p &lt; 0.05). Cellular immune responses using ELISPOT and supervised and unsupervised flow cytometry analyses show that both vaccines modulate the frequency of hemagglutinin-specific CD4<sup>+</sup> and CD8<sup>+</sup> T cell subsets, inducing distinct T cell response profiles. Although cellular analyses are evaluated in a subgroup of the cohort, the data indicate that both QIVs induce robust humoral and cellular immunity in adults, providing mechanistic insights into vaccine-induced protection.</p>

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Influenza vaccines promote humoral and cellular immune responses: a randomized, double-blind, phase 3 trial

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月7日

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  • Linmar Rodríguez-Guilarte,
  • Constanza Méndez,
  • Antonia Reyes,
  • Mariana Rios,
  • Francisca Román,
  • Daniela Moreno-Tapia,
  • Alex Cabrera,
  • Daniela B. Rivera,
  • Cristián Gutiérrez-Vera,
  • Pablo A. Palacios,
  • Andrea Schilling,
  • Sofia Aljaro,
  • Francisca Bascur,
  • Álvaro Rojas,
  • Constanza del Río,
  • Patricio Astudillo,
  • Carlos M. Perez,
  • Loreto Perez,
  • Maite Oyonarte,
  • Patricia E. Fernández Vásquez,
  • Rosa M. Feijoo,
  • Daniel Beltrán Campos,
  • Carlos Tovar De Sousa,
  • Andrea Castejón,
  • Silvana Grandón,
  • Marcela Villarroel,
  • Pía Jara,
  • Loreto Twele,
  • M. Angélica Domínguez,
  • José V. González-Aramundiz,
  • María Javiera Álvarez-Figueroa,
  • Wanqi Yang,
  • Qianqian Xin,
  • Leandro J. Carreño,
  • Mario Calvo,
  • Susan M. Bueno,
  • Hernán F. Peñaloza,
  • Pablo A. González,
  • Alexis M. Kalergis

摘要

Annual vaccination is an effective strategy for preventing severe disease caused by seasonal influenza. Quadrivalent influenza vaccines (QIVs) protect against two strains of influenza A and two strains of influenza B, thereby enhancing the host antiviral neutralizing antibody response and inducing CD4+ and CD8+ T cell responses. Here, we report findings from a randomized, double-blind, active-controlled phase 3 clinical trial (NCT05431725) that includes 334 healthy adults aged 18–64 years and evaluates the humoral and cellular antiviral immune responses induced by two inactivated QIVs, Sinovac-QIV and Vaxigrip-Tetra™. The primary endpoint of the study is the specific antibody responses measured by hemagglutination inhibition (HAI) assays 28 days post-vaccination, while the secondary endpoint is virus-specific T cell responses. Both QIVs elicit significant increases in antibody titers 28 days after vaccination; Sinovac-QIV induces 9–10-fold increases in geometric mean titers, while Vaxigrip-Tetra™ elicits 7–8-fold increases (p < 0.05). Cellular immune responses using ELISPOT and supervised and unsupervised flow cytometry analyses show that both vaccines modulate the frequency of hemagglutinin-specific CD4+ and CD8+ T cell subsets, inducing distinct T cell response profiles. Although cellular analyses are evaluated in a subgroup of the cohort, the data indicate that both QIVs induce robust humoral and cellular immunity in adults, providing mechanistic insights into vaccine-induced protection.