Malfertheiner Peter, Versage Eve, Twuijver Esther Van, Rizzardini Giuliano, Hohenboken Matthew
Department of Gastroenterology, Hepatology and Infectious Diseases, Otto von Guericke University Magdeburg, 39120 Magdeburg, Germany.
Seqirus, Clinical Development, Waltham, MA 02451, USA.
Vaccines (Basel). 2025 Apr 1;13(4):379. doi: 10.3390/vaccines13040379.
: Pandemic influenza may cause substantial morbidity and mortality, especially in older adults and those with immunosuppressive conditions. : In this phase 3, stratified, randomized, controlled, observer-blind, multicenter trial, we evaluated the safety, tolerability, and immunogenicity of an adjuvanted H5N1 vaccine (aH5N1) vs. active control (MF59-adjuvanted trivalent seasonal inactivated influenza vaccine [aTIV]) in 539 adults aged 18-60 and ≥61 years. Participants were further stratified into subgroups that were healthy (18-60 years, n = 91; ≥61 years, n = 89) or had prespecified immunosuppressive conditions (18-60 years, n = 180; ≥61 years, n = 179). Antibody responses were measured with microneutralization and single radial hemolysis (SRH) assays. : aH5N1 increased antibody responses in healthy persons and those with immunosuppressive conditions in both age groups, with SRH geometric mean ratios (GMRs) > 2.5 and >2.0 in participants aged 18-60 and ≥61 years, respectively, meeting former Committee for Medicinal Products for Human Use (CHMP) criteria. Responses measured with the microneutralization and SRH assays were consistent with previous studies of aH5N1. : The aH5N1 vaccine had a clinically acceptable safety and tolerability profile with an AE profile comparable to that observed in previous aH5N1 studies. These findings support the viability of aH5N1 as a pre-pandemic influenza vaccine for the immunization of at-risk individuals when an antigenically matched pandemic influenza vaccine is not yet available.
大流行性流感可能导致大量发病和死亡，尤其是在老年人和免疫抑制状态者中。在这项3期、分层、随机、对照、观察者盲法、多中心试验中，我们评估了一种佐剂H5N1疫苗（aH5N1）与活性对照（MF59佐剂三价季节性灭活流感疫苗[aTIV]）在539名年龄在18 - 60岁及≥61岁成年人中的安全性、耐受性和免疫原性。参与者被进一步分层为健康亚组（18 - 60岁，n = 91；≥61岁，n = 89）或患有预先指定的免疫抑制疾病亚组（18 - 60岁，n = 180；≥61岁，n = 179）。用微量中和试验和单向辐射溶血（SRH）试验测量抗体反应。aH5N1在两个年龄组的健康人和免疫抑制状态者中均增加了抗体反应，18 - 60岁和≥61岁参与者的SRH几何平均比值（GMRs）分别>2.5和>2.0，符合前人类用药产品委员会（CHMP）标准。用微量中和试验和SRH试验测量的反应与先前对aH5N1的研究一致。aH5N1疫苗具有临床可接受的安全性和耐受性特征，不良事件（AE）特征与先前aH5N1研究中观察到的相当。这些发现支持了在尚无抗原匹配的大流行性流感疫苗时，aH5N1作为大流行前流感疫苗用于高危个体免疫接种的可行性。
