一种新型鼻内流感疫苗在中国儿童中的有效性和安全性：一项多中心、随机、双盲、安慰剂对照的IV期临床试验

IF 4.5 3区医学 Q2 IMMUNOLOGY

Vaccine Pub Date : 2025-05-21 DOI:10.1016/j.vaccine.2025.127268

Xiaoling Tian , Yiguo Zhou , Peng Deng , Na Xu , Xiaojun Liu , Ying Guo , Aimin Fang , Pingping Liu , Yi Yan , Lu Yang , Binge Qian , Yuxin Lu , Ying Chen , Yang Zang , Qin-Yi Ma , Juan Du , Mengmeng Li , Beifang Yang , Qiang Lu , Qing-Bin Lu

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引用次数: 0

摘要

背景：新型鼻内流感疫苗甘武®于2020年在中国获批用于3-17岁儿童。该研究旨在开展一项IV期临床试验，以评估该疫苗的有效性和安全性。方法开展一项多中心、随机、双盲、安慰剂对照的IV期临床试验，评估肝武®疫苗在2023 - 2024年流感季节在中国3-17岁儿童中的有效性和安全性。在7个月的随访期间，对疫苗组和安慰剂组的流感样疾病（ILIs）进行监测，并收集ILI病例的鼻咽标本，用于实验室确认流感病毒。主要终点包括疫苗对实验室确认的流感和ILI的有效性，并在整个研究期间进行了全面的安全性监测。结果：该试验共招募了6000名参与者，以1:1的比例随机分配，接受肝武®或安慰剂治疗。该疫苗预防实验室确诊流感的有效性为46.8%(95%可信区间[CI] 25.8% - 61.9%)，其中对甲型H1N1流感的特异性有效性为30.4%，对甲型H3N2流感的特异性有效性为55.1%，对乙型维多利亚流感的特异性有效性为84.6%。实验室确诊的流感在疫苗组的发生率明显较低（危险比0.53,95%可信区间0.38-0.74）。干武®疫苗对ILI的有效率为15.2% （95% CI - 2.3% - 29.7%）。安全性评估显示，两组之间的不良事件发生率相当，3级或更高级别不良事件的发生率低于1%。在12例报告的严重不良反应中，没有一例归因于接种疫苗。结论肝武®疫苗对儿童实验室确诊流感具有中等保护作用，安全性较好。

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Effectiveness and safety of a novel intranasal influenza vaccine in Chinese children: A phase IV multi-Center, randomized, double-blind, placebo-controlled clinical trial

Background

A novel intranasal influenza vaccine named Ganwu® was approved in 2020 for children aged 3–17 years in China. This study aimed to conduct a phase IV clinical trial to assess the effectiveness and safety of this vaccine.

Methods

We conducted a multicenter, randomized, double-blind, placebo-controlled phase IV clinical trial to evaluate the effectiveness and safety of Ganwu® vaccine in children aged 3–17 years in China during 2023 to 2024 influenza season. The influenza-like illnesses (ILIs) were monitored in the vaccine and placebo groups during a follow-up period of seven months, and nasopharyngeal specimens from ILI cases were collected for laboratory confirmation of influenza virus. Primary endpoints included vaccine effectiveness against laboratory-confirmed influenza and ILI, with comprehensive safety monitoring throughout the study period.

Results

The trial enrolled 6000 participants, randomly allocated in a 1:1 ratio to receive either Ganwu® or placebo. The vaccine's effectiveness in preventing laboratory-confirmed influenza was 46.8 % (95 % confidence interval [CI] 25.8 %–61.9 %), with specific effectiveness rates of 30.4 % against A/H1N1, 55.1 % against A/H3N2, and 84.6 % against B/Victoria. Laboratory-confirmed influenza was significantly less frequent in the vaccine group (hazard ratio 0.53, 95 % CI 0.38–0.74). Effectiveness of Ganwu® vaccine against ILI was 15.2 % (95 % CI -2.3 %–29.7 %). Safety assessments demonstrated comparable incidence of solicited adverse events (AE) between groups, with the incidence of grade three or higher AEs below 1 %. Among 12 reported serious AEs, none were attributed to vaccination.

Conclusions

Ganwu® vaccine provided moderate protection against laboratory-confirmed influenza among children with good safety profile.

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来源期刊

Vaccine 医学-免疫学

CiteScore

8.70

自引率

5.50%

发文量

992

审稿时长

131 days

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