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一项针对 ≥ 65 岁健康人群的季节性四价流感疫苗(GC3110A)的安全性和免疫原性研究。

Safety and immunogenicity of a seasonal quadrivalent influenza vaccine (GC3110A) in healthy participants aged ≥ 65 years.

机构信息

Division of Infectious Diseases, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, Republic of Korea.

Division of Infectious Diseases, Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea; Division of Infectious Diseases, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

出版信息

Vaccine. 2021 Jun 16;39(27):3621-3625. doi: 10.1016/j.vaccine.2021.05.001. Epub 2021 May 13.

DOI:10.1016/j.vaccine.2021.05.001
PMID:33992436
Abstract

BACKGROUND

Seasonal Influenza is still considered associated with seasonal morbidity and hospitalization in the elderly population. The World Health Organization (WHO) recommended seasonal quadrivalent influenza vaccine (QIV) to reduce burden of two currently circulating influenza B lineages. Until 2019 Korean National Immunization Program (NIP) recommended trivalent influenza vaccine (TIV) after ongoing debates on cost effectiveness of QIV for elderly population. Although influenza vaccine only showed modest effect on reducing influenza in elderly, this study aimed to evaluate the immunogenicity and safety of inactivated QIV in healthy participants ≥ 65 years of age.

METHODS

A total of 274 healthy participants aged ≥ 65 years received a QIV. Seroconversion-based vaccine efficacy of 4 strains of seasonal influenza was assessed 21 days after vaccination and adverse events were monitored until 180 days after vaccination.

RESULTS

The percentages of participants seroconverted after vaccination on HI antibody against each strain were 36.5% (99/271) to A/H1N1, 47.6% (129/271) to A/H3N2, 40.6% (110/271) to B Yamagata, and 49.1% (133/271) to B Victoria. The percentages of participants seroprotected after vaccination on HI antibody against each strain were 81.2% (220/271) to A/H1N1, 98.5% (267/271) to A/H3N2, 95.2% (258/271) to B Yamagata, and 93.7% (254/271) to B Victoria. There was no serious adverse event (SAE) related with the study vaccine.

CONCLUSION

The quadrivalent split influenza vaccine is expected to offer seroprotection against influenza A and both influenza B lineages even in the elderly population.

摘要

背景

季节性流感仍被认为与老年人的季节性发病和住院有关。世界卫生组织(WHO)建议使用季节性四价流感疫苗(QIV)来减少两种目前流行的乙型流感谱系的负担。在关于 QIV 对老年人群成本效益的持续争论之后,直到 2019 年,韩国国家免疫规划(NIP)才推荐使用三价流感疫苗(TIV)。尽管流感疫苗对降低老年人的流感发病率仅显示出适度的效果,但本研究旨在评估四价流感疫苗在健康≥65 岁老年人中的免疫原性和安全性。

方法

共有 274 名健康≥65 岁的参与者接种了 QIV。接种后 21 天,根据 HI 抗体检测评估 4 种季节性流感疫苗的血清转化率,接种后至 180 天监测不良事件。

结果

接种后 HI 抗体针对每种毒株的血清转化率分别为 A/H1N1 36.5%(99/271)、A/H3N2 47.6%(129/271)、B/Yamagata 40.6%(110/271)和 B/Victoria 49.1%(133/271)。接种后 HI 抗体针对每种毒株的血清保护率分别为 A/H1N1 81.2%(220/271)、A/H3N2 98.5%(267/271)、B/Yamagata 95.2%(258/271)和 B/Victoria 93.7%(254/271)。无与研究疫苗相关的严重不良事件(SAE)。

结论

即使在老年人中,四价流感裂解疫苗也有望提供针对甲型流感和两种乙型流感谱系的血清保护。

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引用本文的文献

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