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不同组合的免疫原性和安全性,涉及第三剂加强针 SARS-CoV-2 灭活疫苗、灭活四价流感疫苗和 23 价肺炎球菌多糖疫苗,在年龄≥60 岁的成年人中的应用:一项 4 期、随机、开放标签研究。

Immunogenicity and safety of different combinations involving a third booster dose of SARS-CoV-2 inactivated vaccine, inactivated quadrivalent influenza vaccine, and 23-valent pneumococcal polysaccharide vaccine in adults aged ≥60 years: a phase 4, randomized, open-label study.

机构信息

Beijing Center for Disease Prevention and Control, Beijing Research Center for Respiratory Infectious Diseases, Beijing, China.

出版信息

Front Immunol. 2024 Aug 20;15:1437267. doi: 10.3389/fimmu.2024.1437267. eCollection 2024.

DOI:10.3389/fimmu.2024.1437267
PMID:39229259
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11368774/
Abstract

BACKGROUND

Concomitant administration of COVID-19, influenza, and pneumococcal vaccines could reduce the burden on healthcare systems. However, the immunogenicity and safety of various combinations of a third booster dose of SARS-CoV-2 inactivated vaccine (CoronaVac), inactivated quadrivalent influenza vaccine (IIV4), and 23-valent pneumococcal polysaccharide vaccine (PPV23), particularly in different age groups, is still unknown.

METHODS

A phase 4, randomized, open-label, controlled trial was conducted in Beijing, China. 636 healthy adults were divided into two age groups (18-59 and ≥60 years) and randomized equally into three groups: CoronaVac and IIV4 followed by PPV23; CoronaVac and PPV23 followed by IIV4; or CoronaVac followed by IIV4 and PPV23, with a 28-day interval between vaccinations. Immunogenicity was evaluated by measuring antibody titers, and safety was monitored. ClinicalTrials.gov Identifier: NCT05298800.

RESULTS

Co-administration of a third dose of CoronaVac, IIV4, and PPV23 in any combination was safe. Among adults aged 18-59, co-administration with PPV23 maintained non-inferiority of antibody levels for CoronaVac and IIV4, despite a slight reduction in antibody responses. This reduction was not observed in participants ≥60 years. Furthermore, co-administration of IIV4 and PPV23 affected seroconversion rates for both vaccines.

CONCLUSIONS

Co-administration of the third dose of SARS-CoV-2 inactivated vaccine with the influenza vaccine, followed by PPV23, may be optimal for adults aged 18-59. In adults ≥60, all vaccine combinations were immunogenic, suggesting a flexible vaccination approach. Since antibody measurements were taken 28 days post-vaccination, ongoing surveillance is essential to assess the longevity of the immune responses.

摘要

背景

同时接种 COVID-19、流感和肺炎球菌疫苗可以减轻医疗系统的负担。然而,不同组合的第三剂 SARS-CoV-2 灭活疫苗(科兴疫苗)、四价流感灭活疫苗(IIV4)和 23 价肺炎球菌多糖疫苗(PPV23)的免疫原性和安全性,特别是在不同年龄组中,仍然未知。

方法

这是一项在中国北京进行的 4 期、随机、开放标签、对照试验。636 名健康成年人被分为两个年龄组(18-59 岁和≥60 岁),并平均分为三组:接种科兴疫苗和 IIV4 后再接种 PPV23;接种科兴疫苗和 PPV23 后再接种 IIV4;或接种科兴疫苗后再接种 IIV4 和 PPV23,两次接种间隔 28 天。通过测量抗体滴度评估免疫原性,监测安全性。临床试验注册号:NCT05298800。

结果

任何组合的第三剂科兴疫苗、IIV4 和 PPV23 联合接种都是安全的。在 18-59 岁的成年人中,尽管抗体反应略有下降,但与 PPV23 联合接种仍能保持科兴疫苗和 IIV4 的抗体水平非劣效性。在≥60 岁的参与者中没有观察到这种下降。此外,接种 IIV4 和 PPV23 联合接种会影响两种疫苗的血清转化率。

结论

对于 18-59 岁的成年人,第三剂 SARS-CoV-2 灭活疫苗与流感疫苗联合接种,随后接种 PPV23,可能是最佳选择。对于≥60 岁的成年人,所有疫苗组合均具有免疫原性,表明接种方式较为灵活。由于抗体测量是在接种后 28 天进行的,因此需要持续监测以评估免疫反应的持久性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c0/11368774/ebdf62ed082b/fimmu-15-1437267-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c0/11368774/15fb3e5f2a63/fimmu-15-1437267-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c0/11368774/36516c990fd2/fimmu-15-1437267-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c0/11368774/2bab42ca3492/fimmu-15-1437267-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c0/11368774/ebdf62ed082b/fimmu-15-1437267-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c0/11368774/15fb3e5f2a63/fimmu-15-1437267-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c0/11368774/36516c990fd2/fimmu-15-1437267-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c0/11368774/2bab42ca3492/fimmu-15-1437267-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c4c0/11368774/ebdf62ed082b/fimmu-15-1437267-g004.jpg

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