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一项针对体弱住院老年人,比较7价肺炎球菌结合疫苗与23价多糖疫苗免疫原性的随机临床试验。

A randomized clinical trial of the immunogenicity of 7-valent pneumococcal conjugate vaccine compared to 23-valent polysaccharide vaccine in frail, hospitalized elderly.

作者信息

Macintyre C Raina, Ridda Iman, Gao Zhanhai, Moa Aye M, McIntyre Peter B, Sullivan John S, Jones Thomas R, Hayen Andrew, Lindley Richard I

机构信息

School of Public Health and Community Medicine, UNSW Australia, The University of New South Wales, Sydney, Australia; National Centre for Immunization Research and Surveillance (NCIRS), Westmead, Australia.

School of Public Health and Community Medicine, UNSW Australia, The University of New South Wales, Sydney, Australia.

出版信息

PLoS One. 2014 Apr 23;9(4):e94578. doi: 10.1371/journal.pone.0094578. eCollection 2014.

DOI:10.1371/journal.pone.0094578
PMID:24760002
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3997415/
Abstract

BACKGROUND

Elderly people do not mount strong immune responses to vaccines. We compared 23-valent capsular polysaccharide (23vPPV) alone versus 7-valent conjugate (PCV7) vaccine followed by 23vPPV 6 months later in hospitalized elderly.

METHODS

Participants were randomized to receive 23vPPV or PCV7-23vPPV. Antibodies against serotypes 3, 4, 6A, 6B, 9V, 14, 18C, 19A, 19F, 23F were measured by enzyme-linked immunosorbent (ELISA) and opsonophagocytic (OPA) assays at baseline, 6 months and 12 months.

RESULTS

Of 312 recruited, between 40% and 72% of subjects had undetectable OPA titres at baseline. After one dose, PCV7 recipients had significantly higher responses to serotypes 9V (both assays) and 23F (OPA only), and 23vPPV recipients had significantly higher responses to serotype 3 (ELISA), 19F and 19A (OPA only). In subjects with undetectable OPA titres at baseline, a proportionately greater rise in OPA titre (P<0.01) was seen for all serotypes after both vaccines. The GMT ratio of OPA was significantly higher at 12 months in the PCV7-23vPPV group for serotypes 6A, 9V, 18C and 23F. OPA titre levels for these serotypes increased moderately after 6 months, whereas immunity waned in the 23vPPV only arm.

CONCLUSION

We did not show overwhelming benefit of one vaccine over the other. Low baseline immunity does not preclude a robust immune response, reiterating the importance of vaccinating the frail elderly. A schedule of PCV7-23vPPV prevents waning of antibody, suggesting that both vaccines could be useful in the elderly. Follow up studies are needed to determine persistence of immunity.

TRIAL REGISTRATION

The Australian Clinical Trials Registry ACTRN12607000387426.

摘要

背景

老年人对疫苗的免疫反应不强。我们比较了单独使用23价荚膜多糖(23vPPV)与7价结合疫苗(PCV7),并在6个月后对住院老年人接种23vPPV的效果。

方法

将参与者随机分为接受23vPPV或PCV7-23vPPV组。在基线、6个月和12个月时,通过酶联免疫吸附(ELISA)和调理吞噬(OPA)试验检测针对血清型3、4、6A、6B、9V、14、18C、19A、19F、23F的抗体。

结果

在招募的312名受试者中,40%至72%的受试者在基线时OPA滴度检测不到。接种一剂后,PCV7接种者对血清型9V(两种试验)和23F(仅OPA试验)的反应明显更高,而23vPPV接种者对血清型3(ELISA)、19F和19A(仅OPA试验)的反应明显更高。在基线时OPA滴度检测不到的受试者中,两种疫苗接种后所有血清型的OPA滴度均有相应更大幅度的升高(P<0.01)。PCV7-23vPPV组在12个月时血清型6A、9V、18C和23F的OPA GMT比值明显更高。这些血清型的OPA滴度在6个月后适度增加,而仅接种23vPPV组的免疫力则有所下降。

结论

我们没有发现一种疫苗比另一种疫苗有压倒性的优势。低基线免疫力并不妨碍产生强烈的免疫反应,这再次强调了为体弱老年人接种疫苗的重要性。PCV7-23vPPV接种方案可防止抗体下降,表明两种疫苗对老年人都可能有用。需要进行后续研究以确定免疫力的持久性。

试验注册

澳大利亚临床试验注册中心ACTRN12607000387426。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4951/3997415/fb28ab25e371/pone.0094578.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4951/3997415/928a184df1a3/pone.0094578.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4951/3997415/bf413737f56a/pone.0094578.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4951/3997415/5aa406cae54b/pone.0094578.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4951/3997415/fb28ab25e371/pone.0094578.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4951/3997415/928a184df1a3/pone.0094578.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4951/3997415/bf413737f56a/pone.0094578.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4951/3997415/5aa406cae54b/pone.0094578.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4951/3997415/fb28ab25e371/pone.0094578.g004.jpg

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