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一种候选大流行性减毒活流感疫苗(pLAIV)针对甲型H7N9流感的安全性和免疫原性评估。

Evaluation of the Safety and Immunogenicity of a Candidate Pandemic Live Attenuated Influenza Vaccine (pLAIV) Against Influenza A(H7N9).

作者信息

Sobhanie Mahdee, Matsuoka Yumiko, Jegaskanda Sinthujan, Fitzgerald Theresa, Mallory Raburn, Chen Zhongying, Luke Catherine, Treanor John, Subbarao Kanta

机构信息

Department of Medicine, University of Rochester Medical Center, New York.

Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Disease, National Institutes of Health, Bethesda.

出版信息

J Infect Dis. 2016 Mar 15;213(6):922-9. doi: 10.1093/infdis/jiv526. Epub 2015 Dec 9.

DOI:10.1093/infdis/jiv526
PMID:26655841
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4760421/
Abstract

BACKGROUND

We evaluated a candidate A/Anhui/2013(H7N9) pandemic live attenuated influenza vaccine (pLAIV) in healthy adults, and assessed the ability of 1 or 2 doses to induce immune memory.

METHODS

Healthy subjects in 2 age groups (18-49 years and 50-70 years) with undetectable hemagglutination-inhibiting (HAI) antibody to H7N9 were enrolled. Younger subjects received either 1 or 2 intranasal doses of 10(7.0) fluorescent focus units of A/Anhui/1/2013 pLAIV, while older subjects received a single dose. All subjects received a single 30-µg dose of unadjuvanted, antigenically matched A/Shanghai2/2013(H7N9) pandemic inactivated influenza vaccine (pIIV) 12 weeks after their first dose of pLAIV.

RESULTS

Both vaccines were well tolerated. Serum HAI antibody responses were detected in 0 of 32 younger subjects and 1 of 17 older subjects after 1 dose of pLAIV and in 2 of 16 younger subjects after a second dose. Strong serum antibody responses were detected after a single subsequent dose of pIIV that was broadly reactive against H7 influenza viruses.

CONCLUSIONS

An A(H7N9) pLAIV candidate was safe in both age groups. Priming with pLAIV resulted in responses to subsequent pIIV that exceeded those seen in naive subjects in previous reports. The A(H7N9) pLAIV induces strong immune memory that can be demonstrated by exposure to subsequent antigenic challenge.

CLINICAL TRIALS REGISTRATION

NCT01995695 and NCT02274545.

摘要

背景

我们在健康成年人中评估了候选A/安徽/2013(H7N9)大流行减毒活流感疫苗(pLAIV),并评估了1剂或2剂诱导免疫记忆的能力。

方法

招募了2个年龄组(18 - 49岁和50 - 70岁)对H7N9血凝抑制(HAI)抗体检测不到的健康受试者。较年轻的受试者鼻内接种1剂或2剂10(7.0)荧光聚焦单位的A/安徽/1/2013 pLAIV,而较年长的受试者接种1剂。所有受试者在首次接种pLAIV 12周后接种1剂30μg的无佐剂、抗原匹配的A/上海2/2013(H7N9)大流行灭活流感疫苗(pIIV)。

结果

两种疫苗耐受性均良好。1剂pLAIV后,32名较年轻受试者中有0名、17名较年长受试者中有1名检测到血清HAI抗体反应;2剂后,16名较年轻受试者中有2名检测到血清抗体反应。在随后单次接种pIIV后检测到强烈的血清抗体反应,该反应对H7流感病毒具有广泛反应性。

结论

A(H7N9)pLAIV候选疫苗在两个年龄组中均安全。用pLAIV进行初次免疫后,对随后pIIV的反应超过了既往报道中未接触过疫苗的受试者。A(H7N9)pLAIV诱导了强大的免疫记忆,这可通过后续抗原激发来证明。

临床试验注册

NCT01995695和NCT02274545。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca32/4760421/4a2aebccf6cd/jiv52603.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca32/4760421/e2affe8496de/jiv52601.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca32/4760421/3120ba605641/jiv52602.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca32/4760421/4a2aebccf6cd/jiv52603.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca32/4760421/e2affe8496de/jiv52601.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca32/4760421/3120ba605641/jiv52602.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ca32/4760421/4a2aebccf6cd/jiv52603.jpg

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