Live Attenuated H5N1 Vaccine(NIAID)(Live Attenuated H5N1 Vaccine(NIAID))

概要

基本信息

药物类型

预防性疫苗

别名-

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域

感染呼吸系统疾病

在研适应症-

非在研适应症

H5N1流感流感病毒感染

原研机构

National Institute of Allergy & Infectious Diseases

在研机构-

非在研机构

National Institute of Allergy & Infectious Diseases

权益机构-

最高研发阶段无进展临床1/2期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Live Attenuated H5N1 Vaccine(NIAID) 相关的临床试验

NCT01578317

/ Completed临床1/2期IIT

Characterization of Innate Immune Responses to AS03 Adjuvanted H5N1 Vaccine Compared to Non-adjuvanted H5N1 Vaccine

Background:
- Adjuvants are substances included in vaccines that stimulate the immune system and increase the body's response to the vaccine. The AS03 adjuvant is used in seasonal flu vaccines in Europe. However, it has not been fully tested in the United States. Researchers want to test the immune responses of people who receive a bird flu vaccine with or without AS03 to better understand how the adjuvant works. This information may help develop better flu vaccines.
Objectives:
- To compare the healthy immune system responses to bird flu vaccine with or without the AS03 adjuvant.
Eligibility:
- Healthy volunteers between 18 and 45 years of age.
Design:
Participants will be screened with a physical exam and medical history.
Participants will be assigned to one of two groups. Each group will have an initial vaccine, followed by a booster vaccine 21 days later. Both vaccinations will use the same type of vaccine. One group will have the vaccine with AS03; the other group will have the vaccine without it.
All participants will have two 36-hour inpatient stays to receive the vaccine. Each stay will involve the vaccination, followed by regular and frequent blood draws. Participants will be monitored for any signs or symptoms that may be caused by the vaccine.
Additional blood samples will be collected 7, 28, 42, and 100 days after the initial vaccination.

开始日期2012-03-20

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT01443663

/ Completed临床1期IIT

Immunogenicity and Safety Study of a 45 Micrograms Dose of Inactivated, Unadjuvanted H5N1 Influenza Vaccine in Prior Recipients of Live Attenuated H5N1 and H7N3 Influenza Vaccines and in H5 and Live Attenuated Vaccine Naïve Individuals

H5N1 is an influenza virus that has the potential to cause an influenza pandemic. This study will evaluate the safety and immune response to an H5N1 influenza vaccine in people who have previously received one of two versions of an H5N1 vaccine or have previously received an H7N3 vaccine and in people who have not previously received any live attenuated influenza vaccine (LAIV).

开始日期2011-10-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

100 项与 Live Attenuated H5N1 Vaccine(NIAID) 相关的临床结果

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100 项与 Live Attenuated H5N1 Vaccine(NIAID) 相关的转化医学

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100 项与 Live Attenuated H5N1 Vaccine(NIAID) 相关的专利（医药）

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2

项与 Live Attenuated H5N1 Vaccine(NIAID) 相关的文献（医药）

2013-03-01·Influenza and Other Respiratory Viruses3区 · 医学

Live attenuated H5N1 vaccine with H9N2 internal genes protects chickens from infections by both Highly Pathogenic H5N1 and H9N2 Influenza Viruses

3区 · 医学

ArticleOA

作者: Young Myong Kang ; Byung Min Song ; Nguyen Tai Nang ; Hyun Soo Kim ; Sang Heui Seo ; Heui Man Kim

Please cite this paper as: Nang et al. (2013) Live attenuated H5N1 vaccine with H9N2 internal genes protects chickens from infections by both Highly Pathogenic H5N1 and H9N2 Influenza Viruses. Influenza and Other Respiratory Viruses 7(2) 120–131.Background The highly pathogenic H5N1 and H9N2 influenza viruses are endemic in many countries around the world and have caused considerable economic loss to the poultry industry.Objectives We aimed to study whether a live attenuated H5N1 vaccine comprising internal genes from a cold‐adapted H9N2 influenza virus could protect chickens from infection by both H5N1 and H9N2 viruses.Methods We developed a cold‐adapted H9N2 vaccine virus expressing hemagglutinin and neuraminidase derived from the highly pathogenic H5N1 influenza virus using reverse genetics.Results and Conclusions Chickens immunized with the vaccine were protected from lethal infections with homologous and heterologous H5N1 or H9N2 influenza viruses. Specific antibody against H5N1 virus was detected up to 11 weeks after vaccination (the endpoint of this study). In vaccinated chickens, IgA and IgG antibody subtypes were induced in lung and intestinal tissue, and CD4+ and CD8+ T lymphocytes expressing interferon‐gamma were induced in the splenocytes. These data suggest that a live attenuated H5N1 vaccine with cold‐adapted H9N2 internal genes can protect chickens from infection with H5N1 and H9N2 influenza viruses by eliciting humoral and cellular immunity.

PLoS Pathogens1区 · 医学

Immunogenicity and Protective Efficacy of a Live Attenuated H5N1 Vaccine in Nonhuman Primates

1区 · 医学

ArticleOA

作者: Kyoko Shinya ; Chris Kafai Li ; Yongping Jiang ; Gongxun Zhong ; Guobin Tian ; Zhigao Bu ; Yongbing Suo ; Shufang Fan ; Jianzhong Shi ; Yuntao Guan ; Hualan Chen ; Xiao-Ning Xu ; Tiegang Tong ; Yoshihiro Kawaoka ; Yuwei Gao ; Jiasheng Song ; Yanbing Li ; Ying Zhang

The continued spread of highly pathogenic H5N1 influenza viruses among poultry and wild birds, together with the emergence of drug-resistant variants and the possibility of human-to-human transmission, has spurred attempts to develop an effective vaccine. Inactivated subvirion or whole-virion H5N1 vaccines have shown promising immunogenicity in clinical trials, but their ability to elicit protective immunity in unprimed human populations remains unknown. A cold-adapted, live attenuated vaccine with the hemagglutinin (HA) and neuraminidase (NA) genes of an H5N1 virus A/VN/1203/2004 (clade 1) was protective against the pulmonary replication of homologous and heterologous wild-type H5N1 viruses in mice and ferrets. In this study, we used reverse genetics to produce a cold-adapted, live attenuated H5N1 vaccine (AH/AAca) that contains HA and NA genes from a recent H5N1 isolate, A/Anhui/2/05 virus (AH/05) (clade 2.3), and the backbone of the cold-adapted influenza H2N2 A/AnnArbor/6/60 virus (AAca). AH/AAca was attenuated in chickens, mice, and monkeys, and it induced robust neutralizing antibody responses as well as HA-specific CD4+ T cell immune responses in rhesus macaques immunized twice intranasally. Importantly, the vaccinated macaques were fully protected from challenge with either the homologous AH/05 virus or a heterologous H5N1 virus, A/bar-headed goose/Qinghai/3/05 (BHG/05; clade 2.2). These results demonstrate for the first time that a cold-adapted H5N1 vaccine can elicit protective immunity against highly pathogenic H5N1 virus infection in a nonhuman primate model and provide a compelling argument for further testing of double immunization with live attenuated H5N1 vaccines in human trials.

100 项与 Live Attenuated H5N1 Vaccine(NIAID) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
流感病毒感染	临床2期	美国	National Institute of Allergy & Infectious Diseases	2012-03-20
H5N1流感	临床2期	美国	National Institute of Allergy & Infectious Diseases	2011-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT01578317 (CTgov)	临床1/2期	流感病毒感染	43	H5N1 vaccine plus AS03 adjuvant (AS03 Adjuvanted)	艱餘餘選餘構壓衊齋鏇(築繭淵遞鬱網鏇襯衊簾) = 觸膚襯遞築淵鏇遞願獵糧鹹願選觸餘餘構鏇糧 (顧糧構鑰蓋網憲鹽範觸, 築鬱網簾願願構選蓋齋 ~ 艱餘鹽繭製憲構網壓築) 更多	-	2019-02-26
				H5N1 vaccine without adjuvant (Unadjuvanted)	艱餘餘選餘構壓衊齋鏇(築繭淵遞鬱網鏇襯衊簾) = 繭構齋糧獵鬱顧膚餘遞糧鹹願選觸餘餘構鏇糧 (顧糧構鑰蓋網憲鹽範觸, 憲憲鹹鹹齋壓獵鬱艱構 ~ 願構獵醖選壓壓夢繭醖) 更多