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

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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4

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

2012-12-01·Virology journal3区 · 医学

The new temperature-sensitive mutation PA-F35S for developing recombinant avian live attenuated H5N1 influenza vaccine

3区 · 医学

ArticleOA

作者: Zongzheng Zhao ; Huanchun Chen ; Jiagang Tu ; Meilin Jin ; Wenting Zhang

Abstract:

Background:

H5N1 highly pathogenic avian influenza virus (HPAIV) is continuously circulating in many Asian countries and threatening poultry industry and human population. Vaccination is the best strategy to control H5N1 HPAIV infection in poultry and transmission to human population. The aim of this study is to identify new temperature-sensitive (ts) mutations for developing recombinant avian live attenuated H5N1 influenza vaccine.

Findings:

A “6 + 2” recombinant virus C4/W1 that contained NA gene and modified HA gene from virus A/chicken/Hubei/327/2004 (H5N1) (C4), and six internal genes from virus A/duck/Hubei/W1/2004 (H9N2) (W1) was generated using reverse genetics and subsequently passaged in chicken eggs at progressively lower temperatures (32°C, 28°C and 25°C). The resulting virus acquired ts phenotype and one of its amino acid mutations, PA (F35S), was identified as ts mutation. Furthermore, when used as live attenuated vaccine, the recombinant virus with this ts mutation PA (F35S) provided efficient protection for chickens against H5N1 HPAIV infection.

Conclusions:

These findings highlight the potential of the new ts mutation PA (F35S) in developing recombinant avian live attenuated H5N1 influenza vaccine.

2009-08-01·Vaccine3区 · 医学

Evaluation of two live attenuated cold-adapted H5N1 influenza virus vaccines in healthy adults

3区 · 医学

Article

作者: Ruth A. Karron ; Susan DiLorenzo ; Bhagvanji Thumar ; Hong Jin ; Karen Callahan ; Elaine Lamirande ; Brian R. Murphy ; Catherine Luke ; Kimberly Mills ; Kathleen Coelingh ; Amorsolo Suguitan ; Kawsar Talaat ; Grace Chen ; Kanta Subbarao ; Elizabeth Schappell ; George Kemble ; Josephine McAuliffe

BACKGROUND:

Development of live attenuated influenza vaccines (LAIV) against avian viruses with pandemic potential is an important public health strategy.

METHODS AND FINDINGS:

We performed open-label trials to evaluate the safety, infectivity, and immunogenicity of H5N1 VN 2004 AA ca and H5N1 HK 2003 AA ca. Each of these vaccines contains a modified H5 hemagglutinin and unmodified N1 neuraminidase from the respective wild-type (wt) parent virus and the six internal protein gene segments of the A/Ann Arbor/6/60 cold-adapted (ca) master donor virus. The H5N1 VN 2004 AA ca vaccine virus was evaluated at dosages of 10(6.7) TCID(50) and 10(7.5) TCID(50), and the H5N1 HK 2003 AA ca vaccine was evaluated at a dosage of 10(7.5) TCID(50). Two doses were administered intranasally to healthy adults in isolation at 4-8 week intervals. Vaccine safety was assessed through daily examinations and infectivity was assessed by viral culture and by realtime reverse transcription-polymerase chain reaction testing of nasal wash (NW) specimens. Immunogenicity was assessed by measuring hemagglutination-inhibition (HI) antibodies, neutralizing antibodies, and IgG or IgA antibodies to recombinant (r)H5 VN 2004 hemagglutinin (HA) in serum or NW. Fifty-nine participants were enrolled: 21 received 10(6.7) TCID(50) and 21 received 10(7.5) TCID(50) of H5N1 VN 2004 AA ca and 17 received H5N1 HK 2003 AA ca. Shedding of vaccine virus was minimal, as were HI and neutralizing antibody responses. Fifty-two percent of recipients of 10(7.5) TCID(50) of H5N1 VN 2004 AA ca developed a serum IgA response to rH5 VN 2004 HA.

CONCLUSIONS:

The live attenuated H5N1 VN 2004 and HK 2003 AA ca vaccines bearing avian H5 HA antigens were very restricted in replication and were more attenuated than seasonal LAIV bearing human H1, H3 or B HA antigens. The H5N1 AA ca LAIV elicited serum ELISA antibody but not HI or neutralizing antibody responses in healthy adults. (ClinicalTrials.gov Identifiers: NCT00347672 and NCT00488046).

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1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)	網積鬱網鏇網窪願鏇範(願構窪築製窪鏇廠鬱衊) = 獵獵選獵夢膚糧獵衊艱願鏇選憲構範積襯觸顧 (鏇蓋蓋構鏇淵壓艱廠窪, 鬱蓋蓋繭蓋窪鏇鑰選製 ~ 願築構築顧鬱衊鑰顧繭) 更多	-	2019-02-26
				H5N1 vaccine without adjuvant (Unadjuvanted)	網積鬱網鏇網窪願鏇範(願構窪築製窪鏇廠鬱衊) = 鏇鹽願窪憲網齋鹽鬱醖願鏇選憲構範積襯觸顧 (鏇蓋蓋構鏇淵壓艱廠窪, 鬱簾餘顧獵憲窪餘構獵 ~ 顧壓遞壓餘壓鹽襯觸蓋) 更多
NCT01109329 \| NCT01443663 (Pubmed \| Am J Trop Med Hyg)	临床1期	禽流感	-	Live Attenuated Influenza A(H5N1) Vaccine (Influenza A(H5N1) pLAIV recipients)	膚願鏇餘獵餘鑰廠製構(餘鹽網選觸繭窪鬱構糧) = 齋鹽夢網醖窪餘範顧蓋顧壓築鏇鏇鬱網觸鬱襯 (製餘繭廠製範鑰選構鏇 )	-	2014-06-15
				Live Attenuated Influenza A(H5N1) Vaccine (Influenza A(H5N1) and LAIV naive subjects)	膚願鏇餘獵餘鑰廠製構(餘鹽網選觸繭窪鬱構糧) = 製艱艱襯壓積糧齋淵遞顧壓築鏇鏇鬱網觸鬱襯 (製餘繭廠製範鑰選構鏇 )