RSVdeltaNS2/delta1313/I1314L(RSVdeltaNS2/delta1313/I1314L)

概要

基本信息

药物类型

减毒活疫苗、预防性疫苗

别名-

靶点-

作用方式-

作用机制-

治疗领域

感染

在研适应症-

非在研适应症

呼吸道合胞体病毒感染

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-

最高研发阶段终止临床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

3

项与 RSVdeltaNS2/delta1313/I1314L 相关的临床试验

NCT03916185

/ Terminated临床1/2期IIT

Randomized Phase I/II Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age

The purpose of this study was to evaluate the safety and immunogenicity of a single dose of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines, RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, and RSV 276, in RSV-seronegative children 6 to 24 months of age.

开始日期2019-06-20

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT03227029

/ Completed临床1期IIT

Randomized Phase I Study of the Infectivity, Safety, and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Infants 6 to 24 Months of Age

The purpose of this study was to evaluate the infectivity, safety, and immunogenicity of the recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age.
This study was a companion study to Center for Immunization Research (CIR) 321.

开始日期2017-09-22

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT01893554

/ Active, not recruiting临床1期IIT

A Phase I Study of the Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine RSV ΔNS2 Δ1313 I1314L, Lot RSV#006A, Delivered as Nose Drops to RSV-Seropositive Children 12 to 59 Months of Age, RSV-Seronegative Infants and Children 6 to 24 Months of Age, and Infants 4 to 6 Months of Age

Human respiratory syncytial virus (RSV) is a common cause of respiratory illness in infants and children around the world. This study will evaluate the safety and immune response to a RSV vaccine in three groups of participants: healthy children who have already had an RSV infection (RSV seropositive), healthy infants and children who have not already had an RSV infection (RSV seronegative), and healthy younger infants who have not been screened for prior RSV infection.

开始日期2013-06-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+1]

100 项与 RSVdeltaNS2/delta1313/I1314L 相关的临床结果

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100 项与 RSVdeltaNS2/delta1313/I1314L 相关的转化医学

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100 项与 RSVdeltaNS2/delta1313/I1314L 相关的专利（医药）

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2

项与 RSVdeltaNS2/delta1313/I1314L 相关的文献（医药）

2022-12-13·The Journal of Infectious Diseases

Evaluation of Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV/ΔNS2/Δ1313/I1314L and RSV/276 in RSV-Seronegative Children

Article

作者: Chadwick, Ellen G ; Aziz, Mariam ; Paul, Mary ; Moye, Jack ; Libous, Jennifer ; Oliva, Jennifer ; Barr, Emily ; Rexroad, Vivian ; Collins, Peter L ; Johnston, Benjamin ; Karron, Ruth A ; Schappell, Elizabeth ; Perlowski, Charlotte ; Cunningham, Coleen K ; Cielo, Mikhaela ; Deville, Jaime G ; Jean-Philippe, Patrick ; Luongo, Cindy ; Yang, Lijuan ; Kelly, Matthew S ; Muresan, Petronella ; McFarland, Elizabeth J ; Buchholz, Ursula J

AbstractBackgroundThis United States-based study compared 2 candidate vaccines: RSV/ΔNS2/Δ1313/I1314L, attenuated by NS2 gene-deletion and temperature-sensitivity mutation in the polymerase gene; and RSV/276, attenuated by M2-2 deletion.MethodsRSV-seronegative children aged 6–24 months received RSV/ΔNS2/Δ1313/I1314L (106 plaque-forming units [PFU]), RSV/276 (105 PFU), or placebo intranasally. Participants were monitored for vaccine shedding, reactogenicity, and RSV serum antibodies, and followed over the subsequent RSV season.ResultsEnrollment occurred September 2017 to October 2019. During 28 days postinoculation, upper respiratory illness and/or fever occurred in 64% of RSV/ΔNS2/Δ1313/I1314L, 84% of RSV/276, and 58% of placebo recipients. Symptoms were generally mild. Cough was more common in RSV/276 recipients than RSV/ΔNS2/Δ1313/I1314L (48% vs 12%; P = .012) or placebo recipients (17%; P = .084). There were no lower respiratory illness or serious adverse events. Eighty-eight and 96% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 recipients were infected with vaccine (shed vaccine and/or had ≥4-fold rises in RSV antibodies). Serum RSV-neutralizing titers and anti-RSV F IgG titers increased ≥4-fold in 60% and 92% of RSV/ΔNS2/Δ1313/I1314L and RSV/276 vaccinees, respectively. Exposure to community RSV during the subsequent winter was associated with strong anamnestic RSV-antibody responses.ConclusionsBoth vaccines had excellent infectivity and were well tolerated. RSV/276 induced an excess of mild cough. Both vaccines were immunogenic and primed for strong anamnestic responses.Clinical Trials RegistrationNCT03227029 and NCT03422237.

2020-06-16·The Journal of Infectious Diseases

Safety and Immunogenicity of the Respiratory Syncytial Virus Vaccine RSV/ΔNS2/Δ1313/I1314L in RSV-Seronegative Children

Article

作者: Buchholz, Ursula J ; Karron, Ruth A ; Mateo, Jocelyn San ; Luongo, Cindy ; Wanionek, Kimberli ; Collins, Peter L

AbstractBackgroundRespiratory syncytial virus (RSV) is the leading global cause of severe pediatric acute respiratory tract illness, and a vaccine is needed. RSV/ΔNS2/Δ1313/I1314L contains 2 attenuating elements: (1) deletion of the interferon antagonist NS2 gene and (2) deletion of codon 1313 of the RSV polymerase gene and the stabilizing missense mutation I1314L. This live vaccine candidate was temperature-sensitive, genetically stable, replication restricted, and immunogenic in nonhuman primates.MethodsA single intranasal dose of RSV/ΔNS2/Δ1313/I1314L was evaluated in a double-blind, placebo-controlled trial (vaccine-placebo ratio, 2:1) at 106 plaque-forming units (PFU) in 15 RSV-seropositive children and at 105 and 106 PFU in 21 and 30 RSV-seronegative children, respectively.ResultsIn RSV-seronegative children, the 105 PFU dose was overattenuated, but the 106 PFU dose was well tolerated, infectious (RSV/ΔNS2/Δ1313/I1314L replication detected in 90% of vaccinees), and immunogenic (geometric mean serum RSV plaque-reduction neutralizing antibody titer, 1:64). After the RSV season, 9 of 20 vaccinees had increases in the RSV titer that were significantly greater than those in 8 of 10 placebo recipients (1:955 vs 1:69, respectively), indicating that the vaccine primed for anamnestic responses after natural RSV exposure.ConclusionRational design yielded a genetically stable candidate RSV vaccine that is attenuated yet immunogenic in RSV-seronegative children, warranting further evaluation.Clinical Trials RegistrationNCT01893554.

100 项与 RSVdeltaNS2/delta1313/I1314L 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
呼吸道合胞体病毒感染	临床2期	美国	National Institute of Allergy & Infectious Diseases	2019-06-20

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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


NCT03916185 (CTgov)	临床1/2期	呼吸道合胞体病毒感染	67	RSV ΔNS2/Δ1313/I1314L Vaccine (RSV ΔNS2/Δ1313/I1314L Vaccine)	艱蓋觸繭壓積製醖簾積(廠餘範壓醖鹽壓積網遞) = 願廠蓋獵鹽糧鬱鏇餘蓋壓觸遞簾製簾遞衊範顧 (襯憲願餘簾製鏇鬱積鏇, 廠積襯獵齋築鏇淵鹽膚 ~ 鹽鬱願顧襯餘鏇網製鏇) 更多	-	2025-02-21
				RSV 6120/ΔNS2/1030s Vaccine (RSV 6120/ΔNS2/1030s Vaccine)	艱蓋觸繭壓積製醖簾積(廠餘範壓醖鹽壓積網遞) = 憲壓艱遞繭觸憲鹹艱繭壓觸遞簾製簾遞衊範顧 (襯憲願餘簾製鏇鬱積鏇, 淵顧鹹獵選選願積網齋 ~ 鑰窪襯蓋鏇鏇築簾齋遞) 更多
NCT03227029 (CTgov)	临床1期	呼吸道合胞体病毒感染	65	RSV ΔNS2/Δ1313/I1314L (RSV ΔNS2/Δ1313/I1314L Vaccine)	夢鬱蓋鑰蓋獵憲齋網積(餘觸繭膚廠繭憲壓衊襯) = 壓繭網鑰憲網簾遞鏇簾糧鹽憲遞積淵網夢蓋餘 (獵鏇襯顧艱膚鏇鹽襯糧, 觸鑰衊獵醖衊醖鬱範築 ~ 醖夢鑰鬱顧鹹膚遞憲餘) 更多	-	2021-01-08
				RSV 276 (RSV 276 Vaccine)	夢鬱蓋鑰蓋獵憲齋網積(餘觸繭膚廠繭憲壓衊襯) = 簾鹽淵鏇築觸壓膚餘襯糧鹽憲遞積淵網夢蓋餘 (獵鏇襯顧艱膚鏇鹽襯糧, 廠鏇淵憲鏇遞選艱壓鹽 ~ 積鏇鹹網網範觸憲壓餘) 更多