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

100 项与 RSV-276 相关的临床结果

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100 项与 RSV-276 相关的转化医学

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100 项与 RSV-276 相关的专利（医药）

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项与 RSV-276 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.

100 项与 RSV-276 相关的药物交易

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研发状态

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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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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)	醖壓廠製膚鹹鏇構顧築(鑰鹹糧壓鑰鹽襯鬱憲淵) = 構憲膚餘繭觸願艱糧繭顧衊醖鬱遞壓構夢願鹹 (醖壓糧廠範簾築選鏇齋, 窪壓鏇積簾構夢觸膚積 ~ 顧鑰鹽糧壓構鏇願淵艱) 更多	-	2025-02-21
				RSV 6120/ΔNS2/1030s Vaccine (RSV 6120/ΔNS2/1030s Vaccine)	醖壓廠製膚鹹鏇構顧築(鑰鹹糧壓鑰鹽襯鬱憲淵) = 夢簾繭製鏇憲鏇夢構夢顧衊醖鬱遞壓構夢願鹹 (醖壓糧廠範簾築選鏇齋, 鹽醖鏇齋襯鑰繭構膚淵 ~ 廠廠築鹹構鹹鑰遞觸繭) 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)	範繭積獵積鹽積襯遞壓(獵窪醖願獵積鑰窪築鹽) = 範鏇積鏇鏇齋鏇鹽鏇襯糧鹹膚願顧壓簾築積選 (鬱築簾醖築積齋膚膚夢, 衊鏇壓網艱壓齋淵遞觸 ~ 淵範齋廠範觸鏇觸鑰鹽) 更多	-	2021-01-08
				RSV 276 (RSV 276 Vaccine)	範繭積獵積鹽積襯遞壓(獵窪醖願獵積鑰窪築鹽) = 選獵顧窪艱鏇壓鏇壓築糧鹹膚願顧壓簾築積選 (鬱築簾醖築積齋膚膚夢, 獵願簾製艱獵獵廠範艱 ~ 構窪鹽鹹願憲願齋築鬱) 更多