Safety and immunogenicity of an intranasal sendai virus-based vaccine for human parainfluenza virus type I and respiratory syncytial virus (SeVRSV) in adults.
Safety and immunogenicity of an intranasal sendai virus-based vaccine for human parainfluenza virus type I and respiratory syncytial virus (SeVRSV) in adults.
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成人中人副流感病毒I型和呼吸道合胞病毒（SeVRSV）鼻内仙台病毒疫苗的安全性和免疫原性。
DOI：
10.1080/21645515.2020.1779517
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发表时间：
2021-02-01
影响因子：
4.8
通讯作者：
Hurwitz JL
中科院分区：
文献类型：
--
作者：
Scaggs Huang F;Bernstein DI;Slobod KS;Portner A;Takimoto T;Russell CJ;Meagher M;Jones BG;Sealy RE;Coleclough C;Branum K;Dickey M;Buschle K;McNeal M;Makowski M;Nakamura A;Hurwitz JL
SeVRSV是一种基于可复制仙台病毒（SeV）的疫苗，携带呼吸道合胞病毒（RSV）融合蛋白（F）基因。未经操作的非重组SeV是一种鼠副流感病毒1型（PIV-1），可用作人副流感病毒1型（hPIV-1）的詹纳疫苗。SeV保护非洲绿色猴（AGM）免受hPIV-1攻击后的感染。重组SeVRSV还靶向RSV，并在RSV攻击后保护AGM免受下呼吸道感染。本研究首次报道了健康成人接种SeVRSV疫苗后的安全性、病毒基因组检测和免疫原性。17名和4名健康成人分别接受鼻内SeVRSV和PBS，随后进行6个月的安全性监测。分别在接种后2周和4周监测病毒基因组（鼻洗液中）和疫苗特异性抗体（血清中）。疫苗耐受性良好，仅轻度至中度反应，安慰剂组也存在。未发生严重反应。正如预期，由于成人中预先存在对hPIV-1和RSV的免疫力，疫苗基因组检测是短暂的。存在对SeV的最小抗体应答和对RSV F的可忽略应答。结果鼓励进一步研究SeVRSV，并在血清阴性儿童中进行临床试验。缩略语：AE-不良事件; SAE-严重不良事件; SeV-Sendai病毒; RSV-呼吸道合胞病毒; PIV-1 -1型副流感病毒; hPIV-1 -1型人副流感病毒; F-RSV融合蛋白; SeVRSV-携带RSV F基因的重组SeV; Ab-抗体; MSW-具有医学意义的喘息; NOCMC-新发慢性医学疾病，mITT-改良意向治疗; ALRI-急性下呼吸道感染。
SeVRSV is a replication-competent Sendai virus (SeV)-based vaccine carrying the respiratory syncytial virus (RSV) fusion protein (F) gene. Unmanipulated, non-recombinant SeV is a murine parainfluenza virus type 1 (PIV-1) and serves as a Jennerian vaccine for human PIV-1 (hPIV-1). SeV protects African green monkeys (AGM) from infection after hPIV-1 challenge. The recombinant SeVRSV additionally targets RSV and protects AGM from lower respiratory infections after RSV challenge. The present study is the first to report on the safety, viral genome detection, and immunogenicity following SeVRSV vaccination of healthy adults. Seventeen and four healthy adults received intranasal SeVRSV and PBS, respectively, followed by six months of safety monitoring. Virus genome (in nasal wash) and vaccine-specific antibodies (in sera) were monitored for two and four weeks, respectively, post-vaccination. The vaccine was well-tolerated with only mild to moderate reactions that were also present in the placebo group. No severe reactions occurred. As expected, due to preexisting immunity toward hPIV-1 and RSV in adults, vaccine genome detection was transient. There were minimal antibody responses to SeV and negligible responses to RSV F. Results encourage further studies of SeVRSV with progression toward a clinical trial in seronegative children. Abbreviations: AE-adverse event; SAE-serious adverse event; SeV-Sendai virus; RSV-respiratory syncytial virus; PIV-1-parainfluenza virus-type 1; hPIV-1-human parainfluenza virus-type 1; F-RSV fusion protein; SeVRSV-recombinant SeV carrying the RSV F gene; Ab-antibody; MSW-medically significant wheezing; NOCMC-new onset chronic medical condition, mITT-modified Intent to Treat; ALRI-acute lower respiratory tract infection.
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影响因子：
3.7
作者：
Russell, Charles J.;Jones, Bart G.;Hurwitz, Julia L.
通讯作者：
Hurwitz, Julia L.
影响因子：
5.5
作者：
Slobod, KS;Shenep, JL;Hurwitz, JL
通讯作者：
Hurwitz, JL
影响因子：
2.2
作者：
Surman, Sherri L.;Rudraraju, Rajeev;Hurwitz, Julia L.
通讯作者：
Hurwitz, Julia L.
影响因子：
5.5
作者：
Hurwitz, JL;Soike, KF;Coleclough, C
通讯作者：
Coleclough, C
DOI：
10.1056/nejmoa0804877
发表时间：
2009-02-05
期刊：
The New England journal of medicine
影响因子：
--
作者：
Hall CB;Weinberg GA;Iwane MK;Blumkin AK;Edwards KM;Staat MA;Auinger P;Griffin MR;Poehling KA;Erdman D;Grijalva CG;Zhu Y;Szilagyi P
通讯作者：
Szilagyi P