[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III study to evaluate the efficacy, safety, and immunogenicity of ExPEC9V vaccination in preventing invasive extraintestinal pathogenic Escherichia coli disease in adults aged 60 years and older with a history of urinary tract infection within the past 2 years

本研究的目的是证明9价肠外致病性大肠埃希菌疫苗(ExPEC9V)与安慰剂相比在预防由 ExPEC9V O血清型所致的首起侵袭性肠外致病性大肠埃希菌疾病(IED)事件的有效性。

[Translation]

The objective of this study was to demonstrate the effectiveness of a 9-valent extraenteral pathogenic Escherichia coli vaccine (ExPEC9V) compared with placebo in preventing a first episode of invasive extraenteral pathogenic Escherichia coli disease (IED) caused by ExPEC9V serotype O.

Start Date17 Jun 2023

Sponsor / Collaborator

Fisher BioServices, Inc.

[+5]

CTR20221418 / TerminatedPhase 3

一项使用基于Ad26.RSV.preF的疫苗预防≥60岁成人中由RSV引起的下呼吸道疾病的随机、双盲、安慰剂对照、3期有效性研究

[Translation] A randomized, double-blind, placebo-controlled, phase 3 efficacy study of an Ad26.RSV.preF-based vaccine to prevent lower respiratory tract illness caused by RSV in adults aged ≥60 years

证明基于Ad26.RSV.preF的研究疫苗与安慰剂相比在预防≥60岁成人经逆转录酶聚合酶链反应（RT-PCR）确认的RSV所致下呼吸道疾病（LRTD）的有效性。

[Translation]

To demonstrate the effectiveness of an investigational Ad26.RSV.preF-based vaccine compared with placebo in preventing reverse transcriptase polymerase chain reaction (RT-PCR)-confirmed RSV-induced lower respiratory tract disease (LRTD) in adults aged ≥60 years.

Start Date08 Aug 2022

Sponsor / Collaborator

Janssen Pharmaceutica NV

[+9]

100 Clinical Results associated with Janssen Vaccines Corp.

0 Patents (Medical) associated with Janssen Vaccines Corp.

Literatures (Medical) associated with Janssen Vaccines Corp.

01 Mar 2004·Journal of microbiology (Seoul, Korea)

Study on persistent infection of Japanese encephalitis virus Beijing-1 strain in serum-free Sf9 cell cultures.

Article

Author: Hur, Byung-Ki ; Park, Jin Yong ; Kang, Heui-Yun ; Ryu, Yeon-Woo ; Kim, Hyun Sung ; Kim, Hun ; Lee, Su Jeen ; Kim, Jong Su ; Han, Sang In ; Park, Yong Wook

Sf9 cells have obvious advantages for the conventional production technology of vaccine. They are useful tools for high concentration and large-scale cultures. Sf9 cells were grown to maximal concentration, 8 x 10(6) cells/ml in a 500ml spinner flask, with a doubling time at the exponentially growing phase of 24.5 hours, using serum-free media. To explore the ability of Sf9 cells to be infected by the Japanese encephalitis (JE) virus Beijing-1 strain, Sf9 cells were infected with the virus. By 4-5 days post-infection, 10-15% of the Sf9 cells showed cytopathic effect (CPE), from granularity to the formation of syncytia and multinucleated giant cells continuously observed over a period of 35 days. Positive fluorescent reactions were detected in 30-40% of cells infected with the JE virus Beijing-1 strain, and the uninfected Sf9 cells were completely negative. Virus particles, propagated in Sf9 and Vero cells, were concentrated by sedimentation on 40% trehalose cushions by ultracentrifugation, and showed identical patterns of viral morphogenesis. Complete virus particles, 40 to 50 nm in diameter, were observed, and JE virus envelope (E) proteins, at 53 kDa, were found in the western blot analysis to the anti-JE virus E protein monoclonal antibody and reacted as a magenta band in the same position to the glycoprotein staining. To evaluate whether the infectious virus was produced in Sf9 cells inoculated with the JE virus Beijing-1 stain, Sf9 cells were inoculated with the virus, and sample harvested every 5 days. The titers of the JE virus Beijing-1 strain rose from 1.0 x 10(5) to 1.5 x 10(6) pfu/ml. The infected Sf9 cells could be sub-cultured in serum-free medium, with no change in the plaque sizes formed by the JE virus Beijing-1 strain in the plaque assay. It is suggested that the ability of the JE virus Beijing-1 strain to infect Sf9 cells in serum-free media will provide a useful insect cell system, where the JE virus replication, cytopathogenicity and vaccine immunogen can be studied.

Journal of Microbiology and Biotechnology

Measurement of free polysaccharide in tetanus toxoid-conjugate vaccine using antibody/ammonium sulfate precipitation

Author: Kim, Li-Seop ; Yoo, Tae Hyeon ; Kim, Hyun-Sung ; Oh, Yong K. ; Kim, Jong-Su ; Bang, Eun-Young ; Hur, Byung-Ki ; Park, Sung-Sik ; Ryu, Yeon-Woo ; Kim, Hun

A method that effectively precipitates capsular polysaccharide of Haemophilus influenzae type b (polyribosylribitol phosphate, PRP) conjugated to tetanus toxoid (TT), PRP TT in a liquid vaccine was developed to measure free PRP present in TT-conjugate vaccine.The method involves adding anti-TT antibody and ammonium sulfate to precipitate PRP-TT conjugate and measuring free PRP in the supernatant.This new method provides a complete precipitation of the total PRP-TT, and provides an accurate and reproducible measurements of free PRP.The accuracy of the assay was confirmed by spiking known amounts of unconjugated PRP to PRP-TT conjugate, and the new method was found to have no effect on free PRP while precipitating PRP-TT.The published acid precipitation method did not produce reproducible results due to incomplete precipitation of PRP-TT, especially when the vaccine is formulated in a salt-buffered solution

Journal of Microbiology (Seoul, Republic of Korea)

Study on persistent infection of Japanese encephalitis virus Beijing-1 strain in serum-free Sf9 cell cultures

Author: Kang, Heui-Yun ; Park, Yong Wook ; Hur, Byung-Ki ; Park, Jin Yong ; Han, Sang In ; Kim, Hun ; Kim, Jong Su ; Ryu, Yeon-Woo ; Kim, Hyun Sung ; Lee, Su Jeen

Sf9 cells have obvious advantages for the conventional production technol. of vaccine.They are useful tools for high concentration and large-scale cultures.Sf9 cells were grown to maximal concentration, 8×10⁶ cells/mL in a 500 mL spinner flask, with a doubling time at the exponentially growing phase of 24.5 h, using serum-free media.To explore the ability of Sf9 cells to be infected by the Japanese encephalitis (JE) virus Beijing-1 strain, Sf9 cells were infected with the virus.By 4-5 days post-infection, 10-15% of the Sf9 cells showed cytopathic effect (CPE), from granularity to the formation of syncytia and multinucleated giant cells continuously observed over a period of 35 days.Pos. fluorescent reactions were detected in 30-40% of cells infected with the JE virus Beijing-1 strain, and the uninfected Sf9 cells were completely neg.Virus particles, propagated in Sf9 and Vero cells, were concentrated by sedimentation on 40% trehalose cushions by ultracentrifugation, and showed identical patterns of viral morphogenesis.Complete virus particles, 40 to 50 nm in diameter, were observed, and JE virus envelope (E) proteins, at 53 kDa, were found in the western blot anal. to the anti-JE virus E protein monoclonal antibody and reacted as a magenta band in the same position to the glycoprotein staining.To evaluate whether the infectious virus was produced in Sf9 cells inoculated with the JE virus Beijing-1 stain, Sf9 cells were inoculated with the virus, and sample harvested every 5 days.The titers of the JE virus Beijing-1 strain rose from 1.0×10⁵ to 1.5×10⁶ pfu/mL.The infected Sf9 cells could be subcultured in serum-free medium, with no change in the plaque sizes formed by the JE virus Beijing-1 strain in the plaque assay.It is suggested that the ability of the JE virus Beijing-1 strain to infect Sf9 cells in serum-free media will provide a useful insect cell system, where the JE virus replication, cytopathogenicity and vaccine, immunogen can be studied.

100 Deals associated with Janssen Vaccines Corp.

100 Translational Medicine associated with Janssen Vaccines Corp.

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Drug(Targets)	Indications	Global Highest Phase

Hantaan virus vaccine (Janssen Vaccines)	Hantavirus Infections More	Approved
JNJ-78901563	Urinary Tract Infections More	Phase 3
Lassa vaccine (Janssen Vaccines/University of Oxford)	Lassa Fever More	Preclinical
NL63 S protein AAV vector vaccine(Crucell)	Common Cold More	Preclinical
Nipah vaccine (Janssen Vaccines/University of Oxford)	Henipavirus Infections More	Preclinical

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