Hantaan virus vaccine (Janssen Vaccines)(Hantaan virus vaccine (Janssen Vaccines)) - 在研适应症：汉坦病毒感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名

Hantaan virus vaccine

靶点-

作用机制

免疫刺激剂

治疗领域

感染

在研适应症

汉坦病毒感染

非在研适应症-

原研机构

Green Cross Vaccine

在研机构

Janssen Vaccines Corp.

非在研机构-

最高研发阶段批准上市

首次获批日期

韩国 (1989-12-25),

汉坦病毒感染

最高研发阶段(中国)-

特殊审评-

登录后查看时间轴

关联

3

项与 Hantaan virus vaccine (Janssen Vaccines) 相关的临床试验

NCT04927936 / Unknown statusN/AIIT

A Multicenter, Randomised, Single-blind, Controlled Trial Among HealthCare Workers (HCW) Vaccinated With Janssen Vaccine: the SWITCH Trial

The key objective of the study is to measure the immune response against SARS-CoV-2 after different vaccinations in Health Care Workers (HCW) from 18 to 65 years old vaccinated once with Janssen vaccine.
Determination of antibodies by a quantitative immunoglobulin G (IgG) assay (LIAISON SARS-CoV-2 TRIMERICS IgG essay) 28 days after second vaccination (booster) comparing, per protocol, the following three groups:
Janssen vaccine/- vs. Janssen vaccine/Janssen vaccine
Janssen vaccine/Janssen vaccine vs. Janssen vaccine/Pfizer vaccine
Janssen vaccine/Janssen vaccine vs. Janssen vaccine/Moderna vaccine

开始日期2021-06-25

申办/合作机构

Erasmus MC

[+3]

NCT02553837 / Unknown status临床3期

Study to Evaluate the Immunogenicity and Safety of Hantavax in Healthy Adult

This study was aimed to evaluate the Immunogenicity and Safety response by vaccinating Hantavax in Healthy Adult.

开始日期2015-11-01

申办/合作机构

Green Cross Co., Ltd.

NCT02360514 / Completed临床3期

Non-comparable and Open Clinical Research to Evaluate Long-term Immunity by Neutralizing Antibody Test of Adults in High Risk Population of HFRS (Hemorrhagic Fever With Renal Syndrome) After Vaccination and Booster Vaccination of Hantavax

This study was aimed evaluate long-term immunity response by neutralizing antibody test of adults in high risk population of HFRS .

开始日期2007-12-01

申办/合作机构

Green Cross Co., Ltd.

100 项与 Hantaan virus vaccine (Janssen Vaccines) 相关的临床结果

登录后查看更多信息

100 项与 Hantaan virus vaccine (Janssen Vaccines) 相关的转化医学

登录后查看更多信息

100 项与 Hantaan virus vaccine (Janssen Vaccines) 相关的专利（医药）

登录后查看更多信息

11

项与 Hantaan virus vaccine (Janssen Vaccines) 相关的文献（医药）

2020-11-01·Vaccine3区 · 医学

Immunogenicity and safety of a modified three-dose priming and booster schedule for the Hantaan virus vaccine (Hantavax): A multi-center phase III clinical trial in healthy adults

3区 · 医学

Article

作者: Kim, Woo Joo ; Song, Joon Young ; Park, Man-Seong ; Yun, Jong Woo ; Bae, Joon-Yong ; Lee, Jacob ; Choi, Won Suk ; Woo, Heung Jeong ; Park, Dae Won ; Jeong, Hye Won ; Cheong, Hee Jin ; Noh, Ji Yun

BACKGROUNDHemorrhagic fever with renal syndrome is a serious health problem in Eurasian countries. This study aimed to evaluate the immunogenicity and safety of formalin-inactivated Hantaan virus vaccine (Hantavax®) with a 3 + 1 vaccination schedule.METHODSA phase III, multi-center clinical trial was conducted to evaluate the immunogenicity and safety of Hantavax® (three primary doses and a booster dose schedule at 0, 1, 2 and 13 months) among healthy adults. Immune responses were assessed using the plaque reduction neutralizing antibody test (PRNT) and immunofluorescent antibody assay (IFA). Systemic and local adverse events were assessed.RESULTSA total of 320 healthy subjects aged ≥19 years were enrolled. Following three primary doses of Hantavax®, the seroconversion rate was 80.97% and 92.81% by PRNT and IFA, respectively. With booster administration, seropositive rates were 67.47% and 95.68% at one-month post-vaccination according to PRNT and IFA, respectively. Solicited local and systemic adverse events were reported in 30.50-42.81% and 16.67-33.75% during the three primary dose vaccination, while those were reported 36.57% and 21.36% after the booster doses. Both local and systemic adverse events did not increase with repeated vaccinations.CONCLUSIONHantavax® showed a high seroconversion rate after the three-dose priming, and additional dose administration with 11-month interval induced good booster effects. (ClinicalTrials.gov Identifier: NCT02553837).

2019-09-30·Journal of Preventive Medicine and Public Health

Introduction of Vaccinomics to Develop Personalized Vaccines in Light of Changes in the Usage of Hantaan Virus Vaccine (Hantavax®) in Korea

Article

作者: Bae, Jong-Myon

The Ministry of Food and Drug Safety of Korea made an official announcement in March 2018 that the total number of inoculations of Hantaan virus vaccine (Hantavax®) would change from 3 to 4. Some aspects of this decision remain controversial. Based on the characteristics of Hantaan virus (HTNV) and its role in the pathogenesis of hemorrhagic fever with renal syndrome, it might be difficult to develop an effective and safe HTNV vaccine through the isolate-inactivate-inject paradigm. With the development of high-throughput 'omics' technologies in the 21st century, vaccinomics has been introduced. While the goal of vaccinomics is to develop equations to describe and predict the immune response, it could also serve as a tool for developing new vaccine candidates and individualized approaches to vaccinology. Thus, the possibility of applying the innovative field of vaccinomics to develop a more effective and safer HTNV vaccine should be considered.

2016-03-01·Vaccine3区 · 医学

Long-term immunogenicity and safety of inactivated Hantaan virus vaccine (Hantavax™) in healthy adults

3区 · 医学

Article

作者: Baek, Luck Ju ; Kim, Woo Joo ; Song, Joon Young ; Noh, Ji Yun ; Cheong, Hee Jin ; Woo, Heung Jeong

BACKGROUNDHemorrhagic fever with renal syndrome is a serious health problem in Eurasian countries, including Korea and China. This study evaluated the long-term immunogenicity and safety of formalin-inactivated Hantaan virus vaccine (Hantavax™).METHODSA phase III, multi-center clinical trial was undertaken to evaluate the immunogenicity and safety of Hantavax™ (three-dose schedule at 0, 1, and 13 months) among healthy adults. Immune response was assessed using the plaque reduction neutralizing antibody test (PRNT) and immunofluorescent antibody assay (IFA). Antibody levels were measured pre-vaccination and at 2, 13, 14, 25, 37, and 49 months after the initial vaccination. Systemic and local adverse events were assessed.RESULTSA total of 226 healthy subjects aged 19-75 years were enrolled. Following two primary doses of Hantavax™, the seroconversion rate was 90.14% by IFA, but it was only 23.24% by PRNT50. With booster administration, seropositive rates were 87.32% and 45.07% at one month post-vaccination according to IFA and PRNT50, respectively. In young adults (19-39 years), the seropositive rate according to PRNT50 reached about 60% after booster vaccination. The mean duration of seropositive response was 735 days for PRNT50 and 845 days for IFA. Solicited local and systemic adverse events occurred in 47.79% and 25.22% of study subjects, respectively, and most were grade 1.CONCLUSIONHantavax™ showed a booster effect and immunogenicity lasting two years with a three-dose schedule. The neutralizing antibody response was quite poor with two primary doses, so an early booster vaccination at 2-6 months might be warranted to provide timely protection to high-risk subjects.

100 项与 Hantaan virus vaccine (Janssen Vaccines) 相关的药物交易

登录后查看更多信息