H5N1 vaccine(Intercell USA)(H5N1 vaccine(Intercell USA))

概要

基本信息

药物类型

疫苗

别名-

靶点-

作用方式

刺激剂

作用机制

免疫刺激剂

治疗领域-

在研适应症-

非在研适应症-

原研机构

Intercell USA, Inc.

在研机构-

非在研机构

Intercell USA, Inc.

权益机构-

最高研发阶段无进展临床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

4

项与 H5N1 vaccine(Intercell USA) 相关的临床试验

NCT01353534

/ Completed临床1/2期

A Phase 1/2, Randomized, Open-Label, Study to Assess the Immunogenicity and Safety of a Vaccine Enhancement Patch (VEP) When Administered With Two Doses of Intramuscular Inactivated Influenza H5N1 Vaccine in Healthy Adults

Groups 1 to 3 will receive two vaccinations on Day 0 and Day 21. Group 1 will receive 3.8µg A/H5N1 antigen formulated with AS03 adjuvant, administered by IM injection. Group 2 will receive 15µg A/H5N1 by IM alone. Group 3 will also receive 15µg A/H5N1 antigen administered IM but followed by the topical application of a VEP at the vaccination site. Group 4 will receive a single vaccination on Day 0 of 30µg A/H5N1antigen by IM, followed by application of a VEP at the vaccination site.
The VEP (Vaccine Enhancement Patch) contains 50 mcg LT (heat-labile enterotoxin of E. coli)

开始日期2011-05-01

申办/合作机构

Intercell USA, Inc.

NCT00908687

/ Completed临床2期

A Randomized Blinded, LT Dose-ranging Study to Assess the Immunogenicity and Safety of Different Doses of LT Adjuvant Patch Administered in Conjunction With Different Doses of Inactivated Influenza A/H5N1 Vaccine in Healthy Adults

This is a Phase 2, randomized, blinded, clinical trial. Up to 500 eligible subjects will be enrolled and randomized in a 1:2:2:1:2:2 ratio into one of six groups, and vaccinated in this study. Subjects will receive an intramuscular injection of the influenza A/H5N1 (low or high dose) on Day 0 with or without a patch (low or high dose).

开始日期2009-05-01

申办/合作机构

Intercell USA, Inc.

[+1]

JPRN-jRCT1090220019

/ Completed临床4期IIT

Phase IV, Open-label Study to Assess the Safety of H5N1 Pre-pandemic Vaccine (BK-KIB-01) - BK-KIB-01

开始日期2008-08-04

申办/合作机构-

100 项与 H5N1 vaccine(Intercell USA) 相关的临床结果

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100 项与 H5N1 vaccine(Intercell USA) 相关的转化医学

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100 项与 H5N1 vaccine(Intercell USA) 相关的专利（医药）

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38

项与 H5N1 vaccine(Intercell USA) 相关的文献（医药）

2022-03-01·Preventive Veterinary Medicine2区 · 农林科学

Benefit-cost analysis of a H7N9 vaccination program in poultry in Guangxi, China

2区 · 农林科学

Article

作者: Kang, Jingli ; Bruce, Mieghan ; Robertson, Ian D ; Shen, Chaojian ; Huang, Baoxu ; Wang, Youming ; Tang, Hao ; Cai, Chang ; Edwards, John

China launched a H7N9 vaccination program in poultry, starting from the Guangxi and Guangdong provinces in July 2017, followed by other provinces in September 2017, as a response to a steep increase of H7N9 influenza human infections from September 2016. Since then, H5-H7 bivalent vaccine has been used in the nationwide avian influenza compulsory vaccination program to replace the existing H5N1 vaccine. However, the economic returns of the H7N9 vaccination program in China have never been adequately assessed. This study was designed to evaluate the economic value of the H7N9 vaccination program in Guangxi by assessing the benefits and costs of the program compared to not vaccinating against H7N9. A benefit-cost analysis (BCA) was undertaken to evaluate the adoption of a vaccination program against H7N9 in each of three consecutive years from July 2017 to June 2020 with the baseline scenario (the absence of H7N9 vaccination in the 12-month period July 2016 to June 2017). Both animal and public health perspectives were included in the BCA framework and took account of both the private and public sectors. Benefit-Cost Ratio (BCR) of the three-year H7N9 vaccination program was 18.6 (90 %PI: 15.4; 21.8), and total Net Present Values reached to CNY 1.63 billion (90 %PI: 1.37 billion; 1.89 billion). The extra revenue generated by the yellow broiler industry comprised 93.8 % of the total benefits after adoption of H7N9 vaccination program in Guangxi. While cost-savings in public health and animal health expenditure avoided were 3.6 % and 2.6 %, respectively. Total costs arising from adoption of the revised vaccination program over the three years were CNY 12.46 million (90 %PI: 11.49 million; 14.14 million), CNY 34.87 million (90 %PI: 31.88 million; 40.06 million), and CNY 44.28 million (90 %PI: 39.66 million; 52.27 million), respectively. Sensitivity analysis found the yellow broiler wholesale prices contributed 97.7 % of the variance of the total NPV of three vaccination years. The study results demonstrate the significant economic advantage of implementing a vaccination program against H7N9 in Guangxi. It also offers a new set of evidence to China's H7N9 vaccination policy and debates around economic values of conducting routine avian influenza vaccination.

2021-02-01·Human Vaccines & Immunotherapeutics3区 · 医学

Immunogenicity of H5N1 influenza vaccines in elderly adults: a systematic review and meta-analysis

3区 · 医学

Review

作者: Huang, Junqiong ; Wu, Xiaoxue ; Shi, Yu ; Zhang, Ke ; Gou, Xiaoqin

Several different vaccines have been produced for human use to prevent the highly pathogenic H5N1 influenza. Some studies reported that the clinical effectiveness of influenza vaccines in older adults may be lower than in younger adults. In this study, a meta-analysis of the immunogenicity of H5N1 influenza vaccines in elderly adults was performed. Database search was conducted in EMBASE, PubMed, the Cochrane Library, Chinese VIP, Wanfang and CBM. A total of 3951 elderly adults from 10 articles were included in the meta-analysis. Compared to a single dose, two doses of H5N1 vaccines resulted in the higher seroconversion and seroprotection. For all groups treated with adjuvanted vaccines, there were significant increases (1.55- to 2.16-fold) in the seroconversion rates (SCRs) and seroprotection rates (SPRs) after two immunizations. Oil-in-water emulsion (OE)-adjuvanted 7.5 μg vaccine caused higher antibody responses than 3.75 μg of vaccine (SCR: risk ratio (RR) = 1.26 (1.19, 1.33); SPR: RR = 1.25 (1.14, 1.36)). Elderly adults exhibited slightly lower antibody responses only when given 7.5 μg of OE-adjuvanted vaccine (SCR: RR = 1.06 (1.01, 1.11)) than younger adults. After treatment with the 7.5 μg of OE-adjuvanted vaccines, the most commonly reported adverse events were injection site pain, swelling and erythema, with the incidence of 32%, 3% and 2%, respectively, and no serious adverse events were found. These data demonstrate that two doses of 7.5 µg of OE-adjuvanted H5N1 vaccine are well tolerated and induce a robust antibody response in elderly adults.

2019-10-01·Journal of Microbiology, Immunology and Infection2区 · 医学

The safety and immunogenicity of a cell-derived adjuvanted H5N1 vaccine – A phase I randomized clinical trial

2区 · 医学

ArticleOA

作者: Chang, Shan-Chwen ; Li, Yu-Han ; Pan, Sung-Ching ; Lin, Ting-Wan ; Hsieh, Erh-Fang ; Lee, Hsiang-Chi ; Lai, Kuan-Lang ; Hsieh, Szu-Min ; Shi-Chung Chang, Stanley ; Chen, Charles ; Cheng, Aristine

BACKGROUNDDevelopment of an efficacious egg-free mock-up H5N1 vaccine is key to our preparedness against pandemic avian flu.METHODSThis is a single-center, randomized, observer-blinded phase I clinical trial evaluating the safety and immunogenicity of an alum-adjuvanted Madin-Darby canine kidney (MDCK)-derived inactivated whole-virion H5N1 influenza vaccine in healthy adults. Hemagglutination inhibition (HAI) and neutralizing antibody titers were measured using horse and turkey red blood cells (RBCs).RESULTSThirty-six adult subjects were randomized to receive two doses of 0.5 mL of the MDCK-derived H5N1 alum-adjuvanted vaccine containing 7.5, 15, or 30 μg of hemagglutinin (HA) 21 days apart. The candidate vaccine was well tolerated and safe across the three dosing groups. The most frequent adverse event was injection site pain (46.5%). Both HAI and neutralizing antibody titers increased after each vaccination in all three dosing groups. The best HAI responses, namely a seroconversion rate of 91.7% and a geometric mean ratio of 9.51 were achieved with the HA dose of 30 μg assayed using horse RBCs at day 42. HAI titers against H5N1 avian influenza virus was significantly higher when measured using horse RBCs compared with turkey RBCs.CONCLUSIONSThis Phase I trial showed the MDCK-derived H5N1 candidate vaccine is safe and immunogenic. The source of RBCs has a significant impact on the measurement of HAI titers (ClinicalTrials.gov number: NCT01675284.).

100 项与 H5N1 vaccine(Intercell USA) 相关的药物交易

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研发状态

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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


NCT00908687 (CTgov)	临床2期	甲型流感病毒感染	500	A/H5N1 (Group 1: 30 µg HA, no LT Patch)	獵構鏇顧憲鹹遞鬱製鑰(觸範簾鹹廠鑰製齋鏇選) = 鏇築範憲艱觸衊淵夢遞積齋壓網築積廠網蓋齋 (築艱製鬱簾膚鹽遞鹹醖, 觸憲糧夢壓築積窪艱製 ~ 觸夢齋築艱餘製鏇醖糧) 更多	-	2014-03-13
				LT Adjuvant Patch+A/H5N1 (Group 2: 30 µg HA + 50 µg LT Patch)	獵構鏇顧憲鹹遞鬱製鑰(觸範簾鹹廠鑰製齋鏇選) = 繭齋範餘艱壓壓衊積觸積齋壓網築積廠網蓋齋 (築艱製鬱簾膚鹽遞鹹醖, 鏇膚鹽願蓋構廠夢齋窪 ~ 窪夢夢齋蓋艱顧顧壓選) 更多