hAd5-Covid-19(hAd5-Covid-19) - 药物靶点：SARS-CoV-2 S protein_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名

Ad5-Covid-S/N vaccine、EUA S-Based Vaccines、SARS-CoV-2 infections vaccine - ImmunityBio

+ [6]

靶点

SARS-CoV-2 S protein

作用方式

抑制剂

作用机制

SARS-CoV-2 S protein抑制剂(冠状病毒刺突糖蛋白抑制剂)

治疗领域

感染呼吸系统疾病

在研适应症-

非在研适应症

新型冠状病毒感染

原研机构

ImmunityBio, Inc.

在研机构-

非在研机构

ImmunityBio, Inc.

最高研发阶段终止临床2/3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

6

项与 hAd5-Covid-19 相关的临床试验

NCT04843722

/ Withdrawn临床1/2期

Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use

This is a phase 1/2 study in adult healthy subjects that have previously been vaccinated with an FDA-authorized vaccine against COVID-19. This clinical trial is designed to assess the safety, efficacy, reactogenicity, and immunogenicity of hAd5-S-Fusion+N-ETSD formulated for subcutaneous, sublingual, and oral (capsule) administration.

开始日期2021-12-01

申办/合作机构

ImmunityBio, Inc.

NCT04845191

/ Withdrawn临床1/2期

Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Subcutaneously- and Orally- Administered Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use

This is a phase 1/2 study in adult healthy subjects that have previously been vaccinated with an FDA-authorized vaccine against COVID-19. This clinical trial is designed to assess the safety, efficacy, reactogenicity, and immunogenicity of hAd5-S-Fusion+N-ETSD formulated for subcutaneous and oral (capsule) administration.

开始日期2021-12-01

申办/合作机构

ImmunityBio, Inc.

NCT04710303

/ Completed临床1期

Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of a Prophylactic COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults (ProVIVA-SA-1)

This is a phase 1b, open-label study in adult healthy participants. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD vaccine and select a dose for future studies.

开始日期2021-03-02

申办/合作机构

ImmunityBio, Inc.

100 项与 hAd5-Covid-19 相关的临床结果

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100 项与 hAd5-Covid-19 相关的转化医学

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100 项与 hAd5-Covid-19 相关的专利（医药）

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1

项与 hAd5-Covid-19 相关的文献（医药）

Frontiers in Immunology2区 · 医学

Dual-Antigen COVID-19 Vaccine Subcutaneous Prime Delivery With Oral Boosts Protects NHP Against SARS-CoV-2 Challenge

2区 · 医学

ArticleOA

作者: Liu, Philip ; Verma, Mohit ; Balint, Joseph ; Peykov, Victor ; Niazi, Kayvan ; Sanford, Daniel C ; Sieling, Peter ; Drew, Jeff ; Gabitzsch, Elizabeth ; Rabizadeh, Shahrooz ; Zakin, Lise ; Adisetiyo, Helty ; Morimoto, Brett ; Bacon, Andrew ; Bezawada, Ashish ; Shin, Annie ; Wong, Raymond ; Spilman, Patricia ; Safrit, Jeffrey T ; Bone, Pete ; Sender, Lennie ; Soon-Shiong, Patrick ; Garban, Hermes ; Dinkins, Kyle ; Rice, Adrian

We have developed a dual-antigen COVID-19 vaccine incorporating genes for a modified SARS-CoV-2 spike protein (S-Fusion) and the viral nucleocapsid (N) protein with an Enhanced T-cell Stimulation Domain (N-ETSD) to increase the potential for MHC class II responses. The vaccine antigens are delivered by a human adenovirus serotype 5 platform, hAd5 [E1-, E2b-, E3-], previously demonstrated to be effective in the presence of Ad immunity. Vaccination of rhesus macaques with the hAd5 S-Fusion + N-ETSD vaccine by subcutaneous prime injection followed by two oral boosts elicited neutralizing anti-S IgG and T helper cell 1-biased T-cell responses to both S and N that protected the upper and lower respiratory tracts from high titer (1 x 106 TCID50) SARS-CoV-2 challenge. Notably, viral replication was inhibited within 24 hours of challenge in both lung and nasal passages, becoming undetectable within 7 days post-challenge.

100 项与 hAd5-Covid-19 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
新型冠状病毒感染	临床3期	美国	ImmunityBio, Inc.	2020-12-09
新型冠状病毒感染	临床3期	美国	ImmunityBio, Inc.	2020-12-09

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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


NCT04591717 (BusinessWire) 人工标引	临床1期	新型冠状病毒感染	20	hAd5 COVID-19 Vaccine+N-ETSD (Low dose)	(襯鏇齋鹽簾鹽製膚糧蓋) = Low dose cohort reports no serious adverse events (SAE), high dose cohort safety analysis ongoing 鑰遞製鹽繭製鹽窪齋獵 (衊繭壓選簾製膚獵餘構 )	积极	2020-11-10
				hAd5 COVID-19 Vaccine+N-ETSD (High dose)