ChAdOx1.tHIVconsv1(ChAdOx1.tHIVconsv1) - 在研适应症：HIV感染_专利_临床

概要

基本信息

药物类型

预防性疫苗

别名-

靶点-

作用机制-

治疗领域

免疫系统疾病感染泌尿生殖系统疾病

在研适应症

HIV感染

非在研适应症-

原研机构

University of Oxford

在研机构

National Institute of Allergy & Infectious Diseases

非在研机构-

最高研发阶段临床1/2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 ChAdOx1.tHIVconsv1 相关的临床试验

NCT06484335 / Not yet recruiting临床1期IIT

Approach to Control HIV With Immune Enhancement and Vaccination (ACHIEV): Safety and Efficacy of Broadly Neutralizing Antibodies Combined With Therapeutic Vaccination for the Induction of HIV Remission

This is a phase I, randomized, double-blind, placebo-controlled clinical trial to investigate the safety of VRC07-523LS and PGDM1400LS in combination with ChAdOx1.tHIVconsv1, ChAdOx1.HIVconsv62 prime, MVA.tHIVconsv4 and A244d11gp120/ALFQ vaccination, and the impact on viral load setpoint during analytic treatment interruption (ATI) in people living with human immunodeficiency virus-1 (HIV-1, PLWH) who have initiated or will initiate antiretroviral therapy (ART) during acute HIV-1 infection (AHI).

开始日期2025-02-01

申办/合作机构

The Henry M. Jackson Foundation

NCT06071767 / Recruiting临床1/2期IIT

A Phase I/IIa Randomized, Placebo-Controlled Trial of Conserved-Mosaic T-cell Vaccine in a Regimen With Vesatolimod and Broadly Neutralizing Antibodies in Adults Initiated on Suppressive Antiretroviral Therapy During Acute HIV-1

The purpose of this study is to evaluate the safety, tolerability, and efficacy of therapeutic vaccination with chimpanzee adenovirus (ChAdV)- and poxvirus modified vaccinia Ankara (MVA)-vectored conserved mosaic T-cell vaccines in a sequential regimen with the Toll-like Receptor 7 (TLR7) agonist vesatolimod (VES) and two broadly neutralizing antibodies (bNAbs) compared to placebo, to induce HIV-1 control during analytic treatment interruption (ATI).

开始日期2024-04-01

申办/合作机构

National Institute of Allergy & Infectious Diseases

[+2]

EUCTR2019-003102-26-IT / Unknown status临床1/2期IIT

Therapeutic vaccination: A Phase I/II Randomized, Placebo-Controlled Trial of ChAdOx1.tHIVconsvX prime-MVA.tHIVconsvX Boost Vaccination Regimen in Early-treated durably-controlling HIV-1 positive Adults. - HIV-CORE 007

开始日期2021-07-14

申办/合作机构

Ospedale San Raffaele Srl

100 项与 ChAdOx1.tHIVconsv1 相关的临床结果

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100 项与 ChAdOx1.tHIVconsv1 相关的转化医学

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100 项与 ChAdOx1.tHIVconsv1 相关的专利（医药）

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3

项与 ChAdOx1.tHIVconsv1 相关的文献（医药）

2023-07-01·Vaccines

Adenovirus Transcriptome in Human Cells Infected with ChAdOx1-Vectored Candidate HIV-1 Vaccine Is Dominated by High Levels of Correctly Spliced HIVconsv1&62 Transgene RNA.

Article

作者: Matthews, David A ; Wee, Edmund G ; Hanke, Tomáš ; Milligan, Rachel

We develop candidate HIV-1 vaccines, of which two components, ChAdOx1.tHIVconsv1 (C1) and ChAdOx1.HIVconsv62 (C62), are delivered by the simian adenovirus-derived vaccine vector ChAdOx1. Aberrant adenovirus RNA splicing involving transgene(s) coding for the SARS-CoV-2 spike was suggested as an aetiology of rare adverse events temporarily associated with the initial deployment of adenovirus-vectored vaccines during the COVID-19 pandemic. Here, to eliminate this theoretically plausible splicing phenomenon from the list of possible pathomechanisms for our HIV-1 vaccine candidates, we directly sequenced mRNAs in C1- and C62-infected nonpermissive MRC-5 and A549 and permissive HEK293 human cell lines. Our two main observations in nonpermissive human cells, which are most similar to those which become infected after the intramuscular administration of vaccines into human volunteers, were that (i) the dominant adenovirus vector-derived mRNAs were the expected transcripts coding for the HIVconsvX immunogens and (ii) atypical splicing events within the synthetic open reading frame of the two transgenes are rare. We conclude that inadvertent RNA splicing is not a safety concern for the two tested candidate HIV-1 vaccines.

2022-12-01·Vaccine

Guillain-Barré syndrome temporally associated with COVID-19 vaccines in Victoria, Australia

Article

作者: Osowicki, Joshua ; Buttery, Jim P ; Crawford, Nigel W ; Kiers, Lynette ; Clothier, Hazel J ; Harris, Adele ; Morgan, Hannah J

Guillain-Barré syndrome (GBS) is an adverse event of special interest (AESI) for surveillance systems monitoring adverse events following immunisation (AEFI) with COVID-19 vaccines. Emerging data support a temporal association between GBS and adenovirus-vector COVID-19 vaccines. We present a case series of GBS reports submitted between February and November 2021 to our enhanced spontaneous surveillance system (SAEFVIC) in Victoria, Australia, following vaccination with either the adenovirus-vector vaccine Vaxzevria ChadOx1-S (AstraZeneca) or an mRNA vaccine (Comirnaty BNT162b2 [Pfizer-BioNTech] or Spikevax mRNA-1273 [Moderna]). For each report, Brighton Collaboration case definitions were used to describe diagnostic certainty. Severity was graded using the GBS Disability Score. The observed incidence of GBS following immunisation against COVID-19 was compared to expected background ICD10-AM G61.0 coded hospitalisations. There were 41 total cases of GBS reported to SAEFVIC following Vaxzevria (n = 38), Comirnaty (n = 3), or Spikevax (n = 0) vaccines. The observed GBS incidence rate exceeded the expected background rate for Vaxzevria only, with 1.85 reports per 100,000 doses following dose 1, higher than the expected rate of 0.39 hospital admissions per 100,000 adults within 42 days of vaccination. Of 38 GBS reports following Vaxzevria, the median age at vaccination was 66 years and median onset of symptoms was 14 days following immunisation. There was one death. Four cases initially categorised as GBS were later reclassified as acute-onset chronic inflammatory demyelinating polyneuropathy. Fatigue was the predominant persisting symptom reported at follow up. Additional global studies are required to characterise risk factors, clinical variability, and to provide precision and generalizability regarding AEFI risks such as GBS associated with different vaccine platforms, which will help inform communication of the potential benefits and risks of COVID19 vaccination.

2021-11-01·Vaccine3区 · 医学

Immune thrombocytopenia following immunisation with Vaxzevria ChadOx1-S (AstraZeneca) vaccine, Victoria, Australia

3区 · 医学

Article

作者: Tran, Huyen ; Morgan, Hannah ; Phuong, Linny K ; Szer, Jeff ; Gordon, Sally F ; Crawford, Nigel W ; Monagle, Paul ; Buttery, Jim P ; Wood, Erica M ; Chunilal, Sanjeev ; Clothier, Hazel J

Emerging evidence suggest a possible association between immune thrombocytopenia (ITP) and some formulations of COVID-19 vaccine. We conducted a retrospective case series of ITP following vaccination with Vaxzevria ChadOx1-S (AstraZeneca) and mRNA Comirnaty BNT162b2 COVID-19 (Pfizer-BioNTech) vaccines and compare the incidence to expected background rates for Victoria during the first six months of the Australian COVID-19 vaccination roll-out in 2021. Cases were identified by reports to the Victorian state vaccine safety service, SAEFVIC, of individuals aged 18 years or older presenting with thrombocytopenia following COVID-19 vaccination without evidence of thrombosis. Twenty-one confirmed or probable cases of ITP were identified following receipt of AstraZeneca (n = 17) or Pfizer-BioNTech (n = 4) vaccines. This translates to an observed incidence of 8 per million doses for AstraZeneca vaccine, twice the expected background rate of 4.1 per million. The observed rate for Pfizer-BioNTech was consistent with the expected background rate. The median time to onset for the cases post AstraZeneca vaccination was 10 days (range 1-78) and median platelet nadir 5 × 10⁹/L (range 0-67 × 10⁹/L). Hospital presentations or admissions for management of symptoms such as bleeding occurred in 18 (86%) of the cases. The majority of cases (n = 11) required intervention with at least 2 therapy modalities. In conclusion, we observed a substantially higher than expected rate of ITP following AstraZeneca vaccination. ITP is the second haematological adverse event, distinct from that of thrombosis with thrombocytopenia syndrome (TTS), observed following AstraZeneca vaccination.

100 项与 ChAdOx1.tHIVconsv1 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
HIV感染	临床2期	美国	National Institute of Allergy & Infectious Diseases	2024-04-01
HIV感染	临床2期	巴西	National Institute of Allergy & Infectious Diseases	2024-04-01

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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


NCT04586673 (CTgov)	临床1期	HIV感染	13	ChAdOx1.tHIVconsv1 (C1) (ChAdOx1.tHIVconsv1 Low Dose)	蓋壓鏇簾襯築觸願廠壓(鬱鏇鹽選壓廠衊築壓蓋) = 艱網廠鏇範艱鏇繭齋憲醖選簾醖積艱鏇淵廠製 (積艱餘夢襯鹹積壓簾鏇, 積繭範獵鬱鑰鹽鏇淵願 ~ 鹹鏇鏇膚夢鏇範鏇憲選) 更多	-	2024-09-03
				MVA.tHIVconsv4 (M4)+MVA.tHIVconsv3 (M3)+ChAdOx1.tHIVconsv1 (C1) (ChADOx1.tHIVconsv1 Higher Dose)	蓋壓鏇簾襯築觸願廠壓(鬱鏇鹽選壓廠衊築壓蓋) = 獵鬱構艱淵築遞壓糧製醖選簾醖積艱鏇淵廠製 (積艱餘夢襯鹹積壓簾鏇, 遞網鬱窪醖廠艱鹹廠顧 ~ 製網願願鏇構鹹壓鏇窪) 更多