A Phase I Clinical Trial to Determine the Safety and Immunogenicity of the Candidate Mycobacterium Avium Subspecies Paratuberculosis (MAP) Vaccines ChAdOx2 HAV and MVA HAV in Healthy Adult Volunteers

A phase I dose escalation study to assess the safety and immunogenicity of the candidate vaccines ChAdOx2 HAV and MVA HAV in healthy volunteers.
Volunteers will be recruited and vaccinated in Oxford, England.
All vaccinations will be administered intramuscularly. Three different doses of the ChAdOx2 HAV will be tested (5x10^9 vp, 2.5x10^10 vp and 5x10^10vp). MVA HAV will be assessed at 2 different doses (5x10^7 and 2x10^8 pfu)
The total duration of the study will be 52 weeks from the day of enrolment for volunteers receiving ChAdOx2 HAV only, 12 weeks for volunteers receiving MVA HAV only and 20 weeks for volunteers receiving ChAdOx2 HAV and MVA HAV.

开始日期2017-03-15

申办/合作机构

University of Oxford

100 项与 ChAdOx2-HAV 相关的临床结果

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100 项与 ChAdOx2-HAV 相关的转化医学

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100 项与 ChAdOx2-HAV 相关的专利（医药）

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项与 ChAdOx2-HAV 相关的文献（医药）

International Journal of Molecular Sciences2区 · 生物学

Development of Viral-Vectored Vaccines and Virus Replicon Particle-Based Neutralisation Assay against Mayaro Virus

2区 · 生物学

ArticleOA

作者: Kümmerer, Beate Mareike ; Reyes-Sandoval, Arturo ; López-Camacho, César ; Kim, Young Chan ; Lücke, Arlen-Celina

Mayaro virus (MAYV) is an emerging alphavirus causing acute febrile illness associated with chronic polyarthralgia. Although MAYV is currently restricted to tropical regions in South America around the Amazon basin, it has the potential to spread globally by Aedes species mosquitoes. In addition, there are currently no specific therapeutics or licenced vaccines against MAYV infection. We have previously shown that an adenovirus based Mayaro vaccine (ChAdOx1 May) was able to provide full protection against MAYV challenge in vaccinated A129 mice and induced high neutralising antibody titres. In this study, we have constructed a replication deficient simian adenovirus (ChAdOx2) and a Modified Ankara Virus (MVA) based vaccine expressing the MAYV structural cassette (sMAYV) similar to ChAdOx1 May, and characterised recombinant MAYV E2 glycoprotein expressed in a mammalian system for immune monitoring. We demonstrate that ChAdOx2 May was able to induce high antibody titres similar to ChAdOx1 May, and MVA May was shown to be an effective boosting strategy following prime vaccination with ChAdOx1 or ChAdOx2 May. In order to measure MAYV neutralising ability, we have developed a virus replicon particle-based neutralisation assay which effectively detected neutralising antibodies against MAYV. In summary, our study indicates the potential for further clinical development of the viral vectored MAYV vaccines against MAYV infections.

Vaccines3区 · 医学

Safety and Immunogenicity of a Novel Recombinant Simian Adenovirus ChAdOx2 as a Vectored Vaccine

3区 · 医学

ArticleOA

作者: Poulton, Ian ; Mitton, Celia H ; Folegatti, Pedro M ; Bellamy, Duncan ; Powlson, Jonathan ; Hill, Adrian V S ; Green, Nicky ; Roberts, Rachel ; Edwards, Nick J ; Mair, Catherine F ; Ewer, Katie J ; Hermon-Taylor, John ; Berrie, Eleanor ; Lawrie, Alison M ; Bowyer, Georgina ; Gilbert, Sarah C

Adenovirus vectored vaccines are a highly effective strategy to induce cellular immune responses which are particularly effective against intracellular pathogens. Recombinant simian adenovirus vectors were developed to circumvent the limitations imposed by the use of human adenoviruses due to widespread seroprevalence of neutralising antibodies. We have constructed a replication deficient simian adenovirus-vectored vaccine (ChAdOx2) expressing 4 genes from the Mycobacterium avium subspecies paratuberculosis (AhpC, Gsd, p12 and mpa). Safety and T-cell immunogenicity results of the first clinical use of the ChAdOx2 vector are presented here. The trial was conducted using a ‘three-plus-three’ dose escalation study design. We demonstrate the vaccine is safe, well tolerated and immunogenic.

100 项与 ChAdOx2-HAV 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
细胞内鸟分枝杆菌感染	临床1期	英国	University of Oxford	2017-03-15
克罗恩病	临床1期	英国	The Jenner Institute Laboratories	2017-01-31
克罗恩病	临床1期	英国	HAV Vaccines Limited	2017-01-31
副结核	临床1期	英国	The Jenner Institute Laboratories	2017-01-31
副结核	临床1期	英国	University of Oxford	2017-01-31
副结核	药物发现	英国	HAV Vaccines Limited	2017-01-31