African trial could potentially support licensure of mpox vaccine in endemic countries and expansion of current regulatory approvals to include childrenCEPI has awarded USD 6.5 million in funding to support the Phase 2 clinical trial which is projected to start later in 2024 COPENHAGEN, Denmark / OSLO, Norway, May 30, 2024 – Bavarian Nordic A/S (OMX: BAVA) and the Coalition for Epidemic Preparedness Innovations (CEPI) today announced a partnership to advance the development of Bavarian Nordic’s mpox vaccine in children in Africa.

非洲试验可能有助于在流行国家获得mpox疫苗的许可证，并扩大目前的监管批准范围，将儿童包括在内。欧洲疫苗研究所已授予650万美元资金，以支持第二阶段临床试验，该试验预计将于2024年5月30日在丹麦/挪威奥斯陆哥本哈根晚些时候开始。巴伐利亚-北欧A/S（OMX:BAVA）和防疫创新联盟（CEPI）今天宣布建立伙伴关系，以推动巴伐利亚-北欧mpox疫苗在非洲儿童中的开发。

CEPI has awarded USD 6.5 million1 to support a Phase 2 clinical study evaluating the immunogenicity and safety of the MVA-BN® non-replicating vaccine in children from 2 years to less than 12 years of age compared to adults aged 18-50 years of age for the prevention of smallpox, mpox and related orthopoxvirus infections.

CEPI已授予650万美元1，用于支持一项2期临床研究，评估MVA-BN®非复制疫苗在2岁至12岁以下儿童中的免疫原性和安全性，与18-50岁的成年人相比，用于预防天花，mpox和相关的正痘病毒感染。

Subject to regulatory approvals, the study plans to enroll a total of approximately 460 healthy individuals in endemic regions without previous mpox infection or poxvirus vaccination, who will receive two doses of the MVA-BN vaccine. Bavarian Nordic will be the sponsor of the trial which will be conducted in one or more African countries with planned initiation later in 2024.

根据监管部门的批准，该研究计划在没有mpox感染或痘病毒疫苗接种的流行地区招募总共约460名健康个体，他们将接受两剂MVA-BN疫苗。巴伐利亚北欧将成为该试验的赞助商，该试验将在一个或多个非洲国家进行，计划于2024年晚些时候启动。

The new trial follows the publication of a continental plan by Africa CDC and African Ministries of Health to strengthen mpox preparedness and response efforts, as well as the World Health Organization’s (WHO) framework for enhancing prevention and control of mpox. Results from this study could provide assurance of the use of this vaccine in children, and thus support an extension of the current regulatory approvals for use of the vaccine in adults to also include children 2-12 years of age.

在这项新的试验之前，非洲疾病预防控制中心和非洲卫生部发布了一项大陆计划，以加强mpox的准备和应对工作，以及世界卫生组织（WHO）加强mpox预防和控制的框架。这项研究的结果可以保证这种疫苗在儿童中的使用，从而支持将目前在成人中使用疫苗的监管批准扩展到包括2-12岁的儿童。

Importantly, the study will also generate evidence on the vaccine .

重要的是，这项研究还将为疫苗提供证据。

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2024-05-30-en

2024-05-30-en