古巴预防和治疗乙型肝炎的疫苗

StephenW

Cuban Prophylactic and Therapeutic Vaccines for Controlling Hepatitis B
Eduardo Pentón-Arias  1 , Julio César Aguilar-Rubido  1
Affiliations
Affiliation

    1
    Hepatitis B Group, Vaccine Department, Biomedical Research Division, CIGB, Havana, Cuba.

    PMID: 33780419 DOI: 10.37757/MR2021.V23.N1.6

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Abstract

Hepatitis B causes liver failure, cirrhosis and cancer. It has an estimated global prevalence of 6%, and 700,000 to 1 million persons die every year of hepatitis B-related causes. In 1989, hepatitis B incidence in Cuba was 14.9 per 100,000 population. To control infection, the Genetic Engineering and Biotechnology Center and the Ministry of Public Health, both in Havana, collaborated on a joint project that first produced natural interferon and recombinant interferon alpha-2b, and later a polyethylene glycolconjugated interferon. As part of the Cuban biotechnology development strategy, the project produced a vaccine against hepatitis B in 1985. At that time, hepatitis B vaccines available elsewhere in the world were costly and inaccessible to Cubans due to the US economic and trade embargo. The Heberbiovac HB preventive vaccine was approved by the Cuban regulatory authority and added to the Cuban newborn vaccination program in 1992 after phase 1-3 clinical trials demonstrated its safety and immunogenicity. From 2001 to 2003, PAHO/WHO qualified and requalified the vaccine four times. When associated with other antigens or molecules, Heberbiovac HB provides a common platform of virus-like particles that can be used in different ways, such as in the pentavalent vaccine containing Bordetella pertussis and Haemophilus infl uenzae type b antigens and tetanus and diptheria toxoids. Thanks to this vaccine, annual incidence of acute hepatitis in Cuba has dropped from more than 2000 cases to fewer than 100, and no infections in children aged 0-15 years have been reported since 2007. It is now used in more than 30 countries, providing protective, long-lasting antibody levels with no reports of serious adverse events. Yet, hepatitis B cannot be eliminated until there are no chronic patients. The comprehensive hepatitis B control project therefore included development of a therapeutic vaccine based on Heberbiovac HB. Using its platform, researchers designed an innovative version of the vaccine that was the precursor of a therapeutic nasal/subcutaneous vaccine for chronic hepatitis B, HeberNasvac. This precursor vaccine, which combines Heberbiovac HB with a recombinant antigen from the virus nucleocapsid (rHBcAg), was patented and licensed in 2015 by the Cuban regulatory authority. This article provides an overview of the progress-to-date on the development of this therapeutic vaccine, including clinical trials (some completed and others ongoing) to determine safety, efficacy and therapeutic benefits.

StephenW

古巴预防和治疗乙型肝炎的疫苗
爱德华多·彭顿·阿里亚斯1，朱利奥·塞萨尔·阿吉拉尔-鲁比多1
隶属关系
联系

    1个
    古巴哈瓦那CIGB生物医学研究部疫苗部门B肝炎小组。

    PMID：33780419 DOI：10.37757 / MR2021.V23.N1.6

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抽象的

乙型肝炎会导致肝衰竭，肝硬化和癌症。据估计，其全球患病率为6％，每年死于乙型肝炎相关疾病的人数为700,000至100万人。 1989年，古巴的乙肝发病率为每10万人中14.9例。为了控制感染，位于哈瓦那的基因工程和生物技术中心与公共卫生部合作开展了一个联合项目，该项目首先生产天然干扰素和重组干扰素α-2b，然后生产聚乙二醇结合的干扰素。作为古巴生物技术发展战略的一部分，该项目于1985年生产了针对乙型肝炎的疫苗。当时，由于美国的经济和贸易禁运，古巴人无法负担得起昂贵的乙型肝炎疫苗。 Heberbiovac HB预防性疫苗已获得古巴监管机构的批准，并在1-3期临床试验证明其安全性和免疫原性后于1992年加入古巴新生儿疫苗接种计划。从2001年到2003年，泛美卫生组织/世卫组织对疫苗进行了四次合格和重新评定。当与其他抗原或分子结合时，Heberbiovac HB提供了可以以不同方式使用的病毒样颗粒的通用平台，例如用于含有百日咳博德特氏菌和流感嗜血杆菌b型抗原以及破伤风和白喉类毒素的五价疫苗。得益于这种疫苗，古巴的急性肝炎年发病率已从2000多例降至不到100例，自2007年以来，没有报告过0-15岁儿童感染的报道。目前，该疫苗已在30多个国家/地区使用，提供保护性持久的抗体水平，而没有严重不良事件的报道。但是，除非没有慢性病，否则不能消除乙型肝炎。因此，全面的乙型肝炎控制项目包括开发基于Heberbiovac HB的治疗性疫苗。研究人员使用其平台设计了该疫苗的创新版本，该疫苗是用于慢性乙型肝炎的治疗性鼻/皮下疫苗HeberNasvac的前身。这种前体疫苗结合了Heberbiovac HB和来自病毒核衣壳（rHBcAg）的重组抗原，于2015年获得古巴监管机构的专利和许可。本文概述了这种治疗性疫苗的最新开发进展，包括确定安全性，功效和治疗益处的临床试验（一些已经完成，还有一些正在进行中）。

StephenW

https://mediccreview.org/wp-cont ... peutic-Vaccines.pdf