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Moderna启动使用基因技术的艾滋病疫苗临床试验

2022-01-28 14:24   美国新闻网   - 

Moderna周四宣布,它已经启动了艾滋病毒基因疫苗的早期临床试验。

这家生物技术公司与非营利组织“国际艾滋病疫苗倡议”合作开发了这种疫苗,它使用的技术与Moderna成功的新冠肺炎疫苗相同。

根据一项研究,第一阶段试验的第一批参与者在华盛顿特区的乔治·华盛顿大学医学和健康科学学院接受了注射公司声明。

IAVI公司总裁兼首席执行官马克·范伯格博士在一份声明中说:“我们非常兴奋能够利用Moderna的mRNA平台推进艾滋病毒疫苗设计的这一新方向。“寻找艾滋病毒疫苗是一项长期而具有挑战性的工作,在免疫原和平台方面拥有新的工具可能是朝着急需的、有效的艾滋病毒疫苗取得快速进展的关键。”

PHOTO: A view of Moderna headquarters in Cambridge, Mass., May 8, 2020.

曼迪·迈耶/盖蒂图像,文件

马萨诸塞州剑桥市的Moderna总部。,2020年5月8日。

全球近3800万人——包括美国约130万人——携带艾滋病毒或人类免疫缺陷病毒,这可能导致潜在的致命疾病艾滋病。

被诊断感染艾滋病毒一度被认为是死刑。根据疾病控制和预防中心的数据,在20世纪90年代中期美国艾滋病流行最严重的时候,每年有5万多人死亡。

如今,艾滋病毒更容易控制,可以使用药物将病毒载量降低到无法检测的水平,这样病毒就不会传播,还可以使用药丸来防止感染艾滋病毒阴性的人。

但是尽管几十年的研究,还没有疫苗被开发出来。几名候选人已经进入临床试验,但在后期阶段失败。

这种新疫苗使用mRNA或信使RNA,它教身体细胞如何制造引发免疫反应的蛋白质。

研究人员不仅开发了一种初级疫苗,还开发了一种助推器,通过基因传递艾滋病毒免疫原——引发免疫反应的分子。

希望这个过程可以诱导特定的白细胞,称为B细胞,然后可以转化为广泛中和抗体,可以中和病毒。

根据声明,试验的第一阶段将在GWU和另外三个地点招募56名健康、艾滋病毒阴性的成年参与者:亚特兰大埃默里疫苗中心的希望诊所;西雅图弗雷德·哈钦森癌症研究中心;和圣安东尼奥的德克萨斯大学健康科学中心。

在志愿者中,48人将接受一到两剂基因疫苗,32人也将接受加强剂。其余八个将只接收助推器。

然后,研究人员将在参与者接受最后一剂疫苗后的六个月内监测新疫苗的安全性和有效性。

Moderna没有立即回应美国广播公司新闻的置评请求。

Moderna launches clinical trial for HIV vaccine that uses mRNA technology

Moderna announced Thursday that it's launched early-stage clinical trials of an HIV mRNA vaccine.

The biotechnology company has teamed up with the nonprofit ​​International AIDS Vaccine Initiative to develop the shot, which uses the same technology as Moderna's successful COVID-19 vaccine.

The first participants in the Phase I trial were given doses at George Washington University School of Medicine and Health Sciences in Washington, D.C., according to acompany statement.

"We are tremendously excited to be advancing this new direction in HIV vaccine design with Moderna's mRNA platform," Dr. Mark Feinberg, president and CEO of IAVI, said in a statement. "The search for an HIV vaccine has been long and challenging, and having new tools in terms of immunogens and platforms could be the key to making rapid progress toward an urgently needed, effective HIV vaccine."

Nearly 38 million people worldwide -- including about 1.3 million in the U.S -- are living with HIV, or human immunodeficiency virus, which can lead to the potentially fatal disease AIDS.

Being diagnosed with HIV was once considered a death sentence. During the height of the U.S. AIDS epidemic in the mid-1990s, more than 50,000 deaths occurred every year, according to the Centers for Disease Control and Prevention.

Today, HIV is much more manageable with medications that can reduce viral loads to undetectable so the virus can't be transmitted, as well as pills that can be taken to prevent infecting those who are HIV-negative.

But despite decades of research, no vaccine has ever been developed. Several candidates have entered clinical trials but failed in later stages.

The new vaccine uses mRNA, or messenger RNA, which teaches the body's cells how to make proteins that trigger immune responses.

Researchers have developed not only a primary vaccine but also a booster to deliver HIV immunogens -- molecules that elicit an immune response -- via mRNA.

The hope is this process can induce specific white blood cells, called B cells, which can then turn into what are known as broadly neutralizing antibodies that can neutralize the virus.

According to the statement, Phase I of the trial will enroll 56 healthy, HIV-negative adult participants at GWU and three additional sites: Hope Clinic of Emory Vaccine Center in Atlanta; Fred Hutchinson Cancer Research Center in Seattle; and the University of Texas-Health Science Center at San Antonio.

Of the volunteers, 48 will receive one or two doses of the mRNA vaccine, and 32 also will receive the booster. The remaining eight will receive just the booster.

Researchers will then monitor for safety and efficacy of the new vaccine for up to six months after participants receive their final dose.

Moderna did not immediately respond to ABC News' request for comment.

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