Malecki Marek, Saetre Bianka
Phoenix Biomolecular Engineering Foundation (PBMEF), San Francisco, CA, USA.
Mol Cell Ther. 2018 Apr;6(1). doi: 10.26781/2052-8426-2018-05. Epub 2018 Apr 30.
For many deadly viruses, there are no preventive and / or therapeutic vaccines approved by health authorities World-wide (e.g., HIV, Ebola, Dengue, and many others). Although, for some viruses, prophylactic vaccines are very effective (e.g., HBV, and many others).In this realm, we design, manufacture, test, and streamline into the clinics novel viral universal vaccines (VUV). VUV have such unique features, that medical vaccination or natural infection induced immunity against some viruses (e.g., HBV) upon the VUV's administration to the infected with other, different viruses patients, is redirected against these other, newly infecting viruses (e.g., HIV).
The specific aim of this work was biomolecular engineering of the HIV universal vaccine comprising the two main functional domains: CD4 or anti-gp120 - as the HIV tagging domain and HBsAg - as the immune response eliciting domain, so that upon its administration the HBV medical immunization or natural infection induced immunity would be redirected, accelerated, and amplified to fight the HIV infection.
Per the Institutional Review Board approval and in compliance with the Declaration of Helsinki, all healthy donors and patients were presented with the Patients' Bill of Rights and provided Patient Informed Consent. All the procedures were pursued by the licensed medical doctors.
METHODS & RESULTS: We have biomolecularly engineered HIV universal vaccine (HIVUV) comprising human CD4 or anti-gp120 and HBsAg of HBV. By immunoblotting and magnetic activated molecular sorting, we have demonstrated high specificity of this vaccine in binding HIV. By flow cytometry and nuclear magnetic resonance, we have demonstrated high efficacy of these vaccines to engage HBV immunized patients' immune system against HIV. Administration of HIVUV to blood or lymph of the HIV+ patients resulted in rapid reduction of the HIV viremia down to undetectable. It also resulted in protection of populations of CD4+ cells against HIV caused decline.
We have demonstrated the proof of concept for high efficacy of VUV, specifically HIVUV, in annihilating HIV. Nevertheless, the same compositions, processes, and methods, for persons skilled in biotechnology, pharmacogenomics, and molecular medicine, are adaptable for other deadly viral infections, which we vigorously pursue.
对于许多致命病毒而言，全球卫生当局尚未批准预防性和/或治疗性疫苗（例如，艾滋病毒、埃博拉病毒、登革热病毒等）。尽管对于某些病毒，预防性疫苗非常有效（例如，乙肝病毒等）。在此领域，我们设计、制造、测试并将新型病毒通用疫苗（VUV）引入临床。VUV具有独特的特性，即当将其给予感染其他不同病毒的患者时，针对某些病毒（例如，乙肝病毒）的医学疫苗接种或自然感染诱导的免疫会被重新导向，以对抗这些新感染的病毒（例如，艾滋病毒）。
这项工作的具体目标是对包含两个主要功能域的艾滋病毒通用疫苗进行生物分子工程改造：作为艾滋病毒标记域的CD4或抗gp120以及作为免疫反应引发域的乙肝表面抗原（HBsAg），以便在接种后，乙肝医学免疫或自然感染诱导的免疫能够被重新导向、加速并增强，以对抗艾滋病毒感染。
经机构审查委员会批准并遵循《赫尔辛基宣言》，向所有健康供体和患者提供了《患者权利法案》并获得了患者知情同意书。所有程序均由持牌医生执行。
我们对包含人类CD4或抗gp120以及乙肝病毒HBsAg的艾滋病毒通用疫苗（HIVUV）进行了生物分子工程改造。通过免疫印迹和磁激活分子分选，我们证明了该疫苗在结合艾滋病毒方面具有高特异性。通过流式细胞术和核磁共振，我们证明了这些疫苗在使乙肝免疫患者的免疫系统对抗艾滋病毒方面具有高效性。将HIVUV注入艾滋病毒阳性患者的血液或淋巴中可使艾滋病毒血症迅速降至无法检测的水平。它还能保护CD4 +细胞群体免受艾滋病毒导致的减少。
我们已经证明了VUV，特别是HIVUV在消灭艾滋病毒方面具有高效性的概念验证。然而，对于生物技术、药物基因组学和分子医学领域的专业人员来说，相同的成分、工艺和方法适用于其他致命病毒感染，我们正在大力开展相关研究。
