中毒性休克综合征(TSS)是一种因细菌毒素引起的严重的循环系统和器官衰竭疾病，通常由葡萄球菌引发。维也纳大学医学院临床药理学部的研究人员与公司合作开发了世界上第一个对抗这种疾病的安全和有效的疫苗，并在第一阶段试验成功测试了它。最近的结果主要发表在《柳叶刀传染病》杂志上。
这种综合症在20世纪80年代1980年代首次被描述。一般败血症或血液中毒症状会发生在月经期间使用了“超级卫生棉条”的年轻女性身上。这就是为什么综合症疾病也被称为“卫生棉条病”。这引起了人们对卫生棉条的吸收能力的质疑。
葡萄球菌几乎在我们所有的部位都存在，尤其是在我们的皮肤和粘膜上。对大多数人来说它们是完全无害的。“然而，对于免疫系统低下的人，它们可以导致严重的疾病，如中毒性休克综合症。”Martha Eibl解释说，他是维也纳大学的医学院免疫学研究所前教授。这个会影响透析，慢性病，有肝脏疾病和心脏手术后恢复的病人。“然而，在50%的情况下，该疾病年轻女性的月经有关。”维也纳大学医学院临床药理学的Bernd Jilma 说。
现在已经发现了安全有效的疫苗在临床一期试验中几乎没有副作用。该试验测试了46名年轻男性和女性，疫苗是从葡萄球菌毒素减毒制成。该疫苗注射到皮肤中，其效果类似于破伤风疫苗，Jilma说。“接种疫苗的免疫效果可持续5年以上。”个体一旦接种疫苗就会有抗体产生，如果细菌威胁身体时疫苗就会有反应。血液测试可以显示一个人是否缺乏抗体。高危人群可以预防接种该疫苗。
“我们正在研究疫苗预防疾病的路上。然而，它仍需要几年的时间才能在临床上使用，”Eibl解释说。二期试验将有更多的人参与其中，现在已经开始了测试。“我们正在寻找更多的志愿者参与该期试验。”Jilma说。
doi:10.1016.S1473-3099(16)30115-3
PMC:
PMID:
Safety, tolerability, and immunogenicity of a recombinant toxic shock syndrome toxin (rTSST)-1 variant vaccine: a randomised, double-blind, adjuvant-controlled, dose escalation first-in-man-trial.
M. Schwameis, B. Rappenser, C. Firbas, C. Gruener, N. Model, N. Stich, A. Roetzer, N. Buchtele, B. Jilma, M. Eibl.
Toxic shock syndrome (TSS) is a severe circulatory and organ failure caused by bacterial toxins, usually triggered by bacteria from the Staphylococcus group. Researchers from MedUni Vienna's Department of Clinical Pharmacology, in collaboration with the company Biomedizinische Forschungsgesellschaft mbH in Vienna, have now developed the world's first safe and effective vaccine against this disease and successfully tested it in a Phase I trial. The promising results were recently published in the leading journal The Lancet Infectious Diseases. This syndrome was first described in the 1980s. General symptoms of sepsis or blood poisoning occurred in young women who had used so-called "super tampons" during their periods. This is why the syndrome was also known as "tampon disease." This subsequently led to the absorption capacity of tampons being regulated. Staphylococci colonize nearly all of us, especially on our skin and mucous membranes. They are totally harmless to most people. "However, for people with weakened immune systems, they can cause serious diseases such as toxic shock syndrome," explains Martha Eibl, director of Biomedizinische Forschungsgesellscaft mbH and former university professor at the Institute for Immunology of the medical faculty of the University of Vienna. This affects dialysis patients, the chronically sick, people with liver diseases and people recovering after heart operations. "Nevertheless, in 50% of cases the disease is associated with menstruation in young women," says Bernd Jilma from MedUni Vienna's Department of Clinical Pharmacology. The vaccine, which has now been found to be safe and effective – and to have practically no side effects – in a clinical Phase I trial, and has been tested on 46 young men and women, was developed from a detoxified Staphylococcus toxin. The vaccine is injected into the skin and its effect is similar to that of a tetanus vaccination, says Jilma. "Immunization with such vaccines lasts for five years or more." once vaccinated, a person develops antibodies, which become active if the germs start to pose a threat. A blood test can show whether someone is short of antibodies. Risk groups could then be preventively vaccinated. "We are well on the way to having a vaccine that prevents this series disease. However, it will still take some years before it is in clinical use," explains Eibl. A Phase II trial with a larger test population has now started, in order to check the initial, promising results. "We are still looking for more volunteers," says Jilma.
