中毒性休克綜合征(TSS)是一種因細(xì)菌毒素引起的嚴(yán)重的循環(huán)系統(tǒng)和器官衰竭疾病,，通常由葡萄球菌引發(fā)。維也納大學(xué)醫(yī)學(xué)院臨床藥理學(xué)部的研究人員與公司合作開(kāi)發(fā)了世界上第一個(gè)對(duì)抗這種疾病的安全和有效的疫苗,，并在第一階段試驗(yàn)成功測(cè)試了它,。最近的結(jié)果主要發(fā)表在《柳葉刀傳染病》雜志上。
這種綜合癥在20世紀(jì)80年代1980年代首次被描述,。一般敗血癥或血液中毒癥狀會(huì)發(fā)生在月經(jīng)期間使用了“超級(jí)衛(wèi)生棉條”的年輕女性身上,。這就是為什么綜合癥疾病也被稱為“衛(wèi)生棉條病”。這引起了人們對(duì)衛(wèi)生棉條的吸收能力的質(zhì)疑,。
葡萄球菌幾乎在我們所有的部位都存在,，尤其是在我們的皮膚和粘膜上。對(duì)大多數(shù)人來(lái)說(shuō)它們是完全無(wú)害的,。“然而,，對(duì)于免疫系統(tǒng)低下的人，它們可以導(dǎo)致嚴(yán)重的疾病,，如中毒性休克綜合癥,。”Martha Eibl解釋說(shuō)，他是維也納大學(xué)的醫(yī)學(xué)院免疫學(xué)研究所前教授,。這個(gè)會(huì)影響透析,，慢性病，有肝臟疾病和心臟手術(shù)后恢復(fù)的病人,。“然而,，在50%的情況下，該疾病年輕女性的月經(jīng)有關(guān),。”維也納大學(xué)醫(yī)學(xué)院臨床藥理學(xué)的Bernd Jilma 說(shuō),。
現(xiàn)在已經(jīng)發(fā)現(xiàn)了安全有效的疫苗在臨床一期試驗(yàn)中幾乎沒(méi)有副作用。該試驗(yàn)測(cè)試了46名年輕男性和女性,，疫苗是從葡萄球菌毒素減毒制成,。該疫苗注射到皮膚中,，其效果類似于破傷風(fēng)疫苗，Jilma說(shuō),。“接種疫苗的免疫效果可持續(xù)5年以上,。”個(gè)體一旦接種疫苗就會(huì)有抗體產(chǎn)生，如果細(xì)菌威脅身體時(shí)疫苗就會(huì)有反應(yīng),。血液測(cè)試可以顯示一個(gè)人是否缺乏抗體,。高危人群可以預(yù)防接種該疫苗。
“我們正在研究疫苗預(yù)防疾病的路上,。然而,，它仍需要幾年的時(shí)間才能在臨床上使用，”Eibl解釋說(shuō),。二期試驗(yàn)將有更多的人參與其中,，現(xiàn)在已經(jīng)開(kāi)始了測(cè)試。“我們正在尋找更多的志愿者參與該期試驗(yàn),。”Jilma說(shuō),。
doi:10.1016.S1473-3099(16)30115-3
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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.
