Part I. Basic Principles. TB vaccines cannot prevent establishment of the inf...">

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首頁(yè)> 美國(guó)衛(wèi)生研究院文獻(xiàn)>Vaccines >Perspectives for Developing New Tuberculosis Vaccines Derived from the Pathogenesis of Tuberculosis: I. Basic Principles II. Preclinical Testing and III. Clinical Testing
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Perspectives for Developing New Tuberculosis Vaccines Derived from the Pathogenesis of Tuberculosis: I. Basic Principles II. Preclinical Testing and III. Clinical Testing

機(jī)譯：從結(jié)核病發(fā)病機(jī)理發(fā)展新的結(jié)核疫苗的前景：I.基本原理II。臨床前測(cè)試以及III。臨床測(cè)試

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>Part I. Basic Principles. TB vaccines cannot prevent establishment of the infection. They can only prevent an early pulmonary tubercle from developing into clinical disease. A more effective new vaccine should optimize both cell-mediated immunity (CMI) and delayed-type hypersensitivity (DTH) better than any existing vaccine. The rabbit is the only laboratory animal in which all aspects of the human disease can be reproduced: namely, the prevention of most primary tubercles, the arrestment of most primary tubercles, the formation of the tubercle’s solid caseous center, the liquefaction of this center, the formation of cavities and the bronchial spread of the disease. In liquefied caseum, virulent tubercle bacilli can multiply extracellularly, especially in the liquefied caseum next to the inner wall of a cavity where oxygen is plentiful. The bacilli in liquefied caseum cannot be reached by the increased number of activated macrophages produced by TB vaccines. Therefore, new TB vaccines will have little or no effect on the extracellular bacillary growth within liquefied caseum. TB vaccines can only increase the host’s ability to stop the development of new TB lesions that arise from the bronchial spread of tubercle bacilli from the cavity to other parts of the lung. Therefore, effective TB vaccines do not prevent the reactivation of latent TB. Such vaccines only control (or reduce) the number of metastatic lesions that result after the primary TB lesion was reactivated by the liquefaction process. (Note: the large number of tubercle bacilli growing extracellularly in liquefied caseum gives rise to mutations that enable antimicrobial resistance—which is a major reason why TB still exists today). >Part II. Preclinical Testing. The counting of grossly visible tubercles in the lungs of rabbits after the inhalation of virulent human-type tubercle bacilli is the most pertinent preclinical method to assess the efficacy of new TB vaccines (because an effective vaccine will stop the growth of developing tubercles before while they are still microscopic in size). Unfortunately, rabbits are rarely used in preclinical vaccine trials, despite their relative ease of handling and human-like response to this infection. Mice do not generate an effective DTH response, and guinea pigs do not generate an effective CMI response. Only the rabbits and most humans can establish the proper amount of DTH and CMI that is necessary to contain this infection. Therefore, rabbits should be included in all pre-clinical testing of new TB vaccines. New drugs (and/or immunological procedures) to reduce liquefaction and cavity formation are urgently needed. A simple intradermal way to select such drugs or procedures is described herein. >Part III. Clinical Testing. Vaccine trials would be much more precise if the variations in human populations (listed herein) were taken into consideration. BCG and successful new TB vaccines should always increase host resistance to TB in naive subjects. This is a basic immunological principle. The efficacies of new and old TB vaccines are often not recognized, because these variations were not identified in the populations evaluated.
機(jī)譯：>第一部分基本原則。結(jié)核病疫苗不能阻止感染的建立。它們只能防止早期的肺結(jié)核發(fā)展為臨床疾病。與任何現(xiàn)有疫苗相比，更有效的新疫苗應(yīng)更好地優(yōu)化細(xì)胞介導(dǎo)的免疫（CMI）和遲發(fā)型超敏反應(yīng)（DTH）。兔子是唯一可以復(fù)制人類疾病各個(gè)方面的實(shí)驗(yàn)動(dòng)物：即，預(yù)防大多數(shù)原發(fā)性結(jié)節(jié)，阻止大多數(shù)原發(fā)性結(jié)節(jié)，結(jié)節(jié)的堅(jiān)固干酪狀中心的形成，該中心的液化，蛀牙的形成和疾病的支氣管擴(kuò)散。在液化酪蛋白中，有毒的結(jié)核桿菌可在細(xì)胞外繁殖，尤其是在液化酪蛋白的腔內(nèi)壁附近，那里有大量的氧氣。結(jié)核病疫苗產(chǎn)生的活化巨噬細(xì)胞數(shù)量增加，無(wú)法達(dá)到液化干酪乳桿菌。因此，新的結(jié)核疫苗對(duì)液化酪蛋白菌內(nèi)細(xì)胞外細(xì)菌的生長(zhǎng)幾乎沒(méi)有影響。結(jié)核疫苗只能提高宿主阻止新結(jié)核病發(fā)展的能力，新結(jié)核病是由于結(jié)核桿菌從腔內(nèi)擴(kuò)散到肺的其他部位而引起的。因此，有效的結(jié)核病疫苗不會(huì)阻止?jié)撛诮Y(jié)核病的再激活。此類疫苗僅控制（或減少）通過(guò)液化過(guò)程重新激活原發(fā)性TB病變后導(dǎo)致的轉(zhuǎn)移性病變的數(shù)量。 （注意：在液化酪蛋白中大量在細(xì)胞外生長(zhǎng)的結(jié)核桿菌會(huì)引起突變，從而產(chǎn)生抗藥性，這是今天結(jié)核病仍然存在的主要原因。） >第二部分。臨床前測(cè)試。評(píng)估吸入強(qiáng)力人型結(jié)核桿菌后兔肺中肉眼可見結(jié)核的計(jì)數(shù)是評(píng)估新結(jié)核病疫苗療效的最相關(guān)的臨床前方法（因?yàn)橛行У囊呙鐣?huì)停止仍未達(dá)到微觀尺寸的發(fā)育中結(jié)節(jié)的生長(zhǎng)）。不幸的是，盡管兔子相對(duì)容易處理并且對(duì)這種感染具有類似人的反應(yīng)能力，但很少在臨床前疫苗試驗(yàn)中使用兔子。小鼠不能產(chǎn)生有效的DTH反應(yīng)，豚鼠也不能產(chǎn)生有效的CMI反應(yīng)。只有兔子和大多數(shù)人才能建立控制這種感染所必需的適量DTH和CMI。因此，在新結(jié)核病疫苗的所有臨床前測(cè)試中均應(yīng)包括兔子。迫切需要減少液化和腔形成的新藥（和/或免疫學(xué)程序）。本文描述了選擇此類藥物或程序的簡(jiǎn)單皮內(nèi)方式。 >第三部分。臨床測(cè)試。如果考慮到人口變化（此處列出），疫苗試驗(yàn)將更加精確?？ń槊绾统晒Φ男陆Y(jié)核病疫苗應(yīng)始終提高天真的受試者對(duì)結(jié)核病的宿主抵抗力。這是基本的免疫學(xué)原理。人們常常不認(rèn)識(shí)新的和舊的結(jié)核病疫苗的功效，因?yàn)樵谠u(píng)估的人群中沒(méi)有發(fā)現(xiàn)這些變異。

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