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急性髓系白血病中白血病相关抗原疫苗接种的临床试验。

Clinical trials in vaccination with leukemia associated antigens in acute myelogenous leukemia.

作者信息

Alsabti E A, Taleb A M, Raji H M, Kalil O Z, Saleh K A

出版信息

Jpn J Exp Med. 1979 Jun;49(3):157-68.

PMID:385948
Abstract

Vaccination with purified leukemia associated antigens (LAA) was performed in sixty adult patients with acute myelogenous leukemia (AML) who were admitted to Medical City, Yermok Hospital, Alshaab Hospital, Altefelalarabie Hospital, Basrah Hospital, Mosul Hospital, Althawra Hospital and Samaon Hospital. LAA were prepared from leukemic cells, using hypotonic lysis and low frequency sonication, followed by discontinuous polyacrylamide gel electrophoresis or column chromatography. Five doses were given intradermally, after discontinuation of the maintenance therapy. Clinical and immunological studies were done prevaccination and used to evaluate the effect of this vaccine. The patients were randomized into two groups: one group included 32 patients who received LAA alone and the other group included 28 patients who received LAA with BCG-cell wall skeleton as an adjuvant. Control groups of patients were also randomized into two subgroups: one subgroup included 30 patients who did not receive any kind of immunotherapy, the other subgroup included 30 patients who received BCG-cell wall skeleton only. All the LAA vaccinated groups showed increased blastogenic response to LAA most pronounced on day 22 and afterwards. There was increased response to non-specific mitogens after vaccination, especially after the 63rd day. All the vaccinated groups showed increased skin reactivity to LAA after vaccination. Fifty-seven of these patients had an initial weak reaction but it became more marked after vaccination. There was a correlation between the blastogenic responses and skin test reactivity to the clinical course. All the nonvaccinated group and those who were given BCG-cell wall skeleton alone died within 9 weeks (range 7--11 weeks) after discontinued chemotherapy making the survival range from 23--40 weeks (median of 29 weeks), in contrast all the vaccinated groups who received LAA alone or in combination with three BCG-cell wall skeleton doses are in complete unmaintained remission ranging in survival from 58 weeks to 74 weeks (median value is 63 weeks).

摘要

对入住医疗城、叶尔莫克医院、阿尔沙布医院、阿尔泰费拉拉比医院、巴士拉医院、摩苏尔医院、阿尔塔乌拉医院和萨马翁医院的60名成年急性髓性白血病(AML)患者进行了纯化白血病相关抗原(LAA)疫苗接种。LAA由白血病细胞制备,采用低渗裂解和低频超声处理,然后进行不连续聚丙烯酰胺凝胶电泳或柱色谱法。在维持治疗中断后,皮内注射五剂。在接种疫苗前进行了临床和免疫学研究,并用于评估该疫苗的效果。患者被随机分为两组:一组包括32名仅接受LAA的患者,另一组包括28名接受LAA联合卡介苗细胞壁骨架作为佐剂的患者。对照组患者也被随机分为两个亚组:一个亚组包括30名未接受任何免疫治疗的患者,另一个亚组包括30名仅接受卡介苗细胞壁骨架的患者。所有接种LAA的组对LAA的增殖反应均增加,在第22天及之后最为明显。接种疫苗后对非特异性有丝分裂原的反应增加,尤其是在第63天之后。所有接种组在接种疫苗后对LAA的皮肤反应性均增加。这些患者中有57名最初反应较弱,但接种疫苗后变得更加明显。增殖反应与皮肤试验反应性与临床病程之间存在相关性。所有未接种组和仅接受卡介苗细胞壁骨架的患者在停止化疗后9周内(范围7-11周)死亡,生存范围为23-40周(中位数为29周),相比之下,所有单独接受LAA或与三剂卡介苗细胞壁骨架联合接种的接种组均处于完全未维持的缓解状态,生存范围为58周-74周(中位数为63周)。

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