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首页> 外文期刊>Vaccine >Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy, BCG-vaccinated, QuantiFERON (R)-TB Gold (+) Kenyan adults without evidence of tuberculosis
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Adenovirus type 35-vectored tuberculosis vaccine has an acceptable safety and tolerability profile in healthy, BCG-vaccinated, QuantiFERON (R)-TB Gold (+) Kenyan adults without evidence of tuberculosis

机译:35型腺病毒载体结核病疫苗在健康,经BCG疫苗接种的QuantiFERON(R)-TB金(+)肯尼亚成年人中具有可接受的安全性和耐受性,无结核病证据

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In a Phase I trial, we evaluated the safety of AERAS-402, an adenovirus 35-vectored TB vaccine candidate expressing 3 Mycobacterium tuberculosis (Mtb) immunodominant antigens, in subjects with and without latent Mtb infection. HIV-negative, BCG-vaccinated Kenyan adults without evidence of tuberculosis, 10 QuantiFERON (R)-TB Gold In-Tube test (QFT-G)(-) and 10 QFT-G(+), were randomized 4:1 to receive AERAS-402 or placebo as two doses, on Days 0 and 56, with follow up to Day 182. There were no deaths, serious adverse events or withdrawals. For 1 AERAS-402 QFT-G() and 1 AERAS-402 QFT-G(+) subject, there were 3 self-limiting severe AEs of injection site pain: 1 after the first vaccination and 1 after each vaccination, respectively. Two additional severe AEs considered vaccine-related were reported after the first vaccination in AERAS-402 QFT-G(+) subjects: elevated blood creatine phosphokinase and neutropenia, the latter slowly improving but remaining abnormal until study end. AERAS-402 was not detected in urine or throat cultures for any subject. In intracellular cytokine staining studies, curtailed by technical issues, we saw modest CD4(+) and CD8+T cell responses to Mtb Ag85A/b peptide pools among both QFTG() and (+) subjects, with trends in the CD4+T cells suggestive of boosting after the second vaccine dose, slightly more so in QFT-G(+) subjects. CD4+ and CD8+ responses to Mtb antigen TB10.4 were minimal. Increases in Adenovirus 35 neutralizing antibodies from screening to end of study, seen in 50% of AERAS-402 recipients, were mostly minimal. This small study confirms acceptable safety and tolerability profiles for AERAS-402, in line with other Phase 1 studies of AERAS-402, now to include QFT-G(+) subjects. Published by Elsevier Ltd.
机译:在一项I期试验中,我们评估了AERAS-402(一种表达35种结核分枝杆菌(Mtb)免疫显性抗原的腺病毒35载体结核菌候选疫苗)在有或没有潜在Mtb感染的受试者中的安全性。 HIV阴性,接种卡介苗的肯尼亚成年人(无结核病证据),10份QuantiFERON(R)-TB金管内测试(QFT-G)(-)和10份QFT-G(+)被随机分配为4:1接受治疗在第0天和第56天服用AERAS-402或安慰剂,分两次服用,直到第182天为止。没有死亡,严重的不良事件或停药。对于1名AERAS-402 QFT-G(+)和1名AERAS-402 QFT-G(+)受试者,存在3种自我限制的注射部位疼痛严重AE:首次接种后1例,每次接种后1例。首次接种AERAS-402 QFT-G(+)受试者后,又报告了另外两种与疫苗相关的严重AE:血肌酸磷酸激酶和中性粒细胞减少,后者缓慢改善,但直到研究结束仍保持异常。在任何受试者的尿液或喉咙培养物中均未检测到AERAS-402。在受技术问题限制的细胞内细胞因子染色研究中,我们发现QFTG()和(+)受试者对Mtb Ag85A / b肽库的适度CD4(+)和CD8 + T细胞反应,以及CD4 + T细胞的趋势提示在第二次疫苗注射后加强免疫,在QFT-G(+)受试者中则略有提高。对Mtb抗原TB10.4的CD4 +和CD8 +反应很小。从AERAS-402接受者中有50%可见,从筛选到研究结束,腺病毒35中和抗体的增加大部分是最小的。这项小型研究证实了AERAS-402可接受的安全性和耐受性,与AERAS-402的其他1期研究一致,现在包括QFT-G(+)受试者。由Elsevier Ltd.发布

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