Background H56:IC31 is a candidate vaccine against tuberculosis (TB) with the potential to reduce TB recurrence rate. It is thus important for future clinical trials to demonstrate safety and immunogenicity of H56:IC31 in individuals treated for TB. Methods 22 adults confirmed to be Mtb negative (by 2 GeneXpert tests or 2 sputum cultures) after four-five months of TB treatment, and not more than 28 days after completion of TB treatment, were randomized to receive two doses of H56:IC31 (5 mg H56:500 nmol IC31; N=16) or placebo (N=6) 56 days apart. Participants were followed for 420 days for safety and immunogenicity. Results H56:IC31 vaccination was associated with an acceptable safety profile, consisting mostly of mild self-limited injection site reactions. No serious adverse events, and no vaccine-related severe adverse events, were reported. H56:IC31 induced a CD4+ T-cell response for Ag85B and ESAT-6, with ESAT-6 being immunodominant, which persisted through six months after the last vaccination. There was some evidence of CD8+ T-cell responses for both Ag85B and ESAT-6, but to a lesser extent than CD4+ responses. Conclusions H56:IC31 was associated with an acceptable safety profile, and induced a predominant CD4+ T-cell response, in adults recently treated for drug-susceptible, uncomplicated pulmonary TB. Trial registration ClinicalTrials.gov, NCT02375698

中文翻译：

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H56:IC31 候选结核疫苗在成功治疗药物敏感肺结核的成人中的安全性和免疫原性：一项 1 期随机试验

背景 H56:IC31 是一种针对结核病 (TB) 的候选疫苗，具有降低结核病复发率的潜力。因此，未来的临床试验必须证明 H56:IC31 在结核病治疗个体中的安全性和免疫原性。方法 22 名在 TB 治疗 45 个月后且在完成 TB 治疗后不超过 28 天被确认为 Mtb 阴性的成人（通过 2 次 GeneXpert 检测或 2 次痰培养）被随机分配接受两剂 H56:IC31（ 5 mg H56:500 nmol IC31；N=16) 或安慰剂 (N=6)，间隔 56 天。参与者对安全性和免疫原性进行了 420 天的随访。结果 H56:IC31 疫苗接种具有可接受的安全性，主要包括轻微的自限性注射部位反应。未报告严重不良事件，也未报告与疫苗相关的严重不良事件。 H56:IC31 诱导针对 Ag85B 和 ESAT-6 的 CD4+ T 细胞反应，其中 ESAT-6 具有免疫优势，这种反应在最后一次疫苗接种后持续六个月。有一些证据表明 CD8+ T 细胞对 Ag85B 和 ESAT-6 都有反应，但程度低于 CD4+ 反应。结论 H56:IC31 与可接受的安全性相关，并且在最近接受药物敏感、无并发症肺结核治疗的成人中诱导了主要的 CD4+ T 细胞应答。试验注册 ClinicalTrials.gov，NCT02375698