Department of Phtysiatry & Pulmonology, Kharkiv National Medical University, Kharkiv, Ukraine.
Immunotherapy. 2013 Oct;5(10):1047-54. doi: 10.2217/imt.13.110.
A 1-month Phase II trial was conducted in 41 patients with pulmonary TB who were randomized into treatment (n = 20) and placebo (n = 21) arms to investigate the safety and efficacy of an orally-administered therapeutic TB vaccine (V7) containing 10 µg heat-killed Mycobacterium vaccae provided by Immodulon Therapeutics Ltd (London, UK).
MATERIALS & METHODS: Both arms received conventional anti-TB therapy administered along with a daily pill of V7 or placebo. The subject population had four categories of TB: drug-sensitive TB; retreated TB; drug-resistant TB; and TB with HIV distributed in V7 and placebo arms at 9:4:7:6 and 14:1:6:8 ratios, respectively.
The mycobacterial clearance in sputum smears was observed in 72.2% (p < 0.0001) and 19% (p = 0.03) of patients on V7 and placebo, respectively. The average weight accrual among V7 recipients was 2.6 kg (p = 0.002) versus -0.2 kg (p = 0.69) in the control group. Except reduction in fever and increased lymphocyte counts, the changes in other secondary end points, such as hemoglobin, erythrocyte sedimentation rate and leukocyte counts, were not statistically different, although the proportion of patients responding favorably to V7 was invariably higher compared with placebo (p = 0.002). In control patients, no difference from baseline levels was noted except decreased hemoglobin content (p = 0.02).
Oral M. vaccae was safe and has potential as an adjunct immunotherapy, targeting mucosal immunity, to improve efficacy and shorten treatment duration of TB chemotherapy.
在 41 例肺结核患者中进行了为期 1 个月的 II 期试验，将他们随机分为治疗组（n=20）和安慰剂组（n=21），以研究由 Immodulon Therapeutics Ltd（英国伦敦）提供的口服治疗性结核疫苗（V7）的安全性和疗效，该疫苗含有 10μg 热灭活的牛分枝杆菌。
两组均接受常规抗结核治疗，并同时给予每日一片 V7 或安慰剂。研究人群的肺结核有四种类型：敏感型肺结核；复治型肺结核；耐药型肺结核；以及 HIV 合并肺结核，在 V7 和安慰剂组中的分布比例分别为 9:4:7:6 和 14:1:6:8。
V7 组和安慰剂组分别有 72.2%（p<0.0001）和 19%（p=0.03）的患者痰涂片结核菌清除。V7 组患者平均体重增加 2.6kg（p=0.002），而对照组则减少 0.2kg（p=0.69）。除发热减轻和淋巴细胞计数增加外，其他次要终点的变化，如血红蛋白、红细胞沉降率和白细胞计数，均无统计学差异，尽管 V7 组患者的反应比例始终高于安慰剂组（p=0.002）。在对照组患者中，除血红蛋白含量下降（p=0.02）外，与基线水平相比无差异。
口服牛分枝杆菌是安全的，具有作为粘膜免疫佐剂的潜力，可提高结核病化疗的疗效并缩短治疗时间。
