Bunyasi E W, Luabeya A K K, Tameris M, Geldenhuys H, Mulenga H, Landry B S, Scriba T J, Schmidt B-M, Hanekom W A, Mahomed H, McShane H, Hatherill M
South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine, and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.
Aeras, Rockville, Maryland, USA.
Int J Tuberc Lung Dis. 2017 Jul 1;21(7):778-783. doi: 10.5588/ijtld.16.0709.
South Africa.
To evaluate the long-term effectiveness of infant modified vaccinia Ankara virus-expressing antigen 85A (MVA85A) vaccination against tuberculosis (TB).
We analysed data from a double-blind randomised placebo-controlled Phase 2b MVA85A infant TB vaccine trial (2009-2012), with extended post-trial follow-up (2012-2014). Isoniazid preventive therapy (IPT) was provided by public health services according to national guidelines. The primary outcome was curative treatment for TB disease. Survival analysis and Poisson regression were used for study analysis.
Total follow-up was 10 351 person-years of observation (pyo). Median follow-up age was 4.8 years (interquartile range 4.4-5.2). There were 328 (12%) TB cases. TB disease incidence was 3.2/100 pyo (95%CI 2.8-3.5) overall, and respectively 3.3 (95%CI 2.9-3.9) and 3.0 (95%CI 2.6-3.5)/100 pyo in the MVA85A vaccine and placebo arms. A total of 304 children (11%) received IPT, with respectively 880 and 9471 pyo among IPT and non-IPT recipients. There were 23 (7.6%) TB cases among 304 IPT recipients vs. 305 (12.9%) among 2374 non-IPT recipients (P = 0.008). IPT effectiveness was 85% (95%CI 76-91).
Extended follow-up confirms no long-term effectiveness of infant MVA85A vaccination, but a six-fold reduction in TB risk can be attributed to IPT. National TB programmes in high TB burden countries should ensure optimal implementation of IPT for eligible children.
南非。
评估婴儿接种表达抗原85A的改良安卡拉痘苗病毒（MVA85A）预防结核病（TB）的长期效果。
我们分析了一项双盲随机安慰剂对照的2b期MVA85A婴儿结核病疫苗试验（2009 - 2012年）的数据，并进行了试验后延长随访（2012 - 2014年）。公共卫生服务机构根据国家指南提供异烟肼预防性治疗（IPT）。主要结局是结核病的治疗。采用生存分析和泊松回归进行研究分析。
总随访时间为10351人年观察期（pyo）。中位随访年龄为4.8岁（四分位间距4.4 - 5.2）。有328例（12%）结核病病例。总体结核病发病率为3.2/100 pyo（95%CI 2.8 - 3.5），MVA85A疫苗组和安慰剂组分别为3.3（95%CI 2.9 - 3.9）和3.0（95%CI 2.6 - 3.5）/100 pyo。共有304名儿童（11%）接受了IPT，IPT接受者和非IPT接受者的观察期分别为880和9471 pyo。304名IPT接受者中有23例（7.6%）结核病病例，2374名非IPT接受者中有305例（12.9%）（P = 0.008）。IPT的有效性为85%（95%CI 76 - 91）。
延长随访证实婴儿接种MVA85A无长期效果，但结核病风险可因IPT降低6倍。高结核病负担国家的国家结核病规划应确保为符合条件的儿童最佳实施IPT。
