Gowtage Sonya, Williams Gareth A, Henderson Ray, Aylett Paul, MacMorran Duncan, Palmer Si, Robertson Andy, Lesellier Sandrine, Carter Stephen P, Chambers Mark A
Bacteriology Department, Animal and Plant Health Agency, Addlestone, Surrey KT15 3NB, UK.
Pest-Tech Ltd., Branch Drain Road, Brookside, RD2 Leeston, New Zealand.
Vaccine. 2017 Feb 7;35(6):987-992. doi: 10.1016/j.vaccine.2016.12.004. Epub 2017 Jan 9.
The oral vaccination of wild badgers (Meles meles) with live Bacillus Calmette-Guérin (BCG) is one of the tools being considered for the control of bovine tuberculosis (caused by Mycobacterium bovis) in the UK. The design of a product for oral vaccination requires that numerous, and often competing, conditions are met. These include the need for a highly palatable, but physically stable bait that will meet regulatory requirements, and one which is also compatible with the vaccine formulation; in this case live BCG. In collaboration with two commercial bait companies we have developed a highly attractive and palatable bait recipe designed specifically for European badgers (Meles meles) that meets these requirements. The palatability of different batches of bait was evaluated against a standardised palatable control bait using captive badgers. The physical properties of the bait are described e.g. firmness and colour. The microbial load in the bait was assessed against European and US Pharmacopoeias. The bait was combined with an edible vaccine carrier made of hydrogenated peanut oil in which BCG vaccine was stable during bait manufacture and cold storage, demonstrating <0.5 log reduction in titre after 117weeks' storage at -20°C. BCG stability in bait was also evaluated at +4°C and under simulated environmental conditions (20°C, 98% Relative Humidity; RH). Finally, iophenoxic acid biomarkers were utilised as a surrogate for the BCG vaccine, to test variants of the vaccine-bait design for their ability to deliver biomarker to the gastrointestinal tract of individual animals. These data provide the first detailed description of a bait-vaccine delivery system developed specifically for the oral vaccination of badgers against Mycobacterium bovis using live BCG.
给野生獾（欧洲獾）口服活卡介苗（BCG）是英国正在考虑用于控制牛结核病（由牛分枝杆菌引起）的工具之一。口服疫苗产品的设计需要满足众多且往往相互矛盾的条件。这些条件包括需要一种高度可口但物理性质稳定的诱饵，该诱饵要符合监管要求，并且还要与疫苗制剂兼容；在这种情况下是活卡介苗。我们与两家商业诱饵公司合作，开发出了一种专门为欧洲獾设计的极具吸引力且可口的诱饵配方，该配方满足这些要求。使用圈养獾，将不同批次诱饵的适口性与标准化的可口对照诱饵进行比较评估。描述了诱饵的物理性质，例如硬度和颜色。根据欧洲和美国药典评估诱饵中的微生物负荷。将诱饵与由氢化花生油制成的可食用疫苗载体混合，在诱饵制造和冷藏过程中，卡介苗在该载体中保持稳定，在-20°C下储存117周后，滴度降低<0.5 log。还在4°C以及模拟环境条件（20°C，相对湿度98%；RH）下评估了卡介苗在诱饵中的稳定性。最后，利用碘芬诺酸生物标志物作为卡介苗的替代物，测试疫苗-诱饵设计的变体将生物标志物递送至个体动物胃肠道的能力。这些数据首次详细描述了一种专门为使用活卡介苗对獾进行口服疫苗接种以预防牛分枝杆菌而开发的诱饵-疫苗递送系统。
