Boehringer Ingelheim Vetmedica, Binger Strasse 173, 55218 Ingelheim, Germany.
Vet Rec. 2010 Dec 4;167(23):899-903. doi: 10.1136/vr.c4140.
The safety of a non-adjuvanted inactivated fungal vaccine for the treatment of dermatophytosis in cats was investigated in two studies: a controlled laboratory study, and a placebo-controlled double-blind field study with a cross-over design in Europe. In the laboratory study, two groups of 10 cats each were administered an intramuscular twofold overdose, followed by five single 1 ml doses, of either vaccine or control product at 14-day intervals. In the field study, cats were treated with three intramuscular injections of 1 ml vaccine administered at 14-day intervals, as recommended by the manufacturer. A total of 89 cats were enrolled in the field study and divided into two groups to receive either vaccine or placebo for the first three treatments, followed by the opposite product for the final three treatments. The cats enrolled in the two studies were 12 weeks of age or older, as recommended by the manufacturer. All the cats were monitored closely for possible injection site reactions, systemic reactions (including changes in rectal body temperature) and adverse events. The results from both studies showed no significant differences between the vaccinated cats and the control or placebo-treated cats with regard to local or systemic reactions. A few mild to moderate local reactions were noted, but these were evenly distributed between the vaccinated and placebo-treated cats and resolved within a few days. No severe or serious adverse events related to the vaccinations were observed.
一项对照实验室研究和一项在欧洲进行的、采用交叉设计的安慰剂对照双盲现场研究。在实验室研究中，两组各 10 只猫分别接受了肌肉内两倍剂量的超剂量接种，然后每隔 14 天接受一次 1 毫升的疫苗或对照产品的单次剂量。在现场研究中，按照制造商的建议，猫接受了三次肌肉内 1 毫升疫苗注射，间隔 14 天。共有 89 只猫参加了现场研究，并分为两组，前三次接受疫苗或安慰剂治疗，然后接受相反的产品进行最后三次治疗。参加两项研究的猫年龄在 12 周或以上，这是制造商推荐的。所有猫都密切监测可能的注射部位反应、全身反应（包括直肠体温变化）和不良事件。这两项研究的结果均表明，接种疫苗的猫与对照组或安慰剂治疗的猫在局部或全身反应方面没有显著差异。少数轻度至中度局部反应被观察到，但这些反应在接种疫苗和安慰剂治疗的猫之间均匀分布，并在几天内消退。未观察到与疫苗接种相关的严重或严重不良事件。
