Bobe Katharina, Ortmann Steffen, Kaiser Christian, Perez-Bravo David, Gethmann Jörn, Kliemt Jeannette, Körner Sophia, Theuß Tobias, Lindner Thomas, Freuling Conrad, Müller Thomas, Vos Ad
Ceva Innovation Center, Am Pharmapark, (D.P.-B. formerly: Institute of Epidemiology, Friedrich-Loeffler-Institute), 06861 Dessau-Rosslau, Germany.
TEW Servicegesellschaft GmbH, Am Pharmapark, (C.K. formerly: Ceva Innovation Center), 06861 Dessau-Rosslau, Germany.
Vaccines (Basel). 2023 Jan 30;11(2):307. doi: 10.3390/vaccines11020307.
(1) Background: The oral vaccination of free-roaming dogs against rabies has been developed as a promising complementary tool for mass dog vaccination. However, no oral rabies vaccine has provided efficacy data in dogs according to international standards. (2) Methods: To test the immunogenicity and efficacy of the third-generation oral rabies virus vaccine strain, SPBN GASGAS, in domestic dogs, dogs were offered an egg-flavoured bait containing 3.0 mL of the vaccine (10 FFU/mL) or a placebo egg-flavoured bait. Subsequently, these 25 vaccinated and 10 control animals were challenged approximately 6 months later with a dog rabies virus isolate. Blood samples were collected at different time points postvaccination and examined by ELISA and RFFIT. (3) Results: All but 1 of the 25 vaccinated dogs survived the challenge infection; meanwhile, all 10 control dogs succumbed to rabies. The serology results showed that all 25 vaccinated dogs seroconverted in ELISA (>40% PB); meanwhile, only 13 of the 25 vaccinated dogs tested seropositive ≥ 0.5 IU/mL) in RFFIT. (4) Conclusions: The SPBN GASGAS rabies virus vaccine meets the efficacy requirements for live oral rabies vaccines as laid down by the European Pharmacopoeia and the WOAH Terrestrial Manual. SPBN GASGAS already fulfilled the safety requirements for oral rabies vaccines targeted at dogs. Hence, the egg-flavoured bait containing SPBN GASGAS is the first oral vaccine bait that complies with WOAH recommendations for the intended use of oral vaccination of free-roaming dogs against rabies.
(1) 背景:针对流浪犬的狂犬病口服疫苗已被开发成为大规模犬类疫苗接种的一种有前景的补充工具。然而,尚无口服狂犬病疫苗根据国际标准提供犬类的效力数据。(2) 方法:为测试第三代口服狂犬病病毒疫苗株SPBN GASGAS在家犬中的免疫原性和效力,给犬只投喂含有3.0 mL疫苗(10 FFU/mL)的鸡蛋味诱饵或安慰剂鸡蛋味诱饵。随后,约6个月后用一种犬狂犬病病毒分离株对这25只接种疫苗的动物和10只对照动物进行攻毒。在接种疫苗后的不同时间点采集血样,并通过ELISA和RFFIT进行检测。(3) 结果:25只接种疫苗的犬只中,除1只外均在攻毒感染中存活;同时,所有10只对照犬均死于狂犬病。血清学结果显示,所有25只接种疫苗的犬只在ELISA中均发生血清转化(>40% PB);同时,25只接种疫苗的犬只中只有13只在RFFIT中检测为血清阳性(≥ 0.5 IU/mL)。(4) 结论:SPBN GASGAS狂犬病病毒疫苗符合欧洲药典和世界动物卫生组织《陆生动物手册》规定的口服狂犬病活疫苗的效力要求。SPBN GASGAS已满足针对犬类的口服狂犬病疫苗的安全性要求。因此,含有SPBN GASGAS的鸡蛋味诱饵是第一种符合世界动物卫生组织关于流浪犬口服狂犬病疫苗预期用途建议的口服疫苗诱饵。