Long-Term Immunogenicity and Efficacy of the Oral Rabies Virus Vaccine Strain SPBN GASGAS in Foxes
Long-Term Immunogenicity and Efficacy of the Oral Rabies Virus Vaccine Strain SPBN GASGAS in Foxes
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DOI：
10.3390/v11090790
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发表时间：
2019-09-01
期刊：
影响因子：
4.7
通讯作者：
Mueller, Thomas
中科院分区：
文献类型：
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作者：
Freuling, Conrad M.;Kamp, Verena To;Mueller, Thomas
为了在一项完全符合药物临床试验质量管理规范（GCP）的研究中评价口服狂犬病减毒活疫苗SPBN GASGAS的长期免疫原性，对46只健康血清阴性红狐进行了研究。（Vulpes vulpes）被分配到两个治疗组：第1组（n = 31）接受含有1.7 ml最低效价（10（6.6）FFU/mL）疫苗的疫苗诱饵，第2组（n = 15）接受安慰剂诱饵。接种后12个月，组1的29只动物和组2的14只动物共接受狐狸狂犬病病毒分离株（10（3.0）MICLD 50/mL）攻毒。虽然90%的动物提供了疫苗诱饵抵抗挑战，只有一只动物（7%）的控制生存。接种后血清转化的所有动物在接种后12个月攻毒感染后存活。狂犬病特异性抗体最早可在接种后14天检测到。根据ELISA和RFFIT中测定的SPBN GASGAS抗体应答动力学，动物在12个月攻毒前观察期内保持稳定的高水平抗体滴度。结果表明，使用该新型狂犬病病毒疫苗株经口成功接种可提供超过1年的长期免疫力，符合欧洲药典规定的许可要求。
To evaluate the long-term immunogenicity of the live-attenuated, oral rabies vaccine SPBN GASGAS in a full good clinical practice (GCP) compliant study, forty-six (46) healthy, seronegative red foxes (Vulpes vulpes) were allocated to two treatment groups: group 1 (n = 31) received a vaccine bait containing 1.7 ml of the vaccine of minimum potency (10(6.6) FFU/mL) and group 2 (n = 15) received a placebo-bait. In total, 29 animals of group 1 and 14 animals of group 2 were challenged at 12 months post-vaccination with a fox rabies virus isolate (10(3.0) MICLD50/mL). While 90% of the animals offered a vaccine bait resisted the challenge, only one animal (7%) of the controls survived. All animals that had seroconverted following vaccination survived the challenge infection at 12 months post-vaccination. Rabies specific antibodies could be detected as early as 14 days post-vaccination. Based on the kinetics of the antibody response to SPBN GASGAS as measured in ELISA and RFFIT, the animals maintained stable antibody titres during the 12-month pre-challenge observation period at a high level. The results indicate that successful vaccination using the oral route with this new rabies virus vaccine strain confers long-term duration of immunity beyond one year, meeting the same requirements as for licensure as laid down by the European Pharmacopoeia.