Long-term immunogenicity and efficacy of the oral rabies virus vaccine strain SPBN GASGAS in Foxes

Freuling, Conrad Martin GND; Kamp, Verena te GND; Klein, Antonia; Günther, Maria GND; Zaeck, Luca Mirko GND; Potratz, Madlin; Eggerbauer, Elisa GND; Bobe, Katharina; Kaiser, Christian; Kretzschmar, Antje; Ortmann, Steffen; Schuster, Peter; Vos, Adriaan; Finke, Stefan GND; Müller, Thomas GND

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 (10⁶.⁶ 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 (10³.⁰ 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.

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Freuling, Conrad / Kamp, Verena / Klein, Antonia / et al: Long-term immunogenicity and efficacy of the oral rabies virus vaccine strain SPBN GASGAS in Foxes. 2019.

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