Abstract
The SAG2 vaccine (RABIGEN® SAG2) is a modified live attenuated rabies virus vaccine, selected from the SAD Bern strain in a two-step process of amino acid mutation using neutralizing monoclonal antibodies. The strain is genetically stable and does not spread in vivo or induce a persistent infection. Its absence of residual pathogenicity was extensively demonstrated in multiple target and non target species (such as wild carnivores and rodent species), including non-human primates. The efficacy of SAG2 baits was demonstrated according to the EU requirements for the red fox and raccoon dog. The use of safe and potent rabies vaccines such as SAG2 largely contributed to the elimination of rabies in Estonia, France, Italy and Switzerland. Importantly, these countries were declared free of rabies after few years of oral vaccination campaigns with SAG2 baits distributed with an appropriate strategy. The excellent tolerance of the SAG2 vaccine has been confirmed in the field since its first use in 1993. No safety issues have been reported, and in particular no vaccine-induced rabies cases were diagnosed, after the distribution of more than 20 million SAG2 baits in Europe.
Highlights
The SAG2 vaccine (RABIGEN® SAG2) is a modified live attenuated rabies virus vaccine, selected from the SAD Bern strain in a two-step process of amino acid mutation using neutralizing monoclonal antibodies
Most modified-live rabies virus vaccines used for oral vaccination (OV) originated from the attenuated Evelyn Rokitnicki Abelseth (ERA) virus strain, which was derived from the original Street-Alabama-Dufferin (SAD) rabies virus strain
The success of rabies management through OV of wildlife populations has been demonstrated in several European countries
Summary
2.1 Development of the SAG2 strain Figure 1 The World Health Organization (WHO) organized several meetings with rabies experts to define safety and efficacy requirements for OV use in wildlife and in dogs [3,4,5,6]. 2.2 Genetic stability The laboratory mouse is one of most susceptible species to rabies virus, and the parental strain SAD Bern is highly pathogenic for adult mice by the intracerebral route [14]. After 10 consecutive passages in BSR cells (a clone of BHK-21 cells), the SAG2 virus was injected intracerebrally to five adult mice. The SAG1 strain was already very stable, since only one of 18 adult mice died after intracerebral inoculation, following the first passage in suckling mouse brain, and none died after the second and third passages. Through a FAIR project (CT 97-3515 “Wildlife vaccination against rabies in difficult and emergency situations and its potential impact on the environment”), different trials were conducted during 1999 and 2000 in Belgium, France, Germany and Italy to assess the stability of all vaccine baits (V-RG, SAG2, SAD B19, SAD P5/P88) available in the EU [29]. The safety of the SAG2 strain by the oral route was confirmed in the dog and the cat when administered at a high (109 PFU) dose [31]
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