IDT Biologika GmbH, Am Pharmapark, 06861 Dessau-Rosslau, Germany.
Friedrich Loeffler Institute, Südufer 10, 17493 Greifswald-Insel Riems, Germany.
Vaccine. 2018 Feb 1;36(6):811-817. doi: 10.1016/j.vaccine.2017.12.076. Epub 2018 Jan 8.
A safety requirement for live vaccines is investigating possible shedding in recipients since the presence of replication competent vaccine in secretions could result in direct and indirect horizontal transmission. This is especially relevant for oral rabies vaccine baits that are deliberately distributed into the environment. In the current study, survival of an oral rabies virus vaccine, SPBN GASGAS, was examined in excretions from different target and non-target species; red fox, raccoon dog, small Indian mongoose, raccoon, striped skunk, domestic dog, domestic cat and domestic pig. Saliva - and (pooled) fecal samples collected at different time points after oral administration of the vaccine strain were examined for the presence of viral RNA (rt-PCR). All PCR-positive and a subset of PCR-negative samples were subsequently investigated for the presence of infectious virus by isolation in cell culture (RTCIT). Up to 7 days post vaccine administration viral RNA could be detected in 50 of 758 fecal samples but no infectious virus was detected in any of the examined PCR-positive fecal samples. In contrast, RNA-fragments were detected in 248 of 1053 saliva swabs for an extended period (up to 10 days) after vaccine administration, but viable virus was only present during the first hours post vaccine administration in 38 samples. No infectious vaccine virus was isolated in saliva swabs taken 24 h or more after vaccine administration. Hence, no active shedding of the vaccine virus SPBN GASGAS after oral administration occurred and the virus isolated during the initial hours was material originally administered and not a result of virus replication within the host. Thus, potential horizontal transmission of this vaccine virus is limited to a short period directly after vaccine bait uptake. It can be concluded that the environmental risks associated with shedding after distributing vaccine baits containing SPBN GASGAS are negligible.
活疫苗的一个安全要求是调查接种者中可能的脱落情况,因为有复制能力的疫苗存在于分泌物中可能导致直接和间接的水平传播。这对于故意分布到环境中的口服狂犬病疫苗诱饵尤其相关。在目前的研究中,不同目标和非目标物种的排泄物中的口服狂犬病病毒疫苗 SPBN GASGAS 的存活情况进行了研究;红狐、浣熊犬、印度小獴、浣熊、条纹臭鼬、家犬、家猫和家猪。在口服疫苗株后不同时间点收集的唾液-和(混合)粪便样本,用 rt-PCR 检测病毒 RNA 的存在。所有 PCR 阳性和部分 PCR 阴性样本随后用细胞培养(RTCIT)进行分离,以检测是否存在传染性病毒。在疫苗接种后 7 天内,在 758 份粪便样本中的 50 份中可检测到病毒 RNA,但在任何检查的 PCR 阳性粪便样本中均未检测到传染性病毒。相比之下,在疫苗接种后长达 10 天的时间内,在 1053 份唾液拭子中的 248 份中检测到 RNA 片段,但在 38 份样本中仅在疫苗接种后最初几小时存在活病毒。在疫苗接种后 24 小时或更长时间采集的唾液拭子中未分离到传染性疫苗病毒。因此,口服接种后 SPBN GASGAS 疫苗病毒不会主动脱落,最初几小时分离到的病毒是最初接种的疫苗,而不是病毒在宿主内复制的结果。因此,这种疫苗病毒的潜在水平传播仅限于接种疫苗诱饵后很短的时间内。可以得出结论,分发含有 SPBN GASGAS 的疫苗诱饵后与脱落相关的环境风险可以忽略不计。