Deutschmann Paul, Forth Jan-Hendrik, Sehl-Ewert Julia, Carrau Tessa, Viaplana Elisenda, Mancera Jose Carlos, Urniza Alicia, Beer Martin, Blome Sandra
Friedrich-Loeffler-Institut, Suedufer 10, 17493, Greifswald, Insel Riems, Germany.
Zoetis Manufacturing and Research Spain, Finca la Riba, Carretera de Camprodon s/n, 17813 L'Hostalnou de Bianya, Girona, Spain.
NPJ Vaccines. 2023 May 29;8(1):78. doi: 10.1038/s41541-023-00669-z.
African swine fever (ASF) has gained panzootic dimensions and commercial vaccines are still unavailable. Recently, a series of live attenuated vaccines has raised hope for an efficacious and safe vaccine, among them "ASFV-G-∆MGF". We tested the latter in an in vivo reversion to virulence study in accordance with International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products guidelines. Upon forced animal passaging, a virus variant emerged that was associated with transient fever and an increased replication and shedding. However, all animals were healthy upon completion of the study and reversion to significant virulence was not observed. The genomic changes did not affect the recombination site but involved deletions and reorganizations in the terminal regions of the genome. Thus, our study underscores that in-depth safety characterization is needed for live ASF vaccines. For this particular candidate, additional studies should target long-term effects and transmission characteristics before thorough benefit-risk analysis can be carried out.
非洲猪瘟（ASF）已呈大流行态势，目前仍无商业化疫苗。最近，一系列减毒活疫苗让人们看到了研发出有效且安全疫苗的希望，其中包括“ASFV-G-∆MGF”。我们根据《兽药注册技术要求国际协调会议指南》，在一项体内毒力返强研究中对后者进行了测试。在强制动物传代后，出现了一种病毒变体，它与短暂发热以及复制和排毒增加有关。然而，在研究结束时所有动物均健康，未观察到向显著毒力的返强情况。基因组变化未影响重组位点，但涉及基因组末端区域的缺失和重排。因此，我们的研究强调，减毒活非洲猪瘟疫苗需要进行深入的安全性表征。对于这一特定候选疫苗，在进行全面的效益风险分析之前，应针对长期影响和传播特性开展更多研究。
