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. 2022 Apr 25;14(5):896.
doi: 10.3390/v14050896.

Evaluation of the Safety Profile of the ASFV Vaccine Candidate ASFV-G-ΔI177L

Affiliations

Evaluation of the Safety Profile of the ASFV Vaccine Candidate ASFV-G-ΔI177L

Xuan Hanh Tran et al. Viruses. .

Abstract

African swine fever (ASF) is the cause of a recent pandemic that is posing a threat to much of the world swine production. The etiological agent, ASF virus (ASFV), infects domestic and wild swine, producing a variety of clinical presentations depending on the virus strain and the genetic background of the pigs infected. No commercial vaccine is currently available, although recombinant live attenuated vaccine candidates have been shown to be efficacious. In addition to determining efficacy, it is paramount to evaluate the safety profile of a live attenuated vaccine. The presence of residual virulence and the possibility of reversion to virulence are two of the concerns that must be evaluated in the development of live attenuated vaccines. Here we evaluate the safety profile of an efficacious live attenuated vaccine candidate, ASFV-G-ΔI177L. Results from safety studies showed that ASFV-G-ΔI177L remains genetically stable and phenotypically attenuated during a five-passage reversion to virulence study in domestic swine. In addition, large-scale experiments to detect virus shedding and transmission confirmed that even under varying conditions, ASFV-G-ΔI177L is a safe live attenuated vaccine.

Keywords: ASF; ASFV; African swine fever; I177L; reversion to virulence; swine; vaccine.

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Conflict of interest statement

The National Veterinary Joint Stock Company has obtained a license from the USDA to commercially produce ASFV-G-∆I177L. Douglas Gladue and Manuel Borca have a patent filed for ASFV-G-dI177L; US Patent number: US11007263B2 issued 18 May 2021.

Figures

Figure 1
Figure 1
Evolution of body temperature in animals IM inoculated with either 103.6 HAD50 (panel 10X), 103.3 HAD50 (panel 5X), or 102.6 HAD50 (panel 1X) of ASFV-G-∆I177L. Data are presented as individual values (expressed as °C) for each of the inoculated animals in each of the different groups.
Figure 2
Figure 2
Evolution of body temperature in animals IM inoculated with ASFV-G-∆I177L during 5 consecutive passages (panels P1–P5, respectively). Data are presented as individual values (expressed as °C) for each of the inoculated animals in each of the different groups.
Figure 3
Figure 3
Evolution of viremia titers in animals IM inoculated with ASFV-G-∆I177L during 5 consecutive passages (panels P1 to P5, respectively). Data are presented as individual values of virus titers (expressed as HAD50/mL) for each of the inoculated animals in each of the different groups.

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