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Research Article

Preclinical Safety Evaluation of Engineered Lactococcus lactis NZ3900 Biotherapeutics Using a 13-Week Repeated Dose Oral Toxicity Study in Rabbits

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References

  • Azizpour, M., S. D. Hosseini, P. Jafari, and N. Akbary. 2017. Lactococcus lactis: A new strategy for vaccination. Avicenna. J. Med. Biotechnol. 9 (4):163–168.
  • Buckley, L. F., and A. Abbate. 2018. Interleukin-1 blockade in cardiovascular diseases: A clinical update. Eur. Heart J. 39 (22):2063–2069. doi:10.1093/eurheartj/ehy128.
  • Charbonneau, M. R., V. M. Isabella, N. Li, and C. B. Kurtz. 2020. Developing a new class of engineered live bacterial therapeutics to treat human diseases. Nat. Commun. 11 (1):1738. doi:10.1038/s41467-020-15508-1.
  • Daniel, C., Y. Roussel, M. Kleerebezem, and B. Pot. 2011. Recombinant lactic acid bacteria as mucosal biotherapeutic agents. Trends Biotechnol. 29 (10):499–508. doi:10.1016/j.tibtech.2011.05.002.
  • de Lacerda, J. R. M., T. F. da Silva, R. E. Vollu, J. M. Marques, and L. Seldin. 2016. Generally recognized as safe (GRAS) Lactococcus lactis strains associated with Lippia sidoides Cham. are able to solubilize/mineralize phosphate. SpringerPlus 5 (1):828. doi:10.1186/s40064-016-2596-4.
  • de Ruyter, P. G., O. P. Kuipers, M. M. Beerthuyzen, I. van Alen-Boerrigter, and W. M. de Vos. 1996. Functional analysis of promoters in the nisin gene cluster of Lactococcus lactis. J. Bacteriol. 178 (12):3434–3439. doi:10.1128/jb.178.12.3434-3439.1996.
  • Emmi, G., M. L. Urban, M. Imazio, M. Gattorno, S. Maestroni, G. Lopalco, L. Cantarini, D. Prisco, and A. Brucato. 2018. Use of interleukin-1 blockers in pericardial and cardiovascular diseases. Curr.Cardiol. Rep. 20 (8):61. doi:10.1007/s11886-018-1007-6.
  • Freidl, R., A. Gstoettner, U. Baranyi, I. Swoboda, F. Stolz, M. Focke-Tejkl, T. Wekerle, R. van Ree, R. Valenta, and B. Linhart. 2017. Blocking antibodies induced by immunization with a hypoallergenic parvalbumin mutant reduce allergic symptoms in a mouse model of fish allergy. J. Allergy Clin. Immunol. 139 (6):1897–1905. doi:10.1016/j.jaci.2016.10.018.
  • Hugenholtz, J., and E. J. Smid. 2002. Nutraceutical production with food-grade microorganisms. Curr. Opin. Biotechnol. 13 (5):497–507. doi:10.1016/S0958-1669(02)00367-1.
  • Kataria, Y., C. Ellervik, and T. Mandrup-Poulsen. 2019. Treatment of type 2 diabetes by targeting interleukin-1: A meta-analysis of 2921 patients. Semin. Immunopathol. 41 (4):413–425. doi:10.1007/s00281-019-00743-6.
  • Kawana, K., K. Adachi, S. Kojima, A. Taguchi, K. Tomio, A. Yamashita, H. Nishida, K. Nagasaka, T. Arimoto, T. Yokoyama, et al. 2014. Oral vaccination against HPV E7 for treatment of cervical intraepithelial neoplasia grade 3 (CIN3) elicits E7-specific mucosal immunity in the cervix of CIN3 patients. Vaccine 32 (47):6233–6239. doi:10.1016/j.vaccine.2014.09.020.
  • Koné-Paut, I., S. Tellier, A. Belot, K. Brochard, C. Guitton, I. Marie, U. Meinzer, B. Cherqaoui, C. Galeotti, N. Boukhedouni, et al. 2020. Phase II open label study with anakinra in intravenous immunoglobulin-resistant Kawasaki disease. Arthritis Rheumatol. 73 (1):151–161. doi:10.1002/art.41481.
  • Lee, M. F., C. H. Chiang, Y. L. Li, N. M. Wang, P. P. Song, S. J. Lin, Y. H. Chen, and H.-C. Lai. 2018. Oral edible plant vaccine containing hypoallergen of American cockroach major allergen per a 2 prevents roach-allergic asthma in a murine model. PLoS One 13 (7):e0201281. doi:10.1371/journal.pone.0201281.
  • Lee, M. F., C. H. Chiang, S. J. Lin, P. P. Song, H. C. Liu, T. J. Wu, and W. W. Lin. 2020. Recombinant Lactococcus lactis expressing Ling Zhi 8 protein ameliorates nonalcoholic fatty liver and early atherogenesis in cholesterol-fed rabbits. BioMed. Res. Int. 2020:1–9. doi:10.1155/2020/3495682.
  • Lee, M. F., C. H. Chiang, S. J. Lin, C. S. Wu, Y. H. Chen, and M. L. S. Oliveira. 2021. Effectiveness and safety of oral lactococci-based vaccine encoding triple common allergens to prevent airway allergy in mice. PLoS One 16 (12):e026133. doi:10.1371/journal.pone.0261333.
  • Mierau, I., and M. Kleerebezem. 2005. 10 years of the nisin-controlled gene expression system (NICE) in Lactococcus lactis. Appl. Microbiol. Biotechnol. 68 (6):705–717. doi:10.1007/s00253-005-0107-6.
  • Mierau, I., P. Leij, I. van Swam, B. Blommestein, E. Floris, J. Mond, and E. J. Smid. 2005. Industrial-scale production and purification of a heterologous protein in Lactococcus lactis using the nisin-controlled gene expression system NICE: The case of lysostaphin. Microb. Cell Fact. 4 (1):15. doi:10.1186/1475-2859-4-15.
  • Nikfar, S., P. Saiyarsarai, B. M. Tigabu, and M. Abdollahi. 2018. Efficacy and safety of interleukin-1 antagonists in rheumatoid arthritis: A systematic review and meta-analysis. Rheumatol. Int. 38 (8):1363–1383. doi:10.1007/s00296-018-4041-1.
  • Powers, N. E., B. Swartzwelter, C. Marchetti, D. M. deGraaf, A. Lerchner, M. Schlapschy, R. Datar, U. Binder, C. K. Edwards, A. Skerra, et al. 2020. Pasylation of IL-1 receptor antagonist (IL-1Ra) retains IL-1 blockade and extends its duration in mouse urate crystal-induced peritonitis. J. Biol. Chem. 295 (3):868–882. doi:10.1016/S0021-9258(17)49941-8.
  • Ridker, P. M., B. M. Everett, T. Thuren, J. G. MacFadyen, W. H. Chang, C. Ballantyne, F. Fonseca, J. Nicolau, W. Koenig, S. D. Anker, et al. 2017. Antiinflammatory therapy with canakinumab for atherosclerotic disease. N. Engl. J. Med. 377 (12):1119–1131. doi:10.1056/NEJMoa1707914.
  • Rosales-Mendoza, S., C. Angulo, and B. Meza. 2016. Food-grade organisms as vaccine biofactories and oral delivery vehicles. Trends Biotechnol. 34 (2):124–136. doi:10.1016/j.tibtech.2015.11.007.
  • Sheets, R., J. Stein, T. S. Manetz, C. Andrews, R. Bailer, J. Rathmann, and P. L. Gomez. 2006. Toxicological safety evaluation of DNA plasmid vaccines against HIV-1, Ebola, Severe Acute Respiratory Syndrome, or West Nile virus is similar despite differing plasmid backbones or gene-inserts. Toxicol. Sci. 91 (2):620–630. doi:10.1093/toxsci/kfj170.
  • Shimizu, H., T. Mizuguchi, E. Tanaka, and S. Shioya. 1999. Nisin production by a mixed-culture system consisting of Lactococcus lactis and Kluyveromyces marxianus. Appl. Environ. Microb. 65 (7):3134–3141. doi:10.1128/AEM.65.7.3134-3141.1999.
  • Smelt, M. J., B. J. de Haan, P. A. Bron, I. van Swam, M. Meijerink, J. M. Wells, M. M. Faas, and P. de Vos. 2012. L. plantarum, L. salivarius, and L. lactis attenuate Th2 responses and increase Treg frequencies in healthy mice in a strain dependent manner. PLoS One 7 (10):e47244. doi:10.1371/journal.pone.0047244.
  • Valenta, R., R. Campana, M. Focke-Tejkl, and V. Niederberger. 2016. Vaccine development for allergen-specific immunotherapy based on recombinant allergens and synthetic allergen peptides: Lessons from the past and novel mechanisms of action for the future. J. Allergy Clin. Immunol. 137 (2):351–357. doi:10.1016/j.jaci.2015.12.1299.

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