A novel ELISA for quantification of glycoprotein in human rabies vaccines using a clinically proven virus neutralizing human monoclonal antibody

References

• WHO Fact Sheet on Rabies. 2019 Sept 27 [Assessed 2019 Nov 3]. https://www.who.int/news-room/fact-sheets/detail/rabies.
   Google Scholar
• Recommendations for an inactivated rabies vaccine for human use produced in cell substrates and embryonated eggs. WHO TRS941 (Annex II); 2007.
   Google Scholar
• Rabies Vaccine Monograph for Human use, Ed. Ph Eur. Monograph 2018. Strasbourg (France): Council of Europe; 2015.
   Google Scholar
• Barth R, Diderrich G, Weinmann E. NIH test, a problematic method for testing potency of inactivated rabies vaccine. Vaccine. 1988 Aug;6(4):369–77. doi:10.1016/0264-410X(88)90185-5.
   PubMed Web of Science ®Google Scholar
• Shank-Retzlaff M, Wang F, Morley T, Anderson C, Hamm M, Brown M, Rowland K, Pancari G, Zorman J, Lowe R, et al. Correlation between mouse potency and in vitro relative potency for human Papillomavirus Type 16 virus-like particles and gardasil (R) vaccine samples. Hum Vaccin. 2005;1:191–97. doi:10.4161/hv.1.5.2126.
   PubMed Web of Science ®Google Scholar
• Giffroy D, Mazy C, Duchêne M. Validation of a new ELISA method for in vitro potency assay of hepatitis B-containing vaccines. Pharmeuropa Bio. 2006;2006:7–14.
   PubMedGoogle Scholar
• Perrin P, Thibodeau L, Sureau P. Rabies immunome (subunit vaccine) structure and immunogenicity. Pre- and post-exposure protection studies. Vaccine. 1985;3:325–32.
   PubMed Web of Science ®Google Scholar
• Celis E, Ou D, Dietzschold B, Koprowski H. Recognition of rabies and rabies-related viruses by T cells derived from human vaccine recipients. J Virol. 1988;62:3128–34.
   PubMed Web of Science ®Google Scholar
• Stokes W, McFarland R, Kulpa-Eddy J, Gatewood D, Levis R, Halder M, Pulle G, Kojima H, Casey W, Gaydamaka A, et al. Report on the international workshop on alternative methods for human and veterinary rabies vaccine testing: state of the science and planning the way forward. Biologicals. 2012;40(5):369–81. doi:10.1016/j.biologicals.2012.07.005.
   PubMed Web of Science ®Google Scholar
• Isbrucker R, Levis R, Casey W, McFarland R, Schmitt M, Arciniega J. Alternative methods and strategies to reduce, refine, and replace animal use for human vaccine post-licensing safety testing: state of the science and future directions. Proc Vaccinol. 2011;5:47e59. antibodies. Microbiol Immunol 1998;42:187e93. doi:10.1016/j.provac.2011.10.004.
   Google Scholar
• Luo TR, Minamoto N, Hishida M, Yamamoto K, Fujise T, Hiraga S, Ito N, Sugiyama M, Kinjo T. Antigenic and functional analyses of the GP of rabies virus using monoclonal antibodies. Microbiol Immunol. 1998;42:187e93.
   Web of Science ®Google Scholar
• Wiktor TJ, Gyorgy E, Schlumberger D, Sokol F, Koprowski H. Antigenic properties of rabies virus components. J Immunol. 1973;110:269e76.
   Web of Science ®Google Scholar
• Nagarajan T, Reddy GS, Mohana Subramanian B, Rajalakshmi S, Thiagarajan D, Tordo N, Jallet C, Srinivasan VA. A simple immuno-capture ELISA to estimate rabies viral GP antigen in vaccine manufacture. Biologicals. 2006;34:21e7.
   Web of Science ®Google Scholar
• Gibert R, Alberti M, Poirier B, Jallet C, Tordo N, Morgeaux S. A relevant in vitro ELISA test in alternative to the in vivo NIH method for human rabies vaccine batch release. Vaccine. 2013;31:6022e9. doi:10.1016/j.vaccine.2013.10.019.
   Web of Science ®Google Scholar
• Gamoh K, Senda M, Itoh O, Muramatsu M, Hirayama N, Koike R, Endoh YS, Minamoto N. Use of ELISA for in vitro potency test of rabies vaccines for animal use. Biologicals. 1996;24:95e101.
   Web of Science ®Google Scholar
• Morgeaux S, Poirier B, Ragan CI, Wilkinson D, Arabin U, Guinet-Morlot F, Levis R, Meyer H, Riou P, Shaid S, et al. Replacement of in vivo human rabies vaccine potency testing by in vitro GP quantification using ELISA - Results of an international collaborative study. Vaccine. 2017 7;35(6):966–71. doi:10.1016/j.vaccine.2016.12.039.
   PubMed Web of Science ®Google Scholar
• Sloan SE, Hanlon C, Weldon W, Niezgoda M, Blanton J, Self J, Rowley KJ, Mandell RB, Babcock GJ, Thomas WD Jr, et al. Identification and characterization of a human monoclonal antibody that potently neutralizes a broad panel of rabies virus isolates. Vaccine. 2007 12;25(15):2800–10. doi:10.1016/j.vaccine.2006.12.031.
   PubMed Web of Science ®Google Scholar
• Wang Y, Rowley KJ, Booth BJ, Sloan SE, Ambrosino DM, Babcock GJ. G GP amino acid residues required for human monoclonal antibody RAB1 neutralization are conserved in rabies virus street isolates. Antiviral Res. 2011;91(2):187–94. doi:10.1016/j.antiviral.2011.06.002.
   PubMed Web of Science ®Google Scholar
• Gogtay N, Thatte U, Kshirsagar N, Leav B, Moline D, Cheslock P, Kapre SV, Kulkarni PS. SII RMab author group. Safety and pharmacokinetics of a human monoclonal antibody to rabies virus: a randomized, dose-escalation phase 1 study in adults. Vaccine. 2012;30:7315–20.
   PubMed Web of Science ®Google Scholar
• Gogtay NJ, Munshi R, Ashwath Narayana DH, Mahendra BJ, Kshirsagar V, Gunale B, Moore S, Cheslock P, Thaker S, Deshpande S, et al. Comparison of a novel human rabies monoclonal antibody to human rabies immunoglobulin for postexposure prophylaxis: a Phase 2/3, randomized, single-blind, noninferiority, controlled study. Clin Infect Dis. 2018 18;66(3):387–95. doi:10.1093/cid/cix791.
   PubMed Web of Science ®Google Scholar
• Kamat V, Rafique A. Designing binding kinetic assay on the bio-layer interferometry (BLI) biosensor to characterize antibody-antigen interactions. Anal Biochem. 2017;536:16–31. doi:10.1016/j.ab.2017.08.002.
   PubMed Web of Science ®Google Scholar
• Kumaraswamy S, Tobias R. Label-free kinetic analysis of an antibody-antigen interaction using biolayer interferometry. Methods Mol Biol. 2015;1278:165–82.
   PubMedGoogle Scholar
• Guideline on bioanalytical method validation EMEA/CHMP/EWP/192217/2009Rev. 1
   Google Scholar
• ICH M10 guideline on bioanalytical method validation.
   Google Scholar
• Carney PJ, Lipatov AS, Monto AS, Donis RO, Stevens J. Flexible label-free quantitative assay for antibodies to influenza virus hemagglutinins. Clin Vaccine Immunol. 2010;17:1407–16.
   PubMedGoogle Scholar
• Dennison SM, Reichartz M, Seaton KE, Dutta S, Wille-Reece U, Hill AVS, Ewer KJ, Rountree W, Sarzotti-Kelsoe M, Ozaki DA, et al. Qualified biolayer interferometry avidity measurements distinguish the heterogeneity of antibody interactions with Plasmodium falciparum circumsporozoite protein antigens. J Immunol. 2018;201(4):1315–26. doi:10.4049/jimmunol.1800323.
   PubMed Web of Science ®Google Scholar
• Kramer RA, Marissen WE, Goudsmit J, Visser TJ, Clijsters-van der Horst M, Bakker AQ, de Jong M, Jongeneelen M, Thijsse S, Backus HH, et al. The human antibody repertoire specific for rabies virus GP as selected from immune libraries. Eur J Immunol. 2005;35:2131–45. doi:10.1002/eji.200526134.
   PubMed Web of Science ®Google Scholar