Expert consensus on the clinical application of ormutivimab injection for use against the rabies virus

References

• Sparrow E, Torvaldsen S, Newall AT, et al. Recent advances in the development of monoclonal antibodies for rabies post exposure prophylaxis: A review of the current status of the clinical development pipeline. Vaccine. 2019;37(Suppl 1):A132–A139. doi: 10.1016/j.vaccine.2018.11.004
   PubMed Web of Science ®Google Scholar
• Both L, Banyard AC, van Dolleweerd C, et al. Passive immunity in the prevention of rabies. Lancet Infect Dis. 2012 May;12(5):397–407.
   PubMed Web of Science ®Google Scholar
• Mohindra R, Suri V, Chatterjee D, et al. Measuring antibody titres following rabies postexposure prophylaxis in immunosuppressed patients: a norm rather than the exception. BMJ Case Rep. 2021 Nov 11;14(11):e245171. doi: 10.1136/bcr-2021-245171
   PubMedGoogle Scholar
• Rupprecht CE, Yager ML, Newhouse RH. Passive Immunity in Rabies Prophylaxis[M]//ERTL H C J. Rabies and Rabies Vaccines Cham: Springer International Publishing; 2020. p. 117–139.
   Google Scholar
• Bourhy H, Dacheux L, Ribadeau-Dumas F. The use of passive rabies immunotherapy: from the past to the future. Biol Aujourdhui. 2010;204(1):71–80. doi: 10.1051/jbio/2009049
   PubMedGoogle Scholar
• Diagnosis WHO Comair, Research, World Health Organization, Veterinary Public Health U. Report of the Sixth WHO consultation on monoclonal antibodies in rabies[M]. The Wistar Institute, 1990 April, Philadelphia, Pennsylvania, USA. Geneva: World Health Organization; 1990. p. 2–3.
   Google Scholar
• Gongal G, Sampath G. Monoclonal antibodies for rabies post-exposure prophylaxis: A paradigm shift in passive immunization. Arch Prev Med. 2020;5(1):35–38.
   Google Scholar
• World Health Organization. Consultation on a rabies monoclonal antibody cocktail for rabies post exposure treatment. Geneva: WHO; 2002Vol. 5p. 23–24.
   Google Scholar
• World Health Organization. Rabies vaccines: WHO position paper-April 2018. Weekly Epidemiological Rec. 2018;93(16):201–220.
   Google Scholar
• World Health Organization. WHO expert consultation on rabies: third report [M]. Geneva: World Health Organization, 2018.
   Google Scholar
• O’Brien KL, Nolan T, SAGE WG on Rabies. The WHO position on rabies immunization-2018 updates. Vaccine. 2019;37(Suppl 1):A85–87. doi: 10.1016/j.vaccine.2018.10.014
   PubMedGoogle Scholar
• World Health Organization. Driving progress towards rabies elimination: new WHO recommendations on human rabies immunization and results of Gavi’s learning agenda on rabies and 2nd international meeting of the Pan-African Rabies Control Network (PARACON): meeting report. Johannesburg, South Africa; 2018 Sep 12–14.
   Google Scholar
• Ilina EN, Larina MV, Aliev TK, et al. Recombinant monoclonal antibodies for rabies post-exposure prophylaxis. Biochemistry (Mosc). 2018 Jan;83(1):1–12.
   PubMed Web of Science ®Google Scholar
• Rupprecht CE, Briggs D, Brown CM, et al. Use of a reduced (4-dose) vaccine schedule for postexposure prophylaxis to prevent human rabies: recommendations of the advisory committee on immunization practices. MMWR Recomm Rep. 2010;59(RR–2):1–9.
   PubMedGoogle Scholar
• Malerczyk C, Freuling C, Gniel D, et al. Cross-neutralization of antibodies induced by vaccination with Purified Chick Embryo Cell Vaccine (PCECV) against different Lyssavirus species. Hum Vaccin Immunother. 2014;10(10):2799–2804. doi: 10.4161/21645515.2014.972741
   PubMed Web of Science ®Google Scholar
• Kopel E, Oren G, Sidi Y, et al. Inadequate antibody response to rabies vaccine in immunocompromised patient. Emerg Infect Dis. 2012;18(9):1493–1495. doi: 10.3201/eid1809.111833
   PubMed Web of Science ®Google Scholar
• Katz ISS, Guedes F, Fernandes ER, et al. Immunological aspects of rabies: a literature review. Arch Virol. 2017;162(11):3251–3268. doi: 10.1007/s00705-017-3484-0
   PubMed Web of Science ®Google Scholar
• Zhou H, Li Y, Chen RF, et al. Chinese Center for Disease Control and Prevention. [Technical guideline for human rabies prevention and control (2016)]. Zhonghua Liu Xing Bing Xue Za Zhi. 2016Feb;37(2):139–163. Chinese. doi: 10.3760/cma.j.issn.0254-6450.2016.02.001
   PubMedGoogle Scholar
• Lang J, Attanath P, Quiambao B, et al. Evaluation of the safety, immunogenicity, and pharmacokinetic profile of a new, highly purified, heat-treated equine rabies immunoglobulin, administered either alone or in association with a purified, Vero-cell rabies vaccine. Acta Trop. 1998;70(3):317–333. doi: 10.1016/S0001-706X(98)00038-2
   PubMed Web of Science ®Google Scholar
• Feige K, Ehrat FB, Kastner SB, et al. Automated plasmapheresis compared with other plasma collection methods in the horse. J Vet Med Physiol Pathol Clin Med. 2003;50(4):185–189. doi: 10.1046/j.1439-0442.2003.00528.x
   PubMedGoogle Scholar
• Gerber F, Tetchi M, Kallo V, et al. RABIES IMMUNOGLOBULIN: Brief history and recent experiences in Côte d’Ivoire. Acta Trop. 2020;211:105629. doi: 10.1016/j.actatropica.2020.105629
   PubMed Web of Science ®Google Scholar
• Johnson N, Cunningham AF, Fooks AR. The immune response to rabies virus infection and vaccination. Vaccine. 2010;28(23):3896–3901. doi: 10.1016/j.vaccine.2010.03.039
   PubMed Web of Science ®Google Scholar
• Tantawichien T, Rupprecht CE. Modern biologics for rabies prophylaxis and the elimination of human cases mediated by dogs. Expert Opin Biol Ther. 2020;20(11):1347–1359. doi: 10.1080/14712598.2020.1766021
   PubMed Web of Science ®Google Scholar
• Gogtay NJ, Munshi R, Ashwath Narayana DH, 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 Jan 18;66(3):387–395. doi: 10.1093/cid/cix791
   PubMed Web of Science ®Google Scholar
• Hobart-Porter N, Stein M, Toh N, et al. Safety and efficacy of rabies immunoglobulin in pediatric patients with suspected exposure. Hum Vaccin Immunother. 2021 Jul 3;17(7):2090–2096. doi: 10.1080/21645515.2020.1854000
   PubMed Web of Science ®Google Scholar
• State drug administration. Biological products registration classification and application data requirements[M]. 2020.
   Google Scholar
• Dietzschold B, Gore M, Casali P, et al. Biological characterization of human monoclonal antibodies to rabies virus. J Virol. 1990 Jun;64(6):3087–3090.
   PubMed Web of Science ®Google Scholar
• Prosniak M, Faber M, Hanlon CA, et al. Development of a cocktail of recombinant-expressed human rabies virus-neutralizing monoclonal antibodies for postexposure prophylaxis of rabies. J Infect Dis. 2003 Jul 1;188(1):53–56. doi: 10.1086/375247
   PubMed Web of Science ®Google Scholar
• Marissen WE, Kramer RA, Rice A, et al. Novel rabies virus-neutralizing epitope recognized by human monoclonal antibody: fine mapping and escape mutant analysis. J Virol. 2005 Apr;79(8):4672–4678.
   PubMed Web of Science ®Google Scholar
• Aman P, Ehlin-Henriksson B, Klein G. Epstein-Barr virus susceptibility of normal human B lymphocyte populations. J Exp Med. 1984;159(1):208–220. doi: 10.1084/jem.159.1.208
   PubMed Web of Science ®Google Scholar
• Traggiai E, Becker S, Subbarao K, et al. An efficient method to make human monoclonal antibodies from memory B cells: potent neutralization of SARS coronavirus. Nat Med. 2004 Aug;10(8):871–875.
   PubMed Web of Science ®Google Scholar
• Bonsignori M, Hwang KK, Chen X, et al. Analysis of a clonal lineage of HIV-1 envelope V2/V3 conformational epitope-specific broadly neutralizing antibodies and their inferred unmutated common ancestors. J Virol. 2011 Oct;85(19):9998–10009.
   PubMed Web of Science ®Google Scholar
• Wu X, Yang ZY, Li Y, et al. Rational design of envelope identifies broadly neutralizing human monoclonal antibodies to HIV-1. Science. 2010 Aug 13;329(5993):856–861. doi: 10.1126/science.1187659
   PubMed Web of Science ®Google Scholar
• Wiktor TJ, Koprowski H. Monoclonal antibodies against rabies virus produced by somatic cell hybridization: detection of antigenic variants. Proc Natl Acad Sci U S A. 1978 Aug;75(8):3938–3942. doi: 10.1073/pnas.75.8.3938
   PubMed Web of Science ®Google Scholar
• Müller T, Dietzschold B, Ertl H, et al. Development of a mouse monoclonal antibody cocktail for post-exposure rabies prophylaxis in humans. PLoS Negl Trop Dis. 2009 Nov 3;3(11):e542. doi: 10.1371/journal.pntd.0000542
   PubMed Web of Science ®Google Scholar
• Morrison SL, Johnson MJ, Herzenberg LA, et al. Chimeric human antibody molecules: mouse antigen-binding domains with human constant region domains. Proc Natl Acad Sci U S A. 1984 Nov;81(21):6851–6855.
   PubMed Web of Science ®Google Scholar
• Both L, van Dolleweerd C, Wright E, et al. Production, characterization, and antigen specificity of recombinant 62-71-3, a candidate monoclonal antibody for rabies prophylaxis in humans. FASEB J. 2013 May;27(5):2055–2065.
   PubMed Web of Science ®Google Scholar
• Chao TY, Ren S, Shen E, et al. SYN023, a novel humanized monoclonal antibody cocktail, for post-exposure prophylaxis of rabies. PLoS negl trop dis. 2017;11(12):e0006133. doi: 10.1371/journal.pntd.0006133
   PubMed Web of Science ®Google Scholar
• Singh S, Kumar NK, Dwiwedi P, et al. Monoclonal antibodies: a review. Curr Clin Pharmacol. 2017;12(2):85–99. doi: 10.2174/1574884712666170809124728
   Google Scholar
• Lu RM, Hwang YC, Liu IJ, et al. Development of therapeutic antibodies for the treatment of diseases. J Biomed Sci. 2020 Jan 2;27(1):1. doi: 10.1186/s12929-019-0592-z
   PubMed Web of Science ®Google Scholar
• Jun W. Practice for prevention and disposal of rabies exposure (2009 edition). China Working Dog. 2010;2:60–61.
   Google Scholar
• Bharti OK, Madhusudana SN, Wilde H. Injecting rabies immunoglobulin (RIG) into wounds only: a significant saving of lives and costly RIG. Hum Vaccin Immunother. 2017;13(4):762–765. doi: 10.1080/21645515.2016.1255834
   PubMed Web of Science ®Google Scholar
• Bharti OK, Madhusudana SN, Gaunta PL, et al. Local infiltration of rabies immunoglobulins without systemic intramuscular administration: an alternative cost effective approach for passive immunization against rabies. Hum Vaccin Immunother. 2016;12(3):837–842. doi: 10.1080/21645515.2015.1085142
   PubMed Web of Science ®Google Scholar
• Madhusudana SN, Ashwin BY, Sudarshan S. Feasibility of reducing rabies immunoglobulin dosage for passive immunization against rabies: results of in vitro and in vivo studies. Hum Vaccin Immunother. 2013;9(9):1914–1917. doi: 10.4161/hv.25431
   PubMed Web of Science ®Google Scholar
• Saesow N, Chaiwatanarat T, Mitmoonpitak C, et al. Diffusion and fate of intramuscularly injected human rabies immune globulin. Acta Trop. 2000;76(3):289–292. doi: 10.1016/S0001-706X(00)00107-8
   PubMed Web of Science ®Google Scholar
• Atanasiu P, Bahmanyar M, Baltazard M, et al. Rabies neutralizing antibody response to different schedules of serum and vaccine inoculations in non-exposed persons. II. Bull World Health Organ. 1957;17(6):911–932.
   PubMedGoogle Scholar
• Bookstaver PB, Akpunonu P, Nguyen HB, et al. Administration of rabies immunoglobulin: Improving evidence-based guidance for wound infiltration. Pharmacotherapy. 2021 Aug;41(8):644–648.
   PubMed Web of Science ®Google Scholar
• Liu X, Li Y, Li J, et al. Comparing recombinant human rabies monoclonal antibody (ormutivimab) with human rabies immunoglobulin (HRIG) for postexposure prophylaxis: A phase III, randomized, double-blind, non-inferiority trial. Int J Infect Dis. 2019 May 19;134:53–62.
   Google Scholar
• de Melo GD, Hellert J, Gupta R, et al. Monoclonal antibodies against rabies: current uses in prophylaxis and in therapy. Curr Opin Virol. 2022 Apr;53:101204.
   PubMed Web of Science ®Google Scholar
• Quiambao BP, Dy-Tioco HZ, Dizon RM, et al. Rabies post-exposure prophylaxis with purified equine rabies immunoglobulin: one-year follow-up of patients with laboratory-confirmed category III rabies exposure in the Philippines. Vaccine. 2009 Nov 27;27(51):7162–7166. doi: 10.1016/j.vaccine.2009.09.036
   PubMed Web of Science ®Google Scholar
• Haradanhalli RS, Fotedar N, Kumari N, et al. Safety and clinical efficacy of human rabies immunoglobulin in post exposure prophylaxis for category III animal exposures. Human Vaccines & Immunotherapeutics. 2022 Jun;10(5):1–5. doi: 10.1080/21645515.2022.2081024
   Google Scholar
• Ejemel M, Smith TG, Greenberg L, et al. A cocktail of human monoclonal antibodies broadly neutralizes North American rabies virus variants as a promising candidate for rabies post-exposure prophylaxis. Sci Rep. 2022 Jun 7;12(1):9403. doi: 10.1038/s41598-022-13527-0
   PubMed Web of Science ®Google Scholar
• World Health Organization. The Selection and Use of Essential Medicines (2021) -TRS 1035. WHO Technical Report Series. 2022 Jan;1035:499–506.
   Google Scholar
• Fan L, Zhang L, Li J, et al. Advances in the progress of monoclonal antibodies for rabies. Hum Vaccin Immunother. 2022 Dec 31;18(1):2026713. doi: 10.1080/21645515.2022.2026713
   PubMed Web of Science ®Google Scholar
• Anwith HS, Ravish HS, Ashwathnarayana DH. Safety of new indigenous human Rabies Monoclonal Antibody (RMAb) for post exposure prophylaxis corresponding author citation article cycle. Indian J Community Health. 2018;30(3):196–201. doi: 10.47203/IJCH.2018.v30i03.004
   Web of Science ®Google Scholar