Safety and Immunogenicity of a novel three-dose recombinant nanoparticle rabies G protein vaccine administered as simulated post exposure immunization: A randomized, comparator controlled, multicenter, phase III clinical study

References

• WHO Expert Consultation on Rabies prevention. Third report. Technical report series no. 1012. Geneva, Switzerland: World Health Organization; 2018.
   Google Scholar
• World Health Organization. Rabies Vaccines and Immunoglobulins: WHO position, WHO/CDS/NTD/NZD/2018.04. Geneva, Switzerland: World Health Organization; 2018.
   Google Scholar
• Minghui R, Stone M, Semedo MH, Nel L. New global strategic plan to eliminate dog-mediated rabies by 2030. Lancet Glob Health. 2018 Aug;6(8):e828–e829. doi: 10.1016/S2214-109X(18)30302-4. Epub 2018 Jun 18. PMID: 29929890.
   Google Scholar
• World Health Organization. Rabies vaccines: WHO position paper – April 2018. Weekly Epidemiological Record, No. 16. 2018;93:201–20.
   Google Scholar
• Vaccine Investment Strategy. Global alliance for vaccines and immunization. [accessed 2021 Mar 30] https://www.gavi.org/about/strategy/vaccine-investment-strategy .
   Google Scholar
• World Health Organization. WHO Expert Consultation on Rabies. Second report. Technical report series no. 931. Geneva (Switzerland): World Health Organization; 2005.
   Google Scholar
• Rupprecht CE, Nagarajan T, Ertl H. Current status and development of vaccines and other biologics for human rabies prevention. Expert Rev Vaccin. 2016;15(6):731–49. doi:10.1586/14760584.2016.1140040.
   PubMed Web of Science ®Google Scholar
• Chutivongse S, Wilde H, Fishbein DB, Baer GM, Hemachudha T. One year study of the 2-1-1 intramuscular post exposure rabies vaccine regimen in 100 severely exposed Thai patients using rabies immune globulin and Vero cell rabies vaccine. Vaccine. 1991;9(8):573–76. doi:10.1016/0264-410X(91)90244-Z.
   PubMed Web of Science ®Google Scholar
• Ravish HS, Rachana AR, Veena V, Ashwath Narayana DH. Compliance to anti-rabies vaccination in post-exposure prophylaxis. Indian J Public Health. 2015;59(1):58–60. doi:10.4103/0019-557X.152867.
   PubMedGoogle Scholar
• Rupprecht CE, Briggs D, Brown CM, Franka R, Katz SL, Kerr HD, Lett S, Levis R, Meltzer MI, Schaffner W, et al. Evidence for a 4-dose vaccine schedule for human rabies post-exposure prophylaxis in previously non-vaccinated individuals. Vaccine. 2009 Nov 27;27(51):7141–8.
   Google Scholar
• Haradanahalli RS, Banerjee R, Kalappa MS, Narayana A, Annadani RR, Bilagumba G. Safety and immunogenicity of rabies vaccine as 4 - dose Essen Intramuscular regimen for post exposure prophylaxis: A non - randomized, comparative controlled study. Hum Vaccin Immunother. 2021 Feb 23:1–6.
   Google Scholar
• World Health Organization. Rabies working group report, SAGE meeting October 2017. [accessed 2021 Mar 30] http://www.who.int/immunization/sage/meetings .
   Google Scholar
• López-Sagaseta J, Malito E, Rappuoli R, Bottomley MJ. Self-assembling protein nanoparticles in the design of vaccines. Comput Struct Biotechnol J. 2016;14:58–68. doi:10.1016/j.csbj.2015.11.001.
   PubMed Web of Science ®Google Scholar
• Hicks DJ, Fooks AR, Johnson N. Developments in rabies vaccines. Clin Exp Immunol. 2012;169(3):199–204. doi:10.1111/j.1365-2249.2012.04592.x.
   PubMed Web of Science ®Google Scholar
• Zalan E, Wilson C, Pukitis D. A microtest for the quantitation of rabies virus neutralizing antibodies. J Biol Stand. 1979;7:213–20. doi:10.1016/S0092-1157(79)80024-4.
   PubMedGoogle Scholar
• World Health Organization. Rabies vaccines: WHO position paper. Weekly Epidemiological Record. No 32, 2010;85:309–29.
   Google Scholar
• World Health Organization. Strategic framework for elimination of human rabies transmitted by dogs in the South-East Asia Region.  WHO Library Cataloguing-in-Publication data 2012 who.int/docs/default-source/searo/india/health-topic-pdf/zoonoses-sfehrtd-sear.pdf
   Google Scholar
• Tarantola A. Four thousand years of concepts relating to rabies in animals and humans, its prevention and its cure. Trop Med Infect Dis. 2017;2:e5. doi:10.3390/tropicalmed2020005.
   PubMedGoogle Scholar
• Sudarshan MK, Haradanhalli RS. Facilities and services of postexposure prophylaxis in anti-rabies clinics: a National assessment in India. Indian J Public Health. 2019;63:S26–30.
   PubMed Web of Science ®Google Scholar
• Haradanhalli SR, Krishna C, Kumar DP, Siddareddy I, Annadani RR. Safety, immunogenicity and clinical efficacy of post exposure prophylaxis in confirmed rabies exposures. Glob Vaccines Immunol. 2016;1:56–59. doi:10.15761/GVI.1000116.
   Google Scholar
• Tran CH, Kligerman M, Andrecy LL, Etheart MD, Adrien P, Blanton JD, Millien M, Wallace RM. Rabies vaccine initiation and adherence among animal-bite patients in Haiti, 2015. PLoS Negl Trop Dis. 2018;12(11):e0006955. doi:10.1371/journal.pntd.0006955.
   PubMed Web of Science ®Google Scholar
• Lilare RR, Rathod N, Narlawar UW. Compliance of post exposure rabies vaccination among patients attending anti-rabies OPD in the government medical college, Nagpur. Int J Community Med Public Health. 2018;5:3045–48. doi:10.18203/2394-6040.ijcmph20182646.
   Google Scholar
• Buchy P, Preiss S, Singh V, Mukherjee P. Heterogeneity of rabies vaccination recommendations across Asia. Trop Med Infect Dis Internet. 2017;1;2(3). doi:10.3390/tropicalmed2030023.
   Google Scholar
• Sudarshan MK, Narayana DHA, Madhusudana SN, Holla R, Ashwin BY, Gangaboraiah B, Ravish HS. Evaluation of a one week intradermal regimen for rabies post-exposure prophylaxis: results of a randomized, open label, active-controlled trial in healthy adult volunteers in India. Hum Vaccines Immunother. 2012;8(8):1077–81. doi:10.4161/hv.20471.
   PubMed Web of Science ®Google Scholar
• Narayana A, Manoharan A, Narayan MS, Kalappa SM, Biligumba G, Haradanahalli R, Anand AM. Comparison of safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases. Hum Vaccines Immunother. 2015;11(7):1748–53. doi:10.1080/21645515.2015.1048938.
   PubMed Web of Science ®Google Scholar
• Shantavasinkul P, Tantawichien T, Wilde H, Sawangvaree A, Kumchat A, Ruksaket N, Lohsoonthorn V, Khawplod P, Tantawichien T. Postexposure rabies prophylaxis completed in 1 week: preliminary study. Clin Infect Dis. 2010;50(1):56–6038. doi:10.1086/649211.
   PubMed Web of Science ®Google Scholar
• Warrell MJ, Riddell A, Yu LM, Phipps J, Diggle L, Bourhy H, Deeks JJ, Fooks AR, Audry L, Brookes SM, et al. A simplified 4-site economical intradermal post-exposure rabies vaccine regimen: a randomised controlled comparison with standard methods. PLoS Negl Trop Dis. 2008;2(4):e224. 35. doi:10.1371/journal.pntd.0000224.
   PubMed Web of Science ®Google Scholar
• Ambrozaitis A, Laiškonis A, Balčiuniene L, Banzhoff A, Malerczyk C. Rabies post-exposure prophylaxis vaccination with purified chick embryo cell vaccine (PCECV) and purified Vero cell rabies vaccine (PVRV) in a four-site intradermal schedule (4-0-2-0-1-1): an immunogenic, cost– effective and practical regimen. Vaccine. 2006;24(19):4116–21. doi:10.1016/j.vaccine.2006.02.036.
   PubMed Web of Science ®Google Scholar
• Cantaert T, Borand L, Kergoat L, Leng C, Ung S, In S, Peng Y, Phoeun C, Hing C, Taing CN, et al. A 1-week intradermal dose-sparing regimen for rabies post-exposure prophylaxis (RESIST-2): an observational cohort study. Lancet Infect Dis. 2019;19(12):1355–62. doi:10.1016/S1473-3099(19)30311-1.
   PubMed Web of Science ®Google Scholar
• Tarantola A, Ly S, Chan M, In S, Peng Y, Hing C, Taing CN, Phoen C, Ly S, Cauchemez S, et al. Intradermal rabies post-exposure prophylaxis can be abridged with no measurable impact on clinical outcome in Cambodia, 2003-2014. Vaccine. 2019;37(Suppl 1):A118–27. doi:10.1016/j.vaccine.2018.10.054.
   PubMed Web of Science ®Google Scholar
• Kessels J, Tarantola A, Salahuddin N, Blumberg L, Knopf L. Rabies post-exposure prophylaxis: a systematic review on abridged vaccination schedules and the effect of changing administration routes during a single course. Vaccine. 2019;37:A107–17. doi:10.1016/j.vaccine.2019.01.041.
   PubMed Web of Science ®Google Scholar
• Hampson K, Abela-Ridder B, Bharti O, Knopf L, Léchenne M, Mindekem R, Tarantola A, Zinsstag J, Trotter C. Modelling to inform prophylaxis regimens to prevent human rabies. Vaccine. 2019;37(Suppl 1):A166–73. doi:10.1016/j.vaccine.2018.11.010.
   PubMed Web of Science ®Google Scholar
• Plotkin S. History of vaccination. Proc Natl Acad Sci U S A. 2014;111(34):12283–87. doi:10.1073/pnas.1400472111.
   PubMed Web of Science ®Google Scholar
• Sudarshan MK, Bhardwaj S, Mahendra BJ, Sharma H, Sanjay TV, Ashwathnarayana DH. An immunogenicity, safety and postmarketing surveillance of a novel adsorbed human diploid cell rabies vaccine (Rabivax®) in Indian subjects. Hum Vaccin. 2008;4(4):275–79. doi:10.4161/hv.4.4.5588.
   PubMed Web of Science ®Google Scholar
• Ashwathnarayana DH, Madhusudhana SN, Sampath G, Tripathy RM, Sudarshan MK. Gangaboraiah. Safety and Immunogenicity Study of a New Purified Chick Embryo Cell Rabies Vaccine Vaxirab-N (Pitman Moore Strain) Manufactured in India. Human Vaccines & Immuntherapeutics. 2014;10:120–25.
   Google Scholar
• World Health Organization. Global elimination of dog-mediated human rabies: report of the rabies global conference, 10-11 December 2015, Geneva, Switzerland.
   Google Scholar