A randomized, observer-blind, controlled phase III clinical trial assessing safety and immunological non-inferiority of Vi-diphtheria toxoid versus Vi-tetanus toxoid typhoid conjugate vaccine in healthy volunteers in eastern Nepal

References

• Garrett DO, Longley AT, Aiemjoy K, Yousafzai MT, Hemlock C, Yu AT, Vaidya K, Tamrakar D, Saha S, Bogoch II, et al. Incidence of typhoid and paratyphoid fever in Bangladesh, Nepal, and Pakistan: results of the surveillance for enteric fever in Asia project. Lancet Glob Health [Internet]. 2022;10(7):e978–8. doi:10.1016/S2214-109X(22)00119-X.
   PubMed Web of Science ®Google Scholar
• Kumar Rai G, Saluja T, Chaudhary S, Tamrakar D, Kanodia P, Giri BR, Shrestha R, Uranw S, Kim DR, Yang JS, et al. Safety and immunogenicity of the Vi-DT typhoid conjugate vaccine in healthy volunteers in Nepal: an observer-blind, active-controlled, randomised, non-inferiority, phase 3 trial. Lancet Infect Dis [Internet]. 2021;22(4):529–40. doi:10.1016/S1473-3099(21)00455-2.
   PubMed Web of Science ®Google Scholar
• Summary of the WHO position paper on typhoid vaccines: wHO position paper- March 2018 [Internet]. [accessed 2023 Feb 7]. https://cdn.who.int/media/docs/default-source/immunization/position_paper_documents/typhoid/pp-typhoid-2018-summary.pdf?sfvrsn=b2fe8d02_2.
   Google Scholar
• Typhoid [Internet]. World Health Organization. World Health Organization; [accessed 2023 Feb 7]. https://www.who.int/news-room/fact-sheets/detail/typhoid#:~:text=WHO%20estimates%20the%20global%20typhoid,children%20are%20at%20highest%20risk.
   Google Scholar
• Lee JS, Mogasale VV, Mogasale V, Lee K. Geographical distribution of typhoid risk factors in low and middle income countries. BMC Infect Dis [Internet]. 2016;16(1):1–10. doi:10.1186/s12879-016-2074-1.
   PubMedGoogle Scholar
• Parry CM, Ribeiro I, Walia K, Rupali P, Baker S, Basnyat B. Multidrug resistant enteric fever in South Asia: unmet medical needs and opportunities. BMJ. 2019;364:1–4.
   Google Scholar
• Meiring JE, Gibani M, Basnyat B, Bentsi-Enchill AD, Clemens J, Darton TC, Date K, Dougan G, Garrett D, Gessner BD, et al. The Typhoid Vaccine Acceleration Consortium (TyVAC): vaccine effectiveness study designs: accelerating the introduction of typhoid conjugate vaccines and reducing the global burden of enteric fever. Report from a meeting held on 26–27 October 2016, Oxford, UK. Vaccine. 2017;35(38):5081–8. doi:10.1016/j.vaccine.2017.08.001.
   PubMed Web of Science ®Google Scholar
• Take on typhoid newsletter June 2022 [Internet]. Take on Typhoid. 2022 [accessed 2023 Feb 7]. https://www.coalitionagainsttyphoid.org/take-on-typhoid-newsletter-june-2022/.
   Google Scholar
• Pichichero ME. Protein carriers of conjugate vaccines: characteristics, development, and clinical trials. Hum Vaccines Immunother. 2013 Dec;9(12):2505–23. doi:10.4161/hv.26109. Epub 2013 Aug 16. PMID: 23955057; PMCID: PMC4162048.
   PubMed Web of Science ®Google Scholar
• Durando P, Faust SN, Torres A. Immunological features and clinical benefits of conjugate vaccines against bacteria. J Immunol Res. 2015;2015:934504. doi:10.1155/2015/934504. Epub 2015 Aug 18. PMID: 26355657; PMCID: PMC4556328.
   PubMed Web of Science ®Google Scholar
• Mirzaei B, Mousavi SF, Babaei R, Bahonar S, Siadat SD, Shafiee Ardestani M, Shahrooei M, Van Eldere J. Synthesis of conjugated PIA-rSesc and immunological evaluation against biofilm-forming Staphylococcus epidermidis. J Med Microbiol. 2019 May;68(5):791–802. doi:10.1099/jmm.0.000910. Epub 2019 Apr 16. PMID: 30990402.
   PubMed Web of Science ®Google Scholar
• Shakya M, Voysey M, Theiss-Nyland K, Colin-Jones R, Pant D, Adhikari A, Tonks S, Mujadidi YF, O’Reilly P, Mazur O, et al. Efficacy of typhoid conjugate vaccine in Nepal: final results of a phase 3, randomised, controlled trial. Lancet Glob Health [Internet]. 2021;9(11):e1561–8. doi:10.1016/S2214-109X(21)00346-6.
   PubMed Web of Science ®Google Scholar
• Syed KA, Saluja T, Cho H, Hsiao A, Shaikh H, Anh Wartel T, Mogasale V, Lynch J, Kim JH, Excler J-L, et al. Review on the recent advances on typhoid vaccine development and challenges ahead. Clin Infect Dis. 2020;71(Suppl 2):S141–50. doi:10.1093/cid/ciaa504.
   PubMedGoogle Scholar
• Thuluva S, Paradkar V, Matur R, Turaga K, Gv SR. A multicenter, single-blind, randomized, phase-2/3 study to evaluate immunogenicity and safety of a single intramuscular dose of biological E’s Vi-capsular polysaccharide-CRM197 conjugate typhoid vaccine (TyphiBEVTM) in healthy infants, children, and adults in comparison with a licensed comparator. Hum Vaccines Immunother. 2022 Nov 30;18(5):2043103. doi:10.1080/21645515.2022.2043103. Epub 2022 Mar 25. PMID: 35333702; PMCID: PMC9196756.
   PubMed Web of Science ®Google Scholar
• Capeding MR, Teshome S, Saluja T, Syed KA, Kim DR, Park JY, Yang JS, Kim YH, Park J, Jo S-K, et al. Safety and immunogenicity of a Vi-DT typhoid conjugate vaccine: phase I trial in Healthy Filipino adults and children. Vaccine [Internet]. 2018;36(26):3794–801. doi:https://doi.org/10.1016/j.vaccine.2018.05.038.
   PubMed Web of Science ®Google Scholar
• Capeding MR, Sil A, Tadesse BT, Saluja T, Teshome S, Alberto E, Kim DR, Park EL, Park JY, Yang JS, et al. Safety and immunogenicity of Vi-DT conjugate vaccine among 6-23-month-old children: phase II, randomized, dose-scheduling, observer-blind study. EClinicalMedicine [Internet]. 2020;27:100540. doi:https://doi.org/10.1016/j.eclinm.2020.100540.
   PubMedGoogle Scholar
• Lee EY, Park JY, Kim DR, Song M, Sahastrabuddhe S, Kim H, Chon Y, Yang JS. Comparison of anti-Vi IgG responses between two clinical studies of typhoid Vi conjugate vaccines (Vi-DT vs Vi-TT). PLoS Negl Trop Dis [Internet]. 2020;14(3):1–11. doi:10.1371/journal.pntd.0008171.
   Web of Science ®Google Scholar
• WHO Technical Report, Series No. 924. Annex 1 guidelines on clinical evaluation of vaccines. World Health Organ. 2004;2004(924):35–102.
   Google Scholar
• Shakya M, Neuzil KM, Pollard AJ. Prospects of future typhoid and paratyphoid vaccines in endemic countries. J Infect Dis. 2021;224(Suppl 7):S770–4. doi:10.1093/infdis/jiab393.
   PubMedGoogle Scholar
• Jin C, Gibani MM, Moore M, Juel HB, Jones E, Meiring J, Harris V, Gardner J, Nebykova A, Kerridge SA, et al. Efficacy and immunogenicity of a Vi-tetanus toxoid conjugate vaccine in the prevention of typhoid fever using a controlled human infection model of Salmonella Typhi: a randomised controlled, phase 2b trial. Lancet [Internet]. 2017;390(10111):2472–80. doi:10.1016/S0140-6736(17)32149-9.
   PubMed Web of Science ®Google Scholar
• Shakya M, Colin-Jones R, Theiss-Nyland K, Voysey M, Pant D, Smith N, Liu X, Tonks S, Mazur O, Farooq YG, et al. Phase 3 efficacy analysis of a typhoid conjugate vaccine trial in Nepal. N Engl J Med. 2019;381(23):2209–18. doi:10.1056/NEJMoa1905047.
   PubMed Web of Science ®Google Scholar
• Mohan VK, Varanasi V, Singh A, Pasetti MF, Levine MM, Venkatesan R, Ella KM. Safety and immunogenicity of a vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar-TCV) in healthy infants, children, and adults in typhoid endemic areas: a multicenter, 2-cohort, open-label, double-blind, randomized controlled phase 3 study. Clin Infect Dis. 2015;61(3):393–402. doi:10.1093/cid/civ295.
   PubMed Web of Science ®Google Scholar
• Reddy R, Reddy B, Sarangi V, Reddy S, Ella R, Vadrevu KM. A multi-centre, post-marketing surveillance study of Vi polysaccharide–tetanus toxoid conjugate vaccine (Typbar TCV®) in India. Hum Vaccines Immunother [Internet]. 2022;18(1). doi:10.1080/21645515.2021.1947761.
   PubMed Web of Science ®Google Scholar
• Chinnasami B, Sadasivam K, Vivekanandhan A, Arunachalam P, Pasupathy S. A study on longevity of immune response after vaccination with Salmonella typhi Vi conjugate vaccine (PedatyphTM) in children. J Clin Diagnostic Res. 2015;9(5):SC01–3. doi:10.7860/JCDR/2015/13302.5903.
   PubMedGoogle Scholar
• Mitra M, Shah N, Ghosh A, Chatterjee S, Kaur I, Bhattacharya N, Basu S. Efficacy and safety of vi-tetanus toxoid conjugated typhoid vaccine (PedaTyph™) in Indian children: school based cluster randomized study. Hum Vaccines Immunother [Internet]. 2016;12(4):939–45. doi:10.1080/21645515.2015.1117715.
   PubMed Web of Science ®Google Scholar
• Kundu R, Kandulna AK, Nayak U, Jangid SK, Babu TR, Vukkala R, Sharma S, Goyal VK, Daultani P, Mittal R, et al. Immunogenicity and safety of typhoid conjugate vaccine in healthyindian subjects: a randomized, active-controlled, comparative clinical trial. Indian Pediatr. 2020;57(7):625–30. doi:10.1007/s13312-020-1890-y.
   PubMed Web of Science ®Google Scholar
• Medise BE, Soedjatmiko S, Gunardi H, Sekartini R, Satari HI, Hadinegoro SR, Wirahmadi A, Puspita M, Sari RM, Yang JS, et al. A novel Vi-diphtheria toxoid typhoid conjugate vaccine is safe and can induce immunogenicity in healthy Indonesian children 2–11 years: a phase II preliminary report. BMC Pediatr. 2020;20(1):1–8. doi:10.1186/s12887-020-02375-4.
   PubMed Web of Science ®Google Scholar
• Carlos JC, Tadesse BT, Borja-Tabora C, Alberto E, Ylade MC, Sil A, Kim DR, Ahn HS, Yang JS, Lee JY, et al. A phase 3, multicenter, randomized, controlled trial to evaluate immune equivalence and safety of multidose and single-dose formulations of vi-DT typhoid conjugate vaccine in healthy filipino individuals 6 months to 45 years of age. Lancet Reg Health West Pac. 2022;24:100484. doi:10.1016/j.lanwpc.2022.100484.
   PubMedGoogle Scholar