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 (TyphiBEV^TM) in healthy infants, children, and adults in comparison with a licensed comparator

References

• Azmatullah A, Qamar FN, Thaver D, Zaidi AK, Bhutta ZA. Systematic review of the global epidemiology, clinical and laboratory profile of enteric fever. J Glob Health. 2015;5(2). doi:10.7189/jogh.05.020407.
   PubMed Web of Science ®Google Scholar
• Stanaway JD, Reiner RC, Blacker BF, Goldberg EM, Khalil IA, Troeger CE. GBD 2017 Typhoid and Paratyphoid Collaborators. The global burden of typhoid and paratyphoid fevers: a systematic analysis for the Global Burden of disease study 2017. Lancet Infect Dis. 2019;19:369–11. doi:10.1016/s1473-3099(18)30685-6.
   PubMed Web of Science ®Google Scholar
• Yang Y-A, Chong A, Song J. Why is eradicating typhoid fever so challenging: implications for vaccine and therapeutic design. Vaccines. 2018;6:45. doi:10.3390/vaccines6030045.
   Web of Science ®Google Scholar
• Khan K. Recent trends in typhoid research- A review. Int J Biosci. 2012;2:110–20.
   Google Scholar
• Makkar A, Gupta S, Khan ID, Gupta RM, Rajmohan KS, Chopra H, Gupta M, Bansal S, Poonia B, Malik M, et al. Epidemiological profile and antimicrobial resistance pattern of enteric fever in a tertiary care hospital of North India - a seven year ambispective study. Acta Medica (Hradec Kralove). 2018;61:125–30. doi:10.14712/18059694.2018.130.
   PubMedGoogle Scholar
• Mukhopadhyay B, Sur D, Gupta SS, Ganguly NK. Typhoid fever: control & challenges in India. Indian J Med Res. 2019;150:437–47. doi:10.4103/ijmr.IJMR_411_18.
   PubMed Web of Science ®Google Scholar
• National Health Profile India: Central Bureau of Health Intelligence. Directorate general of health services. India: Ministry of Health & Family Welfare, Government of India; 2020.
   Google Scholar
• Sinha A, Sazawal S, Kumar R, Sood S, Reddaiah VP, Singh B, Rao M, Naficy A, Clemens JD, and Bhan MK. Typhoid fever in children aged less than 5 years. Lancet. 1999;354:734–37. doi:10.1016/s0140-6736(98)09001-1.
   PubMed Web of Science ®Google Scholar
• John J, Bavdekar A, Rongsen-Chandola T, Dutta S, Kang G. Estimating the incidence of enteric fever in children in India: a multi-site, active fever surveillance of pediatric cohorts. BMC Public Health. 2018;18:18. doi:10.1186/s12889-018-5498-2.
   Web of Science ®Google Scholar
• Brooks WA, Hossain A, Goswami D, Sharmeen AT, Nahar K, Alam K, Ahmed N, Naheed A, Nair GB, and Luby S, et al. Bacteremic typhoid fever in children in an Urban Slum, Bangladesh. Emerg Infect Dis. 2005;11:326–29. doi:10.3201/eid1102.040422.
   PubMed Web of Science ®Google Scholar
• Marks F, Von Kalckreuth V, Aaby P, Adu-Sarkodie Y, El Tayeb MA, Ali M, et al. Incidence of invasive salmonella disease in sub-Saharan Africa: a multicentre population-based surveillance study. Lancet Global Health. 2017;5:e310–e23. doi:10.1016/s2214-109x(17)30022-0.
   PubMed Web of Science ®Google Scholar
• Ochiai RL, Acosta CJ, Danovaro-Holliday MC, Baiqing D, Bhattacharya SK, Agtini MD, Bhutta ZA, Canh DG, Ali M, and Shin S, et al. Domi Typhoid Study Group. A study of typhoid fever in five Asian countries: disease burden and implications for controls. Bull World Health Organ. 2008;86:260–68. doi:10.2471/blt.06.039818.
   PubMed Web of Science ®Google Scholar
• Divyashree S, Nabarro LEB, Veeraraghavan B, Rupali P. Enteric fever in India: current scenario and future directions. Trop Med Int Health. 2016;21:1255–62. doi:10.1111/tmi.12762.
   PubMed Web of Science ®Google Scholar
• Andrews JR, Baker S, Marks F, Alsan M, Garrett D, Gellin BG, Saha SK, Qamar FN, Yousafzai MT, and Bogoch I, et al. Typhoid conjugate vaccines: a new tool in the fight against antimicrobial resistance. Lancet Infect Dis. 2019;19:e26–e30. doi:10.1016/s1473-3099(18)30350-5.
   PubMed Web of Science ®Google Scholar
• Wain J, Hendriksen RS, Mikoleit ML, Keddy KH, Ochiai RL. Typhoid fever. The Lancet. 2015;385:1136–45. doi:10.1016/s0140-6736(13)62708-7.
   PubMed Web of Science ®Google Scholar
• Kasi SG, Shivananda S, Marathe S, Chatterjee K, Agarwalla S, Dhir SK, Verma S, Shah AK, Srirampur S, and Kalyani S, et al. Indian Academy of Pediatrics (IAP) advisory committee on vaccines and immunization practices (ACVIP): recommended immunization schedule (2020-21) and update on immunization for children aged 0 through 18 years. Indian Pediatr. 2021;58:44–53. doi:10.1007/s13312-021-2096-7.
   PubMed Web of Science ®Google Scholar
• Beran J, Goad J. Routine travel vaccines. Travel medicine. London: Elsevier; 2019. pp. 89–100. doi:10.1016/b978-0-323-54696-6.00011-2.
   Google Scholar
• Szu SC. Development of Vi conjugate – a new generation of typhoid vaccine. Expert Rev Vaccines. 2013;12:1273–86. doi:10.1586/14760584.2013.845529.
   PubMed Web of Science ®Google Scholar
• Sur D, Ochiai RL, Bhattacharya SK, Ganguly NK, Ali M, Manna B, Dutta S, Donner A, Kanungo S, and Park JK, et al. A cluster-randomized effectiveness trial of Vi typhoid vaccine in India. N Engl J Med. 2009;361:335–44. doi:10.1056/nejmoa0807521.
   PubMed Web of Science ®Google Scholar
• World Health O. Surveillance standards for vaccine-preventable diseases. Geneva: World Health Organization; 2018.
   Google Scholar
• Micoli F, Rondini S, Pisoni I, Proietti D, Berti F, Costantino P, Rappuoli R, Szu S, Saul A, and Martin LB. Vi-CRM 197 as a new conjugate vaccine against Salmonella Typhi. Vaccine. 2011;29:712–20. doi:10.1016/j.vaccine.2010.11.022.
   PubMed Web of Science ®Google Scholar
• Milligan R, Paul M, Richardson M, Neuberger A. Vaccines for preventing typhoid fever. Cochrane Database Syst Rev. 2018. doi:10.1002/14651858.cd001261.pub4.
   PubMed Web of Science ®Google Scholar
• Verma R, Bairwa M, Chawla S, Prinja S, Rajput M. New generation typhoid vaccines: an effective preventive strategy to control typhoid fever in developing countries. Hum Vaccin. 2011;7:883–85. doi:10.4161/hv.7.8.16282.
   PubMed Web of Science ®Google Scholar
• World Health O. Typhoid vaccines: WHO position paper, March 2018 - recommendations. Vaccine. 2019;37:214–16. doi:10.1016/j.vaccine.2018.04.022.
   PubMed Web of Science ®Google Scholar
• Levine MM, Ferreccio C, Abrego P, Martin OS, Ortiz E, Cryz S. Duration of efficacy of Ty21a, attenuated Salmonella typhi live oral vaccine. Vaccine. 1999;17:S22–S7. doi:10.1016/S0264-410X(99)00231-5.
   PubMed Web of Science ®Google Scholar
• Vashishtha VM, Kalra A. The need & the issues related to new-generation typhoid conjugate vaccines in India. Indian J Med Res. 2020;151:22–34. doi:10.4103/ijmr.IJMR_1890_17.
   PubMed Web of Science ®Google Scholar
• Balaji Chinnasami K, Vivekanandhan A, Arunachalam P, Pasupathy S. A study on longevity of immune response after vaccination with Salmonella Typhi Vi conjugate vaccine (Pedatyph™) in children. J Clin Diagn Res. 2015;9:SC01–SC3. doi:10.7860/jcdr/2015/.5903.
   PubMedGoogle Scholar
• Syed KA, Saluja T, Cho H, Hsiao A, Shaikh H, Wartel TA, Mogasale V, Lynch J, Kim JH, and Excler JL, et al. Review on the recent advances on typhoid vaccine development and challenges ahead. Clin Infect Dis. 2020;71:S141–S50. doi:10.1093/cid/ciaa504.
   PubMed Web of Science ®Google Scholar
• van Damme P, Kafeja F, Anemona A, Basile V, Hilbert AK, De Coster I, Rondini S, Micoli F, Qasim Khan RM, and Marchetti E, et al. Safety, immunogenicity and dose ranging of a new Vi-CRM(1)(9)(7) conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults. PLoS One. 2011;6:e25398. doi:10.1371/journal.pone.0025398.
   PubMed Web of Science ®Google Scholar
• Bhutta ZA, Capeding MR, Bavdekar A, Marchetti E, Ariff S, Soofi SB, Anemona A, Habib MA, Alberto E, and Juvekar S, et al. Immunogenicity and safety of the Vi-CRM197 conjugate vaccine against typhoid fever in adults, children, and infants in south and southeast Asia: results from two randomised, observer-blind, age de-escalation, phase 2 trials. Lancet Infect Dis. 2014;14:119–29. doi:10.1016/S1473-3099(13)70241-X.
   PubMed Web of Science ®Google Scholar
• World Health Organization. Recommendations to assure the quality, safety and efficacy of typhoid conjugate vaccines, Annex 2, TRS No 1030. WHO Expert Committee on Biological Standardization Report of the seventy-second and seventy-third meetings. Geneva: World Health Organisation, 2020.
   Google Scholar
• Typbar-TCV (Typhoid Vi Capsular Polysaccharide-Tetanus Toxoid Conjugate Vaccine). Summary of product charactristics. India: CDSCO; 2018. pp. 1–7.
   Google Scholar
• Fiorino F, Ciabattini A, Rondini S, Pozzi G, Martin LB, Medaglini D. Immunization with the conjugate vaccine Vi-CRM197 against Salmonella Typhi induces Vi-specific mucosal and systemic immune responses in mice. Vaccine. 2012;30:6111–14. doi:10.1016/j.vaccine.2012.05.081.
   PubMed Web of Science ®Google Scholar
• Choi SK, Baik YO, Kim CW, Kim SK, Oh IN, Yoon H, Yu D, and Lee C . An open-label, comparative, single dose, clinical phase study to assess the safety and immunogenicity of typhoid conjugate vaccine (Vi-CRM197) in healthy Filipino adults. Vaccine. 2021;39:2620–27. doi:10.1016/j.vaccine.2021.03.089.
   PubMed Web of Science ®Google Scholar