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Novel Vaccines – Review

A strategic model for developing vaccines against neglected diseases: An example of industry collaboration for sustainable development

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Article: 2136451 | Received 12 Jun 2022, Accepted 12 Oct 2022, Published online: 03 Nov 2022

References

  • United Nations General Assembly. Transforming our world: the 2030 agenda for sustainable development; 2015 [accessed 2021 Jul 29. http://www.un.org/ga/search/view_doc.asp?symbol=A/RES/70/1&Lang=E.
  • Levels & trends in child mortality. Report 2019. Estimates developed by the UN Inter-agency Group for Child Mortality Estimation; 2019 [accessed 2021 Jul 26]. http://childmortality.org/wp-content/uploads/2019/10/UN-IGME-Child-Mortality-Report-2019.pdf.
  • Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the sustainable development goals. Lancet. 2016;388(10063):1–9. doi:10.1016/s0140-6736(16)31593-8.
  • Chapman N, Doubell A, Barnsley P, Goldstein M, Oversteegen L, Chowdhary V, Rugarabamu G, Ong M, Borri J, Hynen A, Policy Cures Research, et al. G-Finder 2019. Uneven progress 2019. http://s3-ap-southeast-2.amazonaws.com/policy-cures-website-assets/app/uploads/2020/02/11150341/G-Finder2019.pdf.
  • Chapman N, Doubell A, Tuttle A, Barnsley P, Goldstein M, Oversteegen L, Chowdhary V, Borri J, Hynen A, Kearney M. Policy Cures Research. G-Finder 2020. Neglected disease research and development: Where to now? 2020. http://policy-cures-website-assets.s3.ap-southeast-2.amazonaws.com/wp-content/uploads/2021/04/15055816/G-FINDER-2020_Final-Report.pdf.
  • Podda A. Aims and role of Novartis Vaccines Institute for Global Health (NVGH). Procedia Vaccinol. 2010;2(2):124–27. doi:10.1016/j.provac.2010.07.003.
  • Saul A, Rappuoli R. The Novartis Vaccines Institute for Global Health: a new initiative for developing vaccines for neglected diseases in developing countries. J Infect Dev Ctries. 2009;2(2):154–55. doi:10.3855/t2.2.154.
  • Saul A, O’Brien KL. Prioritizing vaccines for developing world diseases. Vaccine. 2017;35(Suppl 1):A16–19. doi:10.1016/j.vaccine.2016.10.087.
  • GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018;392(10159):1789–858. doi:10.1016/s0140-6736(18)32279-7.
  • Troeger C, Colombara DV, Rao PC, Khalil IA, Brown A, Brewer TG, Guerrant RL, Houpt ER, Kotloff KL, Misra K, et al. Global disability-adjusted life-year estimates of long-term health burden and undernutrition attributable to diarrhoeal diseases in children younger than 5 years. Lancet Glob Health. 2018;6(3):e255–e269. doi:10.1016/s2214-109x(18)30045-7.
  • 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(4):369–81. doi:10.1016/s1473-3099(18)30685-6.
  • Basnyat B, Qamar FN, Rupali P, Ahmed T, Parry CM. Enteric fever. BMJ. 2021;372:n437. doi:10.1136/bmj.n437.
  • Prudden HJ, Hasso-Agopsowicz M, Black RE, Troeger C, Reiner RC, Breiman RF, Jit M, Kang G, Lamberti L, Lanata CF, et al. Meeting Report: WHO workshop on modelling global mortality and aetiology estimates of enteric pathogens in children under five. Cape Town, 28-29th November 2018. Vaccine. 2020;38(31):4792–800. doi:10.1016/j.vaccine.2020.01.054.
  • Tacconelli E, Carrara E, Savoldi A, Harbarth S, Mendelson M, Monnet DL, Pulcini C, Kahlmeter G, Kluytmans J, Carmeli Y, et al. Discovery, research, and development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosis. Lancet Infect Dis. 2018;18(3):318–27. doi:10.1016/s1473-3099(17)30753-3.
  • Appiah GD, Chung A, Bentsi-Enchill AD, Kim S, Crump JA, Mogasale V, Pellegrino R, Slayton RB, Mintz ED. Typhoid outbreaks, 1989-2018: implications for prevention and control. Am J Trop Med Hyg. 2020;102(6):1296–305. doi:10.4269/ajtmh.19-0624.
  • World Health Organization. Typhoid vaccines: WHO position paper. Week Epidemiol Rec. 2008;83(6):49–59.
  • John J, Van Aart CJ, Grassly NC. The burden of typhoid and paratyphoid in India: systematic review and meta-analysis. PLoS Negl Trop Dis. 2016;10(4):e0004616. doi:10.1371/journal.pntd.0004616.
  • Mukhopadhyay B, Sur D, Gupta SS, Ganguly NK. Typhoid fever: control & challenges in India. Indian J Med Res. 2019;150(5):437–47. doi:10.4103/ijmr.IJMR_411_18.
  • Browne AJ, Kashef Hamadani BH, Kumaran EAP, Rao P, Longbottom J, Harriss E, Moore CE, Dunachie S, Basnyat B, Baker S, et al. Drug-resistant enteric fever worldwide, 1990 to 2018: a systematic review and meta-analysis. BMC Med. 2020;18(1):1. doi:10.1186/s12916-019-1443-1.
  • Yousafzai MT, Karim S, Qureshi S, Kazi M, Memon H, Junejo A, Khawaja Z, Ur Rehman N, Ansari MS, Ali R, et al. Effectiveness of typhoid conjugate vaccine against culture-confirmed Salmonella enterica serotype Typhi in an extensively drug-resistant outbreak setting of Hyderabad, Pakistan: a cohort study. Lancet Glob Health. 2021;9(8):e1154–e1162. doi:10.1016/s2214-109x(21)00255-2.
  • World Health Organization. Typhoid vaccines: WHO position paper, March 2018 - recommendations. Vaccine. 2019;37(2):214–16. doi:10.1016/j.vaccine.2018.04.022.
  • Pulickal AS, Pollard AJ. Vi polysaccharide-protein conjugate vaccine for the prevention of typhoid fever in children: hope or hype? Expert Rev Vaccines. 2007;6(3):293–95. doi:10.1586/14760584.6.3.293.
  • Szu SC, Stone AL, Robbins JD, Schneerson R, Robbins JB. Vi capsular polysaccharide-protein conjugates for prevention of typhoid fever. Preparation, characterization, and immunogenicity in laboratory animals. J Exp Med. 1987;166(5):1510–24. doi:10.1084/jem.166.5.1510.
  • Lin FY, Ho VA, Khiem HB, Trach DD, Bay PV, Thanh TC, Kossaczka Z, Bryla DA, Shiloach J, Robbins JB, et al. The efficacy of a Salmonella typhi Vi conjugate vaccine in two-to-five-year-old children. N Engl J Med. 2001;344(17):1263–69. doi:10.1056/nejm200104263441701.
  • World Health Organization. WHO prequalified vaccines. [accessed 2021 Oct 29]. http://extranet.who.int/pqweb/vaccines/prequalified-vaccines.
  • Akram J, Khan AS, Khan HA, Gilani SA, Akram SJ, Ahmad FJ, Mehboob R. Extensively Drug-Resistant (XDR) typhoid: evolution, prevention, and its management. Biomed Res Int. 2020;2020:6432580. doi:10.1155/2020/6432580.
  • Centers for Disease Control and Prevention. HAN archive - 00439: extensively drug-resistant Salmonella Typhi infections among U.S. residents without international travel; 2021 Feb 12 [accessed 2021 Aug 24]. http://emergency.cdc.gov/han/2021/han00439.asp.
  • Szu SC, Klugman KP, Hunt S. Re-examination of immune response and estimation of anti-Vi IgG protective threshold against typhoid fever-based on the efficacy trial of Vi conjugate in young children. Vaccine. 2014;32(20):2359–63. doi:10.1016/j.vaccine.2014.02.050.
  • Rondini S, Micoli F, Lanzilao L, Hale C, Saul AJ, Martin LB. Evaluation of the immunogenicity and biological activity of the Citrobacter freundii Vi-CRM197 conjugate as a vaccine for Salmonella enterica serovar Typhi. Clin Vaccine Immunol. 2011;18(3):460–68. doi:10.1128/cvi.00387-10.
  • Rondini S, Micoli F, Lanzilao L, Pisoni I, Di Cioccio V, Saul AJ, Martin LB. Characterization of Citrobacter sp. line 328 as a source of Vi for a Vi-CRM197 glycoconjugate vaccine against Salmonella Typhi. J Infect Dev Ctries. 2012;6(11):763–73. doi:10.3855/jidc.2495.
  • Micoli F, Adamo R, Costantino P. Protein carriers for glycoconjugate vaccines: history, selection criteria, characterization and new trends. Molecules. 2018;23(6):1451. doi:10.3390/molecules23061451.
  • Pichichero ME. Protein carriers of conjugate vaccines: characteristics, development, and clinical trials. Hum Vaccin Immunother. 2013;9(12):2505–23. doi:10.4161/hv.26109.
  • Micoli F, Rondini S, Pisoni I, Proietti D, Berti F, Costantino P, Rappuoli R, Szu S, Saul A, Martin LB. Vi-CRM 197 as a new conjugate vaccine against Salmonella Typhi. Vaccine. 2011;29(4):712–20. doi:10.1016/j.vaccine.2010.11.022.
  • van Damme P, Kafeja F, Anemona A, Basile V, Hilbert AK, De Coster I, Rondini S, Micoli F, Qasim Khan RM, Marchetti E, et al. Safety, immunogenicity and dose ranging of a new Vi-CRM197 conjugate vaccine against typhoid fever: randomized clinical testing in healthy adults. PLoS One. 2011;6(9):e25398. doi:10.1371/journal.pone.0025398.
  • Bhutta ZA, Capeding MR, Bavdekar A, Marchetti E, Ariff S, Soofi SB, Anemona A, Habib MA, Alberto E, 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(2):119–29. doi:10.1016/s1473-3099(13)70241-x.
  • Arcuri M, Di Benedetto R, Cunningham AF, Saul A, MacLennan CA, Micoli F. The influence of conjugation variables on the design and immunogenicity of a glycoconjugate vaccine against Salmonella Typhi. PLoS One. 2017;12(12):e0189100. doi:10.1371/journal.pone.0189100.
  • Micoli F, Bjarnarson SP, Arcuri M, Aradottir Pind AA, Magnusdottir GJ, Necchi F, Di Benedetto R, Carducci M, Schiavo F, Giannelli C, et al. Short Vi-polysaccharide abrogates T-independent immune response and hyporesponsiveness elicited by long Vi-CRM(197) conjugate vaccine. Proc Natl Acad Sci USA. 2020;117(39):24443–49. doi:10.1073/pnas.2005857117.
  • Festa G, Kolte A, Carli MR, Rossi M. Envisioning the challenges of the pharmaceutical sector in the Indian health-care industry: a scenario analysis. J Bus Ind Marketing. 2022;37(8):1662–74. doi:10.1108/JBIM-07-2020-0365.
  • Siddalingaiah N, Tuluva S, Turaga K. A multicentre single blind randomised controlled phase-II/III study to evaluate immunogenicity and safety of single intramuscular dose of Biological E’s Vi-capsular polysaccharide-CRM197 conjugate typhoid vaccine in healthy infants, children and adults in comparison with a licensed comparator, IAP ResRCHcon 2020 Abstracts. Indian J Pediatr. 2020;87(11):974–88. doi:10.1007/s12098-020-03504-8.
  • Kasi SG, Shivananda S, Marathe S, Chatterjee K, Agarwalla S, Dhir SK, Verma S, Shah AK, Srirampur S, 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(1):44–53. doi:10.1007/s13312-021-2096-7.
  • Coalition against typhoid, typhoid vaccine acceleration consortium. TYPHIBEV: Questions & Answers; 2021 [accessed 2021 Jul 29]. http://www.coalitionagainsttyphoid.org/wp-content/uploads/2021/06/TYPHIBEV-QA_May-2021.pdf.
  • Butler D. Translational research: crossing the valley of death. Nature. 2008;453(7197):840–42. doi:10.1038/453840a.
  • Kaslow DC, Black S, Bloom DE, Datla M, Salisbury D, Rappuoli R. Vaccine candidates for poor nations are going to waste. Nature. 2018;564(7736):337–39. doi:10.1038/d41586-018-07758-3.
  • O’Brien KL, Binka F, Marsh K, Abramson JS. Mind the gap: jumping from vaccine licensure to routine use. Lancet. 2016;387(10031):1887–89. doi:10.1016/s0140-6736(16)30394-4.
  • Excler JL, Privor-Dumm L, Kim JH. Supply and delivery of vaccines for global health. Curr Opin Immunol. 2021;71:13–20. doi:10.1016/j.coi.2021.03.009.
  • Samarasekera U. CEPI prepares for future pandemics and epidemics. Lancet Infect Dis. 2021;21(5):608. doi:10.1016/s1473-3099(21)00216-4.