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Advances in Vaccines

  • Helen H. MaoEmail author
  • Shoubai Chao
Chapter
Part of the Advances in Biochemical Engineering/Biotechnology book series (ABE, volume 171)

Abstract

Vaccines represent one of the most important advances in science and medicine, helping people around the world in preventing the spread of infectious diseases. However, there are still gaps in vaccination programs in many countries. Out of 11.2 million children born in EU region, more than 500,000 infants did not receive the complete three-dose series of diphtheria, pertussis, and tetanus vaccine before the first birthday. Data shows that there were more than 30,000 measles cases in the European region in recent years, and measles cases are rising in the USA. There are about 20 million children in the world still not getting adequate coverage of basic vaccines. Emerging infectious diseases such as malaria, Ebola virus disease, and Zika virus disease also threaten public health around the world. This chapter provides an overview of recent advances in vaccine development and technologies, manufacturing, characterization of various vaccines, challenges, and strategies in vaccine clinical development. It also provides an overview of recently approved major vaccines for human use.

Graphical Abstract

Keywords

Characterization Dengue vaccine Ebola vaccine Recombinant technology Shingles vaccine Vaccine clinical trials Vaccine development Vaccine manufacturing Viral vaccine 

References

  1. 1.
    GBD 2016 Lower Respiratory Infections Collaborators (2018) Estimates of the global, regional, and national morbidity, mortality, and aetiologies of lower respiratory infections in 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Infect Dis 18:1191–1210Google Scholar
  2. 2.
    Doherty M et al (2016) Vaccine impact: benefits for human health. Vaccine 34:6707–6714PubMedGoogle Scholar
  3. 3.
  4. 4.
  5. 5.
    China CDC. www.china.cdc.cn. Accessed 12 Apr 2019
  6. 6.
    USCDC. www.CDC.gov. Accessed 25 Apr 2019
  7. 7.
    WHO report on Measles. www.who.int. Accessed 12 Apr 2019
  8. 8.
    EMA (2019) European Centre for Disease Prevention and Control, annual epidemiological report for 2017. ECDC, StockholmGoogle Scholar
  9. 9.
    Gouglas D, Le TT et al (2018) Estimating the cost of vaccine development against epidemic infectious diseases: a cost minimisation study. Lancet Glob Health 6:e1386–e1396PubMedGoogle Scholar
  10. 10.
    Mahmoud A et al (2017) Achieving a “Grand Convergence” in global health by 2035. Vaccine 35:A2–A5PubMedGoogle Scholar
  11. 11.
    USCDC. www.uscdc.gov. Accessed 27 Apr 2019
  12. 12.
    USFDA (2017) Encouraging vaccine innovation: promoting the development of vaccines that minimize the burden of infectious diseases in the 21st century report to congress. www.fda.gov
  13. 13.
    Hardt K et al (2016) Vaccine strategies: optimising outcomes. Vaccine 34:6691–6699PubMedGoogle Scholar
  14. 14.
    Lal H et al (2018) Immunogenicity, reactogenicity and safety of 2 doses of an adjuvanted herpes zoster subunit vaccine administered 2, 6 or 12 months apart in older adults: results of a phase III, randomized, open-label, multicenter. Vaccine 34:148–154Google Scholar
  15. 15.
    WHO Website. www.who.int. Accessed 2 Apr 2019
  16. 16.
    Plotkin S et al (2017) The complexity and cost of vaccine manufacturing – an overview. Vaccine 35:4064–4071PubMedPubMedCentralGoogle Scholar
  17. 17.
    Jeyanathan M, Shao Z, Yu X, Harkness R et al (2015) AdHu5Ag85A respiratory mucosal boost immunization enhances protection against pulmonary tuberculosis in BCG-primed non-human primates. PLoS One 10(8):e0135009PubMedPubMedCentralGoogle Scholar
  18. 18.
    Regules JA et al (2014) A recombinant vesicular stomatitis virus Ebola vaccine. N Engl J Med 376:330–341Google Scholar
  19. 19.
    Sharmaa HJ et al (2012) Assessment of safety and immunogenicity of two different lots of diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b vaccine manufactured using small and large scale manufacturing process. Vaccine 30:510–516Google Scholar
  20. 20.
    USFDA, FDA Guidance (2010) Characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications. www.fda.gov/BiologicsBloodVaccine/guidence
  21. 21.
    USFDA. FDA guidance for industry providing clinical evidence of effectiveness for human drug and biological products. Accessed 18 Apr 2019Google Scholar
  22. 22.
    Zhu FC, Hou LH, Li JX et al (2015) Safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in China: preliminary report of a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet 385(9984):2272–2279PubMedGoogle Scholar
  23. 23.
    Wu L, Zhang Z, Gao H et al (2017) Open-label phase I clinical trial of Ad5-EBOV in Africans in China. Hum Vaccin Immunother 13(9):2078–2085PubMedPubMedCentralGoogle Scholar
  24. 24.
    Zhu FC, Wurie AH, Hou LH et al (2017) Safety and immunogenicity of a recombinant adenovirus type-5 vector-based Ebola vaccine in healthy adults in Sierra Leone: a single-centre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet 389(10069):621–628PubMedGoogle Scholar
  25. 25.
    Kovac M et al (2018) Complications of herpes zoster in immunocompetent older adults: incidence in vaccine and placebo groups in two large phase 3 trials. Vaccine 36:1537–1541PubMedGoogle Scholar
  26. 26.
    Chlibek R et al (2013) Safety and immunogenicity of an AS01-adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults ≥50 years of age. J Infect Dis 208:1953PubMedGoogle Scholar
  27. 27.
    USFDA (1997) FDA guidance for industry, for the evaluation of combination vaccines for preventable diseases: production, testing and clinical studies. Accessed 10 Apr 2019Google Scholar
  28. 28.
    WHO. WHO website. www.who.int. Accessed 23 Apr 2019
  29. 29.
    USFDA (2011) FDA guidance for industry general principles for the development of vaccines to protect against global infectious diseasesGoogle Scholar
  30. 30.
    21 CFR Part 601, Subpart H. https://www.law.cornell.edu/cfr/text/21/part-314/subpart-H. Accessed 22 Apr 2019
  31. 31.
    USFDA. Biothrax vaccine. https://www.fda.gov/vaccines-blood-biologics/vaccines/biothrax. Accessed 3 Apr 2019
  32. 32.
    Johnson RW et al (2015) Herpes zoster epidemiology, management, and disease and economic burden in Europe: a multidisciplinary perspective. Ther Adv Vaccines 3(4):109–120PubMedPubMedCentralGoogle Scholar
  33. 33.
    Shingrix Product Insert. www.fda.gov. Accessed 26 Mar 2019
  34. 34.
    Diez-Domingo J et al (2015) Comparison of intramuscular and subcutaneous administration of a herpes zoster live-attenuated vaccine in adults aged ≥50 years: a randomised non-inferiority clinical trial. Vaccine 33:789–795PubMedGoogle Scholar
  35. 35.
    Baize S, Pannetier D, Oestereich L et al (2014) Emergence of Zaire Ebola virus disease in Guinea. N Engl J Med 371(15):1418–1425PubMedGoogle Scholar
  36. 36.
    Kucharski AJ, Edmunds WJ (2014) Case fatality rate for Ebola virus disease in West Africa. Lancet 384(9950):1260PubMedGoogle Scholar
  37. 37.
    WHO (2014) Ebola virus disease. http://www.who.int/mediacentre/factsheets/fs103/en/. Accessed 23 Mar 2019
  38. 38.
    Sheets RL, Stein J, Bailer RT et al (2008) Biodistribution and toxicological safety of adenovirus type 5 and type 35 vectored vaccines against human immunodeficiency virus-1 (HIV-1), Ebola, Marburg are similar despite differing adenovirus serotype vector, manufacturer’s construct, gene inserts. J Immunotoxicol 5(3):315–335PubMedPubMedCentralGoogle Scholar
  39. 39.
    USFDA. Bexsero product insert. www.fda.gov. Accessed 27 Mar 2019
  40. 40.
    USFDA. Trmenba product insert. www.fda.gov. Accessed 27 Mar 2019
  41. 41.
    USCDC. www.uscdc.gov. Accessed 27 Mar 2019
  42. 42.
    USFDA (2016) Gardasil 9 product insert. www.fda.gov
  43. 43.
    Bhatt S, Gething PW, Brady OJ et al (2013) The global distribution and burden of dengue. Nature 496:504–507PubMedPubMedCentralGoogle Scholar
  44. 44.
    Morens DM, Fauci AS et al (2008) Dengue and hemorrhagic fever: a potential threat to public health in the United States. JAMA 299:214–216PubMedGoogle Scholar
  45. 45.
    WHO. Dengue and dengue haemorrhagic fever, Fact sheet No.117. http://www.who.int/mediacentre/factsheets/fs117/en/. Revised Apr 2016
  46. 46.
    WHO (2014) Dengue: guidelines for diagnosis, treatment, prevention and control: new edition. Geneva 2009. WHO, GenevaGoogle Scholar
  47. 47.
    USFDA (2019) Dengue vaccine, VRBPAC briefing document. www.fda.gov Google Scholar
  48. 48.
    McMinn PC et al (2002) An overview of the evolution of enterovirus 71 and its clinical and public health significance. FEMS Microbiol Rev 26:91–107PubMedGoogle Scholar
  49. 49.
    Xu J, Qian Y, Wang S, Serrano JMG, Li W, Huang Z et al (2010) EV71: an emerging infectious disease vaccine target in the far east? Vaccine 28:3516–3521PubMedGoogle Scholar
  50. 50.
    Li YP, Liang ZL, Gao Q, Huang LR, Mao QY, Wen SQ et al (2012) Safety and immunogenicity of a novel human enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, phase I clinical trial. Vaccine 30:3295–3303PubMedGoogle Scholar
  51. 51.
    Zhu F et al (2014) Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med 370(9):818–828PubMedGoogle Scholar
  52. 52.
    Chong P et al (2012) Production of EV71 vaccine candidates. Hum Vaccin Immunother 8(12):1775–1783PubMedPubMedCentralGoogle Scholar
  53. 53.
    Solomon T, Lewthwaite P, Perera D, Cardosa MJ, McMinn P, Ooi MH (2010) Virology, epidemiology, pathogenesis, and control of enterovirus 71. Lancet Infect Dis 10:778–790PubMedPubMedCentralGoogle Scholar
  54. 54.
    Chone P et al (2015) Review of enterovirus 71 vaccines. Clin Infect Dis 60(5):797–780Google Scholar
  55. 55.
    Wu CY et al (2019) The mature EV71 virion induced a broadly cross-neutralizing VP1 antibody against subtypes of the EV71 virus. PLoS One 14(1):e0210553PubMedPubMedCentralGoogle Scholar
  56. 56.
    Vaccines and Related Biological Products Advisory Committee Meeting July 28, 2017. FDA briefing document heplisav-B (Hepatitis B vaccine recombinant and 1018 ISS adjuvant). www.fda.gov
  57. 57.
    Heplisav-B Product Insert. www.USFDA.gov. Accessed 12 Apr 2019
  58. 58.
    Kuan RK et al (2013) Cost-effectiveness of hepatitis B vaccination using HEPLISAV™ in selected adult populations compared to Engerix-B® vaccine. Vaccine 31(37):4024–4032PubMedGoogle Scholar
  59. 59.
    Gilbert CL et al (2011) Safety and immunogenicity of a modified process hepatitis B vaccine in healthy adults ≥50 years. Hum Vaccin 7(12):1336–1342PubMedGoogle Scholar
  60. 60.
    Splawn LM et al (2018) Heplisav-B vaccination for the prevention of hepatitis B virus infection in adults in the United States. Drugs Today (Barc) 54(7):399–405Google Scholar
  61. 61.
    Strezova A et al (2017) A randomized lot-to-lot immunogenicity consistency study of the candidate zoster vaccine HZ/su. Vaccine 35:6700–6706PubMedGoogle Scholar
  62. 62.
    Gsell PS, Camacho A et al (2017) Ring vaccination with rVSV-ZEBOV under expanded access in response to an outbreak of Ebola virus disease in Guinea, 2016: an operational and vaccine safety report. Lancet Infect Dis 7:1276–1128Google Scholar
  63. 63.
    Daouda Sissoko BD et al Resurgence of Ebola virus disease in guinea linked to a survivor with virus persistence in seminal fluid for more than 500 days. Clin Infect Dis 63(10):1353–1356Google Scholar
  64. 64.
    Medaglini D et al Correlates of vaccine-induced protective immunity against Ebola virus disease. Seminars in immunology. Academic Press, CambridgeGoogle Scholar
  65. 65.
    Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V et al (2012) Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the global burden of disease study 2010. Lancet 380:2095–2128PubMedPubMedCentralGoogle Scholar
  66. 66.
    Falsey AR, Hennessey PA, Formica MA, Cox C, Walsh EE (2005) Respiratory syncytial virus infection in elderly and high-risk adults. N Engl J Med 352:1749–1759PubMedGoogle Scholar
  67. 67.
    Hall CB et al (2012) The burgeoning burden of respiratory syncytial virus among children. Infect Disord Drug Targets 12:92–97PubMedGoogle Scholar
  68. 68.
    Dudas RA, Karron RA (1998) Respiratory syncytial virus vaccines. Clin Microbiol Rev 11:430–439PubMedPubMedCentralGoogle Scholar
  69. 69.
    Nair H, Nokes DJ, Gessner BD, Dherani M, Madhi SA, Singleton RJ et al (2010) Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet 375:1545–1555PubMedPubMedCentralGoogle Scholar
  70. 70.
    WHO (2012) Trends in maternal mortality: 1990–2010 WHO, UNICEF, UNFPA, and The World Bank estimates. WHO, Geneva. http://apps.who.int/iris/bitstream/10665/44874/1/9789241503631eng.pdf Google Scholar
  71. 71.
    Higgins D et al (2016) Advances in RSV vaccine research and development - a global agenda. Vaccine 34(26):2870–2875PubMedGoogle Scholar
  72. 72.
    Villafana T et al (2017) Passive and active immunization against respiratory syncytial virus for the young and old. Expert Rev Vaccines 16(7):1–13PubMedGoogle Scholar
  73. 73.
    Hoffman SL et al (2015) The march toward malaria vaccines. Vaccine 33(Suppl 4):D13–D23PubMedPubMedCentralGoogle Scholar
  74. 74.
    Lyke KE (2017) Steady progress toward a malaria vaccine. Curr Opin Infect Dis 30(5):463–470PubMedGoogle Scholar
  75. 75.
    Keitany JG et al (2014) Live attenuated pre-erythrocytic malaria vaccine. Hum Vaccine Immunother 10(10):2903–2909Google Scholar
  76. 76.
    Richie TL et al (2015) Progress with Plasmodium falciparum sporozoite (PfSPZ)-based malaria vaccines. Vaccine 33(52):7452–7461PubMedPubMedCentralGoogle Scholar
  77. 77.
    Olotu A, Urbano V, Hamad A, Eka A et al (2018) Advancing global health through development and clinical trials partnerships: a randomized, placebo-controlled, double-blind assessment of safety, tolerability, and immunogenicity of PfSPZ vaccine for malaria in healthy equatoguinean men. Am J Trop Med Hyg 98(1):308–318PubMedGoogle Scholar
  78. 78.
    CEPI. Targeting diseases with epidemic potential. CEPI. www.CEPI.net. Accessed 26 Mar 2019
  79. 79.
    Zhang C, Maruggi G et al (2019) Advances in mRNA vaccines for infectious diseases. Front Immunol 10:594.  https://doi.org/10.3389/fimmu.2019.00594 CrossRefPubMedPubMedCentralGoogle Scholar
  80. 80.
  81. 81.
    Pinti M et al (2016) Aging of the immune system: focus on inflammation and vaccination. Eur J Immunol 46:2286–2301PubMedPubMedCentralGoogle Scholar
  82. 82.
    Kaufmann SH et al (2014) Challenges and responses in human vaccine development. Curr Opin Immunol 28:18–26PubMedGoogle Scholar
  83. 83.
    Cunningham AL et al (2016) Vaccine development: from concept to early clinical testing. Vaccine 34:6655–6664PubMedGoogle Scholar

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.CanSino Biologics Inc.TianjinChina

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