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History of Rotavirus Vaccines Part I: RotaShield

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History of Vaccine Development

Abstract

According to hieroglyphic evidence, diarrhea is one of the oldest recorded illnesses, dating as far back as 3300 bc [1]. However, despite major discoveries in microbiology during the past century, the etiology of most diarrheal illnesses remained elusive until relatively recently [2, 3]. Although volunteer studies in the 1940s and 1950s showed that oral administration of bacteria-free stool filtrates derived from patients with diarrhea could induce illness, a suspected viral etiologic agent could not be identified.

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Notes

  1. 1.

    Editor’s note: As of 2011, both new vaccines have demonstrated efficacy in developing countries and Rotarix is widely used in Latin America.

References

  1. Kumate J, Isibasi A. Pediatric diarrheal diseases: a global perspective. Pediatr. Infect Dis. 1986; 5(Suppl): S21–28

    Article  PubMed  CAS  Google Scholar 

  2. Connor JD, Barrett-Connor E. Infectious Diarrheas. Pediatr Clin North Am 1967;14:197–221

    PubMed  CAS  Google Scholar 

  3. Yow MD, Melnick JL, Blattner RJ, Stephenson NB, Robinson NM, Burkhardt MA. The association of viruses and bacteria with infantile diarrhea. Am J Epidemiol 1970;92:33–39

    PubMed  CAS  Google Scholar 

  4. Kapikian AZ. The discovery of the 27-nm Norwalk Virus: an historic perspective. J. Infect Dis 2000;181 (Suppl 2) 295–302

    Article  Google Scholar 

  5. Kapikian AZ, Wyatt RG, Dolin R, Thornhill TS, Kalica AR, Chanock RM. Visualization by immune electron microscopy of a 27 nm particle associated with acute nonbacterial gastroenteritis. J. Virol 1972;10:1075–1081

    PubMed  CAS  Google Scholar 

  6. Bishop RF, Davidson GP, Holmes IH, Ruck BJ. Virus particles in epithelial cells of duodenal mucosa from children with acute non-bacterial gastroenteritis. Lancet 1973;302:1281–1283

    Article  Google Scholar 

  7. Green KY. Caliciviridae: The Noroviruses. In Fields Virology, Knipe DM, Howley PM (eds) (Fifth Ed) 2007; pp 949–97 Lippincott Williams & Wilkins, Philadelphia

    Google Scholar 

  8. Estes MK, Kapikian. Rotaviruses. in Fields Virology, Knipe DM, Howley PM (eds) (Fifth Ed) pp 1917–1974 (Lippincott Williams & Wilkins, Philadelphia)

    Google Scholar 

  9. Patel MM, Widdowson M-A, Glass RI, Akazawa K, Vinje J, Parashar UD. Systematic literature review of role of noroviruses in sporadic gastroenteritis. Emerg Infect Dis 2008;14:1224–1231

    Article  PubMed  Google Scholar 

  10. Editorial. More about D and V. Brit. Med J 1974; 5935;1–2

    Google Scholar 

  11. Institute of Medicine. The prospects for immunizing against rotavirus. In New Vaccine Development. Establishing Priorities. Diseases of importance in Developing Countries. (1986). Vol 2: pp 308–316. National Academy Press, Washington

    Google Scholar 

  12. Institute of Medicine. The prospects for immunizing against rotavirus. In New Vaccine Development. Establishing Priorities. Diseases of importance in the United States. (1986). Vol 1: pp 410–423. National Academy Press, Washington

    Google Scholar 

  13. Parashar UD, Burton A, Lanata C, Boschi-Pinto C, Shibuya K, Steele D, Birmingham M, Glass RI. Global mortality associated with rotavirus disease among children in 2004. J Infect Dis 2009;200 (Suppl 1):9–15

    Article  Google Scholar 

  14. Glass RI, Parashar UD, Bresee JS, Turcios R, Fischer TK, Widdowson M-A, Jiang B, Gentsch JR. Rotavirus vaccines: current prospects and future challenges. Lancet 2006;368:323–332

    Article  PubMed  CAS  Google Scholar 

  15. Flewett TH, Bryden AS, Davies H, Woode GN, Bridger JC, Derrick JM. Relation between viruses from acute gastroenteritis of children and newborn calves. Lancet 1974; 304: 61–63

    Article  Google Scholar 

  16. Prasad BVV. In Rotaviruses. Current Topics in Microbiology and Immunology 1994; 185:Cover (adapted from). Ramig RF (ed) Springer, Berlin

    Google Scholar 

  17. Kapikian AZ, Wyatt RG, Levine MM, Yolken RH, Van Kirk DH, Dolin R, Greenberg HB, Chanock RM. Oral administration of a human rotavirus to volunteers: induction of illness and correlates of resistance. J. Infect Dis 1983; 147:95–106

    Article  PubMed  CAS  Google Scholar 

  18. Kapikian AZ, Wyatt RG, Levine MM, Black RE, Greenberg HB, Flores J, Kalica AR, Hoshino Y, Chanock RM. Studies in volunteers with human rotaviruses. Develop. Biol. Standard 1983;53;209–2218

    CAS  Google Scholar 

  19. Wyatt RG, James WD, Bohl EH, Theil KW, Saif LJ, Kalica AR, Greenberg HB, Kapikian AZ, Chanock RM. Human rotavirus type 2: cultivation in vitro. Science 1980;207:189–191

    Article  PubMed  CAS  Google Scholar 

  20. Wyatt RG, Kapikian AZ, Greenberg HB, Kalica AR, Flores J, Hoshino Y, Chanock RM, Levine MM. Development of vaccines against rotavirus disease. Prog Fd Sci 1983;7:189–192

    CAS  Google Scholar 

  21. Wyatt RG, Kapikian AZ, Hoshino Y, Flores J, Midthun K, Greenberg HB, Glass RI, Askaa J, Levine MM, Black RE, Clements ML, Potash L, London WT. Development of rotavirus vaccines. Control and eradication of infectious diseases an international d symposium PAHO copublication series No. 1 1985; pp 17–38

    Google Scholar 

  22. Kapikian AZ, Wyatt RG, Greenberg HB, Kalica AR, Kim HW, Brandt CD, Rodriguez WJ, Parrott RH, Chanock RM. Approaches to immunization of infants and young children against gastroenteritis due to rotaviruses. Rev Infect Dis 1980;2;459–469

    Article  PubMed  CAS  Google Scholar 

  23. Woode GN, Jones J, Bridger J. Levels of colostral antibodies against neonatal calf diarrhea virus. Vet Rec 1975;96:148–149

    Article  Google Scholar 

  24. Bridger JC, Woode GN. Neonatal calf diarrhea: Identification of a reovirus-like (rotavirus) agent in faeces by immunofluorescence and immune electron microscopy. Br Vet J 1975; 131;528–535

    PubMed  CAS  Google Scholar 

  25. Snodgrass DR, Wells PW. Rotavirus infection in lambs: studies on passive protection. Arch Virol 1976; 52:201–205

    Article  PubMed  CAS  Google Scholar 

  26. Snodgrass DR, Madeley CR, Wells PW, Angus KW. Human rotavirus in lambs: infection and passive protection. Infect Immun 1977;16:268–270

    PubMed  CAS  Google Scholar 

  27. Snodgrass DR, Wells PW. Passive immunity in rotavirus infections. J Am Vet Med Assoc 1978;173:L565–569

    Google Scholar 

  28. Lecce JG, King MW, Mock R. Reovirus-like agent associated with fatal diarrhea in neonatal pigs. Infect Immun 1976;14:816–825

    PubMed  CAS  Google Scholar 

  29. Flores J, Perez-Schael I, Blanco M, Garcia D, Vilar M, Cunto W, Gonzalez R, Ubina C, Boher J, Mendez M, Kapikian AZ. Comparison of the reactogenicity and antigenicity of the M37 rotavirus vaccine and the rhesus-rotavirus-based quadrivalent vaccine. Lancet 1980; 336:330–334

    Article  Google Scholar 

  30. Vesikari T, Ruuska T, Koivu HP, Green KY, Flores J, Kapikian AZ. Evaluation of the M37 human rotavirus vaccine in 2-to 6-month-old infants. Pediatr Infect Dis J 1991;10:912–917

    Article  PubMed  CAS  Google Scholar 

  31. Bishop RF, Barnes GL, Cipriani E, Lund JS. Clinical immunity after neonatal rotavirus infection. N. Eng J. Med 1983;309:72–76

    Article  CAS  Google Scholar 

  32. Hoshino Y, Kapikian AZ, Chanock RM. Selection of cold-adapted mutants of human rotaviruses that exhibit various degrees of growth restriction in vitro. J. Virol 1994;68:7598–7602

    PubMed  CAS  Google Scholar 

  33. Treanor JJ. Unpublished studies

    Google Scholar 

  34. Henderson DA. Edward Jenner’s vaccine. Publ. Hlth Reports 1997:112: 116–121. (Reprinted from The Jordan Report: Accelerated Developments of Vaccines 1996, NIAID, NIH)

    Google Scholar 

  35. Woode GN, Bridger JC, Jones JM, Flewett TH, Bryden AS, Davies HA, White GBB. Morphological and antigenic relationships between viruses (rotaviruses) from acute gastroenteritis of children, calves, piglets, mice and foals. Infec Immun 1976;14:804–810

    CAS  Google Scholar 

  36. Kapikian AZ, Cline WL, Kim HE, Kalica AR, Wyatt RG, Van Kirk DH, Chanock RM, James HD Jr, Vaughn AL. Antigenic relationships among the five reovirus-like (RVL) agents by complement fixation (CF) and development of a new substitute CF antigen for the human RVL agent of infantile gastroenteritis. Proc Soc Exp Biol Med 1976;152:535–539

    PubMed  CAS  Google Scholar 

  37. Matsuno S, Inouye S, Kono R. Plaque assay of neonatal calf diarrhea virus and the neutralizing antibody in human sera. J. Clin Microbiol 1977;5:1–4

    PubMed  CAS  Google Scholar 

  38. Wyatt RG, Mebus CA, Yolken RH, Kalica AR, James HD Jr, Kapikian AZ, Chanock RM. Rotaviral immunity in gnotobiotic calves: heterologous resistance to human virus induced by bovine virus. Science 1979;203:548–550

    Article  PubMed  CAS  Google Scholar 

  39. Wyatt RG, Kapikian AZ, Mebus CA. Induction of cross-reactive serum neutralizing antibody to human rotavirus in calves after in utero administration of bovine rotavirus. J Clin Microbiol 1983;18;505–508

    PubMed  CAS  Google Scholar 

  40. Zissis G, Lambert JP, Marbehant P, Marissens D, Lobman M, Charlier P, Delem A, Zygraich N. Protection studies in colostrum-deprived piglets of a bovine rotavirus vaccine candidate using human rotavirus strains for challenge. J Infect Dis 1983;148:1061–1068

    Article  PubMed  CAS  Google Scholar 

  41. Vesikari T, Isolauri E, Delem A, D’Hondt E, Andre FE, Zissis G. Immunogenicity and safety of live oral attenuated bovine rotavirus vaccine strain RIT 4237 in adults and young children. Lancet 1983;322;807–811

    Article  Google Scholar 

  42. Vesikari T, Isolauri E, D’Hondt E, Delem A, Andre FE, Zissis G. Protection of infants against rotavirus diarrhoea by RIT 4237 attenuated bovine rotavirus strain vaccine. Lancet 1984;323:977–981

    Article  Google Scholar 

  43. Vesikari T, Isolauri E, Delem A, D’Hondt E, Andre A, Beards GM, Flewett TH. Clinical efficacy of the RIT 4237 live attenuated bovine rotavirus vaccine in infants vaccinated before a rotavirus epidemic. J. Pediatr 1985;107:189–194

    Article  PubMed  CAS  Google Scholar 

  44. Kapikian AZ, Hoshino Y, Flores J, Midthun K, Glass RI, Nakagomi O, Nakagomi T, Chanock RM, Potash L, Levine MM, Dolin R, Wright PF, Belshe RE, Anderson EL, Vesikari T, Gothefors L, Wadell G, Perez-Schael I. Alternative approaches to the development of a rotavirus vaccine. In: Development of Vaccines and Drugs against Diarrhea. 11th Nobel Conf., Stockholm 1985, pp 192–214 (eds J. Holmgren, A Lindbergh & R Mollby) Studentlitteratur, Lund, Sweden, 1986

    Google Scholar 

  45. Stuker G, Oshiro L, Schmidt NL. Antigenic comparisons of two new rotaviruses from rhesus monkeys. J. Clin. Microbiol 1980; 11:202–203

    PubMed  CAS  Google Scholar 

  46. Kapikian AZ, Midthun, K, Hoshino Y, Flores J, Wyatt RG, Glass RI, Askaa J, Nakagomi O, Nakagomi T, Chanock RM, Levine MM, Clements ML, Dolin R, Wright PF, Belshe RB, Anderson EL, Potash L. Rhesus rotavirus: a candidate vaccine for prevention of human rotavirus disease, In: Vaccines 85 pp 357–367. Cold Spring Harbor Laboratory

    Google Scholar 

  47. Wallace RE, Vasington PJ, Petricciani JC, Hopps HE, Lorenz DE, Kadanka Z. Development of a diploid cell line from fetal rhesus monkey lung for virus vaccine production. In Vitro 1973;8:323–332

    Article  PubMed  CAS  Google Scholar 

  48. Kapikian AZ, Flores J, Hoshino Y, Midthun K, Green KY, Gorziglia M, Chanock RM, Potash L, Perez-Schael I, Gonzalez M, Vesikari T, Gothefors L, Wadell G, Glass RI, Levine MM, Rennels MB, Losonsky G, Christy C, Dolin R, Anderson EL, Belshe RB, Wright PF, Santosham M, Halsey NA, Clements ML, Sears SD, Steinhoff MC, Black RE. Rationale for the development of a rotavirus vaccine for infants and young children. In: Progress in Vaccinology 1989 Vol 2 pp 151–180 (GP Talwar ed). Springer, New York

    Google Scholar 

  49. Christy C, Madore HP, Treanor JJ, Pray K, Kapikian AZ, Chanock RM, Dolin R. Safety and immunogenicity of live attenuated rhesus monkey rotavirus vaccine. J. Infect Dis. 1986;154:1045–1047(correspondence)

    Google Scholar 

  50. Losonsky GA, Rennels MB, Kapikian AZ, Midthun K, Ferra PJ, Fortier DN, Hoffman KM, Baig A, Levine MM. Safety, infectivity, transmissibility and immunogenicity of rhesus rotavirus vaccine (MMU 18006) in infants. Pediatr Infect Dis 1986; 5:25–29

    Article  PubMed  CAS  Google Scholar 

  51. Anderson EL, Belshe RB, Bartram J, Crookshanks-Newman F, Chanock RM, Kapikian AZ. Evaluation of rhesus rotavirus vaccine (MMU 18006) in infants and young children. J. Infect Dis 1986;153:823–831

    Article  PubMed  CAS  Google Scholar 

  52. Perez-Schael I, Gonzalez M, Daoud N, Perez M, Soto I, Garcia D, Daoud G, Kapikian AZ, Flores J. Reactogenicity and antigenicity of the rhesus rotavirus vaccine in Venezuelan children. J. Infect Dis 1987;155;334–338

    Article  PubMed  CAS  Google Scholar 

  53. Rennels MB, Losonsky GA, Schindledecker CL, Hughes TP, Kapikian AZ, Levine MM, the Clinical Study Group (Ferra PJ, Fortier DN, Sutton JM). Immunogenicity and reactogenicity of lowered doses of rhesus rotavirus vaccine strain MMU 18006 in young children. Pediatr Infect Dis J. 1987; 6:260–267

    Google Scholar 

  54. Wright PF, Tajima T, Thompson J, Kokubun K, Kapikian A, Karzon DT. Candidate rotavirus vaccine (rhesus rotavirus strain) in children: an evaluation. Pediatrics 1987;80:473–480

    PubMed  CAS  Google Scholar 

  55. Losonsky GA, Rennels MB, Lim Y, Krall G, Kapikian KZ, Levine MM. Systemic and mucosal responses to rhesus roavirus vaccine MMU 18006. Pediatr Infect Dis J 1988;7:388–393

    Article  PubMed  CAS  Google Scholar 

  56. Vesikari T, Kapikian AZ, Delem A, Zissis. A comparative trial of rhesus monkey (RRV-1) and bovine (RIT 4237) oral rotavirus vaccines in young children. J. Infect Dis 1986;153:832–839

    Article  PubMed  CAS  Google Scholar 

  57. Kapikian AZ, Flores J, Midthun K, Hoahino Y, Green KY, Gorziglia M, Nishikawa K, Chanock RM, Potash L, Perez-Schael I. Strategies for the development of a rotavirus vaccine against infantile diarrhea with an update on clinical trials of rotavirus vaccine. Adv Exp Med Biol 1987;257:67–89

    Google Scholar 

  58. Rennels MB, Losonsky GA, Levine MM, Kapikian AZ, and the Clinical Study Group (Fortier DN, Sutton JM, Ferra PJ and Hoffman KM) Preliminary evaluation of the efficacy of rhesus rotavirus vaccine strain MMU 18006 in young children. Pediatr Infect Dis 1986;5:587–588

    Google Scholar 

  59. Flores J, Perez-Schael I, Gonzalez M, Garcia D, Perez M, Daoud N, Cunto W, Chanock RM, Kapikian AZ. Protection against severe rotavirus diarrhoea by rhesus rotavirus vaccine in Venezuelan infants. Lancet 1987;329; 882–884

    Article  Google Scholar 

  60. Gothefors L, Wadell G, Juto P, Taniguchi K, Kapikian AZ, Glass RI. Prolonged efficacy of rhesis rotavirus vaccine in Swedish children. J Infect Dis 1989;159:753–757

    Article  PubMed  CAS  Google Scholar 

  61. Rennels MB, Losonsky GA, Young AE, Shindledecker CL, Kapikian AZ, Levine MM and the Clinical Study Group. An efficacy trial of rhesus rotavirus vaccine in Maryland. Am J Dis Child 1990;144:601–604

    PubMed  CAS  Google Scholar 

  62. Christy C, Madore HP, Pichichero ME, Gala C, Pincus P, Vosefski D, Hoshino Y, Kapikian AZ, Dolin R. The Elmwood and Panorama pediatric groups: field trial of rhesus rotavirus vaccine in infants. Pedaitr Infect Dis J 1988;7:645–650

    Article  CAS  Google Scholar 

  63. Perez-Schael I, Garcia D, Gonzalez M, Gonzalez R, Daoud N, Perez M, Cunto W, Kapikian AZ, Flores J. Prospective study of diarrheal diseases in Venezuelan children to evaluate the efficacy of rhesus rotavirus vaccine. J. Med Virol 1990;30:219–229

    Article  PubMed  CAS  Google Scholar 

  64. Santosham M, Letson GW, Wolff M, Reid R, Gahagan S, Adams R, Callahan C, Sack RB, Kapikian AZ. A field study of the safety and efficacy of two candidate rotavirus vaccines in a Native American population. J. Infect Dis 1991;163: 483–487

    Article  PubMed  CAS  Google Scholar 

  65. Vesikari T, Rautanen T, Varis T, Beards GM, Kapikian AZ. Rhesus rotavirus candidate vaccine. Clinical trial in children vaccinated between 2 and 5 months of age. Am J Dis Child 1990;144:285–289

    PubMed  CAS  Google Scholar 

  66. Madore, HP, Christy C, Pichichero M, Long C, Pincus P, Vosefsky P, Kapikian AZ, Dolin R, Elmwood, Panorama, and Westfall Pediatric Groups. Field trial of rhesus rotavirus or human-rhesus reassortant vaccine of VP7 serotype 3 or 1 specificity in infants. J. Infect Dis 1992;166:235–243

    Article  PubMed  CAS  Google Scholar 

  67. Kapikian AZ, Flores J, Midthun K, Hoshino Y, Green KY, Gorziglia M, Taniguchi K, Nishikawa K, Chanock RM, Potash L, Perea-schael I, Dolin R, Christy C, Santosham M, Halsey N, Clements ML, Sears SD, Black RE, Levine MM, Losonsky GA, Rennels MB, Gothefors L, Wadell G, Glass RI, Vesikari T, Anderson EL, Belshe RB. Wright PF, Urasawa. Development of a rotavirus vaccine by a “Jennerian” and a modified “Jennerian” approach. In: Modern Approaches to New Vaccines including Prevention of AIDS: Cold Spring Harbor Laboratory. Vaccines 88; 1988 pp 151–159

    Google Scholar 

  68. Lanata C, Black RE, Flores J, Lazo F, Butron B, Linhares A, Huapaya A, Ventura G, Gil A, Kapikian AZ. Immunogenicity, safety and protective efficacy of one dose of the rhesus rotavirus vaccine and serotype 1 and 2 human-rhesus rotavirus reassortants in children from Lima, Peru. Vaccine 1996;14:237–243

    Article  PubMed  CAS  Google Scholar 

  69. Kapikian AZ, Flores J, Hoshino Y, Midthun K, Gorziglia M, Green KY, Chanock RM, Potash L, Sears SD, Clements ML, Halsey NA, Black RE, Perez-Schael I. Prospects for development of a rotavirus vaccine against rotavirus diarrhea in infants and young children. Rev. Infect Dis (Suppl) 1989;3:539–546

    Article  Google Scholar 

  70. Midthun K, Greenberg HB, Hoshino Y, Kapikian AZ, Wyatt RG, Chanock RM, Reassortant rotaviruses as potential live roavirus vaccine candidates. J Virol 1985;53: 949–954

    PubMed  CAS  Google Scholar 

  71. Midthun K, Hoshino Y, Kapikian AZ Chanock RM. Single gene substitution rotavirus reassortants containing the major neutralization protein (VP7) of human rotavirus serotype 4. J Clin Microbiol 1986;24: 822–836

    PubMed  CAS  Google Scholar 

  72. Kapikian AZ, Hoshino Y. To serotype or not to serotype: that is still the question. J. Infect. Dis 2007;195:611–614

    Article  PubMed  Google Scholar 

  73. Kapikian AZ, Hoshino Y, Chanock RM, Perez-Schael I. Efficacy of a quadrivalent rhesus rotavirus-based human rotavirus vaccine aimed at preventing severe rotavirus diarrhea in infants and young children. J. Infect Dis 1996;174 (suppl):65–72

    Article  Google Scholar 

  74. Kapikian AZ, Vesikari T, Ruuska T, Madore HP, Christy C, Dolin R, Flores J, Green KY, Davidson BL, Gorziglia M, Hoshino Y, Chanock RM, Midthun K, Perez-Schael I. An update on the “Jennerian” and modified “Jennerian” approach to vaccination of infants and young children against rotavirus diarrhea. Adv Exp Med Biol 1992; 327:59–69

    PubMed  CAS  Google Scholar 

  75. Kapikian AZ. Rotavirus vaccine: the clinical experience with the rhesus rotavirus-based vaccines. In: Mucosal Vaccines New Trends in Immunization 1996 pp 345–356 (Kiyono H, Ogra PL, McGhee JR eds)

    Google Scholar 

  76. Flores J, Perez-Schael I, Blanco M, Vilar M, Daoud N, Midthun K, Kapikian AZ. Reactions to and antigenicity of two human-rhesus rotavirus reassortant vaccine candidates of serotypes 1 and 2 in Venezelan infants. J. Clin. Microbiol 1989: 27; 512–518

    PubMed  CAS  Google Scholar 

  77. Halsey NA, Anderson EL, Sears SD, Steinhoff M, Wilson M, Belshe RB, Midthun K, Kapikian AZ, Chanock RM, Samorodin R, Burns B, Clements ML. Human-rhesus reassortant vaccines: safety and immunogenicity in adults, infants and children. J. Infect Dis 1988;158:1261–1267

    Article  PubMed  CAS  Google Scholar 

  78. Perez-Schael I, Blanco M, Vilar M,Garcia D,Gonzalez R, Kapikian AZ, Flores J. Clinical studies of a quadrivalent rotavirus vaccine in Venezuelan infants J. Clin Microbiol 1990; 28: 553–558

    PubMed  CAS  Google Scholar 

  79. Flores J, Perez-Schael I, Blanco M, Rojas AM, Alfonzo E, Cespo I, Cunto W, Pittman AL, Kapikian AZ. Reactogenicity and immunogenicity of a high-titer rhesus rotavirus-based quadrivalent rotavirus vaccine. J. Clin Microbiol 1993;31:2439–2445

    PubMed  CAS  Google Scholar 

  80. Linhares AC, Gabbay YB, Mascarenhas JDP, de Freitas RB, Oliveira CS, Bellesi N, Monteiro TA, Lins-Lainson Z, Ramos FLP, Valente SA. Immunogenicity, safety and efficacy of tetravalent rhesus-human, reassortant rotavirus vaccine in Belem, Brazil. Bull WHO 1996:74;491–500

    PubMed  CAS  Google Scholar 

  81. Linhares AC, Lanata CF, Hausdorff WP, Gabbay YB, Black RE. Reappraisal of the Peruvian and Brazilian lower titer tetravalent rhesus-human reassortant rotavirus vaccine efficacy trials: analysis by severity of diarrhea. Pediatr Infect Dis J 1999;18:1001–1006

    Article  PubMed  CAS  Google Scholar 

  82. Kapikian AZ, Flores J, Vesikari T, Ruuska T, Madore HP, Green KY, Gorziglia M, Hoshino Y, Chanock RM, Midthun K, Perez-Shael I. Recent advances in development of a rotavirus vaccine for prevention of severe diarrheal illness of infants and young children. In: Immunology of milk and the neonate 1991 pp 255–264 (Mestecky J et al eds). Plenum Press, New York

    Google Scholar 

  83. Bernstein DI, Glass RI, Rodgers G, Davidson BL, Sack DA, US Rotavirus Vaccine Efficacy Group. Evaluation of rhesus rotavirus monovalent and tetravalent reassortant vaccines in US children. JAMA 1985; 273:1191–1196

    Article  Google Scholar 

  84. Vesikari T, Ruuska T, Green KY, Flores J, Kapikian AZ. Protective efficacy against serotype 1 rotavirus diarrhea by live oral rhesus-human reassortant rotavirus vaccines with human rotavirus serotype 1 or 2 specificity. Pediatr Infect Dis J 1992;11:535–542

    Article  PubMed  CAS  Google Scholar 

  85. Rennels MB, Glass RI, Dennehy PH, Bernstein DI, Pichichero ME, Zito ET, Mack ME, Davidson BL, Kapikian AZ for the United States otavirus Efficacy Group. Safety and efficacy of high-dose rhesus-human reassortant rotavirus vaccines-report of the national multicenter trial. Pediatrics 1996; 97: 7–13

    PubMed  CAS  Google Scholar 

  86. Joensuu J, Koskenniemi E, Pang X-L, Vesikari T. Randomised placebo-controlled trial of rhesus-human reassortant rotavirus vaccine for prevention of severe gastroenteritis. Lancet 1997;350:1205–1209

    Article  PubMed  CAS  Google Scholar 

  87. Perez-Schael I, Guntinas MJ, Perez M, Pagone V, Rojas AM, Gonzalez R, Cunto W, Hoshino Y, Kapikian AZ. Efficacy of the rhesus rotavirus-based quadrivalent vaccine in infants and young children in Venezuela N. Eng. J. Med 1997;337: 1181–1187

    Article  CAS  Google Scholar 

  88. Santosham M, Moulton LH, Reid R, Croll J, Weatherbolt R, Ward R, Forro J, Zito E, Mack M, Brenneman G, Davidson BL. Efficacy and safety of high-dose rhesus-human reassortant vaccine in Native American populations. J Pediatr 1997;131: 632–638

    Article  PubMed  CAS  Google Scholar 

  89. Centers for Disease Control and Prevention. Rotavirus vaccine for the prevention of rotavirus gastroenteritis among children: recommendation of the Advisory Committee on Immunization Practices (ACIP). MMWR 1999;48:577–581

    Google Scholar 

  90. Centers for Disease Control and Prevention. Intussusception among recipients of rotavirus vaccine: United States, 1998–1999. MMWR 1999;48:577–581

    Google Scholar 

  91. Centers for Disease Control and Prevention. Withdrawal of rotavirus vaccine recommendation. MMWR 1999;48:1007

    Google Scholar 

  92. Mato SP, Perrin K, Scardino D, Begue RE. Evaluation of rotavirus vaccine effectiveness in a pediatric group practice. Am J. Epidem 2002;156:1049–1055

    Article  Google Scholar 

  93. Staat MA, Cortese MM, Bresee JS, Begue RE, Vitek C, Rhodes P, Zhang R, Gentsch J, Roberts NE, Jaeger JL, Wars R, Bernstein DI, Dennehy PH. Rhesus rotavirus vaccine effectiveness and factors associated with receipt of vaccine. Pediatr Infect Dis 2006; 25:1013–1016

    Article  Google Scholar 

  94. Tate JE, Curns AT, Cortese MM, Weintraub ES, Hambidge S, Zangwill KM, Patel MM, Baggs JM, Parashar UD. Burden of acute gastroenteritis hospitalizations and emergency department visits in US children that is potentially preventable by rotavirus vaccination: a probe study using the now withdrawn RotaShield vaccine. Pediatrics 2009;123:744–749

    Article  PubMed  Google Scholar 

  95. Kapikian AZ. A rotavirus vaccine for preventing severe diarrhoea of infants and young children: development and withdrawal. In: Chadwick D, Goode JA, eds. Gastroenteritis viruses. Novartis Foundation Symposium 238. Chichester, England. John Wiley and Sons. 1001; 153–171

    Google Scholar 

  96. ACIP. Verbatim transcript of the ACIP meeting (Atlanta GA), 22 October 1999 Nancy Lee and Associates, Certified Cour Reporters 1999;3:1–174

    Google Scholar 

  97. Murphy BM, Morens DM, Simonsen L, Chanock RM, La Montagne JR, Kapikian AZ. Reappraisal of the association of intussusception with the licensed live rotavirus vaccine challenges initial conclusions J. Infect Dis 2003;187: 1301–1308

    Article  PubMed  Google Scholar 

  98. Murphy TV, Gargiullo PM, Massoudi MS et al. Intussusception among infants given an oral rotavirus vaccine. N Engl J Med 2001;344:564–572

    Article  PubMed  CAS  Google Scholar 

  99. Murphy TV, Gargiullo PM, Massoudi MS, et al. Corrections: intussusception among infants given an oral rotavirus vaccine. N Engl Med 2001;344:1564

    Article  Google Scholar 

  100. Kramarz P, France EK, Destefano F, et al. Population-based study of rotavirus vaccination and intussusception. Pediatr Infect Dis J 2001;20:410–416

    Article  PubMed  CAS  Google Scholar 

  101. Simonsen L, Morens D, Elixhauser A, Gerber M,Van Raden M, Blackwelder W. Effect of rotavirus vaccination programme on trends in admission of patients to hospital for intussusception. Lancet 2001;358;1224–1229

    Article  PubMed  CAS  Google Scholar 

  102. Hall AJ. Ecological studies and debate on rotavirus vaccine and intussusception. Lancet 2001;358:1197–1198 (Commentary)

    Google Scholar 

  103. Kapikian AZ. Ecological studies, rotavirus vaccination, and intussusception. Lancet 2002;359:1065–1066 (letter)

    Google Scholar 

  104. Hall AJ. Ecological studies, rotavirus vaccination, and intussusception. Lancet 2002;359:1066 (letter)

    Google Scholar 

  105. Simonsen L, Morens DM, Blackwelder WC. Ecological studies, rotavirus vaccination, and intussusception. Lancet 2002;359:1066–1067 (letter)

    Google Scholar 

  106. Murphy TV, Gargiullo PM, Wharton M. More on Rotavirus Vaccination and Inussusception. N. Engl. J Med 2002;346: 211–212 (letter)

    Google Scholar 

  107. Centers for Disease Control and Prevention Advisory Committee on Immunization Practice. Records of the meeting held on February 20–21, 2002, Atlanta Marriott North Central Hotel, Atlanta

    Google Scholar 

  108. Gay N, Ramsay M, Waight P. Rotavirus vaccination and intussusception. Lancet 1999;354: 956 (Letter)

    Google Scholar 

  109. Pang LC. Intussusception revisited: clinicopathologic analysis of 261 cases, with emphasis on pathogenesis. South. Med J 1989; 82; 215–228

    Article  PubMed  CAS  Google Scholar 

  110. Simonsen L, Viboud C, Elixhauser A, Taylor RJ, Kapikian AZ. More on RotaShield and intussusception: the role of age at the time of vaccination. L. Infect Dis 2005;192 (Suppl 1): 36–42

    Article  Google Scholar 

  111. Kapikian AZ, Simonsen L, Vesikaari T, Hoshino Y, Morens DM, Chanock RM, La Montagne JR, Murphy BM. A hexavalent human rotavirus-bovine rotavirus (UK) reassortant vaccine designed for use in developing countries and delivered in a schedule with the potential to eliminate the risk of intussusception J. Infect Dis 2005;192 (suppl):22–29

    Article  Google Scholar 

  112. Rothman KJ, Young-Xu Y, Arellano F. Age dependence of the relation between reassor-tant rotavirus vaccine (RotaShield) and intussusception. J. Infect Dis 2006: 193:898 (Correspondence)

    Google Scholar 

  113. Rothman KJ, Lee L. Rotashield and intussusception: reanalysis of data demonstrates reduced risk. Chinese J Vaccines and Immunization 2005;11:71–73 (Correspondence)

    Google Scholar 

  114. Simonsen L, Taylor RJ, Elixhauser A, Viboud C, Kapikian AZ. Reply to Rothman et al. J. Infect Dis 2006; 193:898–899 (Correspondence)

    Google Scholar 

  115. Garguillo PM, Murphy TV, Davis RL. Is there a safe age for vaccinating infants with tetravalent rhesus-human reassortant rotavirus vaccine? J. Infect Dis 2006;194:1793–1794 (Correspondence)

    Google Scholar 

  116. Rothman KJ, Arellano FM, Young-Xu Y, Simonsen L, Gargiullo et al. J infect Dis 2006;194;1794–1795

    Google Scholar 

  117. WHO Global Advisory Committee on Vaccine Safety 1-2 December 2005. Rotavirus vaccine safety. Wkly Epid Rec 2006; No 2 vol 81;16–17

    Google Scholar 

  118. Simonsen, L. Unpublished Studies

    Google Scholar 

  119. WHO Position paper Rotavirus Vaccines. Wkly Epid Rep 2007; no 32 vol 82;285–296

    Google Scholar 

  120. Perrin PS, Lindsay FC. Intussusception: a monograph based on 400 cases. Brit J. Surg 1921; 9:46–71

    Article  Google Scholar 

  121. Chen YE, Beasley S, Grimwood K. Intussusception and rotavirus associated hospitalization in New Zealand. Arch Dis Cils. 2005; 10:1077–1081

    Article  Google Scholar 

  122. Justice FA, Auldist AW, Bines JE, Intussusception: trends in clinical presentation and management. J. Gastroenterol Hepatol 2006;21:842–846

    Article  PubMed  Google Scholar 

  123. Tate JE, Simonsen L, Viboud C, Steiner C, Patel M, Curns AT, Parashar UD. Trends in intussusception hospitalizations among Us infants, 1993–2004: implications for monitoring the safety of the new rotavirus vaccination program. Pediatrics 2008;121: e1125–1132

    Article  PubMed  Google Scholar 

  124. Vesikari T, Matson DO, Dennehy P et al. Safety and efficacy of a pentavalent human-bovine (WC2) reassortant rotavirus vaccine N. Eng. J. Med 2006;354: 23–33

    Article  CAS  Google Scholar 

  125. Simonsen L, Taylor RJ, Kapikian AZ. Rotavirus vaccines. N Engl J Med 2006;354:1748 (letter)

    Google Scholar 

  126. US FDA: FDA public Health Notification: Information on RotaTeq and Intussusception February 13, 2007

    Google Scholar 

  127. Haber P, Patel M, Izurieta HS, Baggs J, Gargiullo P, Weintraub E, Cortese M, Braun MM, Belongia EA, Miller E, Ball R, Iskander J, Parashr U. Pediatrics 2008;121:1206–1212

    Article  PubMed  Google Scholar 

  128. Ruiz-Palacios GM, Perez-Schael I, Velazquez FR et al. Safety and efficacy of an attenuated vaccine against rotavirus gastroenteritis. No Engl J Med 2006;354:11–22

    Article  CAS  Google Scholar 

  129. Bresee JS, El Arifeen S, Azim T, Chakraborty J, Mounts AW, Podder G, Gentsch JR, Ward RL, Black R, Glass RI, Yunus M. Safety and immunogenicity of tetravalent rhesus-based roavirus vaccine in Bangladesh. Ped Inf DIs J 2001;20:1136–1143

    Article  CAS  Google Scholar 

  130. Weijer C. The future of research into rotavirus vaccine. Benefits of vaccine may outweigh risks for children in developing countries. BMJ 2000;321:525–526

    Article  PubMed  CAS  Google Scholar 

  131. Ruiz L, Personal Communication

    Google Scholar 

  132. Vesikari T, Karvonen A, Forrest BD, Hoshino Y, Chanock RM, Kapikian AZ. Neonata administration of rhesus rotavirus tetravalent vaccine. Pediatr Infect Dis J 2006;25:118–122

    Article  PubMed  Google Scholar 

  133. Hoshino Y, Jones RW, Ross J, Kapikian AZ. Construction and characterization of rhesus monkey rotavirus (MMU18006)- or bovine rotavirus (UK)-based serotype G5, G8, G9 or G10 single VP7 gene substitution reassortant candidate vaccines. Vaccine 2003;21:3003–3010

    Article  PubMed  CAS  Google Scholar 

  134. Fauci AS. The expanding global health agenda: a welcome development. Nature Med 2007;13;1169–1171

    Article  PubMed  CAS  Google Scholar 

  135. Sidwell RW. Overview of viral agents in pediatric enteric infections. Pediatr Infect Dis 1986; 5 (Suppl):S44–45

    Article  PubMed  CAS  Google Scholar 

  136. Kapikian AZ, Kim HW, Wyatt RG et al. Reovirus-like agent in stools: association with infantile diarrhea and development of serologic tests. Science 1974;185:1049–1053

    Article  PubMed  CAS  Google Scholar 

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  1. Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, DHHS, Bethesda, MD, USA

    Albert Z. Kapikian

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  1. , Emeritus Professor of Pediatrics, University of Pennsylvania, Philadelphia, 19104, Pennsylvania, USA

    Stanley A. Plotkin

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Kapikian, A.Z. (2011). History of Rotavirus Vaccines Part I: RotaShield. In: Plotkin, S. (eds) History of Vaccine Development. Springer, New York, NY. https://doi.org/10.1007/978-1-4419-1339-5_28

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