A critical review on a globally-licensed, live, orally-administrable, monovalent human rotavirus vaccine: Rotarix

Expert Opinion on Biological Therapy

Volumn 9, Issue 8, 2009, Pages 1073-1086

  Nakagomi, Toyoko ^a   Nakagomi, Osamu ^a  

^a NAGASAKI UNIVERSITY   (Japan)

Author keywords

Diarrhoea; Immunization; Intussusception; Rotavirus; Serotype; Vaccine efficacy

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; LIVE VACCINE; NEUTRALIZING ANTIBODY; ORAL POLIOMYELITIS VACCINE; PLACEBO; ROTAVIRUS VACCINE;

AGE; BREAST FEEDING; CHILD; CLINICAL FEATURE; CLINICAL TRIAL; DIARRHEA; DRUG CONTRAINDICATION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; FECES; FEVER; GASTROENTERITIS; HUMAN; HUMAN ROTAVIRUS; IMMUNIZATION; IMMUNOGENICITY; INTESTINE; INTUSSUSCEPTION; NONHUMAN; REVIEW; SEROTYPE; UNITED STATES; VIRUS SHEDDING;

ANIMALS; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; FEMALE; HUMANS; INFANT; INFANT, NEWBORN; INFECTIOUS DISEASE MEDICINE; INTESTINES; MALE; ROTAVIRUS INFECTIONS; ROTAVIRUS VACCINES; VACCINES, ATTENUATED; VIRUS SHEDDING;

BOVINAE; HUMAN ROTAVIRUS A; ROTAVIRUS;

EID: 67650665055     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712590903103787     Document Type: Review

References (76)

1. Bryce J, Boschi-Pinto C, Shibuya K, et al. WHO estimates of the causes of death in children. Lancet 2005;365:1147-1152 (Pubitemid 40417564)
2. Hart CA, Cunliffe NA, Nakagomi O. Diarrhoea caused by viruses. In: Cook GC, Zumla AI, editors, Manson's Tropical Diseases, 22nd edition, Philadelphia: Saunders; 2009. p. 815-824
3. Parashar UD, Gibson CJ, Bresse JS, Glass RI. Rotavirus and severe childhood diarrhea. Emerg Infect Dis 2006;12:304-306
4. Naghipour M, Nakagomi T, Nakagomi O. Issues with reducing the rotavirus-associated mortality by vaccination in developing countries. Vaccine 2008;26:3236-3241
5. Soriano-Gabarró M, Mrukowicz J, Vesikari T, Verstraeten T. Burden of rotavirus disease in European Union countries. Pediatr Infect Dis J 2006;25(Suppl):S7-11 (Pubitemid 43884460)
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;2:1281-1283
7. Kapikian AZ, Wyatt RG, Levine MM, et al. Studies in volunteers with human rotaviruses. Dev Biol Stand 1983;53:209-218
8. Vesikari T, Isolauri E, D'Hondt E, et al. Protection of infants against rotavirus diarrhoea by RIT 4237 attenuated bovine rotavirus strain vaccine. Lancet 1984;1:977-981 (Pubitemid 14148890)
9. Vesikari T, Isolauri E, Delem A, et al. Clinical efficacy of the RIT 4237 live attenuated bovine rotavirus vaccine in infants vaccinated before a rotavirus epidemic. J Pediatr 1985;107:189-194 (Pubitemid 15241906)
10. Vesikari T. Rotavirus vaccines. Scand J Infect Dis 2008;40:691-695
11. De Mol P, Zissis G, Butzler JP, et al. Failure of live, attenuated oral rotavirus vaccine. Lancet 1986;2:108 (Pubitemid 16097112)
12. Hanlon P, Hanlon L, Marsh V, et al. Trial of an attenuated bovine rotavirus vaccine (RIT 4237) in Gambian infants. Lancet 1987:1342-1345 (Pubitemid 17076248)
13. Santosham M, Letson GW, Wolff M, et al. 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
14. Vesikari T, Ruuska T, Delem A, et al. Efficacy of two doses of RIT 4237 bovine rotavirus vaccine for prevention of rotavirus diarrhoea. Acta Paediatr Scand 1991;80:173-180
15. Pérez-Schael I, Guntiñas MJ, Pérez M, et al. Efficacy of the rhesus rotavirus-based quadrivalent vaccine in infants and young children in Venezuela. N Engl J Med 1997;337:1181-1187 (Pubitemid 27454449)
16. Nakagomi T. Rotavirus infection and intussusception: a view from retrospect. Microbiol Immunol 2000;44:619-628 (Pubitemid 30673815)
17. Simonsen L, Viboud C, Elixhauser A, et al. More on RotaShield and intussusception: the role of age at the time of vaccination. J Infect Dis 2005;192(Suppl 1):S36-43 (Pubitemid 41193100)
18. Ruiz-Palacios GM, Pérez-Schael I, Velázquez FR, et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006;354:11-22 (Pubitemid 43048947)
19. Vesikari T, Matson DO, Dennehy P, et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006;354:23-33 (Pubitemid 43048948)
20. Robbins FC. The history of polio vaccine development. In: Plotkin SA, Orenstein WA, editors, Vaccines, 3rd edition, Philadelphia: WB Saunders Co., 1999. p. 13-27
21. World Health Organization. The WHO position paper on rotavirus vaccines. Wkly Epidemiol Rec 2007;82:285-296
22. Unicomb LE, Faruque SM, Malek MA, et al. Demonstration of a lack of synergistic effect of rotavirus with other diarrheal pathogens on severity of diarrhea in children. J Clin Microbiol 1996;34:1340-1342 (Pubitemid 26126926)
23. Dickey M, Jamison L, Michaud L, et al. Rotavirus meningoencephalitis in a previously healthy child and a review of the literature. Pediatr Infect Dis J 2009;28:318-321
24. Blutt SE, Kirkwood CD, Parreno V, et al. Rotavirus antigenaemia and viraemia: a common event? Lancet 2003;362:1445-1449
25. Nakagomi T, Nakagomi O. Rotavirus antigenemia in children with encephalopathy accompanied by rotavirus gastroenteritis. Arch Virol 2005;150:1927-1931 (Pubitemid 41176646)
26. Wilde J, Yolken R, Willoughby R, et al. Improved detection of rotavirus shedding by polymerase chain reaction. Lancet 1991;337:323-326
27. Richardson S, Grimwood K, Gorrell R, et al. Extended excretion of rotavirus after severe diarrhoea in young children. Lancet 1998;351:1844-1848 (Pubitemid 28279708)
28. Ball JM, Tian P, Zeng CQ, et al. Age-dependent diarrhea induced by a rotaviral nonstructural glycoprotein. Science 1996;272:101-104 (Pubitemid 26110759)
29. Horie Y, Nakagomi O, Koshimura Y, et al. Diarrhea induction by rotavirus NSP4 in the homologous mouse model system. Virology 1999;262:398-407 (Pubitemid 29474302)
30. Gentsch JR, Laird AR, Bielfelt B, et al. Serotype diversity and reassortment between human and animal rotavirus strains: implications for rotavirus vaccine programs. J Infect Dis 2005;192(Suppl 1):146-159 (Pubitemid 41193116)
31. Santos N, Hoshino Y. Global distribution of rotavirus serotypes/genotypes and its implication for the development and implementation of an effective rotavirus vaccine. Rev Med Virol 2005;15:29-56 (Pubitemid 40070041)
32. Castello AA, Arguelles MH, Rota RP, et al. Molecular epidemiology of group A rotavirus diarrhea among children in Buenos Aires, Argentina, from 1999 to 2003 and emergence of the infrequent genotype G12. J Clin Microbiol 2006;44:2046-2050
33. Uchida R, Pandey BD, Sherchand JB, et al. Molecular epidemiology of rotavirus diarrhea among children and adults in Nepal: detection of G12 strains with P[6] or P[8] and a G11P[25] strain. J Clin Microbiol 2006;44:3499-3505
34. Cunliffe NA, Gentsch JR, Kirkwood CD, et al. Molecular and serologic characterization of novel serotype G8 human rotavirus strains detected in Blantyre, Malawi. Virology 2000;274:309-320 (Pubitemid 30683513)
35. Cunliffe NA, Bresee JS, Gentsch JR, et al. The expanding diversity of rotaviruses. Lancet 2002;359:640-642
36. Nakagomi O, Nakagomi T. Genomic relationships among rotaviruses recovered from various animal species as revealed by RNA-RNA hybridization assays. Res Vet Sci 2002;73:207-214 (Pubitemid 36004235)
37. Velazquez FR, Matson DO, Calva JJ, et al. Rotavirus infections in infants as protection against subsequent infections. N Engl J Med 1996;335:1022-1028 (Pubitemid 26338732)
38. Bishop RF, Barnes GL, Cipriani E, Lund JS. Clinical immunity after neonatal rotavirus infection. A prospective longitudinal study in young children. N Engl J Med 1983;309:72-76
39. Bernstein DI, Sander DS, Smith VE, et al. Protection from rotavirus reinfection: 2-year prospective study. J Infect Dis 1991;164:277-283
40. Prescribing Information for Rotarix. Silver Spring, MD: FDA, 2009. Available from: fda.gov/downloads/ BiologicsBloodVaccines/Vaccines/ ApprovedProducts/UCM133539.pdf [Last accessed 16 June 2009]
41. Rotavirus vaccines for Australian children: information for GPs and immunisation providers. Sydney, Australia: National Centre for Immunisation. October 2007. Available from: http://www.public.health. wa.gov.au/cproot/421/2/ rotavirus- vaccine-for-children-sep-2006.pdf [Last accessed 16 June 2009]
42. Scientific discussion. London, UK: European Medicines Agency. Avaialable from: http://www.emea.europa.eu/ humandocs/PDFs/epar/rotarix/ Rotarix-H-639-II-01-AR.pdf [Last accessed 16 June 2009]
43. de Oliveira LH, Danovaro-Holliday MC, Matus CR, Andrus JK. Rotavirus vaccine introduction in the Americas: progress and lessons learned. Expert Rev Vaccines 2008;7:345-353
44. Prescribing information for RotaTeq. Whithouse Station, NJ: Merck 1009. Available from: http://www.merck.com/ product/usa/pi-circulars/r/rotateq/ rotateq-pi.pdf [Last accessed 16 June 2009]
45. Asessment report for Rotarix. Procedure N. EMEA/A/H/C/639/X/0010. London: European Medicines Agency, 26 June, 2008. Available from: http://www.emea. europa.eu/humandocs/PDFs/EPAR/ rotarix/Rotarix-H-639-X-10-AR.pdf [Last accessed 16 June 2009]
46. Centers for Disease Control and Prevention. Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). Mortal Morb Wkly Rep Recomm Rep 2009;58(RR-2):1-25
47. Committee on Infectious Diseases. Prevention of Rotavirus Disease: updated Guidelines for Use of Rotavirus Vaccine. Pediatrics 2009;123(5):1412- 1420
48. Bines JE, Liem NT, Justice FA, et al. Intussusception Study Group. Risk factors for intussusception in infants in Vietnam and Australia: adenovirus implicated,but not rotavirus. J Pediatr 2006;149:452-460 (Pubitemid 44468083)
49. Chang EJ, Zangwill KM, Lee H, Ward JI. Lack of association between rotavirus infection and intussusception: implications for use of attenuated rotavirus vaccines. Pediatr Infect Dis J 2002;21:97-102 (Pubitemid 34150605)
50. Dennehy PH, Brady RC, Halperin SA, et al. Comparative evaluation of safety and immunogenicity of two dosages of an oral live attenuated human rotavirus vaccine. Pediatr Infec Dis J 2005;24:481-488 (Pubitemid 40847519)
51. Salinas B, Perez Schael I, Linhares AC, et al. Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RIX4414: a randomized, placebo-controlled trial in Latin American infants. Pediatr Infect Dis J 2005;24:807-816 (Pubitemid 41324890)
52. Phua KB, Quak SH, Lee BW, et al: Evaluation of RIX4414, a live, attenuated rotavirus vaccine, in a randomized, double-blind, placebo-controlled phase 2 trial involving 2464 Singaporean infants. J Infect Dis 2005;192(Suppl 1):S6-16 (Pubitemid 41193096)
53. Steele AD, De Vos B, Tumbo J, et al. Co-administration study in South African infants of a live-attenuated oral human rotavirus vaccine (RIX4414) and poliovirus vaccines. Vaccine. Published online 9 September 2008, doi:10.1016/J.Vaccine.2008.08.034
54. Zaman K, Sack DA, Yunus M, et al. Successful co-administration of a human rotavirus and oral poliovirus vaccines in Bangladeshi infants in a 2-dose schedule at 12 and 16 weeks of age. Vaccine 2009;27:1333-1339
55. Clark HF, Borian FE, Bell LM, et al. Protective effect of WC3 vaccine against rotavirus diarrhea in infants during a predominantly serotype 1 rotavirus season. J Infect Dis 1988;158:570-587 (Pubitemid 18233661)
56. Ward RL, Bernstein DI. Rotarix: a rotavirus vaccine for the world. Clin Infect Dis 2009;48:222-228
57. Bernstein DI, Sack DA, Rothstein E, et al. Efficacy of live, attenuated human rotavirus vaccine 89-12 in infants: a randomised placebo-controlled trial. Lancet 1999;354:287-290 (Pubitemid 29348737)
58. Vesikari T, Karvonen A, Korhonen T, et al. Safety and immunogenicity of RIX4414 live attenuated human rotavirus vaccine in adults, toddlers and previously uninfected infants. Vaccine 2004;22:2836-2842 (Pubitemid 38900662)
59. European Public Assessment Report, Rotarix INN-human rotavirus, live attenuated. London, UK: European Medicines Agency 2006. Available from: http://www.emea.europa.eu/humandocs/ PDFs/EPAR/rotarix/063906en6.pdf [Last accessed 16 June 2009]
60. Zibrik L, Dove W, Mcardle F, et al. Lack of shedding of the RIX4414 live attenuated rotavirus vaccine administered to adult volunteers. Arch Virol 2007;152:1951-1954 (Pubitemid 47498143)
61. Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet 2007;370:1757-1763 (Pubitemid 350137490)
62. Linhares AC, Velázquez FR, Pérez-Schael I, et al. Efficacy and safety of an oral live attenuated human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in Latin American infants: a randomised, double-blind, placebo-controlled phase III study. Lancet 2008;371:1144-1145
63. Madhi S, Lerumo T, Louw C, et al. Efficacy of human rotavirus vaccine RIX4414 (Rotarix) in South African infants during the first year of life- an interim report. In: Program and abstracts of the 8th International Rotavirus Symposium, Istanbul, 2008
64. De Vos B, Han HH, Bouckenooghe A, et al. Live attenuated human rotavirus vaccine, RIX4414, provides clinical protection in infants against rotavirus strains with and without shared G and P genotypes: integrated analysis of randomized controlled trials. Pediatr Infect Dis J 2009;28:261-266
65. Ward R. Mechanisms of protection against rotavirus infection and disease. Pediatr Infect Dis J 2009;28(3 Suppl):S57-9. Review
66. Ward RL. Rotavirus vaccines: how they work or don't work. Expert Rev Mol Med 2008;10:e5. Published online 12 February 2008, doi:10.1017/ S1462399408000574
67. Ward RL. Possible mechanisms of protection elicited by candidate rotavirus vaccines as determined with the adult mouse model. Viral Immunol 2003;16(1):17-24 (Pubitemid 36427736)
68. Cheuvart B, Friedland LR, Abu-elyazeed R, et al. The human rotavirus vaccine RIX4414 in infants: a review of safety and tolerability. Pediatr Infect Dis J 2009;28:225-232
69. Glass RI, Parashar UD, Bresee JS, et al. Rotavirus vaccines: current prospects and future challenges. Lancet 2006;368:323-332 (Pubitemid 44067224)
70. World Health Organization. Global advisory committee on vaccine safety, 17-18 December, 2008. Wkly Epidemiol Rec 2009;84:37-40
71. Nakagomi T, Cuevas LE, Gurgel RG, et al. Apparent extinction of non-G2 rotavirus strains from circulation in Recife, Brazil, after the introduction of rotavirus vaccine. Arch Virol 2008;153:591-593
72. Cunliffe NA, Nakagomi O. A critical time for rotavirus vaccines: a review. Expert Rev Vaccines 2005;4:521-532 (Pubitemid 41297299)
73. Kapikian AZ, Simonsen L, Vesikari T, et al. 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 1):S22-9 (Pubitemid 41193098)
74. Nakagomi O, Cunliffe NA. Rotavirus vaccines: entering a new stage of deployment. Curr Opin Infect Dis 2007;20:501-507 (Pubitemid 47359647)
75. Pun SB, Nakagomi T, Sherchand JB, et al. Detection of G12 human rotaviruses in Nepal. Emerg Infect Dis 2007;1:482-484 (Pubitemid 46348138)
76. Sherchand JB, Nakagomi O, Dove W, et al. Molecular epidemiology of rotavirus diarrhea among children less than 5 years of age in Nepal: predominance of emergent G12 strains over 2 Years. J Infect Dis. (In Press)