Prevention of childhood rotavirus disease through the use of Rotarix™ and RotaTeq™ vaccines

Expert Opinion on Biological Therapy

Volumn 7, Issue 12, 2007, Pages 1881-1892

  Lepage, Philippe ^a   Vergison, Anne ^a  

^a UNIVERSITÉ LIBRE DE BRUXELLES   (Belgium)

Author keywords

Rotavirus; Rotavirus vaccine

Indexed keywords

DIPHTHERIA PERTUSSIS TETANUS VACCINE; HEPATITIS B VACCINE; INFLUENZA VACCINE; ORAL POLIOMYELITIS VACCINE; PLACEBO; PNEUMOCOCCUS VACCINE; ROTAVIRUS VACCINE;

CHILDHOOD DISEASE; CLINICAL TRIAL; DIARRHEA; DIET THERAPY; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FOLLOW UP; GASTROENTERITIS; HEALTH PROGRAM; HUMAN; HYGIENE; IMMUNOGENICITY; INFECTION PREVENTION; INTESTINE INTUSSUSCEPTION; LOWEST INCOME GROUP; ORAL REHYDRATION THERAPY; POSTMARKETING SURVEILLANCE; PREVALENCE; PROPHYLAXIS; REVIEW; ROTAVIRUS; SHELF LIFE; TREATMENT RESPONSE; VACCINATION; VIRUS CLASSIFICATION; VIRUS INFECTION;

ROTAVIRUS;

EID: 37149002555     PISSN: 14712598     EISSN: None     Source Type: Journal    
DOI: 10.1517/14712598.7.12.1881     Document Type: Review

References (76)

1. PARASHAR UD, HUMMELMAN EG, BREESE JS, MILLER MA, GLASS RI: Global illness and deaths caused by rotavirus diseases in children. Emerg. Infect. Dis. (2003) 9:565-572.
2. PARASHAR UD, GIBSON CJ, BREESEJS, BRESEE JS, GLASS RI: Rotavirus and severe childhood diarrhea. Emerg. Infect. Dis. (2006) 12:304-306.
3. BRESEE JS, PARASHAR UD, WIDDOWSON MA, GENTSCH JR, STEELE AD, GLASS RI: Update on rotavirus vacines. Pediatr. Infect. Dis. J. (2005) 24:947-952.
4. GLASS RI, PARASHAR UD, BRESEE JS et al.: Rotavirus vaccines: current prospects and future challenges. Lancet (2006) 368:323-332.
5. LEPAGE P: Rotavirus infection in Europe: time for effective prevention? Pediatr. Infect. Dis. J. (2006) 25:S5-S6.
6. DENNEHY PH: Rotavirus vaccines: an update. Pediatr. Infect. Dis. J. (2006) 25:839-840.
7. SORIANO-GABARRO M, MRUKOWICZ J, VESIKARI T, VERSTRAETEN T: Burden of rotavirus disease in European union countries. Pediatr. Infect. Dis. J. (2006) 25:S7-S11.
8. FRANCO MA, ANGEL J, GREENBERG HB: Immunity and correlates of protection for rotavirus vaccines. Vaccine (2006) 24:2718-2731.
9. PARASHAR UD, BRESEE JS, GENTSCH JR, GLASS RI: Rotavirus. Emerg. Infect. Dis. (1998) 4:561-570.
10. CHEN CM, HUNG T, BRIDGER JC, MCCRAE MA: Chinese adult rotavirus is a group B rotavirus. Lancet (1985) 2(8464):1123-1124.
11. SCHNAGL RD, BONIFACE K, CARDWELL P et al.: Incidence of group C human rotavirus in central Australia and sequence variation of the VP7 and VP4 genes. J. Clin. Microbiol. (2004) 42:2127-2133.
12. SANEKATA T, AHMED MU, KADER A, TANIGUCHI K, KOBAYASHI N: Human group B rotavirus infections cause severe diarrhea in children and adults in Bangladesh. J. Clin. Microbiol. (2003) 41:2187-2190.
13. BURNS JW, SIADAT PM, KRISHNANEYAA, GREENBERG HB: Protective effect of rotavirus VP6-specific IgA monoclonal antibodies that lack neutralizing activity. Science (1996) 272:104-107.
14. BALL JM, TIAN P, ZENG CQ-Y, MORRIS AP, ESTES MK: Age-dependent diarrhea induced by a rotaviral nonstructural glycoprotein. Science (1996) 272:101-104.
15. DESSELBERGER U, WOLLESWINKEL-VAN DEN BOSCH J, MRUKOWICZ J, RODRIGO C, GIAQUINTO C, VESIKARI T: Rotavirus types in Europe and their significance for vaccinarion. Pediatr. Infect. Dis. J (2006) 25:S30-S41.
16. NAKAGOMI O, NAKAGOMI T, ARISAWA K: A lack of significant association between the electropherotype or G-serotype of the infecting strain and disease severity of rotavirus gastroenteritis. Arch. Virol. (2006) 151:1947-1960.
17. CHIBA S, YOKOYAMA T, NAKATA S et al.: Protective effect of naturally acquired homotypic and heterotypic rotavirus antibodies. Lancet (1986) 8504:417-421.
18. VAN DAMME P, GIAQUINTO C1 HUET F, GOTHEFORS L, MAXWELL M, VAN DER WIELEN M; REVEAL STUDY GROUP: Multicenter prospective study of the burden of rotavirus acute gastroenteritis in Europe, 2004-2005: the REVEAL study. J. Infect. Dis. (2007) 195(Suppl. 1):S4-S16.
19. BARNES GL, CALLAGHAN SL, KIRKWOOD CD, BOGDANOVIC-SAKRAN N, JOHNSTON LJ, BISHOP RF: Excrerion of serotype G1 rotavirus strains by asymptomatic staff: a possible source of nosocomial infection. J. Pediatr. (2003) 142:722-725.
20. ANDERSON EJ, WEBER SG: Rotavirus infection in adults. Lancet Infect. Dis. (2004) 4:91-99.
21. GLEIZES O, DESSELBERGER U, TATOCHENKO V et al.: Nosocomial rotavirus infection in European countries: a review of the epidemiology, severity and economic burden of hospital-acquired roravirus disease. Pediatr. Infect. Dis. J. (2006) 25:S12-S21.
22. DENNEHY PH: Transmission of rotavirus and other enteric pathogens in the home. Pediatr. Infect. Dis. J. (2000) 19:S103-S105.
23. RHEINGANS RD, HEYLEN J, GIAQUINTO C: Economics of rotavirus gastroenteritis and vaccination in Europe: what makes sense? Pediatr. Infect. Dis. J. (2006) 25:S48-S55.
24. 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.
25. 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.
26. KING CK, GLASS R, BRESEE JS, DUGGAN C; CENTERS FOR DISEASE CONTROL AND PREVENTION: Managing acute gastroenteritis among children: oral rehydration, maintenance, and nutritional therapy. MMWR Recomm. Rep. (2003) 52(RR-16):1-16.
27. CLEMENS J, RAO M, AHMED F et al.: Breastfeeding and the risk of life-threatening rotavirus diarrhea: prevention or postponement? Pediatrics (1993) 92:680-685.
28. LINHARES AC, BRESEE JS: Rotavirus vaccines in Latin America. Pan. Am. J. Public Health (2000) 8:305-331.
29. VESIKARI T, GIAQUINTO C, HUPPERTZ HI: Clinical trials of rotavirus vaccines in Europe. Pediatr. Infect. Dis. J. (2006) 25:S42-S47.
30. VESIKARI T, ISOLAURI E, DELEM A, D'HONDT E, ANDRE FE, ZISSIS G: Immunogenicity and safety of live attenuated bovine rotavirus vaccine strain RIT 4237 in adults and young children. Lancet (1983) 2:807-811.
31. DE MOL P, ZISSIS G, BUTZLER JP, MUTWEWINGABO A, ANDRE FE: Failure of live, attenuated oral rotavirus vaccine. Lancet (1986) 8498:108.
32. MURPHY TV, GARGIULLO PM, MASSOUDI MS et al.: Intussusception among infants given an oral rotavirus vaccine. N Engl. J. Med. (2001) 344:564-572.
33. HUPPERTZ HI, SORIANO-GABARRO M, GRIMPREL E et al.: Intussusception among young children in Europe. Pediatr. Infect. Dis. J. (2006) 25:S22-S29.
34. SIMONSEN L, VIBOUD C, ELIXHAUSER A, TAYLOR RJ, KAPIKIAN AZ: More on rotashield and intussusception: the role of age at the time of vaccination. J. Infect. Dis. (2005) 192(Suppl. 1):S36-S43.
35. MURPHY BR, MORENS DM, SIMONSONS L et al.: Reappraisal of the association of intussusception with the licensed life rotavirus vaccine challenges initial conclusions. J. Infect. Dis. (2003) 187:1301-1308.
36. RUIZ-PALACIOS GM, PEREZ-SCHAEL IF, VELAZQUEZ R et al.: Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N. Engl. J. Med. (2006) 354:11-22.
37. VESIKARI T, MATSON O, DENNEHY P et al.: Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N. Engl. J. Med. (2006) 354:23-33.
38. DE VOS B, VESIKARI T, LINHARES AC et al.: A rotavirus vaccine for prophylaxis of infants against rotavirus gastroenteritis. Pediatr. Infect. Dis. J. (2004) 23:S179-S182.
39. Rotarix™ European SPC (2007).
40. VESIKARI T, KARVONEN A, KORHÔNEN 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.
41. VESIKARI T, KARVONEN A, PUUSTINEN L et al.: Efficacy of RIX4414 live attenuated human rotavirus vaccine in Finnish infants. Pediatr. Infect. Dis. J. (2004) 23:937-943.
42. SALINAS B, SCHAEL IP, LINHARES AC et al.: Evaluation of safety, immunogenicity and efficacy of an attenuated rotavirus vaccine, RLX4414: a randomized, placebo-controlled trial in Latin American infants. Pediatr. Infect. Dis. J. (2005) 24:807-816.
43. LINHARES AC, RUIZ-PALACIOS GM, GUERRERO ML et al.: A short report on highlights of worldwide development of RIX4414: a Latin American experience. Vaccine (2006) 24:3784-3745.
44. PHUA KB, QUAK SH, LEE BW et al.: Evaluation of RIX4414, a live attenuated rotavirus vaccine, in a randomized, double-blind, placebo-controlled Phase II trial involving 2464 Singapore infants. J. Infect. Dis. (2005) 152(Suppl. 1):S6-S16.
45. MACIAS M, LOPEZ P, VELAZQUEZ FR et al.: The rotavirus vaccine RIX4414 (Rotarix™) is not associated with intussusception in one year old infants. 45th Conference on Antimicrobial Agents and Chemotherapy. Washington, DC, USA (16-19 December 2005):Abstract G-841.
46. RUIZ-PALACIOS GM, GUERRERO ML, BAUTISTA-MARQUEZ A et al.: Dose response and efficacy of a live, attenuated human rotavirus vaccine in Mexican infants. Pediatrics (2007) 120:E253-E261.
47. RUUSKA T, VESIKARI T: Rotavirus disease in Finnish children: use of numerical scores for clinical severity of diarrhoeal episodes. Scand J. Infect. Dis. (1990) 22:259-267.
48. DE VOS B, GILLARD P, CHEUVART B, DEBRUS S, HAN AA, BOUCKENOOGHE A: RIX4414 vaccine efficacy against rotavirus gastroenteritis du to G2P4 strain. 46th Conference on Antimicrobial Agents and Chemotherapy. San Francisco, USA (27-30 September 2006) Abstract G-618.
49. VESIKARIT, PRYMULA R, SCHUSTER V et al.: Early protection against rotavirus, Rotarix™ (RIX4414) experience in a European setting. 12th ICID Abstracts. Lisbon, Portugal (15-18 June 2006). Intern. J. Infect. Dis. (2006) 10(Suppl. 1):Abstract 68.021.
50. VESIKARI T, KARVONEN A, PRYMULA R et al.: Human rotavirus vaccine Rotarix is highly efficacious in Europe during the first two years of life. 25th Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID). Porto, Portugal (2-4 May 2007) Abstract 84.
51. EMMANUEL S, PHUA KB, GOH P et al.: Immunogenicity of an acellular pertussis combination vaccine co-administeted with a novel rotavirus vaccine in Singaporean infants. 23th Meeting of the European Society for Pediatric Infectious Diseases (ESPID). Valencia, Spain (18-20 May 2005).
52. TEJEDOR JC, DIEZ-DELGADO J, ARISTEGUI J et al.: Rotarix™ (RIX4414), an oral human rotavirus vaccine, is highly immunogenic when co-administered with a Neisseria meningitidis serogroup C vaccine (Meningitec™) in healthy infants from Spain. 24th Meeting of the European Society for Pediatric Infectious Diseases (ESPID). Basel, Switzerland (3-5 May 2006) Abstract 456.
53. SCHUSTER V, OTTO W, COHEN R et al.: Rotarix™ (RIX4414), an oral human rotavirus vaccine, is highly immunogenic when co-administered with a Streptococcus pneumoniae conjugate vaccine (Prevenar™) in healthy infants from Spain. 24th Meeting of the European Society for Pediatric Infectious Diseases (ESPID). Basel, Switzerland (3-5 May 2006) Abstract 461.
54. GLASS RI, PARASHAR UD: The promise of new rotavirus vaccines. N. Engl. J. Med. (2006) 354:75-77.
55. CLARK HF, OFFIT PA, PLOTKIN SA, HEATON PM: The new pentavalent rotavirus vaccine composed of bovine (strain WC3)-human rotavirus reassortants. Pediatr. Infect. Dis. J. (2006) 25:577-583.
56. RODRIGUEZ ZM, GOVEIA MG, STEK JE et al.: Concommitant use of an oral pentavalent human-bovine reassortant rotavirus vaccine with licensed parenteral pediatric vaccines in the United States. Pediatr. Infect. Dis. J. (2007) 26:221-227.
57. COMMITTEE ON INFECTIOUS DISEASES: Prevention of rotavirus disease: guidelines for use of rotavirus vaccine. Pediatrics (2007) 119:171-181.
58. CIARLET M, SANI-GROSSO R, YUAN G et al.: Safety and imunogenicity of concomittant use of the pentavalent rotavirus vaccine (RotaTeq™) and oral poliovirus vaccine (OPV). 25th Annual Meeting of the European Society for Pediatric Infectious Diseases (ESPID). Porto, Portugal (2-4 May 2007):Abstract 79.
59. VESIKARI T, VAN DAMME P, GOTHEFORS L, GOVELA M, DALLAS M, HEATON P: Efficacy of RotaTeq™ to reduce any severity and severe rotavirus disease in Europe. 25th International Congress of Pediatrics. Athens, Greece (25-30 August 2007):Abstract PP 1005.
60. CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC): Postmarketing monitoring of inrussusceprion after RotaTeq™ vaccination - United States, 1 February 2006-15 February 2007. MMWR Morb. Mortal. Wkly Rep. (2007) 56:218-221.
61. WHO: Report of the meeting on future directions for rotavirus vaccine research in developing countries. World Health Organization, Geneva, Switzerland (2000):1-56.
62. GLASS RI, BHAN MK, RAY P et al.: Development of candidate rotavirus vaccines derived from neonatal strains in India. J. Infect. Dis. (2005) 192(Suppl. 1):S30-S35.
63. DAS BK, GENTSCH JR, HOSHINO Y et al.: Characterization of the G serotype and genogroup of New Delhi newborn rotavirus strain 116E. Virology (1993) 197:99-107.
64. ITURRIZA GOMARA M, KANG G, MAMMEN A et al.: Characterization of G10P[11] rotaviruses causing acute gastroenteritis in neonates and infants in Vellore, India. J. Clin. Microbiol. (2004) 42:2541-2547.
65. BARNES GL, LUND JS, ADAMS L et al.: Early Phase II trial of human rotavirus vaccine candidate (RV3). Vaccine (2002) 20:2950-2956.
66. KAPIKIAN AZ, SIMONSEN L, VESIKARI T et al.: A hexavalent human rotavirus-bovine rotavirus (UK) reasssortant 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-S29.
67. CLEMENTS-MANN ML, MAKHENE MK, MRUKOWICZ J et al.: Safety and immunogenicity of live attenuated human-bovine (UK) reassortant rotavirus vaccines with VP7-specificity for serotypes 1, 2, 3, or 4 in adults, children and infants. Vaccine (1999) 17:2715-2725.
68. ROJAS OL, CAICEDO L, GUZMAN C et al.: Evaluation of circulating inrestinally committed memory B cells in children vaccinated with attenuated human rotavirus vaccine. Viral Immunol. (2007) 20:300-311.
69. WHO: Rotavirus vaccines: WHO position paper. Wkly Epidemiol. Rec. (2007) 82:285-296.
70. PEREZ-SCHAEL I, SALINAS B, TOMAT M et al.: Efficacy of the human rotavirus vaccine RIX4414 in malnourished children. J. Infect. Dis. (2007) 196:537-540.
71. GLASS RI, BRESEE JS, FISCHER TK, PARASHAR UD, STEELE AD: Rotavirus vaccines: targeting the developing world. J. Infect. Dis. (2005) 192(Suppl. 1):S160-S166.
72. WHO: Cost effectiveness of rotavirus vaccines and other interventions for diarrhoeal diseases: meeting report 2006. Wkly Epidemiol. Rec. (2006) 81:350-353.
73. RHEINGANS RD, CONSTENLA D, ANTIL L, INNIS BL, BREUER T: Potential cost-effectiveness of vaccination for rotavirus gastroenteritis in eight Latin American and Caribbean countries. Rev. Panam. Salud Publica (2007) 4:205-216.
74. JIT M, EDMUNDS WJ: Evaluating rotavirus vaccination in England and Wales. Part II. The potential cost-effectiveness of vaccination. Vaccine (2007) 25:3971-3979.
75. WIDDOWSON MA, MELTZER MI, ZHANG X, BRESEE JS, PARASHAR UD, GLASS RI: Cost-effectiveness and potential impact of rotavirus vaccination in the United States. Pediatrics (2007) 119:684-697.
76. http://www.who.int/vaccine_safety/topics/rotavirus/statement/en/print. html GLOBAL ADVISERY COMMITTEE ON VACCINE SAFETY: Safety of Rotarix™ and RotaTeq™ rotavirus vaccines. World Health Organization (25 July 2006).