Intussusception and rotavirus vaccination: A review of the available evidence

Expert Review of Vaccines

Volumn 8, Issue 11, 2009, Pages 1555-1564

  Patel, Manish M ^a   Haber, Penina ^b   Baggs, James ^b   Zuber, Patrick ^c   Bines, Julie E ^d   Parashar, Umesh D ^e  

^a CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^b NATIONAL CENTER FOR PREPAREDNESS DETECTION AND CONTROL OF INFECTIOUS DISEASES   (United States)

^c WHO   (Switzerland)

^d UNIVERSITY OF MELBOURNE   (Australia)

^e NATIONAL CENTER FOR IMMUNIZATION AND RESPIRATORY DISEASES   (United States)

Author keywords

Diarrhea; Immunization; Intussusception; Rotavirus; Rotavirus vaccine; Safety

Indexed keywords

PLACEBO; ROTAVIRUS VACCINE;

CLINICAL TRIAL; DIARRHEA; DRUG SAFETY; DRUG WITHDRAWAL; FEVER; HUMAN; INFORMATION; INTUSSUSCEPTION; MONITORING; MORBIDITY; PATHOGENESIS; PRIORITY JOURNAL; REVIEW; RISK; VACCINATION; VIRUS INFECTION; VOMITING;

CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; HUMANS; INFANT; INFANT, NEWBORN; INTUSSUSCEPTION; PRODUCT SURVEILLANCE, POSTMARKETING; ROTAVIRUS VACCINES; VACCINES, ATTENUATED;

EID: 70449372182     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/erv.09.106     Document Type: Review

References (47)

1. Ruiz-Palacios GM, Perez-Schael I, Velazquez FR et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N. Engl. J. Med. 354(1), 11-22 (2006). • Large Phase III safety and efficacy trial demonstrating that the monovalent rotavirus vaccine was highly effective against rotavirus diarrhea in middle- and high-income countries, and safe with regard to intussusception.
2. Vesikari T, Matson DO, Dennehy P et al. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N. Engl. J. Med. 354(1), 23-33 (2006). • Large Phase III safety and efficacy trial demonstrating that the pentavalent rotavirus vaccine was highly effective against rotavirus diarrhea in high-income countries, and safe with regard to intussusception.
3. WHO. Rotavirus vaccines. Wkly Epidemiol. Rec. 82(32), 285-295 (2007).
4. Meeting of the immunization Strategic Advisory Group of Experts, April 2009: conclusions and recommendations. Wkly Epidemiol. Rec. 84(23), 220-236 (2009).
5. Belongia EA, Irving SI, Shui IM et al. Real-time surveillance to assess risk of intussusception and other adverse events after pentavalent, bovine-derived rotavirus vaccine. Pediatr. Infect. Dis. J. (2009) (In press).
6. Haber P, Patel M, Baggs J, Parashar UD. Monitoring intussusception following RotaTeq vaccination - data from the US Vaccine Adverse [abstract]. Presented at: 48th ICAAC/46th IDSA Annual Meeting. Washington DC, USA, 25-28 October 2008.
7. Haber P, Patel M, Izurieta HS et al. Postlicensure monitoring of intussusception after RotaTeq vaccination in the United States, February 1, 2006, to September 25, 2007. Pediatrics 121(6), 1206-1212 (2008). • First postlicensure safety monitoring study supporting the clinical trial findings and excluding a risk of a magnitude similar to that of Rotashield® in a narrow time window after vaccination.
8. Global Advisory Committee on Vaccine Safety, 17-18 December 2008. Wkly Epidemiol. Rec. 84(5), 37-40 (2009).
9. Clark A, Sanderson C. Timing of children's vaccinations in 45 low-income and middle-income countries: an analysis of survey data. Lancet 373(9674), 1543-1549 (2009). • Recently published study demonstrating the delays in timeliness of vaccination in developing countries.
10. Patel MM, Clark AD, Glass RI et al. Broadening the age restriction for initiating rotavirus vaccination in regions with high rotavirus mortality: benefits of mortality reduction versus risk of fatal intussusception. Vaccine 27(22), 2916-2922 (2009). • Risk-benefit analysis which demonstrated that the additional lives saved by expanding the age restrictions on initiating rotavirus vaccination would be substantially greater than the number of potential vaccine-associated intussusception deaths.
11. Bines JE, Liem NT, Justice FA et al. Risk factors for intussusception in infants in Vietnam and Australia: adenovirus implicated, but not rotavirus. J. Pediatr. 149(4), 452-460 (2006).
12. Abate H, Linhares AC, Venegas G et al. A multi-center study of intussusception in Latin America: first year results [abstract]. Presented at: International Congress of Pediatrics. Cancun, Mexico, August 15-20, 2004.
13. Buettcher M, Baer G, Bonhoeffer J, Schaad UB, Heininger U. Three-year surveillance of intussusception in children in Switzerland. Pediatrics 120(3), 473-480 (2007). (Pubitemid 47358288)
14. Chen YE, Beasley S, Grimwood K. Intussusception and rotavirus associated hospitalisation in New Zealand. Arch. Dis. Child. 90(10), 1077-1081 (2005). (Pubitemid 41406619)
15. Fischer TK, Bihrmann K, Perch M et al. Intussusception in early childhood: a cohort study of 1.7 million children. Pediatrics 114(3), 782-785 (2004). (Pubitemid 41529539)
16. Gay N, Ramsay M, Waight P. Rotavirus vaccination and intussusception. Lancet 354(9182), 956 (1999).
17. Ho WL, Yang TW, Chi WC, Chang HJ, Huang LM, Chang MH. Intussusception in Taiwanese children: analysis of incidence, length of hospitalization and hospital costs in different age groups. J. Form. Med. Assoc. 104(6), 398-401 (2005).
18. Justice F, Carlin J, Bines J. Changing epidemiology of intussusception in Australia. J. Paediatr. Child. Health 41(9-10), 475-478 (2005).
19. Nelson EA, Tam JS, Glass RI, Parashar UD, Fok TF. Incidence of rotavirus diarrhea and intussusception in Hong Kong using standardized hospital discharge data. Pediatr. Infect. Dis. J. 21(7), 701-703 (2002).
20. O'Ryan M, Lucero Y, Pena A, Valenzuela MT. Two year review of intestinal intussusception in six large public hospitals of Santiago, Chile. Pediatr. Infect. Dis. J. 22(8), 717-721 (2003). (Pubitemid 36999649)
21. Perez-Schael I, Escalona M, Salinas B, Materan M, Perez ME, Gonzalez G. Intussusception-associated hospitalization among Venezuelan infants during 1998 through 2001: anticipating rotavirus vaccines. Pediatr. Infect. Dis. J. 22(3), 234-239 (2003).
22. Saez-Llorens X, Guevara JN. Intussusception and rotavirus vaccines: what is the background risk? Pediatr. Infect. Dis. J. 23(4), 363-365 (2004). (Pubitemid 38508895)
23. Tate JE, Simonsen L, Viboud C et al. Trends in intussusception hospitalizations among US infants, 1993-2004: implications for monitoring the safety of the new rotavirus vaccination program. Pediatrics 121(5), e1125-e1132 (2008).
24. Murphy TV, Gargiullo PM, Massoudi MS et al. Intussusception among infants given an oral rotavirus vaccine. N. Engl. J. Med. 344(8), 564-572 (2001). • Landmark study that demonstrated a strong association between Rotashield vaccination and intussusception.
25. Kramarz P, France EK, Destefano F et al. Population-based study of rotavirus vaccination and intussusception. Pediatr. Infect. Dis. J. 20(4), 410-416 (2001). (Pubitemid 32294750)
26. Murphy TV, Smith PJ, Gargiullo PM, Schwartz B. The first rotavirus vaccine and intussusception: epidemiological studies and policy decisions. J. Infect. Dis. 187(8), 1309-1313 (2003). (Pubitemid 36438971)
27. 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. 192(Suppl. 1), S36-S43 (2005). (Pubitemid 41193100)
28. Rothman KJ, Young-Xu Y, Arellano F. Age dependence of the relation between reassortant rotavirus vaccine (RotaShield) and intussusception. J. Infect. Dis. 193(6), 898; author reply 898-899 (2006).
29. Gargiullo PM, Murphy TV, Davis RL. Is there a safe age for vaccinating infants with tetravalent rhesus-human reassortant rotavirus vaccine? J. Infect. Dis. 194(12), 1793-1794; author reply 1794-1795 (2006).
30. Global Advisory Committee on Vaccine Safety, 1-2 December 2005. Wkly Epidemiol. Rec. 81(2), 15-19 (2006).
31. Simonsen L, Morens D, Elixhauser A, Gerber M, Van Raden M, Blackwelder W. Effect of rotavirus vaccination programme on trends in admission of infants to hospital for intussusception. Lancet 358(9289), 1224-1229 (2001). (Pubitemid 33010847)
32. Chang HG, Smith PF, Ackelsberg J, Morse DL, Glass RI. Intussusception, rotavirus diarrhea, and rotavirus vaccine use among children in New York state. Pediatrics 108(1), 54-60 (2001). (Pubitemid 32592005)
33. 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. 21(2), 97-102 (2002). (Pubitemid 34150605)
34. Ciarlet M, Estes MK, Conner ME. Simian rhesus rotavirus is a unique heterologous (non-lapine) rotavirus strain capable of productive replication and horizontal transmission in rabbits. J. Gen. Virol. 81(Pt 5), 1237-1249 (2000). (Pubitemid 30232709)
35. Uhnoo I, Riepenhoff-Talty M, Dharakul T et al. Extramucosal spread and development of hepatitis in immunodeficient and normal mice infected with rhesus rotavirus. J. Virol. 64(1), 361-368 (1990). (Pubitemid 20032636)
36. Moser CA, Dolfi DV, Di Vietro ML, Heaton PA, Offit PA, Clark HF. Hypertrophy, hyperplasia, and infectious virus in gut-associated lymphoid tissue of mice after oral inoculation with simian-human or bovine-human reassortant rotaviruses. J. Infect. Dis. 183(7), 1108-1111 (2001).
37. Bernstein DI, Glass RI, Rodgers G, Davidson BL, Sack DA. Evaluation of rhesus rotavirus monovalent and tetravalent reassortant vaccines in US children. US Rotavirus Vaccine Efficacy Group. JAMA 273(15), 1191-1196 (1995).
38. Joensuu J, Koskenniemi E, Pang XL, Vesikari T. Randomised placebo-controlled trial of rhesus-human reassortant rotavirus vaccine for prevention of severe rotavirus gastroenteritis. Lancet 350(9086), 1205-1209 (1997). (Pubitemid 127445093)
39. Perez-Schael I, Guntinas MJ, Perez M et al. Efficacy of the rhesus rotavirus-based quadrivalent vaccine in infants and young children in Venezuela. N. Engl. J. Med. 337(17), 1181-1187 (1997). (Pubitemid 27454449)
40. Rennels MB, Glass RI, Dennehy PH et al. Safety and efficacy of high-dose rhesus-human reassortant rotavirus vaccines - report of the National Multicenter Trial. United States Rotavirus Vaccine Efficacy Group. Pediatrics 97(1), 7-13 (1996).
41. Santosham M, Moulton LH, Reid R et al. Efficacy and safety of high-dose rhesus-human reassortant rotavirus vaccine in Native American populations. J. Pediatr. 131(4), 632-638 (1997). (Pubitemid 28006943)
42. Bines JE, Kohl KS, Forster J et al. Acute intussusception in infants and children as an adverse event following immunization: case definition and guidelines of data collection, analysis, and presentation. Vaccine 22(5-6), 569-574 (2004). (Pubitemid 38114883)
43. Baggs J. Rapid cycle analysis of pentavalent rotavirus (RotaTeq® ) vaccine safety in the vaccine safety datalink population. Presented at: Advisory Committee on Immunization Practices (ACIP). Atlanta, GA, USA, 26 June 2008.
44. CDC; ACIP. Rotavirus vaccination coverage and adherence to the Advisory Committee on Immunization Practices (ACIP)-recommended vaccination schedule - United States, February 2006-May 2007. MMWR Morb. Mortal. Wkly Rep. 57(15), 398-401 (2008).
45. Macias M, Lopez P, Velazquez FR et al. The rotavirus vaccine RIX 4414 (Rotarix) is not associated with intussusception in one year old infants [abstract]. Presented at: 45th ICAAC Annual Meeting. Washington DC, USA, 16-19 December 2005 (Poster no. G-841).
46. Tai JH, Curns AT, Parashar UD, Bresee JS, Glass RI. Rotavirus vaccination and intussusception: can we decrease temporally associated background cases of intussusception by restricting the vaccination schedule? Pediatrics 118(2), e258-e264 (2006).
47. Global Advisory Committee on Vaccine Safety, 17-18 June 2009. Wkly Epidemiol. Rec. 84(32), 327-329 (2009). • Report of a recently held WHO meeting where an expert clinical and scientific advisory body recommended that the age eligibility for rotavirus vaccination should be expanded beyond the currently recommended upper limit of 15 weeks for dose 1.