Effectiveness of the live attenuated rotavirus vaccine produced by a domestic manufacturer in China studied using a population-based case-control design

Emerging Microbes and Infections

Volumn 4, Issue 10, 2015, Pages

  Zhen, Shan Shan ^a   Li, Yue ^a   Wang, Song Mei ^a   Zhang, Xin Jiang ^b   Hao, Zhi Yong ^b   Chen, Ying ^a   Wang, Dan ^a   Zhang, Yan Hong ^b   Zhang, Zhi Yong ^b   Ma, Jing Chen ^c   Zhou, Peng ^a   Zhang, Zhen ^a   Jiang, Zhi Wei ^d   Zhao, Yu Liang ^c   Wang, Xuan Yi ^a  

^a FUDAN UNIVERSITY   (China)

^b Zhengding County Center for Disease Control and Prevention   (China)

^c Chronic Diseases Institute   (China)

^d FOURTH MILITARY MEDICAL UNIVERSITY   (China)

Author keywords

Attenuated vaccine; Case control study; China; Effectiveness; Rotavirus

Indexed keywords

LIVE VACCINE; ROTAVIRUS VACCINE;

ADENOVIRUS INFECTION; ARTICLE; ASTROVIRUS INFECTION; CALICIVIRUS INFECTION; CHILD; CHINA; CONTROLLED STUDY; DRUG EFFICACY; HUMAN; IMMUNIZATION; INCIDENCE; INFANT; INFECTIOUS DIARRHEA; MAJOR CLINICAL STUDY; NEWBORN; OUTCOME ASSESSMENT; POPULATION BASED CASE CONTROL STUDY; PRESCHOOL CHILD; PRIORITY JOURNAL; ROTAVIRUS INFECTION; RURAL POPULATION; SEROTYPE; VACCINE PRODUCTION; VIRAL GASTROENTERITIS; ANIMAL; CASE CONTROL STUDY; CLASSIFICATION; COHORT ANALYSIS; DIARRHEA; FECES; GASTROENTERITIS; GENETICS; GENOTYPING TECHNIQUE; HEALTH SURVEY; ISOLATION AND PURIFICATION; ODDS RATIO; ORAL DRUG ADMINISTRATION; QUESTIONNAIRE; ROTAVIRUS; ROTAVIRUS INFECTIONS; SEVERITY OF ILLNESS INDEX; SHEEP; STANDARDS; VIROLOGY;

ADMINISTRATION, ORAL; ANIMALS; CASE-CONTROL STUDIES; CHILD, PRESCHOOL; CHINA; COHORT STUDIES; DIARRHEA; FECES; GASTROENTERITIS; GENOTYPING TECHNIQUES; HUMANS; INFANT; ODDS RATIO; POPULATION SURVEILLANCE; ROTAVIRUS; ROTAVIRUS INFECTIONS; ROTAVIRUS VACCINES; SEVERITY OF ILLNESS INDEX; SHEEP; SURVEYS AND QUESTIONNAIRES; VACCINES, ATTENUATED;

EID: 84979796687     PISSN: None     EISSN: 22221751     Source Type: Journal    
DOI: 10.1038/emi.2015.64     Document Type: Article

References (44)

1. Wang XY, Du L, Von Seidlein L et al. Occurrence of shigellosis in the young and elderly in rural China: Results of a 12-month population-based surveillance study. Am J Trop Med Hyg 2005; 73: 416-422.
2. Yu WL. [Survey on the prevention and treatment of diarrhoea in part of regions, China.] Zhonghua Liu Xing Bing Xue Za Zhi 1989; 10: 257-260. Chinese.
3. Liu N, Xu Z, LiD et al. Update on the disease burden and circulating strains of rotavirus in China: A systematic review and meta-analysis. Vaccine 2014; 32: 4369-4375.
4. Wang XY, Riewpaiboon A, von Seidlein L et al. The potential cost-effectiveness of a rotavirus immunization program in rural China. Clin Infect Dis 2009; 49: 1202-1210.
5. Wang XY, Xu ZY, von Seidlein L et al. Incidence of diarrhea caused by rotavirus infections in rural Zhengding, China: Prospective, population-based surveillance. J Infect Dis 2005; 192: S100-105.
6. Rotavirus vaccines. WHO position paper - January 2013. Wkly Epidemiol Rec 2013; 88: 49-64.
7. Parashar UD, Bresee JS, Gentsch JR et al. Rotavirus. Emerg Infect Dis 1998; 4: 561-570.
8. Fang ZY, Wang B, Kilgore PE et al. Sentinel hospital surveillance for rotavirus diarrhea in the People's Republic of China, August 2001-July 2003. J Infect Dis 2005; 192: S94-99.
9. Orenstein EW, Fang ZY, Xu J et al. The epidemiology and burden of rotavirus in China: A review of the literature from 1983 to 2005. Vaccine 2007; 25: 406-413.
10. Sun LW, Tong ZL, Li LH et al. [Surveillance finding on rotavirus in Changchun children's hospital during July 1998-June 2001.] Zhong Hua Liu Xing Bing Xue Za Zhi 2003; 24: 1010-1012. Chinese.
11. Tong ZL, Ma L, Zhang J et al. [Epidemiological study of rotavirus diarrhea in Beijing, China: A hospital-based surveillance from 1998-2001.] Zhong Hua Liu Xing Bing Xue Za Zhi 2003;24: 1100-1103. Chinese.
12. Cunliffe NA, Bresee JS, Hart CA. Rotavirus vaccines: Development, current issues and future prospects. J Infect 2002; 45: 1-9.
13. World Health Organization. Report of the meeting on future directions for rotavirus vaccine research in developing countries. Geneva: WHO, 2000. Available at http: // www.who.int/iris/handle/10665/66497 (accessed 6 September 2015).
14. Fu C, He Q, Xu J et al. Effectiveness of the Lanzhou lamb rotavirus vaccine against gastroenteritis among children. Vaccine 2012; 31: 154-158.
15. Fu C, Tate JE, Jiang B. Effectiveness of Lanzhou lamb rotavirus vaccine against hospitalized gastroenteritis: Further analysis and update. Hum Vaccine 2010; 6: 953.
16. Fu C, Wang M, Liang J et al. Effectiveness of Lanzhou lamb rotavirus vaccine against rotavirus gastroenteritis requiring hospitalization: A matched case-control study. Vaccine 2007; 25: 8756-8761.
17. Clemens JD, Kotloff KL, Kay B. Generic protocol to estimate the burden of Shigella diarrhoea and dysenteric mortality. Geneva: WHO, 1999. Available at http: // www.who.int/iris/handle/10665/66151 (accessed 6 September 2015).
18. World Health Organization. Generic protocols (i) hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children and (ii) a communitybased survey on utilization of health care services for gastroenteritis in children. In: Biologicals Va, editor. Geneva: WHO, 2002. Available at http: //www.who.int/ immunization/diseases/rotavirus/generic-protocols/en/ (accessed 6 September 2015).
19. Simmonds MK, Armah G, Asmah R et al. New oligonucleotide primers for P-typing of rotavirus strains: Strategies for typing previously untypeable strains. J Clin Virol 2008; 42: 368-373.
20. Jiang X, Huang PW, Zhong WM et al. Design and evaluation of a primer pair that detects both Norwalk- And Sapporo-like caliciviruses by RT-PCR. J Virol Methods 1999; 83: 145-154.
21. 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.
22. Bai ZS, Chen DM, Shen S. [Selection and characterization of strain LLR- 85 for oral rotavirus live vaccine.] Zhong Guo Sheng Wu Zhi Ping Xue Za Zi 1994; 7: 46-52. Chinese.
23. Clark HF, Offit PA, Parashar UD et al. Rotavirus vaccines. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines, 5th edn. Atlanta: Elsevier Inc., 2008: 715-734.
24. Orenstein WA, Bernier RH, Dondero TJ et al. Field evaluation of vaccine efficacy. Bull World Health Organ 1985; 63: 1055-1068.
25. Shapiro ED. Case-control studies of the effectiveness of vaccines: Validity and assessment of potential bias. Pediatr Infect Dis J 2004; 23: 127-131.
26. Schlesselman JJ. Case-control studies: Design, conduct, analysis. New York: Oxford University Press, 1982.
27. 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.
28. Parashar UD, SteeleD, NeuzilKet al. Progresswith rotavirus vaccines: Summary of the Tenth International Rotavirus Symposium. Expert Rev Vaccines 2013; 12: 113-117.
29. Ruiz-Palacios GM, Pé rez-Schael I, Velá zquez FR et al. Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis. N Engl J Med 2006; 354: 11-22.
30. Vesikari T, Matson DO, Dennehy P et al. Safety and efficacy of a pentavalent humanbovine (WC3) reassortant rotavirus vaccine. N Engl J Med 2006; 354: 23-33.
31. Bresee JS, Hummelman E, Nelson EA et al. Rotavirus in Asia: The value of surveillance for informing decisions about the introduction of new vaccines. J Infect Dis 2005; 192: S1-S5.
32. Clemens J, Brenner R, Rao Met al. Evaluating new vaccines for developing countries. Efficacy or effectiveness? JAMA 1996; 275: 390-397.
33. Armah GE, Sow SO, BreimanRF et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in sub-Saharan Africa: A randomised, double-blind, placebo-controlled trial. Lancet 2010; 376: 606-614.
34. Zaman K, Dang DA, Victor JC et al. Efficacy of pentavalent rotavirus vaccine against severe rotavirus gastroenteritis in infants in developing countries in Asia: A randomised, double-blind, placebo-controlled trial. Lancet 2010; 376: 615-623.
35. Soares-Weiser K, Maclehose H, Bergman H et al. Vaccines for preventing rotavirus diarrhoea: Vaccines in use. Cochrane Database Syst Rev 2012; 11: CD008521.
36. Matson DO, O'Ryan ML, Pickering LK et al. Characterization of serum antibody responses to natural rotavirus infections in children by VP7-specific epitopeblocking assays. J Clin Microbiol 1992; 30: 1056-1061.
37. Ward RL, Clemens JD, Knowlton DR et al. Evidence that protection against rotavirus diarrhea after natural infection is not dependent on serotype-specific neutralizing antibody. J Infect Dis 1992; 166: 1251-1257.
38. Li Y, Wang SM, Zhen SS et al. Diversity of rotavirus strains causing diarrhea in , 5 years old Chinese children: A systematic review. PLoS One 2014; 9: E84699.
39. Smith PG, Rodrigues LC, Fine PE. Assessment of the protective efficacy of vaccines against common diseases using case-control and cohort studies. Int J Epidemiol 1984; 13: 87-93.
40. Orenstein WA, Bernier RH, Hinman AR. Assessing vaccine efficacy in the field. Further observations. Epidemiol Rev 1988; 10: 212-241.
41. Comstock GW. Evaluating vaccination effectiveness and vaccine efficacy by means of case-control studies. Epidemiol Rev 1994; 16: 77-89.
42. Zheng JS, Cao L, Guo SC et al. [Survey on the immunization status of category B vaccine among children aged 1 to 2 years in China.] Zhong Guo Yi Miao He Mian Yi 2012; 18: 233-237. Chinese.
43. Wang ZB, Wang W, Guo WS et al. [Survey on vaccination rate of second class vaccine and influencial factors in children in rural areas of nine counties in Henan province.] Wei Sheng Wu Xue Mian Yi Xue Jin Zhan 2013; 41: 53-61. Chinese.
44. Chang J, Hou ZY, Yue DH et al. [Factors related to self-paid vaccination and its related factors among children aged 0-3 years in China.] Zhong Guo Gong Gong Wei Sheng 2014; 30: 579-582. Chinese.