Reactogenicity and immunogenicity of an enterovirus 71 vaccine in chinese healthy children and infants

Pediatric Infectious Disease Journal

Volumn 31, Issue 11, 2012, Pages 1158-1165

  Zhu, Feng Cai ^a   Wang, Jun Zhi ^b   Li, Xiu Ling ^c   Liang, Zheng Lun ^b   Ge, Heng Ming ^d   Meng, Fan Yue ^a   Mao, Qun Ying ^b   Zhang, Yun Tao ^c   Zhang, Zhen Yu ^d   Ji, Hong ^a   Gao, Fan ^b   Guo, Hui Jie ^c   Zhu, Qi Yan ^d   Chu, Kai ^a   Wu, Xing ^b   Li, Jing Xin ^a   Chen, Qing Hua ^b   Chen, Xiao Qin ^b   Zhang, Wei Wei ^e   Hu, Yue Mei ^a   Li, Liang ^a   Li, Feng Xiang ^b   Yao, Xin ^b   Liu, Pei ^e   Wang, Hua ^a   Shen, Xin Liang ^c   more..

^a JIANGSU PROVINCIAL CENTER FOR DISEASE CONTROL AND PREVENTION   (China)

^b NATIONAL INSTITUTES FOR FOOD AND DRUG CONTROL   (China)

^c Beijing Vigoo Biological Co LTD   (China)

^d Donghai County Center for Disease Control and Prevention   (China)

^e SOUTHEAST UNIVERSITY   (China)

Author keywords

children; enterovirus 71 vaccine; immunogenicity; infants; reactogenicity

Indexed keywords

ALUMINUM POTASSIUM SULFATE; ENTEROVIRUS 71 VACCINE; IMMUNOLOGICAL ADJUVANT; NEUTRALIZING ANTIBODY; PLACEBO; UNCLASSIFIED DRUG; VIRUS VACCINE;

ADVERSE OUTCOME; AGE DISTRIBUTION; ARTICLE; BLOOD SAMPLING; CHILD; CHINESE; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EFFICACY; ENTEROVIRUS 71; FEMALE; HUMAN; HUMAN EXPERIMENT; IMMUNE RESPONSE; IMMUNOASSAY; IMMUNOGENICITY; INFANT; INJECTION SITE REACTION; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REACTOGENICITY; SEROCONVERSION; SEX RATIO; VACCINATION; VIRUS IMMUNITY;

ASIAN CONTINENTAL ANCESTRY GROUP; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; ENTEROVIRUS A, HUMAN; ENTEROVIRUS INFECTIONS; HUMANS; INFANT; VIRAL VACCINES;

EID: 84867886016     PISSN: 08913668     EISSN: 15320987     Source Type: Journal    
DOI: 10.1097/INF.0b013e31826eba74     Document Type: Article

References (35)

1. AbuBakar S, Chan YF, Lam SK. Outbreaks of enterovirus 71 infection. N Engl J Med. 2000;342:355-356.
2. Qiu J. Enterovirus 71 infection: a new threat to global public health? Lancet Neurol. 2008;7:868-869.
3. Solomon T, Lewthwaite P, Perera D, et al. Virology, epidemiology, pathogenesis, and control of enterovirus 71. Lancet Infect Dis. 2010;10:778-790.
4. Ooi MH, Wong SC, Lewthwaite P, et al. Clinical features, diagnosis, and management of enterovirus 71. Lancet Neurol. 2010;9:1097-1105.
5. Hsu CH, Lu CY, Shao PL, et al. Epidemiologic and clinical features of nonpolio enteroviral infections in northern Taiwan in 2008. J Microbiol Immunol Infect. 2011;44:265-273.
6. Lee TC, Guo HR, Su HJ, et al. Diseases caused by enterovirus 71 infection. Pediatr Infect Dis J. 2009;28:904-910.
7. McMinn P, Lindsay K, Perera D, et al. Phylogenetic analysis of enterovirus 71 strains isolated during linked epidemics in Malaysia, Singapore, and Western Australia. J Virol. 2001;75:7732-7738. (Pubitemid 32738033)
8. Ho M, Chen ER, Hsu KH, et al. An epidemic of enterovirus 71 infection in Taiwan. Taiwan Enterovirus Epidemic Working Group. N Engl J Med. 1999;341:929-935. (Pubitemid 29441546)
9. Zheng ZM, He PJ, Caueffield D, et al. Enterovirus 71 isolated from China is serologically similar to the prototype E71 BrCr strain but differs in the 5′-noncoding region. J Med Virol. 1995;47:161-167.
10. Notice. The hand-foot-mouth disease integrates the legal infectious disease to manage. Available at: http://www.gov.cn/gzdt/2008-05/03/content- 960344.htm. Accessed May 3, 2008.
11. Chinese Center for Disease Control and Prevention. National Notifiable Infectious Diseases Situation Update, July 2011. Available at: http://www. chinacdc.cn/tjsj/fdcrbbg/. Accessed August 12, 2011.
12. Lee MS, Chang LY. Development of enterovirus 71 vaccines. Expert Rev Vaccines. 2010;9:149-156.
13. Huang ML, Ho MS, Lee MS. Enterovirus 71 vaccine: when will it be available? J Formos Med Assoc. 2011;110:425-427.
14. Wu CN, Lin YC, Fann C, et al. Protection against lethal enterovirus 71 infection in newborn mice by passive immunization with subunit VP1 vaccines and inactivated virus. Vaccine. 2001;20:895-904. (Pubitemid 34015831)
15. Ong KC, Devi S, Cardosa MJ, et al. Formaldehyde-inactivated whole-virus vaccine protects a murine model of enterovirus 71 encephalomyelitis against disease. J Virol. 2010;84:661-665.
16. Chung YC, Ho MS, Wu JC, et al. Immunization with virus-like particles of enterovirus 71 elicits potent immune responses and protects mice against lethal challenge. Vaccine. 2008;26:1855-1862.
17. Tung WS, Bakar SA, Sekawi Z, et al. DNA vaccine constructs against enterovirus 71 elicit immune response in mice. Genet Vaccines Ther. 2007;5:6.
18. Meng FL, Li JX, Li XL; et al. Tolerability and Immunogenicity of an Inactivated Enterovirus 71 Vaccine in Chinese Healthy Adults and Children: an Open Label, Phase 1 Clinical Trial. Hum Vaccin Immunother. 2012;8: 668-674.
19. Liang Z, Mao Q, Gao Q, et al. Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines. Vaccine. 2011;29:9668-9674.
20. The standard guidelines for adverse reactions grading of Vaccine clinical trials. Available at: http://www.sda.gov.cn/WS01/CL0844/9350-5.html. Accessed October 14, 2005.
21. Division of Microbiology and Infectious Diseases Pediatric toxicity table- DRAFT. Available at: http://www.niaid.nih.gov/LabsAndResources/resources/ DMIDClinRsrch/Pages/toxtables.aspx. Accessed November 11, 2007.
22. Liu CC, Guo MS, Lin FH, et al. Purification and characterization of enterovirus 71 viral particles produced from vero cells grown in a serum-free microcarrier bioreactor system. PLoS ONE. 2011;6:e20005.
23. Mao QY, Liao XY, Yu X, et al. Dynamic change of mother-source neutralizing antibodies against enterovirus 71 and coxsackievirus A16 in infants. Chin Med J. 2010;123:1679-1684.
24. Manual for the virological investigation of polio. Available at: http://whqlibdoc. who.int/hq/1997/WHO-EPI-GEN-97.01.pdf. Accessed November 25, 2007.
25. Monath TP, Fowler E, Johnson CT, et al. An inactivated cell-culture vaccine against yellow fever. N Engl J Med. 2011;364:1326-1333.
26. Nicholson KG, Abrams KR, Batham S, et al. Immunogenicity and safety of a two-dose schedule of whole-virion and AS03A-adjuvanted 2009 influenza A (H1N1) vaccines: a randomised, multicentre, age-stratified, head-to-head trial. Lancet Infect Dis. 2011;11:91-101.
27. Huang SW, Kiang D, Smith DJ, et al. Evolution of re-emergent virus and its impact on enterovirus 71 epidemics. Exp Biol Med (Maywood). 2011;236:899-908.
28. Lee MS, Chiang PS, Luo ST, et al. Incidence rates of enterovirus 71 infections in young children during a nationwide epidemic in Taiwan, 2008-09. PLoS Negl Trop Dis. 2012;6:e1476.
29. Lee MS, Lin TY, Chiang PS, et al. An investigation of epidemic enterovirus 71 infection in Taiwan, 2008: clinical, virologic, and serologic features. Pediatr Infect Dis J. 2010;29:1030-1034.
30. Zhu F-C, Liang Z-L, Meng, F-Y, et al. Retrospective study of the incidence of HFMD and seroepidemiology of antibodies against EV71 and CoxA16 in prenatal women and their infants. PLoS One. 2012;7:e37206.
31. Chiu CH, Chu C, He CC, et al. Protection of neonatal mice from lethal enterovirus 71 infection by maternal immunization with attenuated Salmonella enterica serovar Typhimurium expressing VP1 of enterovirus 71. Microbes Infect. 2006;8:1671-1678. (Pubitemid 44128870)
32. Chang LY, King CC, Hsu KH, et al. Risk factors of enterovirus 71 infection and associated hand, foot, and mouth disease/herpangina in children during an epidemic in Taiwan. Pediatrics. 2002;109:e88.
33. Huang ML, Chiang PS, Luo ST, et al. Development of a high-throughput assay for measuring serum neutralizing antibody against enterovirus 71. J Virol Methods. 2010;165:42-45.
34. Lin J, Zhang J, Dong X, et al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial. Lancet. 2006;368:991-997. (Pubitemid 44353667)
35. Luo ST, Chiang PS, Chao AS, et al. Enterovirus 71 maternal antibodies in infants, Taiwan. Emerging Infect Dis. 2009;15:581-584.