Two-year efficacy and immunogenicity of Sinovac Enterovirus 71 vaccine against hand, foot and mouth disease in children

Expert Review of Vaccines

Volumn 15, Issue 1, 2016, Pages 129-137

  Li, Jing ^c   Li, Jing Xin ^a,b   Song, Yu Fei ^c   Wang, Ling ^d   Zhang, Xue Feng ^b   Hu, Yuan Sheng ^c   Hu, Yue Mei ^b   Xia, Jie Lai ^d   Zhu, Feng Cai ^b  

^a THIRD MILITARY MEDICAL UNIVERSITY   (China)

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

^c Sinovac Biotech Co Ltd   (China)

^d FOURTH MILITARY MEDICAL UNIVERSITY   (China)

Author keywords

and mouth disease; efficacy; foot; hand; immunogenicity; safety; Sinovac Enterovirus 71 vaccine

Indexed keywords

ENTEROVIRUS 71 VACCINE; NEUTRALIZING ANTIBODY; PLACEBO; UNCLASSIFIED DRUG; VIRUS VACCINE; VIRUS ANTIBODY;

ANTIBODY BLOOD LEVEL; CHILD; CONFIDENCE INTERVAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; ENTEROVIRUS 71; ENTEROVIRUS INFECTION; FEMALE; FOLLOW UP; HAND FOOT AND MOUTH DISEASE; HUMAN; IMMUNIZATION; IMMUNOGENICITY; INFANT; INFECTION; INFESTATION; INTENTION TO TREAT ANALYSIS; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MULTICENTER STUDY; PHASE 3 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RESPIRATORY TRACT INJURY; REVIEW; THORAX DISEASE; TREATMENT DURATION; VIRUS IMMUNITY; VIRUS STRAIN; BLOOD; CLINICAL TRIAL; DISEASE TRANSMISSION; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ENTEROVIRUS A; HAND, FOOT AND MOUTH DISEASE; IMMUNOLOGY; PATHOLOGY; PREVENTION AND CONTROL; TREATMENT OUTCOME;

ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; CHILD, PRESCHOOL; DISEASE TRANSMISSION, INFECTIOUS; DOUBLE-BLIND METHOD; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; ENTEROVIRUS A, HUMAN; FEMALE; FOLLOW-UP STUDIES; HAND, FOOT AND MOUTH DISEASE; HUMANS; INFANT; MALE; PLACEBOS; TREATMENT OUTCOME; VIRAL VACCINES;

EID: 84951568192     PISSN: 14760584     EISSN: 17448395     Source Type: Journal    
DOI: 10.1586/14760584.2016.1096782     Document Type: Review

References (25)

1. Xing W, Liao Q, Viboud C., et al. Hand, foot, and mouth disease in China, 2008-12: an epidemiological study. Lancet Infectious Diseases. 2014; 14 (4): 308-18.
2. McMinn P, Stratov I, Nagarajan L., et al. Neurological manifestations of enterovirus 71 infection in children during an outbreak of hand, foot, and mouth disease in Western Australia. Clin Infect Dis. 2001; 32 (2): 236-42.
3. 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 (6): e88.
4. Qiu J. Enterovirus 71 infection: a new threat to global public health? Lancet Neurol. 2008; 7 (10): 868-9.
5. Bible JM, Pantelidis P, Chan PK., et al. Genetic evolution of enterovirus 71: epidemiological and pathological implications. Rev Med Virol. 2007; 17 (6): 371-9.
6. Tan X, Huang X, Zhu S., et al. The persistent circulation of enterovirus 71 in Peoples Republic of China: causing emerging nationwide epidemics since 2008. PLoS One. 2011; 6 (9): e25662.
7. Ma E, Lam T, Chan KC., et al. Changing epidemiology of hand, foot, and mouth disease in Hong Kong, 2001-2009. Jpn J Infect Dis. 2010; 63 (6): 422-6.
8. Sarma N, Sarkar A, Mukherjee A., et al. Epidemic of hand, foot and mouth disease in West Bengal, India in August, 2007: a multicentric study. Indian J Dermatol. 2009; 54 (1): 26-30.
9. Mizuta K, Abiko C, Murata T., et al. Frequent importation of enterovirus 71 from surrounding countries into the local community of Yamagata, Japan, between 1998 and 2003. J Clin Microbiol. 2005; 43 (12): 6171-5.
10. Kim KH. Enterovirus 71 infection: an experience in Korea, 2009. Korean J Pediatr. 2010; 53 (5): 616-22.
11. Chua KB, Kasri AR. Hand foot and mouth disease due to enterovirus 71 in Malaysia. Virol Sin. 2011; 26 (4): 221-8.
12. 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 (13): 929-35.
13. Li YP, Liang ZL, Xia JL., et al. Immunogenicity, safety, and immune persistence of a novel inactivated human enterovirus 71 vaccine: a phase II, Randomized, double-blind, placebo-controlled Trial. J Infect Dis. 2014; 209 (1): 46-55.
14. Li YP, Liang ZL, Gao Q., et al. Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: a randomized, placebo-controlled, double-blind, Phase I clinical trial. Vaccine. 2012; 30 (22): 3295-303.
15. Zhu F, Xu W, Xia J., et al. Efficacy, safety, and immunogenicity of an enterovirus 71 vaccine in China. N Engl J Med. 2014; 370 (9): 818-28.
16. Zhang Y, Tan XJ, Wang HY., et al. An outbreak of hand, foot, and mouth disease associated with subgenotype C4 of human enterovirus 71 in Shandong, China. J Clin Virol. 2009; 44 (4): 262-7.
17. Liang Z, Mao Q, Gao Q., et al. Establishing Chinas national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines. Vaccine. 2011; 29 (52): 9668-74.
18. Li JX, Mao QY, Liang ZL., et al. Development of enterovirus 71 vaccines: from the lab bench to Phase III clinical trials. Expert Rev Vaccines. 2014; 13 (5): 609-18.
19. Zhu FC, Meng FY, Li JX., et al. Efficacy, safety, and immunology of an inactivated alum-adjuvant enterovirus 71 vaccine in children in China: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2013; 381 (9882): 2024-32.
20. Solomon T, Lewthwaite P, Perera D., et al. Virology, epidemiology, pathogenesis, and control of enterovirus 71. Lancet Infectious Diseases. 2010; 10 (11): 778-90.
21. Zhang Y, Zhu Z, Yang W., et al. An emerging recombinant human enterovirus 71 responsible for the 2008 outbreak of hand foot and mouth disease in Fuyang city of China. Virol J. 2010; 7 (94).
22. World Health Organization. Guide to clinical management and public health response for hand, foot and mouth disease (HFMD) [Internet]. 2011 [cited 2015 Oct 7]. Available from: www.wpro.who.int/publications/docs/GuidancefortheclinicalmanagementofHFMD.pdf
23. Mao Q, Cheng T, Zhu F., et al. The cross-neutralizing activity of enterovirus 71 subgenotype c4 vaccines in healthy Chinese infants and children. Plos One. 2013; 8 (11): e79599.
24. Huang ML, Chiang PS, Chia MY., et al. Cross-reactive neutralizing antibody responses to enterovirus 71 infections in young children: implications for vaccine development. PLoS Negl Trop Dis. 2013; 7 (2): e2067.
25. Schmidt NJ, Lennette EH, Ho HH. An apparently new enterovirus isolated from patients with disease of the central nervous system. J Infect Dis. 1974; 129 (3): 304-9.