Safety and immunogenicity of a novel human Enterovirus 71 (EV71) vaccine: A randomized, placebo-controlled, double-blind, Phase I clinical trial

Vaccine

Volumn 30, Issue 22, 2012, Pages 3295-3303

  Li, Yan Ping ^a   Liang, Zheng Lun ^b   Gao, Qiang ^c   Huang, Li Rong ^a   Mao, Qun Ying ^b   Wen, Shu Qun ^a   Liu, Yan ^c   Yin, Wei Dong ^c   Li, Rong Cheng ^a   Wang, Jun Zhi ^b  

^a The Center for Disease Control and Prevention of the Guangxi Zhuang Autonomous Region   (China)

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

^c Sinovac Biotech Co Ltd   (China)

Author keywords

Enterovirus 71; EV71 vaccine; Immunogenicity; Safety

Indexed keywords

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

ADULT; ARTICLE; CHILD; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE COMPARISON; DRUG ERUPTION; DRUG SAFETY; DRUG TOLERABILITY; ENTEROVIRUS 71; ENTEROVIRUS INFECTION; FEVER; HUMAN; IMMUNE RESPONSE; IMMUNOGENICITY; INFANT; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SCHOOL CHILD; VACCINATION;

ADOLESCENT; ADULT; ANTIBODIES, NEUTRALIZING; ANTIBODIES, VIRAL; CHILD; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; DRUG TOXICITY; ENTEROVIRUS A, HUMAN; FEMALE; HUMAN EXPERIMENTATION; HUMANS; INFANT; INJECTIONS, INTRAMUSCULAR; MALE; MIDDLE AGED; PLACEBOS; VACCINATION; VIRAL VACCINES; YOUNG ADULT;

EID: 84859829557     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.03.010     Document Type: Article

References (28)

1. Schmidt N.J., Lennette E.H., Ho H.H. An apparently new enterovirus isolated from patients with disease of the central nervous system. J Infect Dis 1974, 129(3):304-309.
2. Bible J.M., Pantelidis P., Chan P.K., Tong C.Y. Genetic evolution of enterovirus 71: epidemiological and pathological implications. Rev Med Virol 2007, 17(6):371-379.
3. Shindarov L.M., Chumakov M.P., Voroshilova M.K., Bojinov S., Vasilenko S.M., Iordanov I., et al. Epidemiological, clinical, and pathomorphological characteristics of epidemic poliomyelitis-like disease caused by enterovirus 71. J Hyg Epid Microb Im 1979, 23(3):284-295.
4. Nagy G., Takátsy S., Kukán E., Mihály I., Dömök I. Virological diagnosis of enterovirus type 71 infections: experiences gained during an epidemic of acute CNS diseases in Hungary in 1978. Arc Virol 1982, 71(3):217-227.
5. Chan L.G., Parashar U.D., Lye M.S., Ong F.G., Zaki S.R., Alexander J.P., et al. Deaths of children during an outbreak of hand, foot, and mouth disease in Sarawak, Malaysia: clinical and pathological characteristics of the disease. For the Outbreak Study Group. Clin Inf D 2000, 31(3):678-683.
6. Ho M., Chen E.R., Hsu K.H., Twu S.J., Chen K.T., Tsai S.F., et al. An epidemic of enterovirus 71 infection in Taiwan. Taiwan Enterovirus Epidemic Working Group. N Engl J Med 1999, 341(13):929-935.
7. Tu P.V., Thao N.T., Perera D., et al. Epidemiologic and virologic investigation of hand, foot, and mouth disease, southern Vietnam, 2005. Emerg Infect Dis 2007, 13(11):1733-1741.
8. AbuBakar S., Sam I.C., Yusof J., Lim M.K., Misbah S., MatRahim N., et al. Enterovirus 71 outbreak, Brunei. Emerg Infect Dis 2009, 15(1):79-82.
9. Hand, foot and mouth disease, 2000-2003, Japan. Infectious Agents Surveillance Report 2004, 25(9):224-225.
10. WHO: report on the hand, foot and mouth disease outbreak in Fuyang City, Anhui Province and the prevention and control in China. [Accessibility verified May 7, 2008]. http://www.wpro.who.int/NR/rdonlYres/591D6A7B-FB15-4E94-A1E9-1D3381847D60/0/HFMDCCDC20080515ENG.pdf.
11. Chinese CDC National notifiable infectious diseases situation update July 2011, [Accessibility verified August 12, 2011]. http://www.%20chinacdc.cn/tjsj/fdcrbbg/.htm.
12. Chen H.L., Huang J.Y., Chu T.W., Tsai T.C., Hung C.M., Lin C.C., et al. Expression of VP1 protein in the milk of transgenic mice: a potential oral vaccine protects against enterovirus 71 infection. Vaccine 2008, 26(23):2882-2889.
13. Chung C.Y., Chen C.Y., Lin S.Y., Chung Y.C., Chiu H.Y., Chi W.K., et al. Enterovirus 71 virus-like particle vaccine: improved production conditions for enhanced yield. Vaccine 2010, 28(43):6951-6957.
14. Ong K.C., Devi S., Cardosa M.J., Wong K.T. Formaldehyde-inactivated whole-virus vaccine protects a murine model of enterovirus 71 encephalomyelitis against disease. J Virol 2010, 84(1):661-665.
15. Bek E.J., Hussain K.M., Phuektes P., Kok C.C., Gao Q., Cai F., et al. Formalin-inactivated vaccine provokes cross-protective immunity in a mouse model of human enterovirus 71 infection. Vaccine 2011, 29(29-30):4829-4838.
16. Zhang D., Lu J. Enterovirus 71 vaccine: close but still far. Int J Infect Dis 2010, 14(9):e739-e743.
17. Liang Z.L., Mao Q.Y., Gao Q., Li X.L., Dong C.H., Yu X., et al. Establishing China's national standards of antigen content and neutralizing antibody responses for evaluation of enterovirus 71 (EV71) vaccines. Vaccine 2011, 29(52):9668-9674.
18. Gomes Mde L., de Castro C.M., Oliveira M.J., da Silva E.E. Neutralizing antibodies to enterovirus 71 in Belém, Brazil. Mem I Oswaldo Cruz 2002, 97(1):47-49.
19. Mao Q.Y., Liao X.Y., Yu X., Li N., Zhu F.C., Zeng Y., et al. Dynamic change of mother source neutralizing antibodies against enterovirus 71 and coxsackievirus A16 in infants. Chin Med J. 2010, 123(13):1679-1684.
20. Mao Q.Y., Li N., Yu X., Yao X., Li F., Lu F., et al. Antigenicity: animal protective effect and genetic of candidate vaccine strains of enterovirus 71. Arch Virol 2012, 157(1):37-41.
21. Cassidy W.M., Watson B., Ioli V.A., Williams K., Bird S., West D.J. A randomized trial of alternative two- and three-dose hepatitis B vaccination regimens in adolescents: antibody responses, safety, and immunologic memory. Pediatrics 2001, 107(4):626-631.
22. Liglof T., van Hattum J., Kaplan K.M., Corrigan J., Duval I., Jensen E., et al. An open study of subcutaneous administration of inactivated hepatitis A vaccine (VAQTA) in adults: safety, tolerability, and immunogenicity. Vaccine 2001, 19(28-29):3968-3971.
23. Lin J.T., Zhang J.S., Dong X.P., Fang H., Chen J., Su N., et al. Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomized controlled trial. Lancet 2006, 368(9540):991-997.
24. Ooi E.E., Phoon M.C., Ishak B., Chan S.H. Seroepidemiology of human enterovirus 71, Singapore. Emerg Infect Dis 2002, 8(9):995-997.
25. Solomon T., Lewthwaite P., Perera D., Cardosa M.J., McMinn P., Ooi M.H. Virology, epidemiology, pathogenesis, and control of enterovirus 71. Lancet Infect Dis 2010, 10(11):778-790.
26. Wu C.N., Lin Y.C., Fann C., Liao N.S., Shih S.R., Ho M.S. Protection against lethal enterovirus 71 infection in newborn mice by passive immunization with subunit VP1 vaccines and inactivated virus. Vaccine 2001, 20(5-6):895-904.
27. Foo D.G., Alonso S., Chow V.T., Poh C.L. Passive protection against lethal enterovirus 71 infection in newborn mice by neutralizing antibodies elicited by a synthetic peptide. Microbes Infect 2007, 9(11):1299-1306.
28. Chang L.Y., King C.C., Hsu K.H., Ning H.C., Tsao K.C., Li C.C., 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.