Study of the integrated immune response induced by an inactivated EV71 vaccine.
Enterovirus 71 (EV71), a major causative agent of hand-foot-and-mouth disease (HFMD), causes outbreaks among children in the Asia-Pacific region. A vaccine is urgently needed. Based on successful pre-clinical work, phase I and II clinical trials of an inactivated EV71 vaccine, which included the participants of 288 and 660 respectively, have been conducted. In the present study, the immune response and the correlated modulation of gene expression in the peripheral blood mononuclear cells (PBMCs) of 30 infants (6 to 11 months) immunized with this vaccine or placebo and consented to join this study in the phase II clinical trial were analyzed. The results showed significantly greater neutralizing antibody and specific T cell responses in vaccine group after two inoculations on days 0 and 28. Additionally, more than 600 functional genes that were up- or down-regulated in PBMCs were identified by the microarray assay, and these genes included 68 genes associated with the immune response in vaccine group. These results emphasize the gene expression profile of the immune system in response to an inactivated EV71 vaccine in humans and confirmed that such an immune response was generated as the result of the positive mobilization of the immune system. Furthermore, the immune response was not accompanied by the development of a remarkable inflammatory response.


BACKGROUND
NCT01391494 and NCT01512706.
Institute of Medical Biology, Chinese Academy of Medicine Science, Peking Union Medical College, Kunming, People's Republic of China.
Longding
L
Liu
Ying
Y
Zhang
Jingjing
J
Wang
Hongling
H
Zhao
Li
L
Jiang
Yanchun
Y
Che
Haijin
H
Shi
Rongcheng
R
Li
Zhaojun
Z
Mo
Teng
T
Huang
Zhenglun
Z
Liang
Qunying
Q
Mao
Lichun
L
Wang
Chenghong
C
Dong
Yun
Y
Liao
Lei
L
Guo
Erxia
E
Yang
Jing
J
Pu
Lei
L
Yue
Zhenxin
Z
Zhou
Qihan
Q
Li
D000818:Animals; D057134:Antibodies, Neutralizing / Q000097:blood* / Q000276:immunology; D000914:Antibodies, Viral / Q000097:blood* / Q000276:immunology; D016207:Cytokines / Q000097:blood / Q000235:genetics / Q000276:immunology; D004311:Double-Blind Method; D004770:Enterovirus / Q000276:immunology*; D020869:Gene Expression Profiling; D005786:Gene Expression Regulation / Q000187:drug effects* / Q000276:immunology; D006232:Hand, Foot and Mouth Disease / Q000235:genetics / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D007111:Immunity, Cellular / Q000187:drug effects*; D007223:Infant; D007963:Leukocytes, Mononuclear / Q000276:immunology / Q000378:metabolism / Q000821:virology; D046228:Microarray Analysis; D010919:Placebos; D014611:Vaccination; D015164:Vaccines, Inactivated; D014765:Viral Vaccines / Q000008:administration & dosage / Q000276:immunology*
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D016207:Cytokines; D010919:Placebos; D015164:Vaccines, Inactivated; D014765:Viral Vaccines