PMID- 23922377
OWN - NLM
STAT- MEDLINE
DCOM- 20140331
LR  - 20131217
IS  - 1537-6613 (Electronic)
IS  - 0022-1899 (Linking)
VI  - 209
IP  - 1
DP  - 2014 Jan 1
TI  - Immunogenicity, safety, and immune persistence of a novel inactivated human 
      enterovirus 71 vaccine: a phase II, Randomized, double-blind, placebo-controlled 
      Trial.
PG  - 46-55
LID - 10.1093/infdis/jit429 [doi]
AB  - BACKGROUND: Vaccination is considered a top priority for the control of human 
      enterovirus 71 (EV71) infection outbreaks. METHODS: On the basis of phase I trial 
      results, we conducted a double-blind, randomized, controlled trial to evaluate 
      the optimal dose, immunogenicity, safety and immune persistence of the vaccine. A 
      total of 480 healthy infants were randomly assigned to receive 2 injections of 
      100 U of vaccine, 200 U of vaccine, 400 U of vaccine, or placebo. Solicited 
      adverse events (AEs) within 7 days and unsolicited AEs within 28 days after each 
      vaccination were collected for safety evaluation. Blood samples were collected 
      for neutralizing antibody assay. RESULTS: EV71 vaccine was well tolerated, and no 
      dose-related safety concerns were observed. Two doses of the vaccine yielded 
      seropositivity frequencies of 92.3%, 95.9%, and 99.0% (with titers >/=1:8) in the 
      100 U, 200 U, and 400 U groups, respectively. Geometric mean titers measured by 
      neutralizing antibody assay increased to 60.2 (95% confidence interval [CI], 
      41.9-86.4), 72.8 (95% CI, 50.8-104.3), and 252.1 (95% CI, 180.8-351.6) for the 
      100 U, 200 U, and 400 U groups, respectively. The dose-response relationship, 
      with the 400 U dose showing higher immunogenicity than the 100 U and 200 U doses, 
      remained until 13 months after the second vaccination, despite waning antibody 
      levels. CONCLUSIONS: The 400 U dose was recommended as the optimal dose for the 
      phase III trial because of its good safety profile and higher immunogenicity.
FAU - Li, Yan-Ping
AU  - Li YP
AD  - Center for Disease Control and Prevention of the Guangxi Zhuang Autonomous 
      Region, Nanning.
FAU - Liang, Zheng-Lun
AU  - Liang ZL
FAU - Xia, Jie-Lai
AU  - Xia JL
FAU - Wu, Jun-Yu
AU  - Wu JY
FAU - Wang, Ling
AU  - Wang L
FAU - Song, Li-Fei
AU  - Song LF
FAU - Mao, Qun-Ying
AU  - Mao QY
FAU - Wen, Shu-Qun
AU  - Wen SQ
FAU - Huang, Ren-Guo
AU  - Huang RG
FAU - Hu, Yuan-Sheng
AU  - Hu YS
FAU - Yao, Xin
AU  - Yao X
FAU - Miao, Xu
AU  - Miao X
FAU - Wu, Xing
AU  - Wu X
FAU - Li, Rong-Cheng
AU  - Li RC
FAU - Wang, Jun-Zhi
AU  - Wang JZ
FAU - Yin, Wei-Dong
AU  - Yin WD
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20130806
PL  - United States
TA  - J Infect Dis
JT  - The Journal of infectious diseases
JID - 0413675
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Vaccines, Inactivated)
RN  - 0 (Viral Vaccines)
SB  - IM
MH  - Antibodies, Neutralizing/blood/immunology
MH  - Antibodies, Viral/blood/immunology
MH  - Child, Preschool
MH  - Double-Blind Method
MH  - Enterovirus A, Human/*immunology
MH  - Female
MH  - Humans
MH  - Immunologic Memory/immunology
MH  - Infant
MH  - Male
MH  - Vaccines, Inactivated/administration & dosage/adverse effects/immunology
MH  - Viral Vaccines/*administration & dosage/adverse effects/immunology
OTO - NOTNLM
OT  - EV71 vaccine
OT  - immune persistence
OT  - immunogenicity
OT  - safety
EDAT- 2013/08/08 06:00
MHDA- 2014/04/01 06:00
CRDT- 2013/08/08 06:00
PHST- 2013/08/08 06:00 [entrez]
PHST- 2013/08/08 06:00 [pubmed]
PHST- 2014/04/01 06:00 [medline]
AID - jit429 [pii]
AID - 10.1093/infdis/jit429 [doi]
PST - ppublish
SO  - J Infect Dis. 2014 Jan 1;209(1):46-55. doi: 10.1093/infdis/jit429. Epub 2013 Aug 
      6.