PMID- 30803843
OWN - NLM
STAT- MEDLINE
DCOM- 20200812
LR  - 20200812
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 37
IP  - 13
DP  - 2019 Mar 22
TI  - Immunogenicity, safety, cross-reaction, and immune persistence of an inactivated 
      enterovirus A71 vaccine in children aged from two months to 11 years in Taiwan.
PG  - 1827-1835
LID - S0264-410X(19)30218-X [pii]
LID - 10.1016/j.vaccine.2019.02.023 [doi]
AB  - BACKGROUND: To fight against enterovirus A71 (EV-A71)-associated diseases, 
      vaccine development was initiated in Taiwan focusing on two-month-old infants. 
      METHODS: We conducted a phase II, double-blind, randomised, placebo-controlled 
      study on infants and children aged two months to 11 years. This study was 
      conducted in 4 parts (2a, 2b, 2c, and 2d) with age de-escalation sequentially. 
      Two doses were administered with a 28-day or 56-day interval. Participants aged 
      two months to <two years received a booster dose at one year after the first 
      dose. During the surveillance period, solicited adverse events (AEs) and 
      unsolicited AEs were recorded for safety evaluation. Blood samples were collected 
      for neutralising antibody assay at various times. Immune persistence and booster 
      effects were also assessed. RESULTS: A total of 363 children completed the study. 
      Most AEs were mild and unrelated to treatment. No vaccine-related serious adverse 
      events (SAEs) were reported. Geometric mean titres (GMTs) of serum neutralising 
      antibody titres increased profoundly. Most participants in the vaccine groups 
      achieved defined seroprotection (neutralization titre >/= 1:32) after the second 
      vaccination and persisted for two years. Furthermore, the EV-A71 vaccine could 
      provide a cross-reaction against other EV-A71 strain genotypes: B5, C4a, C4b, and 
      C5. CONCLUSIONS: The mid dose of the EV-A71 vaccine elicited high immune response 
      and were tolerable in participants aged between two months and 11 years in all 
      dosing groups.
CI  - Copyright (c) 2019 Elsevier Ltd. All rights reserved.
FAU - Huang, Li-Min
AU  - Huang LM
AD  - Department of Pediatrics, National Taiwan University Children's Hospital, Taipei, 
      Taiwan.
FAU - Chiu, Cheng-Hsun
AU  - Chiu CH
AD  - Department of Pediatrics, Chang Gung Children's Hospital, Chang Gung University 
      College of Medicine, Taoyuan, Taiwan.
FAU - Chiu, Nan-Chang
AU  - Chiu NC
AD  - Department of Pediatrics, MacKay Children's Hospital, Taipei, Taiwan; Department 
      of Medicine, Mackay Medical College, New Taipei City, Taiwan.
FAU - Lin, Chien-Yu
AU  - Lin CY
AD  - Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.
FAU - Li, Ming-Ta
AU  - Li MT
AD  - Department of Pediatrics, Hsinchu MacKay Memorial Hospital, Hsinchu, Taiwan.
FAU - Kuo, Tsun-Yung
AU  - Kuo TY
AD  - Department of Biotechnology and Animal Science, National Ilan University, Ilan, 
      Taiwan.
FAU - Weng, Yi-Jen
AU  - Weng YJ
AD  - Clinical Development Department, Medigen Vaccine Biologics Corp., Taipei, Taiwan.
FAU - Hsieh, Erh-Fang
AU  - Hsieh EF
AD  - Clinical Development Department, Medigen Vaccine Biologics Corp., Taipei, Taiwan.
FAU - Tai, I-Chen
AU  - Tai IC
AD  - Clinical Development Department, Medigen Vaccine Biologics Corp., Taipei, Taiwan. 
      Electronic address: kathytai@medigenvac.com.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20190222
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Vaccines, Inactivated)
RN  - 0 (Viral Vaccines)
SB  - IM
MH  - Age Factors
MH  - Antibodies, Neutralizing/immunology
MH  - Antibodies, Viral/immunology
MH  - Child
MH  - Child, Preschool
MH  - Cross Reactions/*immunology
MH  - Enterovirus A, Human/*immunology
MH  - Enterovirus Infections/*immunology/*prevention & control
MH  - Female
MH  - Humans
MH  - Immunization Schedule
MH  - *Immunogenicity, Vaccine
MH  - Infant
MH  - Male
MH  - Patient Outcome Assessment
MH  - Taiwan
MH  - Vaccination
MH  - Vaccine Potency
MH  - Vaccines, Inactivated/administration & dosage/adverse effects/*immunology
MH  - Viral Vaccines/administration & dosage/adverse effects/*immunology
OTO - NOTNLM
OT  - Cross-reaction
OT  - EV-A71 vaccine
OT  - Immune persistence
OT  - Immunogenicity
OT  - Two-month-old infant
EDAT- 2019/02/26 06:00
MHDA- 2020/08/13 06:00
CRDT- 2019/02/27 06:00
PHST- 2018/09/06 00:00 [received]
PHST- 2019/01/18 00:00 [revised]
PHST- 2019/02/03 00:00 [accepted]
PHST- 2019/02/26 06:00 [pubmed]
PHST- 2020/08/13 06:00 [medline]
PHST- 2019/02/27 06:00 [entrez]
AID - S0264-410X(19)30218-X [pii]
AID - 10.1016/j.vaccine.2019.02.023 [doi]
PST - ppublish
SO  - Vaccine. 2019 Mar 22;37(13):1827-1835. doi: 10.1016/j.vaccine.2019.02.023. Epub 
      2019 Feb 22.