PMID- 32451212
OWN - NLM
STAT- MEDLINE
DCOM- 20210427
LR  - 20210427
IS  - 1873-2518 (Electronic)
IS  - 0264-410X (Linking)
VI  - 38
IP  - 46
DP  - 2020 Oct 27
TI  - Efficacy, immunogenicity and safety of a trivalent live human-lamb reassortant 
      rotavirus vaccine (LLR3) in healthy Chinese infants: A randomized, double-blind, 
      placebo-controlled trial.
PG  - 7393-7400
LID - S0264-410X(20)30531-4 [pii]
LID - 10.1016/j.vaccine.2020.04.038 [doi]
AB  - BACKGROUND: A randomized, double-blind, placebo-controlled multicenter trial was 
      conducted in healthy Chinese infants to assess the efficacy, immunogenicity and 
      safety of a novel trivalent live human-lamb reassortant rotavirus vaccine (LLR3) 
      against rotavirus gastroenteritis (RVGE). METHODS: Healthy children aged 
      6-13 weeks were enrolled and randomized (1:1) to either 3 oral doses of LLR3 or 
      placebo according to a 0, 1, 2 month schedule. The objectives were to evaluate 
      vaccine efficacy (VE) against RVGE of any-severity, severe RVGE (sRVGE) and 
      inpatient caused by rotavirus serotypes contained in the vaccine and not 
      contained in the vaccine after the third dose. Immunogenicity was also assayed in 
      a subgroup. All adverse events (AEs) were collected from 30 min after each dose 
      for immediate reaction, even to the entire study period, including the serious 
      AEs (SAEs) and intussusception. RESULTS: VE against RVGE of any-severity, sRVGE 
      and inpatient caused by any serotype was 56.6% (95% CI: 50.7, 61.8), 70.3% (95% 
      CI: 60.6, 77.6) and 74.0% (95% CI: 57.5, 84.1) respectively. VE against RVGE of 
      any-severity, sRVGE caused by serotypes not contained in vaccine were 54.2% (95% 
      CI: 47.5, 60.1) and 70.4% (95% CI: 60.4, 77.9). The rate of seroconversion and 
      four-fold increase of rotavirus serotype G2-, G3-, and G4-specific IgA is 60.8%, 
      58.0%, and 60.6% in vaccine group, which was higher than 21.35%, 22.7%, and 23.1% 
      in placebo group (p < 0.0001 for G2, G3, G4), as well as the Geometric Mean Titer 
      (GMT). Through the entire trial, 65.91% and 67.79% of participants reported at 
      least one AE, and 0.02% and 0.02% reported SAEs in the vaccine and placebo 
      groups, respectively. Two intussusception cases were reported both in vaccine and 
      placebo group. CONCLUSIONS: In Chinese infants, LLR3 provided a substantial 
      protection against RVGE of any-severity, sRVGE and inpatient caused by any 
      serotype, and showed well immunogenicity and safety.
CI  - Copyright (c) 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Xia, Shengli
AU  - Xia S
AD  - Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.
FAU - Du, Jialiang
AU  - Du J
AD  - National Institutes for Food and Drug Control, Beijing 102629, China.
FAU - Su, Jia
AU  - Su J
AD  - Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.
FAU - Liu, Yueyue
AU  - Liu Y
AD  - National Institutes for Food and Drug Control, Beijing 102629, China.
FAU - Huang, Lili
AU  - Huang L
AD  - Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.
FAU - Yu, Qingchuan
AU  - Yu Q
AD  - National Institutes for Food and Drug Control, Beijing 102629, China.
FAU - Xie, Zhiqiang
AU  - Xie Z
AD  - Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.
FAU - Gao, Jiamei
AU  - Gao J
AD  - National Institutes for Food and Drug Control, Beijing 102629, China.
FAU - Xu, Bianli
AU  - Xu B
AD  - Henan Center for Disease Control and Prevention, Zhengzhou 450000, China.
FAU - Gao, Xuejun
AU  - Gao X
AD  - Lanzhou Institute of Biological Products Co Ltd, Lanzhou 730046, China.
FAU - Guo, Tai
AU  - Guo T
AD  - National Institutes for Food and Drug Control, Beijing 102629, China.
FAU - Liu, Yan
AU  - Liu Y
AD  - National Institutes for Food and Drug Control, Beijing 102629, China. Electronic 
      address: liuyan418@nifdc.org.cn.
FAU - Zhou, Xu
AU  - Zhou X
AD  - Lanzhou Institute of Biological Products Co Ltd, Lanzhou 730046, China. 
      Electronic address: kathzhou@sina.com.
FAU - Yang, Huan
AU  - Yang H
AD  - Center for Drug Evaluation, National Medical Products Administration, Beijing 
      100022, China. Electronic address: 13691354049@163.com.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20200523
PL  - Netherlands
TA  - Vaccine
JT  - Vaccine
JID - 8406899
RN  - 0 (Antibodies, Viral)
RN  - 0 (Rotavirus Vaccines)
RN  - 0 (Vaccines, Attenuated)
SB  - IM
MH  - Adolescent
MH  - Animals
MH  - Antibodies, Viral
MH  - Child
MH  - China
MH  - Double-Blind Method
MH  - *Gastroenteritis/prevention & control
MH  - Humans
MH  - Infant
MH  - *Rotavirus
MH  - *Rotavirus Infections/prevention & control
MH  - *Rotavirus Vaccines/adverse effects
MH  - Sheep
MH  - Vaccines, Attenuated/adverse effects
OTO - NOTNLM
OT  - Efficacy
OT  - Immunogenicity
OT  - Rotavirus gastroenteritis
OT  - Rotavirus vaccine
OT  - Safety
COIS- Declaration of Competing Interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper.
EDAT- 2020/05/27 06:00
MHDA- 2021/04/28 06:00
CRDT- 2020/05/27 06:00
PHST- 2019/09/16 00:00 [received]
PHST- 2020/04/13 00:00 [revised]
PHST- 2020/04/16 00:00 [accepted]
PHST- 2020/05/27 06:00 [pubmed]
PHST- 2021/04/28 06:00 [medline]
PHST- 2020/05/27 06:00 [entrez]
AID - S0264-410X(20)30531-4 [pii]
AID - 10.1016/j.vaccine.2020.04.038 [doi]
PST - ppublish
SO  - Vaccine. 2020 Oct 27;38(46):7393-7400. doi: 10.1016/j.vaccine.2020.04.038. Epub 
      2020 May 23.