Evidence map›Paper›PMID 35632416›Full record

ArticleVaccines2022

Immunogenicity and Safety of a Booster Dose of Live Attenuated Varicella Vaccine, and Immune Persistence of a Primary Dose for Children Aged 2 to 6 Years.

Yukai Zhang, Lei Wang, Yanxia Wang, Wei Zhang, Ningning Jia, Zhiqiang Xie, Lili Huang, Wangyang You, Weifeng Lu, Erwei Li and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02981836 (A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02981836 phase3completednot on this map

A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children

TypeinterventionalSponsorSinovac (Dalian) Vaccine Technology Co., Ltd.Ran2016 to 2017Enrolled5,997ConditionsVaricellaArmsInvestigational live attenuated varicella vaccine, diluent of lyophilized vaccine
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Yukai ZhangClinical Laboratory, Jinshui District Center for Disease Control and Prevention, Zhengzhou 450003, China.
Lei WangClinical R&D Center, Sinovac Biotech Co., Ltd., Beijing 100085, China.
Yanxia WangVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450018, China.
Wei ZhangVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450018, China.
Ningning JiaClinical R&D Center, Sinovac Biotech Co., Ltd., Beijing 100085, China.
Zhiqiang XieVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450018, China.
Lili HuangVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450018, China.
Wangyang YouVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450018, China.
Weifeng LuXiangfu District Center for Disease Control and Prevention, Kaifeng 475199, China.
Erwei LiXiangfu District Center for Disease Control and Prevention, Kaifeng 475199, China.
Feilong GaoXiangfu District Center for Disease Control and Prevention, Kaifeng 475199, China.
Yuansheng HuClinical R&D Center, Sinovac Biotech Co., Ltd., Beijing 100085, China.
Fanhong MengResearch Department, Sinovac (Dalian) Vaccine Technology Co., Ltd., Dalian 116620, China.
Shengli XiaVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhengzhou 450018, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the immunogenicity and safety of a booster dose of live attenuated varicella vaccine (VarV) manufactured by Sinovac (Dalian) Vaccine Technology Co. Ltd., and the immune persistence of a primary dose in 2- to 6-year-old children.

methodsA phase IV, open-label study was conducted in China. Children previously vaccinated with a single dose of VarV at 1~3 years old received one dose of homologous VarV in the first year, the second year, or the third year after the primary immunization as booster immunization. Immune persistence was evaluated in an immune persistence analysis set, while immunogenicity was evaluated in a per-protocol analysis set, and safety was evaluated in a safety analysis set. The primary endpoint was the seropositive rate and the seroconversion rate of VarV antibody. The trial was registered at ClinicalTrials.gov (NCT02981836).

resultsFrom July 2018 to August 2020, a total of 849 vaccinated children received the booster vaccination of VarV, one booster dose for each child (301 vaccinated in the first year after primary immunization (Group 1), 276 vaccinated in the second year after primary immunization (Group 2), 272 vaccinated in the third year after primary immunization (Group 3)). The seropositive rates were 99.34%, 97.83%, and 98.16% in Groups 1-3, with GMTs of 1:22.56, 1:18.49, and 1:18.45, respectively. Thirty days after the vaccine booster dose, the seropositive rates of the three groups were all 100% and the seroconversion rates were 52.54%, 67.46%, and 66.67%, with GMTs of 1:68.49, 1:76.32 and 1:78.34, respectively. The seroconversion rates in Groups 2 and 3 were both higher than that in Group 1 (

conclusionsVarV had good immune persistence in 1~3 years after primary immunization. A vaccine booster dose for children aged 1~3 years after primary immunization recalled specific immune response to varicella-zoster virus, with no safety concerns increased.

Indexed as

boosterimmune persistenceimmunogenicitylive attenuated varicella vaccinesafety

Identifiers

PMID35632416
PMCPMC9146173

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Registered trials

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