Evidence map›Paper›PMID 36376310›Full record

Trial reportNature communications2022

Safety and immunogenicity following a homologous booster dose of CoronaVac in children and adolescents.

Lei Wang, Zhiwei Wu, Zhifang Ying, Minjie Li, Yuansheng Hu, Qun Shu, Jing Li, Huixian Wang, Hengming Zhang, Wenbin Jiao and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialClinical Trial, Phase II
In one paragraph

Trial report in Nature communications, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04551547 (A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 20% of its field
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.

NCT04551547 phase1 / phase2completednot on this map

A Randomized, Double-Blinded, Placebo-Controlled, Phase Ⅰ/Ⅱ Clinical Trial, to Evaluate the Safety and Immunogenicity of the SARS-CoV-2 Inactivated Vaccine (Vero Cell) in Healthy Population Aged 3-17 Years

TypeinterventionalSponsorSinovac Research and Development Co., Ltd.Ran2020 to 2023Enrolled552ConditionsCOVID-19ArmsTwo doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of placebo at the schedule of day 0,28
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 12 citations in OpenAlex.

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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

13 authors at 4 institutions in 1 country.

Lei Wang *National Immunisation Programme, Chinese Center for Disease Control and Prevention, Beijing, China.ORCID 0000-0002-8902-3262
Zhiwei Wu *Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, Hebei Province, China.
Zhifang Ying *National Institutes for Food and Drug Control, Beijing, China.
Minjie LiHebei Provincial Center for Disease Control and Prevention, Shijiazhuang, Hebei Province, China.ORCID 0000-0002-6830-5658
Yuansheng HuSinovac Biotech Ltd., Beijing, China.
Qun ShuBeijing Key Tech Statistics Technology Co., Ltd., Beijing, China.
Jing LiSinovac Life Sciences Co., Ltd., Beijing, China.
Huixian WangZanhuang County Center for Disease Control and Prevention, Zanhuang, Hebei Province, China.
Hengming ZhangSinovac Biotech Ltd., Beijing, China.
Wenbin JiaoZanhuang County Center for Disease Control and Prevention, Zanhuang, Hebei Province, China.
Lin WangSinovac Life Sciences Co., Ltd., Beijing, China.ORCID 0000-0002-2571-4320
Yuliang ZhaoHebei Provincial Center for Disease Control and Prevention, Shijiazhuang, Hebei Province, China. yuliang_zh1@163.com.ORCID 0000-0002-2160-8870
Qiang GaoSinovac Life Sciences Co., Ltd., Beijing, China. gaoq@sinovac.com.ORCID 0000-0001-6825-3440
Hebei Provincial Center for Disease Control and Prevention · CNSinovac Biotech · CNChinese Center For Disease Control and Prevention · CNNational Institutes for Food and Drug Control · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Data on safety and immunity elicited by a third booster dose of inactivated COVID-19 vaccine in children and adolescents are scarce. Here we conducted a study based on a double-blind, randomised, placebo-controlled phase 2 clinical trial (NCT04551547) to assess the safety and immunogenicity of a third dose of CoronaVac. In this study, 384 participants in the vaccine group were assigned to two cohorts. One received the third dose at a 10-months interval (cohort 1) and the other one at a 12-months interval (cohort 2). The primary endpoint is safety and immunogenicity following a third dose of CoronaVac. The secondary endpoint is antibody persistence following the primary two-dose schedule. Severities of local and systemic adverse reactions reported within 28 days after dose 3 were mild and moderate in both cohorts. A third dose of CoronaVac increased GMTs to 681.0 (95%CI: 545.2-850.7) in cohort 1 and 745.2 (95%CI: 577.0-962.3) in cohort 2. Seropositivity rates against the prototype were 100% on day 28 after dose 3. Seropositivity rates against the Omicron variant were 90.6% (cohort 1) and 91.5% (cohort 2). A homologous booster dose of CoronaVac is safe and induces a significant neutralising antibody levels increase in children and adolescents.

Indexed as

COVID-19COVID-19 VaccinesAdolescentAntibodies, NeutralizingAntibodies, ViralChildDouble-Blind MethodHumansSARS-CoV-2Antibodies, NeutralizingAntibodies, ViralCOVID-19 Vaccines

Identifiers

PMID36376310
PMCPMC9663200
OpenAlexW4308988359

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.