Evidence map›Paper›PMID 35660738›Full record

Trial reportNature communications2022

Six-month follow-up of a booster dose of CoronaVac in two single-centre phase 2 clinical trials.

Qianqian Xin, Qianhui Wu, Xinhua Chen, Bihua Han, Kai Chu, Yan Song, Hui Jin, Panpan Chen, Wanying Lu, Tuantuan Yang and 5 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
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 2 registered trials, which are not on this map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 9% 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.

NCT04352608 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 in Healthy Adults Aged 18~59 Years

TypeinterventionalSponsorSinovac Research and Development Co., Ltd.Ran2020 to 2021Enrolled744ConditionsCOVID-19ArmsTwo doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule, Two doses of placebo at the emergency vaccination schedule, Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule
NCT04383574 phase1 / phase2completednot on this map

A Randomized, Double-blind, Placebo-controlled Clinical Trial, to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cell), in Healthy Elderly Aged 60 Years and Above

TypeinterventionalSponsorSinovac Life Sciences Co., Ltd.Ran2020 to 2022Enrolled422ConditionsCOVID-19ArmsTwo doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28, Two doses of placebo at the schedule of day 0,28, Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
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  7. Vaccines for the Prevention of Coronavirus Disease 2019 in Older Adults.Infectious disease clinics of North America · 2023
    Review
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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

15 authors at 4 institutions in 2 countries.

Qianqian Xin *Sinovac Biotech, Beijing, China.
Qianhui Wu *School of Public Health, Fudan University, Key Laboratory of Public Health Safety, Ministry of Education, Shanghai, China.
Xinhua Chen *School of Public Health, Fudan University, Key Laboratory of Public Health Safety, Ministry of Education, Shanghai, China.
Bihua Han *Hebei Provincial Center for Disease Control and Prevention, Shijiazhuang, Hebei, China.
Kai Chu *Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, China.
Yan SongSuining County Center for Disease Control and Prevention, Jiangsu, China.
Hui JinRenqiu Center for Disease Control and Prevention, Hebei, China.
Panpan ChenRenqiu Center for Disease Control and Prevention, Hebei, China.
Wanying LuSchool of Public Health, Fudan University, Key Laboratory of Public Health Safety, Ministry of Education, Shanghai, China.
Tuantuan YangSinovac Biotech, Beijing, China.
Minjie LiHebei Provincial Center for Disease Control and Prevention, Shijiazhuang, Hebei, China. liminjie507@163.com.ORCID 0000-0002-6830-5658
Yuliang ZhaoHebei Provincial Center for Disease Control and Prevention, Shijiazhuang, Hebei, China. yuliang_zh1@163.com.ORCID 0000-0002-2160-8870
Hongxing PanJiangsu Provincial Center for Disease Control and Prevention, Nanjing, China. panhongxing@126.com.ORCID 0000-0002-3791-1241
Hongjie YuSchool of Public Health, Fudan University, Key Laboratory of Public Health Safety, Ministry of Education, Shanghai, China. yhj@fudan.edu.cn.ORCID 0000-0002-6335-5648
Lin WangSinovac Life Sciences, Beijing, China. wanglin@sinovac.com.ORCID 0000-0002-2571-4320
Hebei Provincial Center for Disease Control and Prevention · CNFudan University · CNSinovac Biotech · CNJiangsu Provincial Center for Disease Control and Prevention · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Determining the duration of immunity induced by booster doses of CoronaVac is crucial for informing recommendations for booster regimens and adjusting immunization strategies. In two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials, immunogenicity and safety of four immunization regimens are assessed in adults aged 18 to 59 years and one immunization regimen in adults aged 60 years and older, respectively. Serious adverse events occurring within 6 months after booster doses are recorded as pre-specified secondary endpoints, geometric mean titres (GMTs) of neutralising antibodies one year after the 3-dose schedule immunization and 6 months after the booster doses are assessed as pre-specified exploratory endpoints, GMT fold-decreases in neutralization titres are assessed as post-hoc analyses. Neutralising antibody titres decline approximately 4-fold and 2.5-fold from day 28 to day 180 after third doses in adults aged 18-59 years of age and in adults aged 60 years and older, respectively. No safety concerns are identified during the follow-up period. There are increases in the magnitude and duration of humoral response with homologous booster doses of CoronaVac given 8 months after a primary two-dose immunization series, which could prolong protection and contribute to building our wall of population immunity. Trial number: NCT04352608 and NCT04383574.

Indexed as

COVID-19SARS-CoV-2AdolescentAdultAgedAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesFollow-Up StudiesHumansMiddle AgedYoung AdultAntibodies, NeutralizingAntibodies, ViralCOVID-19 Vaccines

Identifiers

PMID35660738
PMCPMC9166693
OpenAlexW4281702570

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.