Evidence map›Paper›PMID 38641791›Full record

Trial reportBMC infectious diseases2024

Immunogenicity and safety of a recombinant COVID-19 vaccine (ZF2001) as heterologous booster after priming with inactivated vaccine in healthy children and adolescents aged 3-17 years: an open-labeled, single-arm clinical trial.

Tao Huang, Qianqian Hu, Xiang Zhou, Huaiyu Yang, Wei Xia, Feng Cao, Minglu Deng, Xiaoxue Teng, Fan Ding, Zaixin Zhong and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05895110 (To Evaluate the Immunogenicity and Safety of Sequentially Enhanced Recombinant Novel Coronavirus Vaccine), 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
0.4field-weighted citation impact, top 42% 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.

NCT05895110 nacompletednot on this map

To Evaluate the Immunogenicity and Safety of Sequentially Enhanced Recombinant Novel Coronavirus Vaccine (CHO Cells) in Patients Aged 3-17 Years After Completion of Two Doses of Novel Coronavirus Inactivated Vaccine

TypeinterventionalSponsorAnhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Ran2022 to 2022Enrolled240ConditionsCOVID-19ArmsRecombinant Novel Coronavirus vaccine (CHO Cells)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Trial
  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

13 authors at 3 institutions in 1 country.

Tao Huang *Hunan Provincial Center for Disease Control and Prevention, Changsha, 410005, China.
Qianqian Hu *Anhui Zhifei Longcom Biopharmaceutical, Hefei, 230601, China.
Xiang Zhou *Anhui Zhifei Longcom Biopharmaceutical, Hefei, 230601, China.
Huaiyu Yang *Anhui Zhifei Longcom Biopharmaceutical, Hefei, 230601, China.
Wei XiaHunan Provincial Center for Disease Control and Prevention, Changsha, 410005, China.
Feng CaoXiangtan Center for Disease Control and Prevention, Xiangtan, 411100, China.
Minglu DengAnhui Zhifei Longcom Biopharmaceutical, Hefei, 230601, China.
Xiaoxue TengAnhui Zhifei Longcom Biopharmaceutical, Hefei, 230601, China.
Fan DingAnhui Zhifei Longcom Biopharmaceutical, Hefei, 230601, China.
Zaixin ZhongAnhui Zhifei Longcom Biopharmaceutical, Hefei, 230601, China.
Lidong GaoHunan Provincial Center for Disease Control and Prevention, Changsha, 410005, China. gldlj@hotmail.com.
Jiufeng SunGuangdong Provincial Institute of Public Health, Guangzhou, 511430, China. sunjiuf@163.com.
Lihui GongAnhui Zhifei Longcom Biopharmaceutical, Hefei, 230601, China. gonglihui@zhifeishengwu.com.
Hunan Provincial Center for Disease Control and Prevention · CNGuangdong Provincial Center for Disease Control and Prevention · CNXiangtan University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Considering that neutralizing antibody levels induced by two doses of the inactivated vaccine decreased over time and had fallen to low levels by 6 months, and homologous and heterologous booster immunization programs have been implemented in adults in China. The booster immunization of recombinant COVID-19 vaccine (ZF2001) after priming with inactivated vaccine in healthy children and adolescents has not been reported. We performed an open-labeled, single-arm clinical trial to evaluate the safety and immunogenicity of heterologous booster immunization with ZF2001 after priming with inactivated vaccine among 240 population aged 3-17 years in China. The primary outcome was immunogenicity, including geometric mean titers (GMTs), geometric mean ratios (GMRs) and seroconversion rates of SARS-CoV-2 neutralizing antibodies against prototype SARS-CoV-2 and Omicron BA.2 variant at 14 days after vaccination booster. On day 14 post-booster, a third dose booster of the ZF2001 provided a substantial increase in antibody responses in minors, and the overall occurrence rate of adverse reactions after heterologous vaccination was low and all adverse reactions were mild or moderate. The results showed that the ZF2001 heterologous booster had high immunogenicity and good safety profile in children and adolescents, and can elicit a certain level of neutralizing antibodies against Omicron.Trial registration NCT05895110 (Retrospectively registered, First posted in ClinicalTrials.gov date: 08/06/2023).

Indexed as

COVID-19COVID-19 VaccinesVaccines, SubunitAdolescentAntibodies, NeutralizingAntibodies, ViralChildChild, PreschoolHumansImmunogenicity, VaccineSARS-CoV-2Vaccines, InactivatedAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesVaccines, InactivatedVaccines, SubunitZF2001 COVID-19 vaccineBooster immunizationCOVID-2019ImmunogenicitySafetySARS-CoV-2Vaccine

Identifiers

PMID38641791
PMCPMC11027523
OpenAlexW4394949176

What Socratic 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 Socratic graph.