Evidence map›Paper›PMID 37881130›Full record

Trial reportHuman vaccines & immunotherapeutics2023

Safety, tolerability, and immunogenicity of a CpG/Alum adjuvanted SARS-CoV-2 recombinant protein vaccine (ZR202-CoV) in healthy adults: Preliminary report of a phase 1, randomized, double-blind, placebo-controlled, dose-escalation trial.

Guang-Wei Feng, Zhong-Fang Wang, Peng He, Qin-Ying Lan, Ling Ni, Ya-Zheng Yang, Chen-Fei Wang, Ting-Ting Cui, Li-Li Huang, Yong-Qiang Yan and 14 more

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 3 citations in OpenAlex.

  1. 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

24 authors at 9 institutions in 3 countries.

Guang-Wei FengVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhenzhou, HA, China.
Zhong-Fang WangState Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, GD, China.
Peng HeDepartment of Hepatitis and Enterovirus Vaccine, National Institutes for Food and Drug Control, Beijing, China.
Qin-Ying LanR&D Department, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Ling NiSchool of Medicine, Tsinghua University, Beijing, China.
Ya-Zheng YangSchool of Medicine, Tsinghua University, Beijing, China.
Chen-Fei WangDepartment of Hepatitis and Enterovirus Vaccine, National Institutes for Food and Drug Control, Beijing, China.
Ting-Ting CuiState Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, GD, China.
Li-Li HuangVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhenzhou, HA, China.
Yong-Qiang YanVaccine Program Office, Xiangcheng County Center for Disease Control and Prevention, Xiangcheng, HA, China.
Zhi-Wei JiangStatistics and Decision Sicence, Beijing Key Tech Statistical Consulting Co. Ltd, Beijing, China.
Qing YangR&D Department, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Bang-Wei YuR&D Department, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Xi HanR&D Department, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Jing-Jing ChenR&D Department, Walvax Biotechnology Co. Ltd, Kunming, Yunnan, China.
Shu-Yuan YangR&D Department, Walvax Biotechnology Co. Ltd, Kunming, Yunnan, China.
Lin YuanR&D Department, Walvax Biotechnology Co. Ltd, Kunming, Yunnan, China.
Ling-Yun ZhouR&D Department, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Ge LiuR&D Department, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Ke LiR&D Department, Shanghai Zerun Biotechnology Co. Ltd, Shanghai, China.
Zhen HuangR&D Department, Walvax Biotechnology Co. Ltd, Kunming, Yunnan, China.
Jin-Cun ZhaoState Key Laboratory of Respiratory Disease & National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, GD, China.
Zhong-Yu HuDepartment of Hepatitis and Enterovirus Vaccine, National Institutes for Food and Drug Control, Beijing, China.
Zhi-Qiang XieVaccine Clinical Research Center, Henan Provincial Center for Disease Control and Prevention, Zhenzhou, HA, China.
Shanghai CASB Biotechnology (China) · CNWalmart (United States) · USHenan Provincial Center for Disease Control and Prevention · CNNational Institutes for Food and Drug Control · CNGuangzhou Medical University · CNTsinghua University · CNCenter for Disease Control · TWGuangzhou Regenerative Medicine and Health Guangdong Laboratory · CNStatistical Research (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This was a phase 1 dose-escalation study of ZR202-CoV, a recombinant protein vaccine candidate containing a pre-fusion format of the spike (S)-protein (S-trimer) combined with the dual-adjuvant system of Alum/CpG. A total of 230 participants were screened and 72 healthy adults aged 18-59 years were enrolled and randomized to receive two doses at a 28-day interval of three different ZR202-CoV formulations or normal saline. We assessed the safety for 28 days after each vaccination and collected blood samples for immunogenicity evaluation. All formulations of ZR202-CoV were well-tolerated, with no observed solicited adverse events ≥ Grade 3 within 7 days after vaccination. No unsolicited adverse events ≥ Grade 3, or serious adverse events related to vaccination occurred as determined by the investigator. After the first dose, detectable immune responses were observed in all subjects. All subjects that received ZR202-CoV seroconverted at 14 days after the second dose by S-binding IgG antibody, pseudovirus and live-virus based neutralizing antibody assays. S-binding response (GMCs: 2708.7 ~ 4050.0 BAU/mL) and neutralizing activity by pseudovirus (GMCs: 363.1 ~ 627.0 IU/mL) and live virus SARS-CoV-2 (GMT: 101.7 ~ 175.0) peaked at 14 days after the second dose of ZR202-CoV. The magnitudes of immune responses compared favorably with COVID-19 vaccines with reported protective efficacy.

Indexed as

COVID-19COVID-19 VaccinesAdjuvants, ImmunologicAdolescentAdultAlum CompoundsAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodHumansImmunogenicity, VaccineMiddle AgedSARS-CoV-2Vaccines, SubunitVaccines, SyntheticYoung AdultAdjuvants, ImmunologicAlum Compoundsaluminum sulfateAntibodies, NeutralizingAntibodies, ViralCOVID-19 VaccinesVaccines, SubunitVaccines, SyntheticZR202-CoV COVID-19 vaccineclinical trialCOVID-19immunogenicityplacebo-controlledrecombinant protein vaccinesafetySARS-CoV-2 vaccine

Identifiers

PMID37881130
PMCPMC10644802
OpenAlexW4387950760

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.