Evidence map›Paper›PMID 36560490›Full record

ArticleVaccines2022

Preclinical Toxicity and Immunogenicity of a COVID-19 Vaccine (ZF2001) in Cynomolgus Monkeys.

Hongzhong Yang, Wei Pan, Guoyu Chen, Enqi Huang, Qijiong Lu, Yunxiang Chen, Ying Chen, Zhengbiao Yang, Lei Wen, Siming Zhang and 5 more

Open access · goldAbstract 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. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 25% 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

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 9 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Update on Omicron variant and its threat to vulnerable populations.Public health in practice (Oxford, England) · 2024
    Review
  6. Article
  7. Article
  8. 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

15 authors at 3 institutions in 1 country.

Hongzhong YangCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Wei PanCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Guoyu ChenCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Enqi HuangAnhui Zhifei Longcom Biopharmaceutical Co., Ltd., Hefei 230088, China.
Qijiong LuCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Yunxiang ChenCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Ying ChenCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Zhengbiao YangCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Lei WenCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Siming ZhangCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Cong XuCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Wanqiang LvCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Lianpan DaiCAS Key Laboratory of Pathogen Microbiology and Immunology, Institute of Microbiology, Chinese Academy of Sciences, Beijing 100101, China.
Changwei WuAnhui Zhifei Longcom Biopharmaceutical Co., Ltd., Hefei 230088, China.
Lijiang ZhangCenter of Safety Evaluation and Research, Hangzhou Medical College, Hangzhou 310053, China.
Hangzhou Medical College · CNZhejiang Academy of Medical Sciences · CNInstitute of Microbiology · CN

Funding

National Key R&D Program of China 2018YFA0903200National Key R&D Program of China 2020YFC0842300the Projects of Science Technology, Department of Zhejiang Province 2020C03053the Projects of Science Technology, Department of Zhejiang Province 2021C03077
6 · The paper itself

Abstract

Although the new coronavirus disease 2019 (COVID-19) outbreak occurred in late 2019, it is still endemic worldwide, and has become a global public health problem. Vaccination against SARS-CoV-2 is considered to be the most effective intervention to prevent the spread of COVID-19. ZF2001 is a recombinant protein vaccine based on SARS-CoV-2 receptor-binding domain (RBD) subunit which contains aluminum adjuvant. In order to advance our research on ZF2001 into clinical trial, we investigated the general toxicity and immunogenicity of ZF2001 in cynomolgus monkeys and assessed the possible target organs for vaccine-induced toxicity. In the present research, we observed no significant systemic toxicities and abnormal cardiovascular and respiratory events following four times injections of intramuscular ZF2001 in cynomolgus monkeys. Histological examination revealed recoverable inflammatory changes in quadricep muscle and adjacent lymph node at the vaccine injection site. As expected, the vaccine can produce a strongly specific binding antibody and neutralizing antibodies in cynomolgus monkeys after inoculation. Taken together, our regulatory toxicology research proves the safety and immunogenicity of the ZF2001 vaccine, supporting its entry into large scale clinical trials.

Indexed as

COVID-19cynomolgus monkeyimmunogenicitysafety evaluationZF2001 vaccine

Identifiers

PMID36560490
PMCPMC9781319
OpenAlexW4311633531

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.