Evidence map›Paper›PMID 40097460›Full record

ArticleNPJ vaccines2025

A randomized phase I trial of intranasal SARS-CoV-2 vaccine dNS1-RBD in children aged 3-17 years.

Kai Chu, Jiali Quan, Xiaohui Liu, Qi Chen, Xia Zang, Hanmin Jiang, Donglin Liu, Xiafei Chu, Chunlan Zhuang, Jinle Han and 6 more

Abstract read
In one paragraph

Article in NPJ vaccines, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
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. Article
  2. 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

16 authors.

Kai Chu *Jiangsu Provincial Centre for Disease Control and Prevention, Public Health Research Institute of Jiangsu Province, Nanjing, Jiangsu, China.
Jiali Quan *State Key Laboratory of Vaccines for Infectious Diseases, Xiang an Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Xiaohui Liu *State Key Laboratory of Vaccines for Infectious Diseases, Xiang an Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Qi ChenState Key Laboratory of Vaccines for Infectious Diseases, Xiang an Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Xia ZangDongtai Centre for Disease Control and Prevention, Yancheng, Jiangsu, China.
Hanmin JiangDongtai Centre for Disease Control and Prevention, Yancheng, Jiangsu, China.
Donglin LiuDongtai Centre for Disease Control and Prevention, Yancheng, Jiangsu, China.
Xiafei ChuBeijing Wantai Biological Pharmacy Enterprise, Beijing, China.
Chunlan ZhuangState Key Laboratory of Vaccines for Infectious Diseases, Xiang an Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Jinle HanBeijing Wantai Biological Pharmacy Enterprise, Beijing, China. hanjinle@ystwt.com.
Xiangzhong YeBeijing Wantai Biological Pharmacy Enterprise, Beijing, China.
Hongxing PanJiangsu Provincial Centre for Disease Control and Prevention, Public Health Research Institute of Jiangsu Province, Nanjing, Jiangsu, China. panhongxing@126.com.
Shoujie HuangState Key Laboratory of Vaccines for Infectious Diseases, Xiang an Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China. huangshoujie@xmu.edu.cn.ORCID http://orcid.org/0000-0001-5012-2274
Ting WuState Key Laboratory of Vaccines for Infectious Diseases, Xiang an Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.
Jun ZhangState Key Laboratory of Vaccines for Infectious Diseases, Xiang an Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.ORCID http://orcid.org/0000-0002-6601-9180
Ningshao XiaState Key Laboratory of Vaccines for Infectious Diseases, Xiang an Biomedicine Laboratory, School of Public Health, Xiamen University, Xiamen, China.ORCID http://orcid.org/0000-0003-0179-5266

Funding

National Natural Science Foundation of China (National Science Foundation of China) 92369108
6 · The paper itself

Abstract

The intranasal SARS-CoV-2 vaccine dNS1-RBD (Pneucolin®), based on a live-attenuated influenza virus vector, has obtained Emergency Use Authorization in China for individuals aged 18 years and older. Here, we conducted a single-center, double-blind, placebo-controlled, age de-escalation phase 1 clinical trial to evaluate the safety of the dNS1-RBD in children aged 3-17 years (ChiCTR2300068044). Sixty-three participants received 2 intranasal doses of the vaccine or placebo at days 0 and 14. Safety assessments included adverse events/reactions within 30 days and serious adverse events (SAEs) over 12 months. Blood and nasal secretion samples were collected to further monitor blood indices and viral shedding. The vaccine group showed similar adverse reaction rates to the placebo group (39.0% vs 36.4%), with no SAEs related to vaccination. Data suggested that the dNS1-RBD vaccine is well-tolerated in children aged 3-17 years, and warrants further studies on its safety, immunogenicity and efficacy in this population.

Identifiers

PMID40097460
PMCPMC11914604

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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.