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

IF 6.5 1区医学 Q1 IMMUNOLOGY

NPJ Vaccines Pub Date : 2025-03-17 DOI:10.1038/s41541-025-01096-y

Kai Chu, Jiali Quan, Xiaohui Liu, Qi Chen, Xia Zang, Hanmin Jiang, Donglin Liu, Xiafei Chu, Chunlan Zhuang, Jinle Han, Xiangzhong Ye, Hongxing Pan, Shoujie Huang, Ting Wu, Jun Zhang, Ningshao Xia

{"title":"A randomized phase I trial of intranasal SARS-CoV-2 vaccine dNS1-RBD in children aged 3-17 years.","authors":"Kai Chu, Jiali Quan, Xiaohui Liu, Qi Chen, Xia Zang, Hanmin Jiang, Donglin Liu, Xiafei Chu, Chunlan Zhuang, Jinle Han, Xiangzhong Ye, Hongxing Pan, Shoujie Huang, Ting Wu, Jun Zhang, Ningshao Xia","doi":"10.1038/s41541-025-01096-y","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":19335,"journal":{"name":"NPJ Vaccines","volume":"10 1","pages":"50"},"PeriodicalIF":6.5000,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11914604/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"NPJ Vaccines","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1038/s41541-025-01096-y","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"IMMUNOLOGY","Score":null,"Total":0}

引用次数: 0

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.

查看原文本刊更多论文

3-17岁儿童鼻内SARS-CoV-2疫苗dNS1-RBD的随机I期试验

基于减毒活流感病毒载体的SARS-CoV-2鼻内疫苗dNS1-RBD （Pneucolin®）已获得中国18岁及以上个人紧急使用授权。在这里，我们进行了一项单中心、双盲、安慰剂对照、年龄降级的1期临床试验，以评估dNS1-RBD在3-17岁儿童中的安全性（ChiCTR2300068044）。63名参与者在第0天和第14天接受了2剂鼻内疫苗或安慰剂。安全性评估包括30天内的不良事件/反应和12个月内的严重不良事件（sae）。采集血液和鼻分泌物标本，进一步监测血液指标和病毒脱落情况。疫苗组的不良反应率与安慰剂组相似（39.0% vs 36.4%），未发生与疫苗接种相关的不良反应。数据显示，dNS1-RBD疫苗在3-17岁儿童中耐受性良好，值得进一步研究其在该人群中的安全性、免疫原性和有效性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

NPJ Vaccines Immunology and Microbiology-Immunology

CiteScore

11.90

自引率

4.30%

发文量

146

审稿时长

11 weeks

期刊介绍： Online-only and open access, npj Vaccines is dedicated to highlighting the most important scientific advances in vaccine research and development.