Safety and Immunogenicity of a New Rotavirus-Inactivated Vaccine in the Chinese Adolescent Population: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial
The majority of adverse events (AEs) were deemed Grade 1 or 2, suggesting that the vaccine's safety profile is suitable for healthy adolescents. For the primary immunogenicity endpoints, a preliminary examination of the GMTs and the positive transfer rate of neutralizing antibodies in the different experimental groups revealed that, in adolescents aged 6-17, the high-dose group displayed significantly higher levels of neutralizing antibodies compared to the medium- and low-dose groups. Adolescents had few side effects from the new inactivated rotavirus vaccination, and it elicited an immune response.
Authors
- Jiamei Gao (ORCID: https://orcid.org/0009-0009-8131-213X)
- Qian Tong (ORCID: https://orcid.org/0000-0002-5899-7910)
- Xiaochen Lin (ORCID: https://orcid.org/0000-0002-0829-6761)
- Jun Ye (ORCID: https://orcid.org/0000-0002-0631-556X)
- Na Yin
- Jing Pu (ORCID: https://orcid.org/0000-0002-1851-8583)
- Qingchuan Yu (ORCID: https://orcid.org/0000-0002-2500-285X)
- Dongyang Zhao (ORCID: https://orcid.org/0000-0003-2165-2983)
- Yan Zhou (ORCID: https://orcid.org/0000-0003-4793-7303)
- Xiaoqing Hu (ORCID: https://orcid.org/0000-0001-9824-1109)
- Guangwei Feng
- Xiangjing Kuang
- Xinling Liu (ORCID: https://orcid.org/0000-0003-3106-670X)
- Yan Liu (ORCID: https://orcid.org/0000-0002-2566-6867)
- Rong Chen (ORCID: https://orcid.org/0000-0001-8751-9590)
- Yong Zhang (ORCID: https://orcid.org/0000-0002-2692-5437)
- Hongjun Li (ORCID: https://orcid.org/0000-0001-6941-9852)
- Yanxia Wang (ORCID: https://orcid.org/0000-0002-2348-0946)
- Zhongyu Hu (ORCID: https://orcid.org/0000-0001-5781-971X)
- Jinyuan Wu (ORCID: https://orcid.org/0000-0001-6125-1821)
- Lili Huang (ORCID: https://orcid.org/0000-0002-3939-6028)
- Jiebing Tan
- Shan Yi
- Wangyang You
Institutions
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- China Banking Regulatory Commission (CN)
- National Institutes for Food and Drug Control (CN)
- Henan Provincial Center for Disease Control and Prevention (CN)
Publication Details
- Journal
- Vaccines
- Published
- 2025-03-30
- DOI
- https://doi.org/10.3390/vaccines13040369
- Primary Topic
- Viral gastroenteritis research and epidemiology
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Fundamental Research Funds for the Central Universities