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Published on: April 19, 2024
Current status of vaccine clinical trials registered on China's Drug Trial Registration and information disclosure
Sumei Zhong1,2, Zhiqiang Lin1, Junrong Li1
1Fujian Provincial Center for Disease Control and Prevention, Fuzhou, Fujian, China.
Background:
Vaccines are critical tools in global infectious disease prevention, especially amid emerging threats such as COVID-19 and HPV-related cancers. In China, vaccine development has gained momentum due to increasing public health demands and supportive regulatory reforms. However, comprehensive analyses of the broader landscape of vaccine clinical trials remain limited. This study aims to provide a systematic overview of vaccine clinical trials registered in China from 2013 to 2024, examining trends in trial design, phase distribution, vaccine types, and geographic distribution.
Methods:
We retrieved data from the Drug Trial Registration and Information Publication Platform using keywords including "vaccine," "BCG," and "toxoid." After deduplication and exclusion of non-vaccine entries, 620 eligible vaccine clinical trials were included. Data on trial design, phase, recruitment status, participant demographics, vaccine type, and institutional affiliations. The data were extracted and statistically analyzed by Microsoft Excel 2021, IBM SPSS Statistics version 21andArcGIS 10.8.1, respectively.
Results:
Among the 620 trials, the majority were parallel-group (84.84%), randomized (81.94%), and double-blind (67.58%). Phase I and III trials accounted for the largest proportions (30.27% and 35.75%, respectively). Influenza (17.1%), HPV (13.4%), and pneumococcal (9.8%) vaccines were the most frequently studied. Most trials were led by CDCs (92.3%) and conducted in eastern provinces, with Jiangsu, Henan, and Guangxi accounting for over half of all trials. The number of registered trials increased steadily from 2013 to 2019, peaking in 2021 and 2023.
Conclusions:
China has seen consistent growth in vaccine clinical trial activity, supported by regulatory enhancements and public health priorities. While trial volume and geographic spread have expanded, opportunities remain to increase multi-center collaboration, insurance coverage, and diversity in trial phases and vaccine types. These findings provide a foundation for evidence-based policy-making and strategic planning in China's vaccine development landscape.
Insights
China
Area of Science:
- Clinical Research
- Vaccinology
- Public Health
Background:
- Vaccines are crucial for preventing infectious diseases and addressing emerging health threats like COVID-19.
- China's vaccine development is advancing due to public health needs and regulatory support.
- Limited comprehensive analyses exist on vaccine clinical trials in China.
Purpose of the Study:
- To systematically review vaccine clinical trials registered in China from 2013 to 2024.
- To analyze trends in trial design, phase distribution, vaccine types, and geographic focus.
- To provide insights into the evolving landscape of vaccine research in China.
Main Methods:
- Data sourced from the Drug Trial Registration and Information Publication Platform.
- Included 620 eligible vaccine clinical trials after deduplication and exclusion.
- Analyzed trial design, phase, participant demographics, vaccine type, and institutional affiliations.
Main Results:
- Most trials were parallel-group (84.84%), randomized (81.94%), and double-blind (67.58%).
- Phase I (30.27%) and Phase III (35.75%) trials were most common.
- Influenza (17.1%), HPV (13.4%), and pneumococcal (9.8%) vaccines were frequently studied; trials concentrated in eastern provinces.
Conclusions:
- China shows consistent growth in vaccine clinical trial activity.
- Opportunities exist to enhance multi-center collaboration and trial diversity.
- Findings support evidence-based policy for China's vaccine development.
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