Study on immune persistence of the CTN-1V strain rabies vaccine in humans
Open accessAbstract
This study is a single-arm, single-center phase IV clinical trial on a rabies vaccine that has been marketed in China. The Vero cells and CTN-1V strain are used in the rabies vaccine product. The purpose of this study was to investigate the safety, immunogenicity and immune persistence of this product. One hundred and forty-nine participants were enrolled to the study, all of whom were included in the safety analysis set (SS), among which 116 participants were included in the protocol analysis set (PPS), One hundred and fifteen participants were included in the 6-month immune persistence analysis set (IPS6) and 111 in the 12-month immune persistence analysis set IPS12. Results showed that: 1) In the SS analysis set, adverse reactions were mainly pyrexia and pain at the vaccination site, the severity of which were mostly grade 1, and concentrated in 0-3 days after vaccination. No grade 3 or above adverse events and serious adverse events (SAE) related to the experimental vaccine were observed. 2) In the PPS analysis set, the antibody positive conversion rate reached 100% at 14 days after full immunization of the pre-immunized negative population; The antibody geometric mean titer (GMT) (95% CI) was 14.82 (13.00, 16.90). 3) The positive rate of serum neutralizing antibody was 93.91 % and the GMT at 1.58 IU/ml at 6 months after full immunization. The positive rate of neutralizing antibody was 85.59 % and GMT at 1.30 IU/ml at 12 months after immunization. Our results show that the human rabies vaccine with the CTN-1V strain and Vero cells as matrix had good safety, immunogenicity and immune persistence in our study.
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Longitudinal clinical data revealed that the CTN-1 vaccine is safe and effective, making it suitable for rabies prevention and control in China.
“longitudinal clinical data revealed that the vaccine is safe and effective, making it suitable for rabies prevention and control in China [18,21,22,23].”
From Evaluation of the Efficacy of the Vaccine Production Process in Removing Residual Host Cell DNA from the Vero Cell Rabies Vaccine (2024) · cites this paper as [21]
The Abstract (page not provided) reports good safety, immunogenicity, and antibody persistence for the CTN-1V vaccine in a longitudinal clinical trial in China. The study did not measure prevention of rabies, so its findings do not establish clinical effectiveness or the broader conclusion that the vaccine is suitable for rabies prevention and control in China. (LLM, conf=0.84)
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Self-citation
- Authors
- Wang, L., Li, J., Mu, Q., Zhu, L., Wang, Y., Sheng, Y., Zhao, D., Yang, G., Yu, X., Wu, X., & Miao, L.
- Affiliations
- National Institutes for Food and Drug Control (CN)
- Guizhou Center for Disease Control and Prevention (CN)
- Corresponding author
- Yu, Xiaoqing
- Wu, Xiaohong
- Venue
- Journal of Virus Eradication
- Publisher
- Elsevier BV
- Published
- 2024-03
- Volume
- 10
- Issue
- 1
- Pages
- 100365
- ISSN
- 2055-6640 (ISSN-L)
- PMC
- PMC10999804
- OpenAlex
- W4392518902
- Cited by
- 4
- References
- 17
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 1
- FWCI
- 0.93
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Journal of Virus Eradication (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Topics
- Life Sciences › Immunology and Microbiology › Virology › Rabies epidemiology and control
- Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
- Health Sciences › Medicine › Epidemiology › Virology and Viral Diseases
- Keywords
- rabies vaccine, Vero cells, immune persistence, vaccine safety, immunogenicity, neutralizing antibodies, antibody geometric mean titer, adverse events, post-marketing surveillance
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