A simulated, randomized study on the safety and immunogenicity of three consecutive commercial-scale batches of the CTN-1V strain human rabies vaccine to verify the inter-batch consistency
Open accessAbstract
In this study, we sought to evaluate the inter-batch consistency and safety of the CTN-1 V human rabies vaccine (Vero cells). A total of 594 healthy participants aged 10-60 years were enrolled from Mianzhu, Sichuan Province, and randomized into three batch groups to receive vaccination via the Essen Regimen, that is, a single dose on days 0, 3, 7, 14, and 28 in the deltoid muscle of the upper arm. The serum antibody geometric mean concentration (GMC) and positive conversion rate of each group were determined using a rapid fluorescence focus inhibition test (RFFIT) before the first-dose immunization, 14 d after the first-dose immunization, and 14 d and 12 mo after full immunization. Adverse events (AEs) 30 min and 30 d after immunization were observed in each group. There were 322 cases of AEs during the observation period, with an overall incidence of 54.4%. The incidences of AEs in groups A, B, and C were 57.4%, 51.5%, and 54.3%, respectively. There were no significant differences among the groups (P > .05). Moreover, there were no significant differences (P > .05) in the serum GMC or antibody-positive conversion rate between any two groups at any time point. The bilateral 95% confidence interval of the GMC ratio between any two groups 14 d after the first-dose immunization was within the range of 0.67-1.50. This study shows that the CTN-1 V human rabies vaccine (Vero cells) has reliable safety and stable immunogenicity between batches.
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
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 [18]
The Discussion (page not provided) reports reliable safety and sustained antibody responses up to 12 months for the CTN-1V vaccine. The study measured immunogenicity, not prevention of rabies, and does not establish that the vaccine is suitable for rabies prevention and control across China. (LLM, conf=0.84)
Experimental — accuracy not yet measuredAfter passage and adaptation to Vero cells, the CTN strain was transformed into a fixed strain with suitable safety and immunogenicity.
“After passage and adaptation to Vero cells, it was transformed into a fixed strain with suitable safety and immunogenicity [18].”
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 [18]
The Introduction (page unavailable) identifies CTN-1 V as the vaccine’s production strain and describes its good immunogenicity. The Abstract (page unavailable) reports reliable safety and stable immunogenicity for the Vero-cell vaccine. Neither passage says that passage and adaptation to Vero cells transformed the CTN strain into a fixed strain. (LLM, conf=0.82)
Experimental — accuracy not yet measured
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Cites
No references could be resolved yet.
Research works printed but not linked: 13
- [1]Hm F Jr, Petersen BW, Robertson KL, Rupprecht CE. Rabies: still a uniformly fatal disease? Historical occurrence, epidemiological trends, and paradigm shifts. Curr Infect Dis Rep. 2012; 14(4): 1– 9. doi: 10.1007/s11908-012-0268-2. PMID: 22699971. 22699971 · DOI
- [2]Hampson K, Coudeville L, Lembo T, Sambo M, Kieffer A, Attlan M, Barrat J, Blanton JD, Briggs DJ, Cleaveland S, et al. Estimating the global burden of endemic canine rabies [published correction appears in PLoS Negl Trop Dis. 2015 May;9(5):e0003786]. PLoS Negl Trop Dis. 2015; 9(4): e0003709. doi: 10.1371/journal.pntd.0003709. PMID: 25881058. 25881058 PMC4400070 · DOI
- [3]Pichon S, Guinet-Morlot F, Minutello M, Donazzolo Y, Rouzier R, Chassard D, Fitoussi S, Hou V. A serum-free, purified Vero cell rabies vaccine is safe and as immunogenic as the reference vaccine Verorab for pre-exposure use in healthy adults: results from a randomized controlled phase-II trial. Vaccine. 2013; 31(18): 2295– 301. doi: 10.1016/j.vaccine.2013.02.058. PMID: 23510665 23510665 · DOI
- [5]Guanmu D, Gelin X, Qiyou X, Dingming W, Yuemei H, Dunjin Z, Ping W, Yongzhen Z, Xiaoming Y, Fengcai Z, et al. Epidemiological investigation of rabies virus in domestic dogs, cats, and wild animals and observation on the immune effect of different rabies vaccines in China. Chin J Virol. 2007; 23(6): 417– 23. doi: 10.3321/j.1000-8721.2007.06.001. · DOI
- [6]Manrong C, Jie W, Shengli M, Gelin X. Protection of CTN-1V human rabies vaccine prepared by CTN strain against challenge with representative rabies street virus strains in China. Chin J Biol. 2008; 21(9): 786– 87. doi: 10.13200/j.cjb.2008.09.55.chengmr.018. · DOI
- [7]Huang T, Li Y, Mo S, Li J, Nan R, Zhou L, Wang M, Nie F, Chen J, Yang T, et al. Safety and immunogenicity of domestic rabies vaccine (Vero cells) for human use prepared with CTN-1V strain in healthy population. Chin J Biologicals. 2018; 31(6): 624– 628, 637. doi: 10.13200/j.cnki.cjb.002201. · DOI
- [9]Ling Z, Tianxi Z, Kewen S, Siwei T, Ji S, Haipeng Y. Evaluation of the efficacy of rapid fluorescent foci inhibition test for the detection of rabies virus neutralizing antibodies. Chin J Health Inspection. 2021; 31: 2076– 79.
- [10]World Health Organization. Rabies vaccines: WHO position paper, April 2018 - Recommendations. Vaccine. 2018; 36(37): 5500– 03. doi: 10.1016/j.vaccine.2018.06.061. PMID: 30107991. 30107991 · DOI
- [11]Fishbein DB, Yenne KM, Dreesen DW, Teplis CF, Mehta N, Briggs DJ. Risk factors for systemic hypersensitivity reactions after booster vaccinations with human diploid cell rabies vaccine: a nationwide prospective study. Vaccine. 1993; 11(14): 1390– 94. doi: 10.1016/0264-410x(93)90167-v. PMID: 8310759 8310759 · DOI
- [13]Haupt W. Rabies-risk of exposure and current trends in prevention of human cases. Vaccine. 1999; 17(13–14): 1742– 49. doi: 10.1016/s0264-410x(98)00447-2. PMID: 10194833 10194833 · DOI
- [14]Manning SE, Rupprecht CE, Fishbein D, Hanlon CA, Lumlertdacha B, Guerra M, Meltzer MI, Dhankhar P, Vaidya SA, Jenkins SR, et al. Human rabies prevention-United States, 2008: recommendations of the advisory committee on immunization practices. MMWR Recomm Rep. 2008; 57(RR–3): 1– 28. PMID: 18496505. 18496505
- [15]Xinxiong Z, Yutao Z, Wei C, Wen S, Huafang D, Shi H, Zuolin H, Lingbing Z, Gelin X. Clinical trials of adjuvant-free freeze-dried rabies vaccine for human use. Chin J Biol. 2007; 4: 276– 77. doi: 10.13200/j.cjb.2007.04.49.zhengxx.014. · DOI
- [16]Lirong H, Tengrong L, Guiqiu P, Shouchun C, Wei Z, Yuting H, Mingli L, Yanping L. Safety and immunogenicity of freeze-dried rabies vaccine (Vero cells) for human use in healthy population at ages of 10 - 60 years. Chin J Biol. 2017; 30(3): 283– 87. doi: 10.13200/j.cnki.cjb.001685. · DOI
Cited by
Sorted by citations
Li, J., Pan, R., Yue, F., Gao, T., Wu, X., Shi, L., Wang, Y., Zhao, D., Lan, Z., Chen, H., et al. (2024) · Vaccines · doi:10.3390/vaccines12121379 · Cited by 8 · see citing works
Self-citationStudy on immune persistence of the CTN-1V strain rabies vaccine in humans
Wang, L., Li, J., Mu, Q., Zhu, L., Wang, Y., Sheng, Y., Zhao, D., Yang, G., Yu, X., Wu, X., et al. (2024) · Journal of Virus Eradication · doi:10.1016/j.jve.2024.100365 · Cited by 4 · see citing works
Self-citation
- Authors
- Zhou, L., Liu, J., Li, J., Liu, X., Zhang, J., Nie, F., Chen, J., Chai, J., Lv, J., Wang, M., Yu, J., Wu, W., Li, Y., & Zhang, Y.
- Affiliations
- General Manager Office, Dalian Aleph Biomedical Co., Ltd., Dalian, China
- Sichuan University (CN)
- National Institutes for Food and Drug Control (CN)
- Sichuan Center for Disease Control and Prevention (CN)
- Quality Control Department, Dalian Aleph Biomedical Co., Ltd., Dalian, China
- R&D Department, Dalian Aleph Biomedical Co., Ltd., Dalian, China
- Scientific Affairs Department, Simoon Record Beijing Co., Ltd., Beijing, China
- Project Management Department, Simoon Record Beijing Co., Ltd., Beijing, China
- Corresponding author
- Li, Yuhua
- Zhang, Yuhui
- Venue
- Human Vaccines & Immunotherapeutics
- Publisher
- Informa UK Limited
- Published
- 2022-11-21
- Volume
- 18
- Issue
- 6
- Pages
- 2138049-2138049
- ISSN
- 2164-5515 (ISSN-L)
- 2164-554X
- PMC
- PMC9746391
- OpenAlex
- W4309513372
- Cited by
- 5
- References
- 0
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 3
- FWCI
- 0.33
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Human Vaccines & Immunotherapeutics (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- Key Research and Development Program of Liaoning Provincial Department of Science and Technology
- Topics
- Life Sciences › Immunology and Microbiology › Virology › Rabies epidemiology and control
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Endocrinology › Diphtheria, Corynebacterium, and Tetanus
- Health Sciences › Medicine › Epidemiology › Virology and Viral Diseases
- Keywords
- rabies vaccine, Vero cell vaccine, vaccine safety, immunogenicity, adverse events, rabies post-exposure prophylaxis
- MeSH terms
- Immunogenicity, Vaccine, Animals, Antibodies, Viral, Chlorocebus aethiops, Humans, Rabies, Rabies Vaccines, Vaccination, Vero Cells, Healthy Volunteers
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
