Immunogenicity Persistence of Different Immunization Regimens of Rabies Vaccine in the 10–60 Years Age Group: A Follow-Up Report Based on Phase III Clinical Trial
<b>Objectives:</b> This study evaluated the 12-month persistence of rabies virus-neutralizing antibody (RVNA) following different immunization regimens of freeze-dried human rabies vaccine (Vero cells) in individuals aged 10-60 years within the Chinese population. <b>Methods:</b> Number of 600 participants from phase III clinical trials who completed the fullimmunization were randomly assigned into one of three groups, four-dose experimental group, five-dose experimental group, and five-dose control group. The experimental group received the vaccine from Shandong Yeedu Biotechnology Co., while the control group used the vaccine from Liaoning Chengda Biotechnology Co., Ltd. The antibody-positive rate and geometric mean concentration (GMC) were calculated, and analysis of variance was used to compare the results among the three groups. <b>Results:</b> The study included 200 participants in the four-dose experimental group, 186 in the five-dose experimental group, and 214 in the five-dose control group. Twelve months post-immunization, the overall RVNA-positive rates were 97.00%, 93.55%, and 94.86% in the four-dose experimental, five-dose control, and five-dose experimental groups, respectively. The GMCs of RVNA were 2.50, 2.05, and 2.04 IU/mL for the respective groups. The age-stratified analysis exhibited high positivity rates across age groups (≤21, 21-50, and ≥50), with rates ranging from 88.4% to 100%, and GMCs were between 1.75 and 2.61 IU/mL. <b>Conclusions:</b> Twelve months after full immunization, the overall RVNA-positive rate remained high across all dosing regimens, demonstrating satisfactory immunogenicity persistence. This indicates that both the four-dose and five-dose regimens are effective in maintaining long-term immunity against rabies.
Authors
- Zhaojun Mo (ORCID: https://orcid.org/0000-0001-5183-4302)
- Leitai Shi (ORCID: https://orcid.org/0000-0001-9713-8855)
- Yunpeng Wang (ORCID: https://orcid.org/0000-0002-9740-9544)
- Shouchun Cao (ORCID: https://orcid.org/0000-0001-6212-260X)
- Danhua Zhao (ORCID: https://orcid.org/0000-0002-1950-4845)
- Zhiang Wu
- Xiaohong Wu (ORCID: https://orcid.org/0009-0002-6471-1285)
- Haiyan Liang (ORCID: https://orcid.org/0009-0004-9854-9663)
- Jia Li (ORCID: https://orcid.org/0000-0002-1167-5439)
Institutions
- National Institutes for Food and Drug Control (CN)
- Guangxi Center for Disease Prevention and Control (CN)
Publication Details
- Journal
- Vaccines
- Published
- 2024-10-24
- DOI
- https://doi.org/10.3390/vaccines12111209
- Citations
- 1
- Primary Topic
- Rabies epidemiology and control
- Type
- article
- Field-Weighted Citation Impact
- 0.29