Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China
Background Adolescents and adults who contract chickenpox are at a higher risk of severe complications. Vaccination with the varicella vaccine (VarV) effectively prevents chickenpox.Research design and methods In this phase III, single-center, randomized, double-blind, active-controlled trial, 1,200...
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Taylor & Francis Group
2025-12-01
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| Series: | Expert Review of Vaccines |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/14760584.2025.2457463 |
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| author | Yang Zhang Shiyuan Wang Guifan Li Jinhui Shi Xianyun Chang Hao Zhang Fengcai Zhu Jingxin Li Hongxing Pan Jinfang Sun |
| author_facet | Yang Zhang Shiyuan Wang Guifan Li Jinhui Shi Xianyun Chang Hao Zhang Fengcai Zhu Jingxin Li Hongxing Pan Jinfang Sun |
| author_sort | Yang Zhang |
| collection | DOAJ |
| description | Background Adolescents and adults who contract chickenpox are at a higher risk of severe complications. Vaccination with the varicella vaccine (VarV) effectively prevents chickenpox.Research design and methods In this phase III, single-center, randomized, double-blind, active-controlled trial, 1,200 healthy participants randomly assigned in a 1:1 ratio to receive two doses of either the test vaccine or the active control vaccine. Varicella-zoster virus (VZV) antibody was detected before vaccination and 42 days after two doses of vaccination.Results The lower limits of the 95% CI for the differences in seroconversion rates and geometric mean titer (GMT) ratios between the two groups were greater than their respective pre-set non-inferiority margins. The overall incidence of Adverse events (AEs) and adverse reactions (ARs) in the test group were significantly lower than those in the control group. Additionally, the incidence rates of swelling and fatigue were lower in the test group compared to the control group after vaccination.Conclusions The test freeze-dried live attenuated VarV demonstrated good immunogenicity and higher safety compared to the active control vaccine in healthy participants aged 13-55 years.Clinical trials registration www.clinicaltrials.gov identifier: NCT06592456. |
| format | Article |
| id | doaj-art-9fcbb3e9f8b942f08d2ba9045e181437 |
| institution | Kabale University |
| issn | 1476-0584 1744-8395 |
| language | English |
| publishDate | 2025-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Expert Review of Vaccines |
| spelling | doaj-art-9fcbb3e9f8b942f08d2ba9045e1814372025-02-07T07:56:43ZengTaylor & Francis GroupExpert Review of Vaccines1476-05841744-83952025-12-0110.1080/14760584.2025.2457463Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in ChinaYang Zhang0Shiyuan Wang1Guifan Li2Jinhui Shi3Xianyun Chang4Hao Zhang5Fengcai Zhu6Jingxin Li7Hongxing Pan8Jinfang Sun9Department of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, PR ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, PR ChinaRegistration Department, Beijing Minhai Biotechnology Co.,Ltd, Beijing, ChinaRegistration Department, Beijing Minhai Biotechnology Co.,Ltd, Beijing, ChinaRegistration Department, Beijing Minhai Biotechnology Co.,Ltd, Beijing, ChinaRegistration Department, Beijing Minhai Biotechnology Co.,Ltd, Beijing, ChinaVaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR ChinaVaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR ChinaVaccine Clinical Evaluation Department, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, PR ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Southeast University, Nanjing, PR ChinaBackground Adolescents and adults who contract chickenpox are at a higher risk of severe complications. Vaccination with the varicella vaccine (VarV) effectively prevents chickenpox.Research design and methods In this phase III, single-center, randomized, double-blind, active-controlled trial, 1,200 healthy participants randomly assigned in a 1:1 ratio to receive two doses of either the test vaccine or the active control vaccine. Varicella-zoster virus (VZV) antibody was detected before vaccination and 42 days after two doses of vaccination.Results The lower limits of the 95% CI for the differences in seroconversion rates and geometric mean titer (GMT) ratios between the two groups were greater than their respective pre-set non-inferiority margins. The overall incidence of Adverse events (AEs) and adverse reactions (ARs) in the test group were significantly lower than those in the control group. Additionally, the incidence rates of swelling and fatigue were lower in the test group compared to the control group after vaccination.Conclusions The test freeze-dried live attenuated VarV demonstrated good immunogenicity and higher safety compared to the active control vaccine in healthy participants aged 13-55 years.Clinical trials registration www.clinicaltrials.gov identifier: NCT06592456.https://www.tandfonline.com/doi/10.1080/14760584.2025.2457463Varicella vaccinephase IIIimmunogenicitysafetyadolescentsadults |
| spellingShingle | Yang Zhang Shiyuan Wang Guifan Li Jinhui Shi Xianyun Chang Hao Zhang Fengcai Zhu Jingxin Li Hongxing Pan Jinfang Sun Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China Expert Review of Vaccines Varicella vaccine phase III immunogenicity safety adolescents adults |
| title | Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China |
| title_full | Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China |
| title_fullStr | Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China |
| title_full_unstemmed | Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China |
| title_short | Immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years: a double-blind, randomized, active-controlled phase iii clinical trial in China |
| title_sort | immunogenicity and safety of a live attenuated varicella vaccine in healthy subjects aged between 13 to 55 years a double blind randomized active controlled phase iii clinical trial in china |
| topic | Varicella vaccine phase III immunogenicity safety adolescents adults |
| url | https://www.tandfonline.com/doi/10.1080/14760584.2025.2457463 |
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