This study consists of two parts. Part 1 is a retrospective cohort study and part 2 is a prospective cohort study. In Part 1 ,the scaled logit model was used to assess the correlation between varicella-zoster virus (VZV) antibody titers using fluorescent-antibody-to-membrane-antigen assay (FAMA) 30 days after varicella vaccine immunization and the risk of subsequent varicella breakout/disease , to determine the protective threshold for achieving FAMA antibodies. Part 2 was to validate the model in part 1.

Start Date10 Oct 2024

Sponsor / Collaborator

Sinovac (Dalian) Vaccine Technology Co. Ltd.

NCT06484686 / Not yet recruitingPhase 4

An Open-label Clinical Trial to Evaluate the Immunity Persistence of Live Attenuated Varicella Vaccine at 6 and 10 Years After Booster Dose Immunization With Live Attenuated Varicella Vaccine

This an open-label phase Ⅳ clinical trial of live attenuated varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.The purpose of this study is to evaluate the immunity persistence of live attenuated varicella vaccine at 6 and 10 years after booster dose.

Start Date01 Sep 2024

Sponsor / Collaborator

Sinovac (Dalian) Vaccine Technology Co. Ltd.

CTR20240871 / RecruitingPhase 1

评价口服六价重配轮状病毒减毒活疫苗（Vero细胞）在健康成人、儿童中的开放性观察及在健康婴儿中安全性、耐受性和免疫原性的随机、双盲、安慰剂对照Ⅰ期临床试验

[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability and immunogenicity of oral hexavalent reassortant rotavirus live attenuated vaccine (Vero cells) in healthy adults and children and in healthy infants

主要目的：评价轮状疫苗在健康成人、儿童和婴儿中的安全性；次要目的：评价轮状疫苗在健康成年人、儿童和婴儿中的安全性；评价轮状疫苗在健康婴儿中的免疫原性和免疫持久性；评价健康婴儿接种轮状疫苗后的粪便排毒情况；评价健康婴儿接种轮状疫苗后的粪便样本中轮状疫苗毒株重配、返祖情况。

[Translation]

Primary objective: To evaluate the safety of rotavirus vaccine in healthy adults, children and infants; Secondary objectives: To evaluate the safety of rotavirus vaccine in healthy adults, children and infants; To evaluate the immunogenicity and immune persistence of rotavirus vaccine in healthy infants; To evaluate the fecal excretion of rotavirus vaccine in healthy infants after rotavirus vaccine vaccination; To evaluate the reassortment and reversion of rotavirus vaccine strains in fecal samples of healthy infants after rotavirus vaccine vaccination.

Start Date27 Mar 2024

Sponsor / Collaborator

Sinovac (Dalian) Vaccine Technology Co. Ltd.

[+1]

100 Clinical Results associated with Sinovac (Dalian) Vaccine Technology Co. Ltd.

0 Patents (Medical) associated with Sinovac (Dalian) Vaccine Technology Co. Ltd.

Literatures (Medical) associated with Sinovac (Dalian) Vaccine Technology Co. Ltd.

01 Jan 2024·Vaccine

Immunogenicity and safety of a live-attenuated varicella vaccine in a healthy population aged 13 years and older: A randomized, double-blind, controlled study

Article

Author: Wang, Yanxia ; Luan, Chunfang ; Jia, Ningning ; Chen, Zhen ; Huang, Lili ; Li, Changgui ; Feng, Guangwei ; Yuan, Hongxue ; Quan, Yaru ; Tan, Jiebing ; Song, Yufei ; You, Wangyang

OBJECTIVESVaccines for prevention against varicella are important for adolescents and adults, who have an increased risk of severe varicella. This study aimed to evaluate the immunogenicity and safety of a two-dose immunization schedule of a live-attenuated varicella vaccine (VarV) manufactured by Sinovac (Dalian) in healthy adolescents and adults.METHODSA randomized, double-blind, controlled clinical trial was conducted in healthy population aged ≥ 13 years old in China. Participants in block 1 were randomly assigned (1:1) to receive two doses of either the test vaccine or an active control vaccine, administered 4, 6 or 8 weeks apart. Participants in block 2 were randomly assigned (2:1) to receive two doses of test vaccine or placebo, administered 10 weeks apart. The primary immunogenicity endpoint was the seroconversion rates and GMTs of varicella zoster virus (VZV) antibodies measured by fluorescent-antibody-to-membrane-antigen (FAMA) 4 weeks post-immunization. The primary safety endpoint was the incidence of adverse reactions within 4 weeks after each dose.RESULTSA total of 2398 participants were enrolled. The seroconversion rates of VZV antibodies were 79.55 % in the test group and 76.41 % in the active control group respectively 4 weeks after two doses of pooled schedule, with the difference of 3.14 % (95 %CI: -0.69 %, 6.97 %). The GMTs were 1:162.07 and 1:160.04 respectively, with the ratio of 1.013 (95 %CI: 0.910, 1.127). Both the seroconversion rates and GMTs reached the prespecified non-inferiority criteria. Two-dose schedule with an interval of 10 weeks could also induce high immune responses, with a seroconversion rate of 83.22 % and a GMT of 1:160.38 in the test group. Safety profiles were similar among the test group, active control group and placebo group.CONCLUSIONVarV, manufactured by Sinovac (Dalian), demonstrated higher immune response and better flexibility in the immunization schedule among heathy population aged 13 years and older, without increased safety risk.

01 Aug 2019·Clinical Microbiology and InfectionQ1 · MEDICINE

Efficacy, safety and immunogenicity of live attenuated varicella vaccine in healthy children in China: double-blind, randomized, placebo-controlled clinical trial

Q1 · MEDICINE

Article

Author: Yuan, L ; Xu, B ; Luan, C ; Bao, M ; Wang, Y ; Tian, X ; Xia, S ; Huang, L ; Zeng, G ; Chen, Z ; Chen, J ; Xie, Z ; Hao, B ; Huang, J ; Wu, J

OBJECTIVESTo evaluate the efficacy, safety and immunogenicity of a human diploid cell SV-1 strain-based live attenuated varicella vaccine in children aged 1 to 12 years.METHODSWe conducted a randomized, double-blind, placebo-controlled trial in China in which healthy children were randomly assigned in a 1:1 ratio to receive one dose of varicella vaccine or placebo. The efficacy monitoring period was 6 to 7 months for each subject. The primary endpoint was the occurrence of laboratory-confirmed varicella. Efficacy and immunity were assessed in the per-protocol cohort, and safety was assessed in the total vaccinated cohort. The file was registered with ClinicalTrials.gov (NCT02981836).RESULTSBetween 22 August 2016 and 19 September 2016, a total of 5997 children (2997 in the varicella vaccine group and 3000 in the placebo group) were vaccinated, and 5991 children (2995 in the varicella vaccine group and 2996 in the placebo group) were included in the per-protocol efficacy cohort. The efficacy of the vaccine was 87.1% (95% confidence interval, 69.7-94.5) against varicella (six cases vs. 46 cases) and 89.2% (95% confidence interval, 72.9-95.7) breakthrough varicella (five cases vs. 46 cases). No significant difference in solicited adverse reactions was found between the two groups. Serious advent events occurred among 0.8% (25/2998) children in the vaccine group and 0.7% (22/2999) in the placebo group. In the immunogenicity subgroup, the seroconversion rate was 97.1% (339/349) in the vaccine group. An antibody titre of 1:8 was associated with protection against varicella.CONCLUSIONSThe varicella vaccine was effective in the prevention of varicella in children.

Zhongguo Shengwu Zhipinxue Zazhi

Development and verification of a fluorescent quantitative reverse transcription-polymerase chain reaction assay for infectious titer of live attenuated mumps vaccine

Author: Wang, Shuang ; Li, Jing ; Liu, Xian-chao ; Meng, Fan-hong ; Yin, Wei-dong ; Huang, Jin-feng ; Sha, Xue-yan

Objective: To develop and verify a fluorescent quant. reverse transcription-polymerase chain reaction (RT-PCR) assay for infectious titer of live attenuated mumps vaccine.Methods: Primers and Taq Man fluorescent probe were designed specific to the conserved region of hemagglutinin (H) gene of live attenuated mumps vaccine virus strain S79.The final product prepared with strain S79, with a lot Number of 05008, was served as a referenceVero cells were inoculated with the reference or test sample, then broken by hypoosmotic method combined with freeze-thawing method, of which the supernatant was collected and determined by fluorescent quant. RT-PCR.The time for virus infection was optimized, and the developed method was verified for specificity, precision and accuracy.Results: The optimal time for virus infection was 18 h.The developed fluorescent quant. RT-PCR assay was specific to live attenuated mumps vaccine, while no amplification curves were observed in the vaccine after inactivation, varicella virus, rabies virus, measles virus, rebulla virus or Vero cells.The relative standard deviations (RSDs) of six groups of data on samples at four concentrations (1, 1:5, 1:52 and 1:53) were less than 5%.The R2 values of regression equation of standard curves of samples at four concentrations (1, 1:5, 1:52 and 1:53) determined by various personnel on various dates were more than 0.97, with RSDs of less than 5%.The difference between determination results of 11 batches of live attenuated mumps vaccine by the developed method and by CPE method was not more than 0.2 Lg CCID₅₀/mL, which showed no significant difference (P>0.05).Conclusion: The developed fluorescent quant. RT-PCR assay for infectious titer of live attenuated mumps vaccine showed high specificity, precision and accuracy, which was rapid, simple, and suitable for the inhouse quality control during production

100 Deals associated with Sinovac (Dalian) Vaccine Technology Co. Ltd.

100 Translational Medicine associated with Sinovac (Dalian) Vaccine Technology Co. Ltd.

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Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

IND Application

Phase 1 Clinical

Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Varicella zoster virus vaccine(Sinovac Biotech Ltd.)	Varicella Zoster Virus Infection More	Approved
Mumps virus vaccine (Sinovac (Dalian) Vaccine Technology Co. Ltd.)	Mumps More	Approved
Rotavirus vaccine (Sinovac Biotech)	Viral gastroenteritis due to Rotavirus More	Phase 1
Rotavirus vaccine(Sinovac)	-	IND Application

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