[Translation] A single-center, blinded, placebo- and positive vaccine-controlled phase I clinical trial of the safety, tolerability, and preliminary exploration of immunogenicity of quadrivalent influenza virus split vaccine (MDCK cells) in healthy people aged 6 months and above

主要目的：四价流感病毒裂解疫苗（MDCK细胞）在6月龄及以上健康人群中接种的安全性。次要目的：四价流感病毒裂解疫苗（MDCK细胞）在6月龄及以上健康人群中接种的免疫原性。探索性目的：探索3~8岁人群以2种免疫程序接种四价流感病毒裂解疫苗（MDCK细胞）的免疫原性。

[Translation]

Primary objective: Safety of quadrivalent influenza virus split vaccine (MDCK cells) in healthy people aged 6 months and above. Secondary objective: Immunogenicity of quadrivalent influenza virus split vaccine (MDCK cells) in healthy people aged 6 months and above. Exploratory objective: Explore the immunogenicity of quadrivalent influenza virus split vaccine (MDCK cells) in 2 immunization schedules in people aged 3 to 8 years.

Start Date30 Mar 2024

Sponsor / Collaborator

Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.

[+2]

CTR20221439 / CompletedPhase 3

四价流感病毒裂解疫苗（成人规格）在中国 3 岁及以上健康人群中进行的单中心、随机、双盲、同类制品平行对照Ⅲ期临床试验

[Translation] A single-center, randomized, double-blind, parallel-controlled phase III clinical trial of quadrivalent influenza virus split vaccine (adult specification) in healthy people aged 3 years and above in China

主要目的：评价试验疫苗在 3 周岁及以上人群中接种的免疫原性。次要目的：评价试验疫苗在 3 周岁及以上人群中接种的安全性。

[Translation]

Primary objective: To evaluate the immunogenicity of the trial vaccine in people aged 3 years and above. Secondary objective: To evaluate the safety of the trial vaccine in people aged 3 years and above.

Start Date10 May 2022

Sponsor / Collaborator

Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.

CTR20211439 / CompletedPhase 1/2

四价流感病毒裂解疫苗（成人规格）在中国3岁及以上健康人群中进行的单中心、开放式设计I/II期临床试验

[Translation] A single-center, open-label phase I/II clinical trial of quadrivalent influenza virus split vaccine (adult specification) in healthy people aged 3 years and above in China

主要目的是初步评价四价流感病毒裂解疫苗的安全性和耐受性。次要目的是探索四价流感病毒裂解疫苗在 3-8 周岁人群中 2 针次免疫程序的免疫原性和安全性。所有受试者接种后观察30分钟即时反应、0~7天的全身和局部不良事件、0~28/30天不良事件，报告免后6个月严重不良事件。检测受试者免前和末次免疫后30天外周静脉血血清中HI抗体，评价试验疫苗的免疫原性。

[Translation]

The primary objective is to preliminarily evaluate the safety and tolerability of the quadrivalent influenza virus split vaccine. The secondary objective is to explore the immunogenicity and safety of the two-dose immunization program of the quadrivalent influenza virus split vaccine in people aged 3-8 years. All subjects were observed for immediate reactions within 30 minutes after vaccination, systemic and local adverse events within 0-7 days, and adverse events within 0-28/30 days, and serious adverse events were reported 6 months after vaccination. HI antibodies were detected in the peripheral venous serum of the subjects before immunization and 30 days after the last immunization to evaluate the immunogenicity of the trial vaccine.

Start Date20 Jun 2021

Sponsor / Collaborator

Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.

100 Clinical Results associated with Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.

01 Jan 2018·Cellular Physiology and Biochemistry

The Protective Effects of the A/ZJU01/ PR8/2013 Split H7N9 Avian Influenza Vaccine Against Highly Pathogenic H7N9 in BALB/c Mice

Article

Author: Wu, Nan-Ping ; Hu, Chen-Yu ; Hu, Feng-Yu ; Yao, Hangping ; Zhang, Fu-Chun ; Wu, Xiao-Xin ; Ou, Hui-Lin ; Yao, Wei ; Yu, Dong-Shan ; Weng, Tian-Hao ; Deng, Xi-Long ; Li, Lan-Juan

Background/Aims: Since the first case of novel H7N9 infection was reported, China has experienced five epidemics of H7N9. During the fifth wave, a highly pathogenic H7N9 strain emerged. In order to assess whether the H7N9 vaccine based on A/Zhejiang/DTID-ZJU01/2013(H7N9) was effective in protecting against highly pathogenic H7N9, we conducted this study. Methods: Groups of mice were immunized twice by intraperitoneal injection with 500 µl of either split vaccine alone or MF59-adjuvanted vaccine. Serum was collected 2 weeks after the second vaccine booster. The hemagglutinin inhibition test was conducted on vaccine seed and highly pathogenic H7N9 to evaluate the neutralization of highly pathogenic H7N9. We also immunized mice and challenged them with highly pathogenic H7N9. Mice were observed for illness, weight loss, and death at 1 week and 2 weeks post-infection. Then, the mice were sacrificed and lungs were removed. Antibody responses were assessed and pathological changes in the lung tissue were evaluated. Results: The ability of serum to neutralize highly pathogenic H7N9 was reduced. In mice, highly pathogenic H7N9 was more virulent than A/Zhejiang/DTID-ZJU01/2013(H7N9). After challenge with highly pathogenic H7N9, all mice died while mice challenged with A/Zhejiang/DTID-ZJU01/2013(H7N9) all recovered. The A/ZJU01/PR8/2013 split H7N9 avian influenza vaccine was able to protect against infection with highly pathogenic H7N9 in mice, with or without MF59. Moreover, H7N9 vaccine adjuvanted with MF59 produced high antibody levels, which lead to better protection. Conclusions: The A/ZJU01/PR8/2013 split H7N9 avian influenza vaccine based on A/Zhejiang/DTID-ZJU01/2013(H7N9) is effective in protecting against highly pathogenic H7N9. H7N9 vaccine adjuvanted with MF59 offers better protection against infection with highly pathogenic H7N9. In order to make the H7N9 vaccine applicable to humans, further clinical trials are required to evaluate MF59 adjuvanted vaccine. Meanwhile, the vaccine strain should be updated based on the highly pathogenic H7N9 gene sequence.

03 Nov 2017·Oncotarget

Longevity of protective immune responses induced by a split influenza A (H7N9) vaccine mixed with MF59 adjuvant in BALB/c mice

Article

Author: Li, Lanjuan ; Wu, Nanping ; Wu, Xiaoxin ; Yu, Dongshan ; Yao, Hangping ; Wang, Frederick X.C. ; Weng, Tianhao ; Wu, Haibo ; Cheng, Linfang ; Lu, Xiangyun ; Ou, Huilin ; Chen, Honglin ; Yao, Wei

The influenza virus is a serious threat to public health worldwide. A novel avian influenza A (H7N9) virus with a mortality rate of approximately 30% has been identified as an unusually dangerous virus for humans by the World Health Organization. Pathogenic H7N9 continue to represent a public health concern, and several candidate vaccines are currently in development. We generated candidate H7N9 vaccine strains using reverse genetics, consisting of hemagglutinin and neuraminidase genes derived from a human H7N9 virus and the remaining genes from the PR8 (A/PuertoRico/8/34 (H1N1)) virus. This H7N9 vaccine exhibited superior efficacy when combined with MF59 compared to other adjuvants. Immunized BALB/c mice were followed to determine the duration of the protective immune response. Antibody levels decreased to between one-half and one-eighth of the peak values four months after the final dose of the vaccine. Previously vaccinated mice received an A/Zhejiang/DTID-ZJU01/2013 H7N9 challenge six months post-vaccination, and all remained protected. We also verified that MF59 enhanced the HI, MN, and IgG antibody titers to influenza antigens. The humoral immune response and Th2 cytokine production following influenza challenge was potently induced in the animals that received the split vaccine. Therefore, the split H7N9 influenza vaccine with the MF59 adjuvant could effectively induce antibody production and protect mice from H7N9 virus challenge even after six months.

06 Dec 2016·Oncotarget

Preclinical evaluation of the safety and pathogenicity of a live attenuated recombinant influenza A/H7N9 seed strain and corresponding MF59-adjuvanted split vaccine

Article

Author: Wu, Haibo ; Weng, Tianhao ; Yao, Hangping ; Han, Chengcong ; Wu, Nanping ; Li, Lanjuan ; Wang, Frederick X.C. ; Lu, Xiangyun ; Ou, Huilin ; Chen, Honglin ; Cheng, Linfang ; Yao, Wei ; Yu, Dongshan

Developing a safe and effective H7N9 influenza vaccine was initiated in early spring 2013, following human infections with a novel avian influenza A (H7N9) virus. In this study, a candidate H7N9 vaccine seed strain is produced using reverse genetics, with HA and NA derived from a human H7N9 virus and the remaining genes from the PR8 backbone virus which grows well in eggs. We verified that the virulence and transmissibility of the recombinant H7N9 vaccine seed strain were decreased as compared to wild-type H7N9 virus, to levels comparable with PR8. Using the seed virus, we produced a monovalent split influenza A (H7N9) MF59-adjuvanted vaccine that was immunogenic in mice. Our H7N9 vaccine is selected for clinical investigation and potential human use. To assess the safety of our H7N9 vaccine, we performed acute toxicity, repeated dose toxicity and active systemic anaphylaxis tests. Our results showed that, under the conditions used in this study, the NOEAL (no obvious adverse effect level) was 30 μg/0.5 mL.

100 Deals associated with Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Nov 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

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Group A and C Meningococcal Polysaccharide Vaccine(Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.)	Meningitis More	Approved
Haemorrhagic fever with renal syndrome bivalent vaccine(Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.)	Hemorrhagic Fevers, Viral More	Approved
Influenza A virus H1N1 vaccine	Influenza A virus infection More	Approved
Diphtheria,Tetanus and Acellular Pertussis Combined Vaccine,Adsorbed(Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.)	Whooping Cough More	Approved
Group A polysaccharide vaccine(Zhejiang Tianyuan Bio-Pharmaceutical Co., Ltd.)	Meningitis, Meningococcal More	Approved

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