Delving into the Latest Updates on Human papillomavirus vaccine recombinant 9-valent (Shanghai Zerun Biotechnology) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine, Genetically engineered subunit vaccine

Synonyms

9-valent HPV Recombinant Vaccine (Zerun Biotechnology), 9-valent HPV vaccine (Zerun Biotechnology), Recombinant 9-valent HPV Vaccine (Zerun Biotechnology)

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Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsInfectious DiseasesDigestive System Disorders+ [1]

Active Indication

Anus NeoplasmsHuman Papillomavirus InfectionUterine Cervical Cancer+ [2]

Inactive Indication

Condylomata AcuminataUterine Cervical DysplasiaVulvar intraepithelial neoplasia

Originator Organization

Shanghai Zerun Biotechnology Co., Ltd.

Active Organization

Shanghai Zerun Biotechnology Co., Ltd.

Inactive Organization

Walvax Biotechnology Co., Ltd.

License Organization-

Drug Highest PhasePhase 3

First Approval Date-

Regulation-

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Primary objective: To evaluate the immunogenicity of the 9-valent HPV vaccine in women aged 16-26 years at 0, 2, and 6 months compared with the commercially available 9-valent human papillomavirus vaccine (Saccharomyces cerevisiae). Secondary objective: To evaluate the safety of the 9-valent HPV vaccine. Exploratory objective: To explore the immune response after 1 and 2 doses of the 9-valent HPV vaccine.

Start Date01 Sep 2022

Sponsor / Collaborator

Shanghai Zerun Biotechnology Co., Ltd.

NCT05580341

/ Unknown statusPhase 3

A Phase III, Randomized, Blinded, Positive-controlled Study to Compare the Immunogenicity of Zerun 9-valent Human Papillomarivus (Types 6, 11, 16, 18, 31, 33, 45, 52 and 58) Recombinant Vaccine (Pichia Pastoris) in Healthy Female Subjects Aged 16-26 Years.

This study will evaluate the immunogenicity and safety of Zerun 9-valent HPV recombinant vaccine in healthy female 16-26 years of age by comparing with GARDASIL®9.

Start Date01 Sep 2022

Sponsor / Collaborator

Shanghai Zerun Biotechnology Co., Ltd.

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100 Clinical Results associated with Human papillomavirus vaccine recombinant 9-valent (Shanghai Zerun Biotechnology)

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100 Translational Medicine associated with Human papillomavirus vaccine recombinant 9-valent (Shanghai Zerun Biotechnology)

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100 Patents (Medical) associated with Human papillomavirus vaccine recombinant 9-valent (Shanghai Zerun Biotechnology)

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4

Literatures (Medical) associated with Human papillomavirus vaccine recombinant 9-valent (Shanghai Zerun Biotechnology)

31 Dec 2025·Human Vaccines & Immunotherapeutics

Stability study of recombinant 9-valent human papillomavirus vaccine based on Escherichia coli expression system

Article

Author: Liu, Yongjiang ; Liu, Shujuan ; Zhang, Haijiang ; Zhang, Hongcai ; Chen, Xuejiao ; Yu, Xinyu ; Wang, Huan ; Liu, Yang ; Chen, Dan ; Shen, Ercui ; Jin, Guiying ; Zhao, Li ; Wang, Di ; Li, Shuang ; Wang, Yan ; Liu, Yuying ; Shi, Yazheng ; Yin, Fei ; Du, Xiaoli ; Zhou, Shuyi ; Guo, Jiaping ; Shang, Lulu ; Yang, Zengmin ; Chen, Xiao ; Zhang, Yao ; Wu, Shuming ; Li, Ling

This study reports on the long-term stability of a recombinant 9-valent HPV vaccine, addressing a gap in the literature as previous research did not extend beyond 72 months. The vaccine targets HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 and was produced using an E. coli expression system. We optimized soluble HPV L1 protein expression by truncating the N- and C-termini, resulting in HPV L1 virus-like particles (VLPs). Structural analysis confirmed the VLPs' resemblance to natural ones, suitable for vaccine production. Stability testing encompassed appearance, dosage, pH, osmolarity, aluminum content, polysorbate 80, in vitro relative potency, abnormal toxicity, in vivo potency, sterility, and endotoxin levels. The vaccine showed stability under extreme conditions of light (4500 lx) and shaking table vibration (10-30 rpm) for at least 7 days at 5 ± 3°C. Long-term storage at 5 ± 3°C maintained stability for up to 72 months, while accelerated testing at 25 ± 2°C showed stability for at least 12 months. The findings suggest that the vaccine's potency is best preserved under protection from high temperatures and direct light, with even harsh conditions not significantly compromising stability. This enhances the global distribution potential of the HPV vaccine.

01 Sep 2024·Archives of Pathology & Laboratory Medicine

Epidemiology Characteristics and Potential Cervical Cancer Screening Value of Vulvar Human Papillomavirus in Chinese Women: A Multicenter Cross-Sectional Study

Article

Author: Ji, Ying ; Wang, Xinyu ; Xie, Hongyu ; Zhang, Xiaofei ; Fu, Yunfeng ; Dong, Xiaohui ; Lu, Weiguo ; Li, Xiao

Context.—Noninvasive self-sampling is a convenient option that may be highly accepted by women for home-based detection, which could increase the screening rate for cervical cancer (CC) and reduce its incidence and mortality.Objective.—To compare the distribution of high-risk human papillomavirus (hr-HPV) between the vulva and cervix and to explore the clinical value of vulvar HPV detection in CC screening.Design.—The study was nested within a clinical trial on a recombinant HPV 9–valent vaccine for women ages 20 to 45 years. Women with paired vulvar and cervical specimens were included and underwent cytology and HPV detection. The consistency of HPV detection between vulvar and cervical specimens was evaluated using Cohen κ statistics. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were used to evaluate the diagnostic accuracy of primary CC screening. The primary end points were cervical intraepithelial neoplasia (CIN) grade 2/3 or worse (CIN2+/3+).Results.—A total of 7999 women were enrolled, and 83/33 cases were diagnosed as CIN2+/CIN3+. The HPV-positive rate in vulvar specimens (1785 of 7999; 22.32%) was higher than that in cervical specimens (1390 of 7999; 17.38%), and there were no significant differences in the distribution of hr-HPV genotypes between the vulva and cervix in patients with CIN2+/CIN3+. Vulva-based HPV primary screening showed sensitivity, specificity, PPV, and NPV comparable to those for cervix-based HPV primary CC screening in the detection of CIN3+.Conclusions.—The distribution of vulvar and cervical HPV was similar in patients with CIN2+/CIN3+. Vulva-based HPV primary CC screening had acceptable diagnostic efficacy and might be used as a modality for primary CC screening.

27 Nov 2023·Clinical chemistry and laboratory medicine

Diagnostic accuracy of extended HPV DNA genotyping and its application for risk-based cervical cancer screening strategy.

Article

Author: Li, Xiao ; Rao, Xuan ; Yao, Lifang ; Xie, Hongyu ; Zhang, Juan ; Li, Junyan ; Wang, Xinyu ; Ji, Ying ; Wang, Hui

OBJECTIVESTo evaluate the consistency of 14 high-risk HPVs (hr-HPVs) detection between extended HPV DNA genotyping and a well-validated partial HPV genotyping kit, and to explore the diagnostic accuracy of risk stratification strategy based on extended HPV genotyping for cervical cancer (CC) screening.METHODSBaseline data from a clinical trial of recombinant HPV 9-valent vaccine in China was analyzed. All enrolled women aged 20-45 years received cervical cytology, HPV detection by extended and partial HPV genotyping kits. Those who met the indications would further receive colposcopy. The primary endpoints were cervical intraepithelial neoplasia 2/3 or worse (CIN2+/CIN3+).RESULTSA total of 8,000 women were enrolled between April 2020 and July 2020 and 83/33 cases were diagnosed as CIN2+/CIN3+. The overall agreement between the extended and partial HPV genotyping was 92.66 %. And the agreement further increased with the progression of lesions, which lead to similarly high sensitivity and negative predictive value of these kits. A stratified triage strategy of CC screening was constructed based on the immediate CIN2+/CIN3+ risk of specific HPV. Compared with the conventional HPV primary CC screening strategy, the risk-based strategy had higher specificity for CIN (CIN2+: 94.84 vs. 92.46 %, CIN3+: 96.05 vs. 91.92 %), and needed fewer colposcopies for detecting one cervical disease.CONCLUSIONSExtended HPV genotyping had good agreement with a well-validated partial HPV genotyping CC primary screening kit in hr-HPV detection. Extended HPV genotyping could facilitate risk-based stratified management strategy and improve the diagnostic accuracy of primary CC screening.

100 Deals associated with Human papillomavirus vaccine recombinant 9-valent (Shanghai Zerun Biotechnology)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Anus Neoplasms	Phase 3	China	Shanghai Zerun Biotechnology Co., Ltd.	01 Sep 2022
Condylomata Acuminata	Phase 3	China	Walvax Biotechnology Co., Ltd.	01 Sep 2022
Human Papillomavirus Infection	Phase 3	China	Shanghai Zerun Biotechnology Co., Ltd.	01 Sep 2022
Uterine Cervical Cancer	Phase 3	China	Shanghai Zerun Biotechnology Co., Ltd.	01 Sep 2022
Uterine Cervical Dysplasia	Phase 3	China	Walvax Biotechnology Co., Ltd.	01 Sep 2022
Vaginal Neoplasms	Phase 3	China	Shanghai Zerun Biotechnology Co., Ltd.	01 Sep 2022
Vulvar intraepithelial neoplasia	Phase 3	China	Walvax Biotechnology Co., Ltd.	01 Sep 2022
Vulvar Neoplasms	Phase 3	China	Shanghai Zerun Biotechnology Co., Ltd.	01 Sep 2022