Delving into the Latest Updates on Human papillomavirus vaccine recombinant bivalent (Zerun Biotechnology) with Synapse

Primary purpose: To evaluate the long-term immune persistence of healthy women aged 9-30 years after bivalent HPV vaccination according to the 0, 2, and 6 month immunization schedule. Secondary purpose: To collect and analyze the occurrence of HPV-related diseases after vaccination and explore the long-term protective effect of bivalent HPV vaccine.

Start Date30 Aug 2024

Sponsor / Collaborator

Yuxi Zerun Biotechnology Co., Ltd.

CTR20230857 / RecruitingPhase 4

一项多中心、开放、长期扩展研究评估在311-HPV-1003研究时18-30岁健康女性接种双价人乳头瘤病毒疫苗（毕赤酵母）的长期保护效力、免疫持久性

[Translation] A multicenter, open-label, long-term extension study to evaluate the long-term protective efficacy and immune persistence of a bivalent human papillomavirus vaccine (Pichia pastoris) in healthy women aged 18-30 years who were vaccinated during the 311-HPV-1003 study

主要目的：评价18-30岁健康女性接种双价人乳头瘤病毒疫苗（毕赤酵母）的长期保护效力次要目的：评价18-30岁健康女性接种双价人乳头瘤病毒疫苗（毕赤酵母）的免疫持久性

[Translation]

Primary objective: To evaluate the long-term protective efficacy of bivalent human papillomavirus vaccine (Pichia pastoris) in healthy women aged 18-30 years. Secondary objective: To evaluate the immune persistence of bivalent human papillomavirus vaccine (Pichia pastoris) in healthy women aged 18-30 years.

Start Date27 Mar 2023

Sponsor / Collaborator

Yuxi Zerun Biotechnology Co., Ltd.

CTR20230424 / RecruitingPhase 4

一项开放、长期扩展研究评估在311-HPV-1004研究时9-26岁健康女性接种双价人乳头瘤病毒疫苗（毕赤酵母）的免疫持久性

[Translation] An open-label, long-term extension study evaluating the durability of immunity in healthy women aged 9 to 26 years who received a bivalent human papillomavirus vaccine (Pichia pastoris) during study 311-HPV-1004

主要目的：评价在311-HPV-1004研究入组时9-26岁健康女性接种双价HPV疫苗的长期免疫持久性（首剂接种后第84月、108月和132月）。次要目的：评价采用高通量假病毒检测方法评估311-HPV-1004研究第0、7、12、24和36月中和抗体水平（仅限于本次311-HPV-1004-EXTEND研究入组时的受试者）。

[Translation]

Primary objective: To evaluate the long-term immunity persistence of bivalent HPV vaccine in healthy women aged 9-26 years at the time of enrollment in the 311-HPV-1004 study (84 months, 108 months, and 132 months after the first dose). Secondary objective: To evaluate the neutralizing antibody levels at 0, 7, 12, 24, and 36 months in the 311-HPV-1004 study using a high-throughput pseudovirus assay (limited to subjects enrolled in this 311-HPV-1004-EXTEND study).

Start Date25 Mar 2023

Sponsor / Collaborator

Yuxi Zerun Biotechnology Co., Ltd.

100 Clinical Results associated with Human papillomavirus vaccine recombinant bivalent (Zerun Biotechnology)

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100 Translational Medicine associated with Human papillomavirus vaccine recombinant bivalent (Zerun Biotechnology)

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100 Patents (Medical) associated with Human papillomavirus vaccine recombinant bivalent (Zerun Biotechnology)

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Literatures (Medical) associated with Human papillomavirus vaccine recombinant bivalent (Zerun Biotechnology)

31 Dec 2024·Human Vaccines & Immunotherapeutics

Opportunities and challenges for human papillomavirus vaccination in China

Review

Author: Li, Jingran ; Zhao, Yun ; Wei, Lihui ; Li, Mingzhu ; Zhao, Chao ; Shi, Yujing

Current estimates of the HPV infection rate in China vary by geographic region (9.6-23.6%), with two age peaks in prevalence in women ≤20-25 years of age and 50-60 years of age. HPV-16, 52 and 58 are the most commonly-detected HPV genotypes in the Chinese population. In China, five HPV vaccines are licensed and several others are undergoing clinical trials. Multiple RCTs have shown the efficacy and safety of the bvHPV (Cervarix), Escherichia coli-produced bvHPV (Cecolin), Pichia pastoris-produced bvHPV (Walrinvax), qvHPV (Gardasil) and 9vHPV (Gardasil-9) vaccines in Chinese populations, including two studies showing long-term efficacy (≥8 years) for the bvHPV and qvHPV vaccines. Real-world data from China are scarce. Although modeling studies in China show HPV vaccination is cost-effective, uptake and population coverage are relatively low. Various policies have been implemented to raise awareness and increase vaccine coverage, with the long-term aim of eliminating cervical cancer in China.

14 May 2024·Journal of Virology

Recombinant bivalent subunit vaccine combining truncated VP4 from P[7] and P[23] induces protective immunity against prevalent porcine rotaviruses

Article

Author: Zhang, Xuehan ; Li, Peng ; Wang, Wei ; Zhou, Jinzhu ; Zhu, Xuejiao ; Tao, Ran ; Bian, Xianyu ; Li, Bin ; Li, Sufen ; Sun, Min ; Wang, Jianxin ; Han, Nan ; Tang, Xuechao

ABSTRACTPorcine rotaviruses (PoRVs) cause severe economic losses in the swine industry. P[7] and P[23] are the predominant genotypes circulating on farms, but no vaccine is yet available. Here, we developed a bivalent subunit PoRV vaccine using truncated versions (VP4*) of the VP4 proteins from P[7] and P[23]. The vaccination of mice with the bivalent subunit vaccine elicited more robust neutralizing antibodies (NAbs) and cellular immune responses than its components, even at high doses. The bivalent subunit vaccine and inactivated bivalent vaccine prepared from strains PoRVs G9P[7] and G9P[23] were used to examine their protective efficacy in sows and suckling piglets after passive immunization. The immunized sows showed significantly elevated NAbs in the serum and colostrum, and the suckling piglets acquired high levels of sIgA antibodies from the colostrum. Challenging subunit-vaccinated or inactivated-vaccinated piglets with homologous virulent strains did not induce diarrhea, except in one or two piglets, which had mild diarrhea. Immunization with the bivalent subunit vaccine and inactivated vaccine also alleviated the microscopic lesions in the intestinal tissues caused by the challenge with the corresponding homologous virulent strain. However, all the piglets in the challenged group displayed mild to watery diarrhea and high levels of viral shedding, whereas the feces and intestines of the piglets in the bivalent subunit vaccine and inactivated vaccine groups had lower viral loads. In summary, our data show for the first time that a bivalent subunit vaccine combining VP4*P[7] and VP4*P[23] effectively protects piglets against the diarrhea caused by homologous virulent strains.IMPORTANCEPoRVs are the main causes of diarrhea in piglets worldwide. The multisegmented genome of PoRVs allows the reassortment of VP4 and VP7 genes from different RV species and strains. The P[7] and P[23] are the predominant genotypes circulating in pig farms, but no vaccine is available at present in China. Subunit vaccines, as nonreplicating vaccines, are an option to cope with variable genotypes. Here, we have developed a bivalent subunit candidate vaccine based on a truncated VP4 protein, which induced robust humoral and cellular immune responses and protected piglets against challenge with homologous PoRV. It also appears to be safe. These data show that the truncated VP4-protein-based subunit vaccine is a promising candidate for the prevention of PoRV diarrhea.

01 Nov 2023·Vaccine

Comparison of the safety and persistence of immunogenicity of bivalent HPV16/18 vaccine in healthy 9–14-year-old and 18–26-year-old Chinese females: A randomized, double-blind, non-inferiority clinical trial

Article

Author: Yang, Qing ; Jiang, Zhi-Wei ; Li, Chang-Gui ; Xia, Jie-Lai ; Li, Juan ; Chen, Jing-Jing ; Li, Jian-Biao ; Yu, Bang-Wei ; Li, Wei ; Li, Yan-Ping ; Huang, Li-Rong ; Ji, Min ; Li, Rong-Cheng ; Mo, Zhao-Jun ; Shi, Li-Wei ; Li, Ke ; Yan, Xue-Mei ; Qi, Yang-Yang ; Dong, Yu-Lian ; Yuan, Lin ; Zhou, Ling-Yun

BACKGROUNDWe assessed the safety, immunogenicity and antibody persistence of two- and three-dose schedules of the novel bivalent HPV16/18 vaccine (HPV-2, Walrinvax) in the per-protocol target population of initially seronegative 9-14 year-old girls, including a non-inferiority comparison with the three-dose schedule in 18-26 year-old women.METHODSThis randomized phase 3b trial in Guangxi Zhuang Autonomous Region, China, involved healthy Chinese females in two age cohorts; 600 girls aged 9-14 years and 300 women aged 18-26 years. Girls were randomly assigned (1:1) to receive either two (Months 0,6) or three (Months 0,2,6) intramuscular doses of HPV-2. All participants were monitored for immunogenicity as neutralizing antibodies up to 36 months. Primary objectives were non-inferiority analyses of immunogenicity between two- and three-dose girl groups and adult women at Month 7; safety assessments were based on participant-completed diary cards.RESULTSAll groups demonstrated marked increases in neutralizing antibodies against HPV 16 and 18 that persisted above baseline to 36 months. Month 7 responses in both girl groups were non-inferior to those in the women and were statistically higher after two-doses than girls or women who received three doses. GMTs waned after month 7, but then maintained a plateau level until month 36. Vaccination was well tolerated in all groups with no serious adverse events reported.CONCLUSIONSImmune responses to two doses of HPV-2 vaccine in adolescent girls were non-inferior to those after three doses in young women, an age cohort in which clinical efficacy of HPV-2 against cervical cancer has been demonstrated.

100 Deals associated with Human papillomavirus vaccine recombinant bivalent (Zerun Biotechnology)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Human Papillomavirus-Related Cervical Adenocarcinoma In Situ	ID	Yuxi Zerun Biotechnology Co., Ltd.	10 Oct 2024
Human Papillomavirus-Related Cervical Intraepithelial Neoplasia	ID	Yuxi Zerun Biotechnology Co., Ltd.	10 Oct 2024
Human Papillomavirus-Related Cervical Carcinoma	CN	Yuxi Zerun Biotechnology Co., Ltd.	24 Mar 2022

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Human Papillomavirus Infection	Discovery	CN	Shanghai Zerun Biotechnology Co., Ltd.	01 Jul 2020
HPV16 Infection	Discovery	CN	Shanghai Zerun Biotechnology Co., Ltd.	26 Sep 2013
Uterine Cervical Cancer	Discovery	CN	Shanghai Zerun Biotechnology Co., Ltd.	26 Sep 2013
Uterine Cervical Dysplasia	Discovery	CN	Shanghai Zerun Biotechnology Co., Ltd.	26 Sep 2013