Immunogenicity Non-inferiority Immuno-bridging Study of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58) Vaccine (E.Coli) in Healthy Population Aged 9-17 Years Old vs Aged 18-26 Years Old

This is a open label clinical trial to evaluate the safety and immunogenicity of a Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58)Vaccine(E.Coli) manufactured by Xiamen Innovax Biotech CO., Ltd., in healthy population aged 9-17 years old in comparison with aged 18-26.

开始日期2021-09-19

申办/合作机构

厦门万泰沧海生物技术有限公司

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100 项与重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗(大肠埃希菌)（厦门万泰沧海）相关的临床结果

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100 项与重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗(大肠埃希菌)（厦门万泰沧海）相关的转化医学

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100 项与重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗(大肠埃希菌)（厦门万泰沧海）相关的专利（医药）

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项与重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗(大肠埃希菌)（厦门万泰沧海）相关的文献（医药）

2024-09-01·EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES

Oral HPV infection clearance and acquisition after nonavalent vaccination in men who have sex with men and transgender women: a prospective analysis

Article

作者: Rossotti, Roberto ; Puoti, Massimo ; Bana, Nicholas Brian ; Baldassari, Luca ; Moioli, Maria Cristina ; Vismara, Chiara ; Calzavara, Daniele ; Tamburini, Andrea Marco ; D'Amico, Federico ; Bossolasco, Simona ; Baiguera, Chiara ; Canetti, Diana ; Cernuschi, Massimo ; Fanti, Diana ; Nava, Alice

Oral HPV infection is the main risk factor for the development of oropharyngeal carcinoma. Men who have sex with men (MSM), especially if living with HIV (PLWH), are at increased risk of infection and consequently of cancer development. Aim of this study is to evaluate the impact of nonavalent vaccine on oral HPV infection in a cohort of MSM and transgender women (TGW). This prospective study included all MSM and TGW who started nonavalent HPV vaccination from May 2019 to September 2021. Oral rinse was collected before each vaccine administration and after six months of follow up. Descriptive statistics were used. Kaplan Meier probability curves and Cox regression models for HPV acquisition and clearance were calculated. The analysis included 211 individuals (202 MSM and 9 TGW). PLWH were 138 (65.4%). Baseline oral rinse was positive in 30 subjects (14.2%). Positivity rate did not change over time (p = 0.742), even when restricting the analysis only to high-risk genotypes (p = 0.575) and to genotypes covered by vaccine (p = 0.894). The risk to acquire HPV infection was 12.8% at one year and 33.4% at two years after vaccination. The probability to clear the infection was 67.6% at one year and 87.9% at two years. HIV infection had no impact on vaccine efficacy. Age above 45 years was the only factor associated to HPV acquisition (aHR 4.06, 95% CI 1.03-15.98, p = 0.045). Prevalence of oral HPV infection was higher in PLWH, but HIV had no impact on viral clearance or acquisition after vaccination.

2024-01-01·Journal of the European Academy of Dermatology and Venereology : JEADV

Association between HPV infection and penile cancer and penile intraepithelial neoplasia: A retrospective observational study

Article

作者: Azevedo, F ; Macieira, R ; Guimaraes, Maria Jose ; Lisboa, C

Abstract:

Background:

Penile cancer is rising in most European countries. Several risk factors have been identified, namely human papillomavirus (HPV) infection. However, the exact role of HPV in penile cancer carcinogenesis is still unknown. Clarifying the contribution of HPV in penile cancer is crucial as it may improve prevention and treatment strategies.

Objective:

To describe the characteristics of patients with penile cancer and penile intraepithelial neoplasia (PeIN), evaluate the prevalence of HPV‐DNA in tumour tissue and identify differences between patients with and without HPV‐DNA.

Methods:

A retrospective observational study including patients with histological diagnosis of penile squamous cell carcinoma (SCC) or PeIN between 2012 and 2021 in a university hospital was carried out. HPV analysis was performed using Anyplex™ II HPV28 Detection that detects and identifies 28 HPV types. (sensitivity of 95.9%).

Results:

A total of 25 patients were included. Most of the tumours identified were invasive SCC (n = 11) and SCC in situ (PeIN 3) (n = 8). PeIN1/2 was found in the remaining six patients. HPV‐DNA was tested in all tissue specimens and was detected in 18 of them. High risk HPV DNA was identified in all positive HPV samples, except one. HPV types included in the nonavalent HPV vaccine were identified in 16 of the 18 samples positive for HPV‐DNA. Stratifying patients according to HPV‐DNA detection, we found that patients with HPV‐DNA were younger (57.5 years vs. 70 years, p = 0.047), less likely to have phimosis (5.8% vs. 42.9%, p = 0.022) and more likely to have PeIN lesions than invasive SCC (85.7% vs. 27.8%, p = 0.025).

Conclusion:

This study shows a prevalence of HPV‐DNA in penile SCC and premalignant lesions of 45.5% and 92.9%, respectively. Identifying HPV involvement in SCC and PeIN pathology has the potential to guide treatment and enhance follow‐up strategies.

2024-01-01·Cancer Control

Factors Influencing Knowledge and Acceptance of Nonavalent Human Papillomavirus Vaccine Among University Population in Southern China: A Cross-Sectional Study

Article

作者: Liu, Li ; Fang, Peiwan ; Yuan, Weicheng ; Zheng, Haiyan ; Pan, Jie ; Chen, Mianjia ; Yu, Xiaolin ; Chen, Miao

Background:

Vaccine hesitancy among young Chinese remains a challenge, contributing to low vaccination rates for the nonavalent Human Papillomavirus (HPV) vaccine. This study evaluated the knowledge and acceptance of this vaccine among students at a southern Chinese university and identified factors influencing these outcomes.

Methods:

This cross-sectional, anonymous questionnaire survey was conducted from April to November 2023 at a multi-campus university in southern China. The questionnaire was comprised of three sections: the first collected demographic data; the second evaluated students’ knowledge of the nonavalent HPV vaccine on a scale from 0 to 15, with cut-off points at 5 and 10 delineating low, medium, and high knowledge levels, respectively; the third section assessed vaccine acceptance on a scale from 8 to 40, using scores above the 50th percentile as the benchmark for positive acceptance.

Results:

Among the participants, 18% demonstrated low-level, 40.20% medium-level, and 41.70% high-level knowledge of the nonavalent HPV vaccine. Notably, 71.95% of respondents showed positive acceptance, whereas 28.05% expressed negative acceptance. Male students and those with lower economic conditions (monthly living expenses below 1000 RMB, P = 0.004; 1000-1499 RMB, P = 0.012) exhibited lower knowledge levels. As for acceptance, female students and those with higher monthly living expenses (1000-1499 RMB, P = 0.007; 1500-1999 RMB, P = 0.002; over 2000 RMB, P = 0.002) demonstrated greater vaccine acceptance. A positive correlation was noted between the level of knowledge and vaccine acceptance (rs = 0.256, P < 0.001).

Conclusions:

Gender and economic status are significantly associated with nonavalent HPV vaccine knowledge and acceptance among university students. These findings highlight the potential impact of targeted educational initiatives, especially for economically disadvantaged male students, in enhancing vaccine uptake rates.

项与重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗(大肠埃希菌)（厦门万泰沧海）相关的新闻（医药）

2023-12-20

·佰傲谷BioValley

万泰九价HPV疫苗推出尚存在不确定性

近日（12月19日），万泰生物公告表示，经核实，公司的九价HPV疫苗Ⅲ期主临床试验V8期访视的现场工作已完成，目前正在进行标本检测工作。万泰生物表示，根据目前国家关于疫苗注册管理的相关规定，公司的九价HPV疫苗的审批及获得批准的时间尚存在不确定性。无法预估推出时间作为推出首款国产HPV疫苗的疫苗开发商，凭借先发优势，在过去3年内万泰生物的业绩实现了迅猛增长。馨可宁（二价HPV疫苗）上市当年，万泰生物营收同比猛增98.88%，达23.54亿元。2021年营收至57.50亿元，同比增长144.25%。2022年万泰生物营收突破百亿，达111.85亿元，同比增长94.51%；馨可宁也成为了万泰生物总营收占比超过七成的“大单品”，是公司营收的中流砥柱。然而自从与沃森开打价格战后，馨可宁的销售收入出现较大幅度下降，导致万泰生物今年出现了首次业绩下滑。目前万泰最被寄予厚望的就是公司的九价HPV疫苗了（馨可宁9）。2023年7月底，万泰率先公布了馨可宁9和佳达修9头对头免疫原性比较III期临床试验结果，这也是首个公布的国产9价HPV疫苗与佳达修 9头对头的Ⅲ期临床试验PK结果。结果显示，在符合方案集（PPS-I）中，馨可宁9和佳达修在9九个HPV型别中和抗体的阳转率均为100%，馨可宁9 HPV 6/31/45/52/58中和抗体的几何平均浓度（GMC）略高于佳达修9，而HPV 11/16/18/33中和抗体的GMC略低于佳达修9。所有型别中和抗体GMC比值（馨可宁9/佳达修9）95%置信区间下限值均高于预设的非劣效界值。因此，在全程接种后1个月，馨可宁9诱导的免疫应答非劣效于佳达修9。此外，馨可宁9组的总体不良反应发生率为42.6%，与佳达修9的47.3%相当，安全性良好。该试验的公布也使得万泰生物在9价HPV疫苗研发之争中取得先机，最有机会成为第一个国产获批、率先抢占市场的9价HPV疫苗。不过根据万泰此次公告所述，馨可宁9的审批及获得批准的时间尚存在不确定性当前风险包括但不限于如下几点：在V8访视期内发现的持续感染病例不足，未能满足临床终点病例数要求，需在下次访视中继续收集病例；商业化工艺验证无法按计划完成，导致具备商业化生产条件的时间延后；上述多种情况均可能导致产品上市的时间延后。决赛圈领域的竞争9价HPV疫苗（佳达修9）目前仅由美国默沙东一家公司生产供应，自其2018年4月在国内上市以来，始终处于供应紧缺、一针难求的状态。虽然万泰和沃森的在产能和价格优势上基本实现进口二价HPV疫苗的国产替代，但还是无法动摇“进口9价HPV疫苗”在国内的市场地位。去年，佳达修9在国内的扩龄接种削弱了国产二价HPV疫苗的年龄优势。在加大了供应量后，其批签发量仍然维持了高增长，2023年前三季度，智飞生物的九价HPV疫苗批签发97批次（+87%），Q3单季度批签发48批次，同比增长300%。尽快打破默沙东独占9价HPV疫苗的局面，加速9价HPV疫苗的国产替代也成了多家国内企业急切攻破的壁垒。目前，多家国内疫苗厂商都加快了9价HPV疫苗的研发步伐，除了万泰生物之外，沃森生物、瑞科生物、康乐卫士、博唯生物4家厂商的9价HPV疫苗都推进到Ⅲ期临床阶段。对于已经进入III期临床试验的国产9价HPV疫苗企业而言，“决赛圈”里的竞争分秒必争，谁能成为第一家备受关注。本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀ ········

疫苗临床3期财报

2023-08-25

·佰傲谷BioValley

大打价格战后，万泰生物弊端显现

2023年8月24日晚，万泰生物公布2023年半年报，上半年实现营业收入41.64亿元，同比减少29.78%；归属于母公司所有者的净利润17.02亿元，同比减少36.78%。万泰生物表示，业绩不达预期，主要受其二价HPV疫苗及新冠相关产品销售收入出现较大下降等因素拖累，导致净利润下降，馨可宁的销售收入从去年同期下跌22.4%，至33.87亿元。首款国产HPV疫苗之光2020年5月，万泰生物自主研发的二价HPV疫苗“馨可宁”上市，使其成为国内第一家、全球第三家HPV疫苗生产商，打破了默沙东、GSK对国内HPV疫苗市场的垄断局面。相较于GSK的二价HPV疫苗希瑞适，接种程序少且价格更低的竞争优势的馨可宁就很快成为国内二价HPV市场的“香饽饽”。2020年上市后的仅半年时间，馨可宁的市场份额就达到了16%。2021年馨可宁在二价HPV疫苗中的签发批次居首，达到65%，而进口的二价HPV疫苗批签发批次占比仅达到5%。凭借首款国产2价HPV疫苗的先发优势，万泰生物也实现业绩的大幅增长。馨可宁上市当年，万泰生物营收在上年基础上增加11.71亿元，其中，馨可宁获得营收6.93亿元。2021年，公司业绩继续大涨，营收同比增144.25%至57.50亿元，归母净利润同比增长198.59%至20.21亿元。2022年，万泰生物营收突破百亿，达111.85亿元。“馨可宁”销售额争锋相对的价格战虽然打破了进口HPV疫苗的垄断，但是并没有动摇一直以来的备受欢迎的九价HPV疫苗地位，去年默沙东九价HPV疫苗在中国扩龄接种，更加带动其需求显著增长。另一方面，两款国产HPV疫苗开打惨烈的价格战，很可能是导致馨可宁销售意外滑坡的重要因素之一。2022年3月，沃森生物自主研发的二价HPV疫苗沃泽惠获批上市，成为了国内第二家能够上市生产销售二价HPV疫苗的企业。上市晚了近两年的以价格优势突击二价HPV市场，“沃泽惠”246元/支的定价明显低于万泰生物（329/支），而在多次的政府HPV疫苗采购项目中，沃森生物也凭借低价拿到更多的采购量。有赖于HPV疫苗市场供不应求的局面，一直以自费市场为重心的万泰并未跟随沃森大幅降价，在政府HPV疫苗采购项目中，保持了与以自费同等竞价水平。不过，随着沃森生物以价格更低的拿到更多采购订单，以及越来越大的公费接种HPV疫苗市场，万泰终于也和沃森打起了价格战。今年广东省的HPV疫苗采购项目中，万泰以高达64.7%降幅获得独家中标，低至116元/支。由此，两方的价格战正式打响。首款国产九价HPV疫苗的悬念目前万泰最被被寄予厚望的就是九价HPV疫苗（馨可宁9），目前正处于III期临床阶段。在今年的IPVC大会上，万泰公布了馨可宁9的免疫原性数据，结果显示，馨可宁9其免疫原性、耐受性均表现良好，9种抗体中有5种型别中和抗体几何平均浓度点值略高于进口九价HPV疫苗，4种型别中和抗体几何平均浓度点值略低于进口九价苗，总体效果相当。国内HPV疫苗需求持续增长，市场规模不断扩大，“国产九价HPV疫苗”也成为兵家必争之地。目前，多家国内疫苗厂商都加快了九价HPV疫苗的研发步伐，除万泰生物外，沃森生物、瑞科生物（02179）、康乐卫士（833575）、博唯生物这4家厂商的九价HPV疫苗都进入了Ⅲ期临床阶段。瑞科生物、康乐卫士此前也对外公布了规划其九价HPV疫苗申请上市时间，瑞科生物在2022年的中报业绩中，计划于2025年向国家药监局提交九价HPV疫苗REC603的上市申请。康乐卫士2023年3月在北交所发布的招股书中预计，于2026年底提交九价HPV疫苗(女性适应症)上市申请。参考出处：万泰&沃森HPV疫苗价格激战国产之光，HPV疫苗2价击败4价本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处﹀‍‍ ·········点亮在看，传递信息♥

财报疫苗带量采购核酸药物

100 项与重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗(大肠埃希菌)（厦门万泰沧海）相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
乳头状瘤病毒感染	临床3期	中国	北京万泰生物药业股份有限公司	2020-09-05
乳头状瘤病毒感染	临床3期	中国	厦门大学	2020-09-05