A Phase 3 Open-Label Clinical Trial to Study the Immunogenicity, Safety and Tolerability of Recombinant Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine (V501) in Chinese Girls Aged 9-19 Years and Young Women Aged 20-26 Years

This study is designed to evaluate the immunogenicity, safety, and tolerability of Gardasil® (quadrivalent human papillomavirus [qHPV] vaccine, V501) in Chinese girls aged 9-19 years and young women aged 20-26 years. The primary hypothesis of the study states that at 1 month postdose 3, a 3-dose regimen of V501 induces non-inferior geometric mean titers (GMTs) for serum anti-HPV 6, anti-HPV 11, anti-HPV 16, anti-HPV 18 in girls aged 9-19 years compared to young women aged 20-26 years.

开始日期2018-08-31

申办/合作机构

Merck Sharp & Dohme Corp.

100 项与人瘤病毒相关性宫颈原位腺癌相关的临床结果

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100 项与人瘤病毒相关性宫颈原位腺癌相关的转化医学

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0 项与人瘤病毒相关性宫颈原位腺癌相关的专利（医药）

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项与人瘤病毒相关性宫颈原位腺癌相关的文献（医药）

2023-09-01·International journal of radiation oncology, biology, physics

The Updated World Health Organization Classification Better Predicts Survival in Patients With Endocervical Adenocarcinoma (KROG 20-07).

Article

作者: Yoon, Meesun ; Choi, Jin Hwa ; Kim, Yeon Joo ; Park, Won ; Kim, Kyu-Rae ; Kim, Young Seok ; Cho, Won Kyung ; Kim, Hyun-Soo ; Kwon, Sun Young ; Kang, Jun ; Kim, Yong Bae ; Kim, Nah Ihm ; Kim, Yeon-Sil ; Kim, Jin Hee

PURPOSEThe 2020 World Health Organization classification divided endocervical adenocarcinoma (ADC) into human papillomavirus-associated (HPVA) and human papillomavirus-independent (HPVI) ADCs. This multi-institutional study aimed to investigate the clinical features and prognosis of patients with endocervical ADC based on the updated World Health Organization classification.METHODS AND MATERIALSWe retrospectively reviewed the 365 patients with endocervical ADC who underwent radical hysterectomy from 7 institutions. Tumor characteristics, patterns of failure, and survival outcomes were compared between HPVA and HPVI ADCs.RESULTSTwo hundred seventy-five (75.3%) and 90 (24.7%) patients had HPVA and HPVI ADC diagnoses, respectively. In all cases, the 5-year disease-free survival (DFS) and overall survival (OS) rates were 58.2% and 71.3%, respectively. HPVI ADC showed higher rates of local recurrence (25.6% vs 10.9%) and distant metastasis (33.3% vs 17.5%) than HPVA ADC. Multivariate survival analysis revealed that HPVI ADC showed significantly worse DFS (hazard ratio [HR], 1.919; 95% confidence interval [CI], 1.324-2.781; P < .001), distant metastasis-free survival (HR, 2.100; 95% CI, 1.397-3.156; P < .001), and OS (HR, 2.481; 95% CI, 1.586-3.881; P < .001) than HPVA ADC. Patients with gastric- and serous-type HPVI ADC had significantly worse OS than those with other HPVI ADCs (P = .020). Similarly, invasive stratified mucin-producing-type HPVA ADC showed significantly worse OS than other HPVA ADCs (P < .001).CONCLUSIONSWe demonstrated that HPVI ADC exhibited inferior DFS and OS and higher rates of local and distant recurrence compared with HPVA ADC. Gastric- and serous-type HPVI ADCs and invasive stratified mucin-producing-type HPVA ADC showed worse OS than other types of HPVI and HPVA ADCs, respectively. Our observation of significant differences in prognoses according to the histologic types needs to be validated in larger cohorts of patients with endocervical ADC.

2022-02-01·Journal of Clinical Immunology2区 · 医学

A Nationwide Study of GATA2 Deficiency in Norway—the Majority of Patients Have Undergone Allo-HSCT

2区 · 医学

Article

作者: Benneche, Andreas ; Lundman, Emma ; Aukrust, Pål ; Stray-Pedersen, Asbjørg ; Heier, Ingvild ; Myhre, Anders E ; Galteland, Eivind ; Spetalen, Signe ; Alme, Charlotte ; Holla, Øystein L ; Fevang, Børre ; Nordøy, Ingvild ; Fløisand, Yngvar ; Gedde-Dahl, Tobias ; Sorte, Hanne S ; Jørgensen, Silje F ; Kulseth, Mari Ann ; Flægstad, Trond ; Buechner, Jochen

AbstractPurposeGATA2 deficiency is a rare primary immunodeficiency that has become increasingly recognized due to improved molecular diagnostics and clinical awareness. The only cure for GATA2 deficiency is allogeneic hematopoietic stem cell transplantation (allo-HSCT). The inconsistency of genotype–phenotype correlations makes the decision regarding “who and when” to transplant challenging. Despite considerable morbidity and mortality, the reported proportion of patients with GATA2 deficiency that has undergone allo-HSCT is low (~ 35%). The purpose of this study was to explore if detailed clinical, genetic, and bone marrow characteristics could predict end-point outcome, i.e., death and allo-HSCT.MethodsAll medical genetics departments in Norway were contacted to identify GATA2 deficient individuals. Clinical information, genetic variants, treatment, and outcome were subsequently retrieved from the patients’ medical records.ResultsBetween 2013 and 2020, we identified 10 index cases or probands, four additional symptomatic patients, and no asymptomatic patients with germlineGATA2variants. These patients had a diverse clinical phenotype dominated by cytopenia (13/14), myeloid neoplasia (10/14), warts (8/14), and hearing loss (7/14). No valid genotype–phenotype correlations were found in our data set, and the phenotypes varied also within families. We found that 11/14 patients (79%), with known GATA2 deficiency, had already undergone allo-HSCT. In addition, one patient is awaiting allo-HSCT. The indications to perform allo-HSCT were myeloid neoplasia, disseminated viral infection, severe obliterating bronchiolitis, and/or HPV-associated in situ carcinoma. Two patients died, 8 months and 7 years after allo-HSCT, respectively.ConclusionOur main conclusion is that the majority of patients with symptomatic GATA2 deficiency will need allo-HSCT, and a close surveillance of these patients is important to find the “optimal window” for allo-HSCT. We advocate a more offensive approach to allo-HSCT than previously described.

2019-12-01·Journal of Global Oncology

HES1 Protein Modulates Human Papillomavirus–Mediated Carcinoma of the Uterine Cervix

Article

作者: Sharma, Shashi ; Rath, Gayatri ; Mehrotra, Ravi ; Sharma, Vishwas ; Tripathi, Richa ; Bharadwaj, Mausumi ; Hussain, Showket

PURPOSE Cervical cancer (CC) is the most common cancer affecting women worldwide. Human papillomavirus (HPV) infection is a major contributing factor for the development of CC. The development of CC occurs progressively from precancer stages to cancerous stages (ie, invasive squamous cell carcinoma [ISCC] and adenocarcinoma [ADC]). ADC is a rare form of CC that develops from the mucinous endocervical epithelium. It is believed that the downstream targets of Notch signaling contribute to the etiology of CC. One such target is HES1, whose role in the modulation of ADC is unknown. The purpose of this study is to determine the role of HES1 protein in HPV-associated ADC subtype of CC and also to compare its expression in histologic subtypes of precancer and ISCC. PATIENTS AND METHODS A total of 148 patients (30 with precancers, 98 with ISCC, and 20 with ADC) and 40 normal control participants were analyzed for the expression of HES1 via immunohistochemistry, with results validated by immunoblotting. RESULTS The comparison between HPV-16 and HES1 expression was significant in precancer (cervical intraepithelial neoplasia grades 1 to 3; P = .013), ISCC (International Federation of Gynecology and Obstetrics stages I to IV; P = .001), and ADC ( P = .007). An overall significant mean difference was observed between HES1, JAG1, and Notch-3 proteins in precancer ( P = .001), ISCC ( P = .001), and ADC ( P = .001). Pairwise comparisons between HES1 and JAG1 and HES1 and Notch-3 were also found to be significant. CONCLUSION This study showed that among all HPV-16–positive precancers, the major HES1 positivity signal arises from cervical intraepithelial neoplasia grades 2 and 3 that develops into ISCC. Moreover, HPV-16–positive ADC also showed an association with HES1. The HES1, JAG1, and Notch-3 proteins showed their synergistic role in modulating HPV associated ADC along with histologic subtypes of precancer and ISCC of CC.

项与人瘤病毒相关性宫颈原位腺癌相关的新闻（医药）

2024-10-10

·药研网

沃森生物:双价HPV疫苗在印度尼西亚获批上市

10月10日，沃森生物发布公告，子公司玉溪泽润的双价人乳头瘤病毒疫苗近日获得印度尼西亚食品与药品管理局的产品上市许可证，预灌封和西林瓶两个品规均获批。该疫苗主要用于预防由高危型HPV16、18型引起的相关疾病，如宫颈癌等。宫颈癌是印度尼西亚最大的卫生筹资负担之一。约95%的宫颈癌是由人乳头瘤病毒感染引起的，近年来，该病的死亡率呈上升趋势，接种HPV疫苗是重要的预防宫颈癌的措施之一。2023年12月，印度尼西亚卫生部正式发布了《印度尼西亚2023-2030国家宫颈癌消除计划》，印度尼西亚政府将根据每年预算分配及《印度尼西亚2023-2030国家宫颈癌消除计划》就相关产品进行招标。玉溪泽润双价HPV疫苗主要用于预防因高危型HPV16、18型所致的相关疾病，如：宫颈癌，2级、3级宫颈上皮内瘤样病变（CIN2/3）和宫颈原位腺癌（AIS）。该疫苗于2022年正式上市，并于2024年8月通过了世界卫生组织预认证（WHOPQ认证）。沃森生物的主要营收产品“二价HPV疫苗”为例，在2022年上市销售后，这款疫苗在当年为沃森生物带来了超50亿的营收。此次获得印度尼西亚《上市许可证》，是沃森生物国际化战略取得的重大进展。 End 声明：本公众号所有发文章(包括原创及转载文章)系出于传递更多信息之目的，且注明来源和作者。本公众号欢迎分享朋友圈或大群，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载/商务/投稿 | 联系微信15618157102（sum_Gmi）商务合作稿件征集点击了解详情往期回顾 1 8月 | 高达22家药企裁员 2 国产首款四价HPV疫苗拟纳入优先审评 3 3. 7亿美元!今年规模最大的生物医药融资诞生

上市批准疫苗财报