主要目的：评价四价重组人乳头瘤病毒（6/11/16/18型）疫苗（汉逊酵母）（以下简称“四价HPV疫苗”）接种于18-45岁中国女性预防HPV16/18型别感染相关的CIN2+宫颈病变的保护效力。次要目的：1）评价四价HPV疫苗接种于18-45岁中国女性全程免疫30天后预防HPV6/11/16/18型别感染相关的12个月持续感染（12-month Persistent Infection, PI12保护效力； 2）评价四价HPV疫苗接种于18-45岁中国女性全程免疫30天后预防HPV6/11/16/18型别感染相关的6个月持续感染保护效力； 3）评价四价HPV疫苗接种于18-45岁中国女性全程免疫30天后预防HPV6/11/16/18型别感染相关的外生殖器和阴道病变（包括：生殖器疣、VIN1+、AIN1+和VaIN1+）的保护效力； 4）评价四价HPV疫苗接种于18-45岁中国女性的免疫原性； 5）评价四价HPV疫苗接种于18-45岁中国女性的安全性。

开始日期2022-12-09

申办/合作机构

上海博唯生物科技有限公司

NCT05584332 / Terminated临床3期

A Multicenter,Randomized, Placebo-Controlled, and Double-blind Phase Ⅲ Study to Evaluate the Efficacy, Immunogenicity and Safety of Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Aged 18-45 Years

This study is designed to evaluate the vaccine efficacy, immunogenicity and safety of the 4-valent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 18-45 Years .

开始日期2022-12-09

申办/合作机构

上海博唯生物科技有限公司

CTR20221050 / Recruiting临床3期

评价四价重组人乳头瘤病毒（6/11/16/18 型）疫苗（汉逊酵母）接种于9-45 岁中国女性免疫持久性的开放性临床试验

评价 9-45 岁中国女性按 0，2，6 月免疫程序接种四价重组人乳头瘤病毒（6/11/16/18 型）疫苗（汉逊酵母）后的免疫持久性。

开始日期2022-05-14

申办/合作机构

上海博唯生物科技有限公司

100 项与四价重组人乳头瘤病毒（6/11/16/18型）疫苗（汉逊酵母）(上海博唯生物科技) 相关的临床结果

登录后查看更多信息

100 项与四价重组人乳头瘤病毒（6/11/16/18型）疫苗（汉逊酵母）(上海博唯生物科技) 相关的转化医学

登录后查看更多信息

100 项与四价重组人乳头瘤病毒（6/11/16/18型）疫苗（汉逊酵母）(上海博唯生物科技) 相关的专利（医药）

登录后查看更多信息

项与四价重组人乳头瘤病毒（6/11/16/18型）疫苗（汉逊酵母）(上海博唯生物科技) 相关的文献（医药）

2022-04-01·Journal of Lower Genital Tract Disease4区 · 医学

Cervical Intraepithelial Neoplasia 3 (Cervical Intraepithelial Neoplasia 3/High-Grade Squamous Intraepithelial Lesion) in Human Papillomavirus–Vaccinated Women—Results From a Tertiary Referral Center

4区 · 医学

Article

作者: Domröse, Christian Markus ; Einzmann, Thomas ; Schömig-Markiefka, Birgid ; Silling, Steffi ; Mallmann, Michael Rudolf ; Wieland, Ulrike ; Mallmann, Peter ; Pilch, Henryk

ObjectiveHigh-grade cervical intraepithelial neoplasia (CIN 3) still develops in some vaccinated women despite established effectiveness of prophylactic human papillomavirus (HPV) vaccination. The purpose of this study was to define characteristics of women with CIN 3 after HPV vaccination referred to a gynecological dysplasia unit.Materials and MethodsRetrospective analysis of HPV-vaccinated women with CIN 3 in a single German center. Between July 2018 and September 2020, 791 women were referred to our university hospital–based dysplasia unit for colposcopic evaluation of abnormal cytological findings. Human papillomavirus vaccination status was retrieved. Human papillomavirus typing was performed in lesional biopsies and cervical swabs.ResultsNine women were identified who had previously been vaccinated with the quadrivalent HPV vaccine (Q-HPV) and were diagnosed with histologically confirmed CIN 3/high-grade squamous intraepithelial lesion. The Q-HPV had been administered between 12 and 28 years of age and 1–13 years before CIN 3 diagnosis. Nine different high-risk (HR)-HPV types were found in the CIN 3 biopsies, 6 monoinfections (twice HPV 16, once HPV 18, HPV 31, HPV 52, HPV 58, respectively) and 3 dual infections (HPV 33 + 52, HPV 51 + 52, HPV 53 + 66). Seven of these 9 HR-HPV types are not covered by Q-HPV, but only 2 CIN 3 lesions carried HR-HPV types not included in the nonavalent HPV vaccine.ConclusionsIt is important to implement vaccination recommendations and administer HPV vaccination as early as possible in HPV-naive individuals. Because not all HR-HPV types are covered by the available HPV vaccines, other types may still cause CIN 3/high-grade squamous intraepithelial lesion. This requires further screening after vaccination, especially in women who were previously vaccinated with the bivalent or the quadrivalent HPV vaccine.

2022-01-01·International Journal of STD & AIDS4区 · 医学

Efflorescence of acquired epidermodysplasia verruciformis due to immune reconstitution inflammatory syndrome-like mechanisms following anti-HPV vaccination in a HIV-positive patient

4区 · 医学

Article

作者: Trentalange, Alice ; Parietti, Michele ; Calcagno, Andrea ; Ribero, Simone ; Conti, Luca ; Trunfio, Mattia ; Bonora, Stefano ; Delmonte, Sergio

Epidermodysplasia verruciformis (EV) is a rare cutaneous pre-cancerous condition characterized by presence of flat, scaly macules, verruca-like papillomatous papules, seborrheic keratosis-like lesions, and pink-red pityriasis versicolor-like macules. The disease is caused by abnormal susceptibility to certain specific beta-HPV subtypes, most commonly 5 and 8. Classic EV is genetically determined, but in immunocompromised individuals, an acquired form can occur. Only 48 cases of acquired EV (AEV) in people living with HIV have been described. We describe a case of AEV in a 36-year-old HIV-positive man with an history of stable optimal CD4 cell count and undetectable HIV viral load. The AEV significantly deteriorated after the administration of the second dose of the quadrivalent anti-HPV vaccine and did not improve despite local treatment, anti-HPV vaccination completion, and persistently optimal combined antiretroviral treatment adherence. To the best of our knowledge, this is the first report of an AEV deterioration with a clinical and temporal pattern mimicking an immune reconstitution inflammatory syndrome (IRIS) following anti-HPV vaccination, instead of low CD4 count restoration. After reviewing the current literature, we have hypothesized a vaccine-mediated IRIS-like phenomenon in the pathogenesis of the disease.

2021-08-01·Pediatric Infectious Disease Journal4区 · 医学

Immunogenicity and Safety of a Tetravalent Dengue Vaccine Administered Concomitantly or Sequentially With Quadrivalent Human Papillomavirus Vaccine in Boys and Girls 9–13 Years of Age in Malaysia

4区 · 医学

Article

作者: Ghazali, Nor Faizah ; Hassan, Jamiyah ; Sulaiman, Sofiah ; Hasim, Ruziaton ; Koh, Mia Tuang ; Sivapunniam, Selva Kumar ; Mascareñas, Cesar ; Vigne, Claire ; Zocchetti, Celine ; Meyer, Stephanie ; Toh, Myew-Ling ; Toh, Teck-Hock

Background:Incorporating dengue vaccination within existing vaccination programs could help improve dengue vaccine coverage. We assessed the immunogenicity and safety of a quadrivalent human papillomavirus (HPV) vaccine administered concomitantly or sequentially with a tetravalent dengue vaccine (CYD-TDV) in healthy children 9–13 years of age in Malaysia.Methods:In this phase IIIb, open-label, multicenter study (NCT02993757), participants were randomized 1:1 to receive 3 CYD-TDV doses 6 months apart and 2 doses of quadrivalent HPV vaccine concomitantly with, or 1 month before (sequentially), the first 2 CYD-TDV doses. Only baseline dengue-seropositive participants received the 3 doses. Antibody levels were measured at baseline and 28 days after each injection using an enzyme-linked immunosorbent assay for HPV-6, -9, -16 and -18, and the 50% plaque reduction neutralization test for the 4 dengue serotypes; immunogenicity results are presented for baseline dengue-seropositive participants. Safety was assessed throughout the study for all participants.Results:At baseline, 197 of 528 (37.3%) randomized participants were dengue-seropositive [n = 109 (concomitant group) and n = 88 (sequential group)]. After the last HPV vaccine dose, antibody titers for HPV among baseline dengue-seropositive participants were similar between treatment groups, with between-group titer ratios close to 1 for HPV-6 and 0.8 for HPV-11, -16, and -18. After CYD-TDV dose 3, dengue antibody titers were similar between treatment groups for all serotypes [between-group ratios ranged from 0.783 (serotype 2) to 1.07 (serotype 4)]. No safety concerns were identified.Conclusions:The immunogenicity and safety profiles of CYD-TDV and quadrivalent HPV vaccines were unaffected when administered concomitantly or sequentially in dengue-seropositive children.

100 项与四价重组人乳头瘤病毒（6/11/16/18型）疫苗（汉逊酵母）(上海博唯生物科技) 相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
雄激素不敏感综合征	临床3期	中国	上海博唯生物科技有限公司	2022-12-09
子宫颈发育不良	临床3期	中国	上海博唯生物科技有限公司	2022-12-09
阴道上皮内瘤变	临床3期	中国	上海博唯生物科技有限公司	2022-12-09
外阴上皮内瘤变	临床3期	中国	上海博唯生物科技有限公司	2022-12-09
尖锐湿疣	临床3期	中国	上海博唯生物科技有限公司	2022-05-14
宫颈癌	临床3期	中国	上海博唯生物科技有限公司	2022-05-14