[Translation] A single-center, randomized, double-blind, controlled clinical trial to evaluate the immunogenicity and safety of the scaled-up recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 9-valent vaccine (Escherichia coli) in Chinese women aged 18-26 years

主要目的：评价重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗（大肠埃希菌，600L工艺）的免疫原性是否非劣效于重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗（大肠埃希菌，60L工艺）。次要目的：评价试验疫苗的安全性。

[Translation]

Primary objective: To evaluate whether the immunogenicity of the recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-valent vaccine (Escherichia coli, 600L process) is non-inferior to that of the recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 nine-valent vaccine (Escherichia coli, 60L process). Secondary objective: To evaluate the safety of the experimental vaccine.

Start Date06 Apr 2024

Sponsor / Collaborator

Xiamen Innovax Biotech Co., Ltd.

[+2]

NCT05056402 / Active, not recruitingPhase 3IIT

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.

Start Date19 Sep 2021

Sponsor / Collaborator

Xiamen Innovax Biotech Co., Ltd.

[+1]

CTR20212272 / Active, not recruitingPhase 3

对9-17岁健康受试者进行的重组人乳头瘤病毒6/11/16/18/31/33/45/52/58型九价疫苗（大肠埃希菌）随机，开放的免疫原性桥接临床试验

[Translation] A randomized, open-label, immunogenicity bridging clinical trial of the recombinant human papillomavirus 6/11/16/18/31/33/45/52/58 9-valent vaccine (Escherichia coli) in healthy subjects aged 9-17 years

主要目的：评价受试疫苗在9-17岁健康人群中各HPV型别的免疫原性是否非劣效于18-26岁健康女性；次要目的： 1）评价受试疫苗在9-14岁健康人群采用两针免疫程序的各HPV型别的免疫原性是否非劣效于18-26岁健康女性采用三针免疫程序； 2）评价受试疫苗的安全性。

[Translation]

Main purpose: To evaluate whether the immunogenicity of the test vaccine against each HPV type in healthy people aged 9-17 years is non-inferior to that of healthy women aged 18-26 years; Secondary purpose: 1) To evaluate whether the immunogenicity of the test vaccine against each HPV type in healthy people aged 9-14 years with a two-dose immunization schedule is non-inferior to that of healthy women aged 18-26 years with a three-dose immunization schedule; 2) To evaluate the safety of the test vaccine.

Start Date19 Sep 2021

Sponsor / Collaborator

Xiamen Innovax Biotech Co., Ltd.

[+2]

100 Clinical Results associated with Human papillomavirus recombinant vaccine nonavalent (Xiamen Innovax Biotech)

100 Translational Medicine associated with Human papillomavirus recombinant vaccine nonavalent (Xiamen Innovax Biotech)

100 Patents (Medical) associated with Human papillomavirus recombinant vaccine nonavalent (Xiamen Innovax Biotech)

Literatures (Medical) associated with Human papillomavirus recombinant vaccine nonavalent (Xiamen Innovax Biotech)

01 Nov 2024·European Journal of Clinical Microbiology & Infectious Diseases

Trends in human papillomavirus infection and genotype distribution among males in Chongqing, China (2017–2022): an observational study

Article

Author: Chen, Hongjiao ; Wu, Guangjie ; Tang, Xiaojun ; Hu, Yanqi ; Yi, Xiyang

PURPOSEThis study aimed to investigate Human papillomavirus (HPV) infection and genotyping in men from Chongqing and analyze age-related trends to provide insights for HPV prevention and vaccination plans tailored for men in Chongqing, China.METHODSThis study is an observational study. We investigated male patients who underwent HPV screening at two hospitals in Chongqing from 2017 to 2022, totaling 4,381 cases, aged 18 to 85. HPV genotyping was conducted using the Hybribio Rapid GenoArray kit.RESULTSAmong the 4,381 men, the overall HPV prevalence was 14.9%, peaking at 19.3% in 2022. Single HPV infection was 11.5%, and multiple infection was 3.4%. The most prevalent genotypes were HPV-52, HPV-16, and HPV-58. Single high-risk HPV infection peaked in the 36-45 age group, while multiple high-risk HPV infection decreased with age (P-trend < 0.01). Prevalence in the ≤ 25 age group was 3.7%. Single low-risk HPV infection also decreased with age (P-trend = 0.03). Genotypes covered by the nonavalent vaccine had the highest prevalence, increasing with age. Co-infection of HPV-16 with HPV-52 and HPV-58 was common. Single HPV infections were prevalent in cases of urethritis (30.8%), anogenital warts (36.4%), and genital warts (26.3%), while multiple HPV infections were significant in anogenital warts (18.2%).CONCLUSIONSSingle HPV infection was predominant in Chongqing, with HPV-52, HPV-16, HPV-58, HPV-53, and HPV-39 being the most prevalent genotypes. The prevalence of genotypes covered by the nonavalent vaccine increased with age. This study offers valuable insights for developing male-specific HPV prevention strategies in Chongqing.

01 Sep 2024·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

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

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.

01 Jan 2024·Journal of the European Academy of Dermatology and Venereology

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

Article

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

AbstractBackgroundPenile 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.ObjectiveTo 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.MethodsA 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%).ResultsA 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).ConclusionThis 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.

100 Deals associated with Human papillomavirus recombinant vaccine nonavalent (Xiamen Innovax Biotech)

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Indication	Highest Phase	Country/Location	Organization	Date
Human Papillomavirus Infection	Phase 3	CN	Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.	05 Sep 2020
Human Papillomavirus Infection	Phase 3	CN	Xiamen University	05 Sep 2020

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