Immunogenicity and safety of the 9-valent human papillomavirus vaccine in Chinese females 9–45 years of age: A phase 3 open-label study

Lv, Huakun; Wang, Shenyu; Liang, Zhenzhen; Yu, Wei; Yan, Chuanfu; Chen, Ying-ping; Hu, Xiaosong; Fu, Rong; Zheng, Minghuan; Group, Thomas; Luxembourg, Alain; Liao, Xueyan; Chen, Zhiping

doi:10.1016/j.vaccine.2022.02.061

Cited by 8 publications

(11 citation statements)

References 38 publications

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“…Regarding 9v-HPV vaccine immunogenicity, a phase-III openlabel study (NCT03903562) among 1990 females (9-19 years, n=690; 20-26 years, n=650; 27-45 years, n=650) demonstrated that 99% of participants seroconverted to the corresponding vaccine for their HPV type after one month when they received 3 doses(100% seroconversion of all participants, with the exception of HPV18 in 20-26-year old group (99.8% seroconversion)). The anti-HPV6/11/16/18/31/33/45/ 52/58 seroconversion percentages in 9-19-year-old and 27-45-year-old Chinese females were not inferior than those of 20-26 years old females (13). Based on these results, the NMPA approved extending the age of the 9v-HPV vaccine for 9-45-year-old women in August 2022.…”

Section: -Valent Hpv Vaccinementioning

confidence: 84%

“…The phase III open-label study(NCT03903562) compared the 9-valent HPV vaccine in 9-45-year-old Chinese females demonstrated that injection-site AEs were common such as injection-site pain (39.2%,45.2%, and 39.8%) and injection-site erythema (9.3%, 11.2%, and 7.4%) in the 9–19-year, 20–26-year, and 27–45-year age groups, respectively. No SAEs, or related discontinuations, or deaths were confirmed to be vaccine-related ( 13 ).…”

Section: Safetymentioning

confidence: 99%

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Immunogenicity, efficacy, and safety of human papillomavirus vaccine: Data from China

Zhao

et al. 2023

Front. Immunol.

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The incidence rate and mortality rate of cervical cancer have steadily increased in young women in China. Therefore, it is critical to improve HPV vaccination rates, particularly for the younger population. There are currently five types of prophylactic vaccines in China: bivalent HPV vaccine (AS04-HPV-16/18), quadrivalent HPV vaccine, 9-valent HPV vaccine, homemade Escherichia coli-produced HPV bivalent vaccine, and Pichia pastoris produced HPV bivalent vaccine. All these five HPV vaccines have completed relevant clinical trials in China, and have been proven to be generally well-tolerated and immunogenic, efficacious against persistent HPV-related infections and genital precancerous lesions (data for 9-valent HPV vaccine is absent), and have demonstrated acceptable safety profiles, as previously shown in global studies. Given that the HPV vaccination rate in China is still very low, additional HPV vaccine coverage is needed to reduce the incidence and mortality rates of cervical cancer.

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Section: -Valent Hpv Vaccinementioning

confidence: 84%

Section: Safetymentioning

confidence: 99%

Immunogenicity, efficacy, and safety of human papillomavirus vaccine: Data from China

Zhao

et al. 2023

Front. Immunol.

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“…[27][28][29] In this study, we classified HPV26, HPV53, HPV73, HPV82 as hrHPV types in addition to the 14 hrHPV genotypes detected in US Food and Drug Administration (FDA)-approved commercial kits. Both Tellgen method and YangBio method detected the same 16 hrHPV types (HPV16, 18,31,33,35,39,45,51,52,53,56,58,59,66,68,82). In addition, HPV26 was detected by Tellgen method, while HPV73 was detected by YangBio method.…”

Section: Hpv Genotypingmentioning

confidence: 90%

“…Our patient cohort was mostly comprised of unvaccinated women who predominantly underwent cervical biopsy due to abnormal cervical screening test results. Although several HPV vaccines are available in China, they have not yet been officially included in the national vaccination program 15–18 . Additionally, financial and psychosocial barriers inevitably exist for those interested in electing to receive the vaccine in different regions and provinces 17,19–21 .…”

Section: Discussionmentioning

confidence: 99%

“…Although several HPV vaccines are available in China, they have not yet been officially included in the national vaccination program. [15][16][17][18] Additionally, financial and psychosocial barriers inevitably exist for those interested in electing to receive the vaccine in different regions and provinces. effectiveness and production of herd immunity associated have been presented from several countries.…”

Section: Distribution Of Hrhpv Genotypes In Endocervical Glandular Le...mentioning

confidence: 99%

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Extended human papillomavirus genotype distribution in cervical intraepithelial neoplasia and cancer: Analysis of 40 352 cases from a large academic gynecologic center in China

Tang

Jones

Jiang

et al. 2022

Journal of Medical Virology

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Our aim was to conduct a large epidemiologic analysis of the distribution of human papilloma virus (HPV) genotypes associated with cervical neoplasias and cancers at a major Chinese gynecologic center. The pathologic database was searched for cervical histopathologic diagnoses with prior HPV genotyping from liquid cervical cytology specimens obtained ≤6 months before biopsy. HPV testing was performed by using the Tellgenplex HPV27 or YanengBio HPV23 genotyping assays. A total of 40 352 cases meeting study criteria were identified. High risk human papillomavirus (hrHPV) was detected in 94.1% of squamous cancers compared to in only 83.3% of cervical adenocarcinomas. The prevalence of multiple HPV infections was highest in cervical intraepithelial neoplasia 1 (CIN1) (33.8%) and decreased with increasing severity of squamous lesions. The distribution of HPV genotypes was similar between CIN1 and histopathologic‐negative cases. HPV16 was one of the three most common hrHPV genotypes before all histopathologic abnormalities, ranging from 72.0% for cervical cancers, 38.7% for CIN2/3/AIS, 13.1% for CIN1, and 9.1% for biopsy‐negative cases. HPV16 and HPV18 accounted for over 87.2% of detected hrHPV genotypes for all glandular intraepithelial neoplastic lesions and cancers, whereas squamous lesions did not show this pattern. 80.3% of cervical cancers were associated with genotypes covered by HPV16/18 vaccines and 89.6% with genotypes covered by 9‐valent vaccination.

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Risk factors for human papillomavirus infection and disease: A targeted literature summary

del Pino,

Vorsters,

Joura

et al. 2024

Journal of Medical Virology

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Adolescents are the primary cohort for routine human papillomavirus (HPV) vaccination, but unvaccinated adults may also benefit. A lack of consensus on which adults to target and the presence of reimbursement barriers likely contribute to the lag in adult vaccinations, highlighting missed prevention opportunities. Understanding factors contributing to risk of HPV infection and disease could help in decision making on vaccination. This review summarizes existing literature on risk factors for HPV infection and disease and includes 153 studies reporting relative risks or odds ratios for factors associated with HPV infection or disease in adults, published between 2009 and 2020. Despite inconsistent design and reporting of risk factors across studies, this review confirmed several risk factors associated with adult infection, including human immunodeficiency virus positivity, number of sex partners, and smoking. These findings can support policymaking, guideline development, and clinical decision making for HPV vaccination and screening of high‐risk adult groups.

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Immunogenicity and safety of the 9-valent human papillomavirus vaccine in Chinese females 9–45 years of age: A phase 3 open-label study

Cited by 8 publications

References 38 publications

Immunogenicity, efficacy, and safety of human papillomavirus vaccine: Data from China

Immunogenicity, efficacy, and safety of human papillomavirus vaccine: Data from China

Extended human papillomavirus genotype distribution in cervical intraepithelial neoplasia and cancer: Analysis of 40 352 cases from a large academic gynecologic center in China

Risk factors for human papillomavirus infection and disease: A targeted literature summary

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