Although human papillomavirus (HPV) infection constitutes a significant public health challenge, the HPV vaccination coverage remains suboptimal in China. Recent roll-out of new policies calls for an updated evaluation on the knowledge, attitude, and practice on HPV and HPV vaccination among adolescents and their parents. This nationwide cross-sectional survey targeted adolescents aged 9-17 y paired with one of their parents. Sociodemographic factors and the awareness, knowledge, attitude, practice and willingness toward HPV and HPV vaccination were collected for adolescents and their parents. Univariable and multivariable regression analyses were conducted to evaluate the factors associated with the knowledge, attitude, and practice of adolescents and their parents. A total of 1,000 pairs of adolescents and their parents were included. Awareness of HPV and HPV vaccine was 34.2% and 43.9% among adolescents, and 61.0% and 68.0% among parents. Although 77.0% of the adolescents and 78.2% of the parents believed in the benefits of HPV vaccine on adolescents, the vaccination rate remained low among adolescents (7.4%). The willingness toward HPV vaccination was significantly higher among the unvaccinated adolescents whose parents acknowledged the risk of HPV infection on themselves or communicated with their children about reproductive health. The findings underscored critical gaps in knowledge, attitude, and practice toward HPV and HPV vaccination among Chinese adolescents and their parents. To address these challenges, family-oriented, school-based and physician-led educational initiatives, enhancement of the accessibility and convenience of HPV vaccination, expansion of HPV vaccine indications, and evidence to support its inclusion in the National Immunization Program are needed.
Vulvar and vaginal cancers significantly impact women’s health and quality of life. This study analyzes the prevalence of human papillomavirus (HPV), clinicopathological characteristics, treatment patterns, and survival outcomes, to understand their relationships and better guide prevention and therapy for Chinese patients with vulvar or vaginal cancer. We conducted a retrospective, multicenter study across nine tertiary hospitals located in seven regions of China, including patients diagnosed and treated between 2017 and 2021. Data were collected from medical records and standardized questionnaires, with routine clinical follow-up. Continuous variables were analyzed using the Wilcoxon rank-sum test, while categorical variables were compared using the chi-square test or Fisher’s exact test, as appropriate. Survival outcomes, including overall survival and disease-free survival, were evaluated using the Kaplan-Meier method and multivariable cox proportional hazards regression. A total of 218 patients (131 vulvar, 87 vaginal) were analyzed. HPV infection was significantly higher in vaginal than vulvar cancer (76.1
BACKGROUND:Cecolin, a bivalent human papillomavirus (2vHPV) vaccine produced with Escherichia coli, has demonstrated safety and efficacy and is now widely used globally. We aimed to report the efficacy, safety, and immunogenicity profile of the nine-valent (9vHPV) vaccine, Cecolin 9. METHODS:We conducted a multicentre, double-blind, randomised, controlled, phase 3 trial at five local health centres in the Jiangsu and Sichuan provinces in China. Eligible participants were healthy, non-pregnant women aged 18-45 years with an intact cervix, no previous HPV vaccination, and between one and four lifetime sexual partners. Participants were stratified by age (18-29 and 30-45 years) and randomly assigned (1:1) with an interactive web response system (central randomisation with block sizes of eight) to receive three doses of either the 9vHPV vaccine (vaccine group) or the 2vHPV vaccine (control group) at day 0, month 1, and month 6. All participants, investigators, and laboratory personnel were masked to group assignment. The coprimary outcomes were immunogenicity, defined as non-inferiority of neutralising antibodies against HPV 16 and 18 at month 7 in the per-protocol set, and persistent infection (≥12 months), associated with HPV 31, 33, 45, 52, and 58 in the modified intention-to-treat population. Non-inferiority was identified for the lower limit of the 95% CI of the geometric mean concentration (GMC) ratio (9vHPV vs 2vHPV) at a margin of 0·5 and a seroconversion rate difference (9vHPV - 2vHPV) at a margin of -5%. Both criteria had to be met to establish non-inferiority. This trial is registered with ClinicalTrials.gov (NCT04537156) and follow-up is ongoing. FINDINGS:Between Sept 5 and Dec 10, 2020, 11 024 individuals were screened, of whom 9327 (84·6%) eligible women were randomly assigned to the vaccine group (4663 [50·0%]) and the control group (4664 [50·0%]). In the per-protocol set, antibody responses against HPV 16 and 18 in the vaccine group were non-inferior to those in the control group. The GMC ratio was 0·60 (95% CI 0·56-0·66) for HPV 16 and 0·64 (0·58-0·70) for HPV 18; the difference in seroconversion rates was 0·0% (95% CI -0·49 to 0·48) for HPV 16 and -0·12% (-0·67 to 0·33) for HPV 18. In the modified intention-to-treat population, 9vHPV vaccine efficacy against 12-month persistent infection associated with HPV types 31, 33, 45, 52, and 58 was 98·2% (95% CI 89·6-100). Adverse reactions were reported by 2432 (52·1%) of 4664 participants in the vaccine group and by 1966 (42·2%) of 4663 in the control group. Serious adverse events occurred at a similar rate between the vaccine group (512 [11·0%]) and the control group (481 [10·3%]); none were considered related to vaccination. INTERPRETATION:The E coli-produced 9vHPV vaccine was well tolerated, immunogenic, and highly protective against vaccine-targeted HPV types. Given its low production cost, this vaccine has the potential to improve global access to high-valency HPV vaccination. FUNDING:National Key R&D Program of China, National Natural Science Foundation of China, Natural Science Foundation of Beijing Municipality, Natural Science Foundation of Xiamen Municipality, Fundamental Research Funds for the Central Universities, and Xiamen Innovax. TRANSLATION:For the Chinese translation of the abstract see Supplementary Materials section.
To identify screening intervals and BI-RADS–specific management pathways that balance cancer detection yield against recall burden in ultrasound-based breast cancer screening in China. We analysed 1,694,838 ultrasound examinations reported with BI-RADS (2018–2023). For BI-RADS 1/2, inter-screen intervals were evaluated by recall rate, cancer detection rate (CDR), positive predictive value (PPV), and early-stage proportion. For BI-RADS 0/3/4/5, we assessed associations between biopsy waiting time and PPV/early-stage proportion, and examined imaging follow-up outcomes for BI-RADS 4A. Among 337,497 screening intervals following BI-RADS 1/2, longer intervals were associated with higher CDR (0.13–0.54 per 1,000) but higher recall (17.4
OBJECTIVE:To evaluate the 5-year efficacy of thermal ablation (TA) for cervical intraepithelial neoplasia (CIN) and high-risk HPV (hrHPV) clearance in Chinese women. METHODS:A total of 17,202 women aged 20-65 years were recruited to screening cohorts in 2017-2018 from 3 rural counties in Shanxi and Inner Mongolia and an urban area in Shenzhen with follow-up evaluations until 2022. The hrHPV-positive women with ablation-eligible lesions on colposcopy underwent biopsy and TA (n = 228) in one visit. A loop electrosurgical excision procedure (LEEP) or cold knife conization (CKC) was recommended for ineligible women with high-grade CIN on histology (n = 106 and 41, respectively), while untreated hrHPV-positive women served as controls. Treated women had annual hrHPV testing and cytology. Untreated women had annual hrHPV testing. Positive cases were referred for colposcopy, with biopsy performed when indicated. Cure rates and hrHPV clearance rates were analyzed using Kaplan-Meier and competing risk models with sub-distribution hazard ratios (SHRs) assessing treatment effects. RESULTS:The 5-year cure rate for CIN1 regressing to normal was 79.0% after TA treatment and the 5-year cure rate for CIN2 regressing to CIN1/normal was 87.9%, comparable to LEEP (90.3%) and CKC (94.4%) for CIN2 (P = 0.54). The TA cure (66.0%) was significantly lower for CIN3 than LEEP and CKC (97.0% and 94.1%; P = 0.006). TA achieved 98.0% 5-year hrHPV clearance in CIN1/normal cases, which was higher than untreated women (87.7%; SHR = 0.81, 95% CI = 0.73-0.90), particularly for HPV16 (SHR = 0.67), HPV31 (SHR = 0.56), and HPV33 (SHR = 0.65). The 5-year hrHPV clearance after TA was comparable to LEEP and CKC for CIN2/3. CONCLUSIONS:TA provides durable efficacy for CIN1 and CIN2 and promotes hrHPV clearance, reducing progression risk. It could complement excisional treatments for CIN2 and enhance treatment accessibility in low-resource settings.
Therapeutic HPV vaccines (TxVs) may complement existing cervical cancer prevention strategies, particularly for women already infected with HPV who derive limited benefit from prophylactic vaccination. As China advances toward the WHO 90–70–90 cervical cancer elimination targets, understanding the potential health impact of therapeutic vaccines under varying implementation scenarios is critical. We developed a two-stage hybrid model combining a dynamic HPV transmission model with a natural history model of HPV-related disease progression to project the long-term health impact of therapeutic HPV vaccines in China from 2025 to 2125. Two vaccine types aligned with WHO Preferred Product Characteristics were evaluated: one targeting HPV infection clearance (TxV1) and one targeting treatment of cervical intraepithelial neoplasia (CIN) grade 2 or 3 (TxV2). Vaccination was modelled under two use cases: population-based delivery and integration into existing national screening programmes. Outcomes included cervical cancer cases and deaths averted, relative reductions compared with no therapeutic vaccination, age-standardised incidence, and the projected year of elimination. One-way and probabilistic sensitivity analyses evaluate model uncertainty. In the base case, screening-integrated TxV1 (Use Case 2) could avert up to 834.0 thousand cervical cancer cases (12.7
In China, cervical cancer incidence and mortality have continued to increase despite more than 15 years of nationwide organized screening, raising questions about the population-level impact of screening. Using national cancer registry data from 2004 to 2018, we analyzed temporal trends in age-standardized incidence rates (ASIRs) and mortality rates (ASMRs), as well as age-specific rates, using Joinpoint regression, and assessed their correlations with age-specific screening coverage. From 2004 to 2018, ASIR increased from 6.06 to 11.81 per 100,000, but the annual growth rate slowed markedly after 2007, declining from 12.5 % (95 % CI: 9.7 ∼ 15.5 %) to 3.1 % (95 % CI: 2.7 ∼ 3.4 %). Among women aged 35-44 years, incidence trends shifted from a sharp rise to a sustained decline. By contrast, ASMR rose steadily from 2.07 to 3.44 per 100,000, with an average annual increase of 4.1 % (95 % CI: 3.4 ∼ 4.8 %). Notably, mortality stabilized after a rapid early rise among women aged 40-44 years, the group with the highest screening coverage. Correlation analysis revealed strong positive associations between higher screening coverage and the deceleration of incidence (ρ = 0.85, p < 0.001) and mortality trends (ρ = 0.69, p = 0.014). These findings suggest that increased screening coverage may already be moderating incidence and mortality trends in specific age groups, particularly women aged 35-44 years. However, nationwide declines have yet to emerge, especially in rural populations where screening coverage remains low and disease burden is high. Expanding access and improving screening quality are critical to accelerate progress toward cervical cancer control in China.
Introduction The economically emerging countries contributed to over half of the global cervical cancer (CC) burden and are good examples showing how rapid economic growth and health policy change affect the trends of CC burden. This study aimed to analyse the time trends of CC burden across Brazil, Russia, India, China and South Africa (BRICS) and associations with age, period and birth cohort from 1992 to 2021.Methods Data on CC incident cases, deaths, age-standardised incidence rates (ASIRs) and age-standardised mortality rates (ASMRs) were sourced from the Global Burden of Disease Study 2021 to demonstrate the temporal trends of CC burden for BRICS countries from 1992 to 2021. An age-period-cohort model was used to determine the net drift, local drift, longitudinal age curves, as well as period and cohort relative risks regarding CC incidence and mortality.Results Between 1992 and 2021, the ASIR of CC decreased from 16.5 to 15.6 per 100 000 women (−5.5%) and the ASMR declined from 10.1 to 6.7 per 100 000 women (−33.7%) in BRICS. Brazil reported continuous decreases in both CC incidence (net drift: −1.1%, 95% CI −1.1% to −1.0%) and mortality (net drift: −1.7%, 95% CI −1.80% to −1.6%). India also had reduced CC incidence and mortality but experienced worsening period effects from 2012 onwards. Russia and China experienced decreasing trends in mortality yet increasing trends in incidence, and there were apparent unfavourable trends among young and middle-aged women in Russia. South Africa maintained the highest CC incidence (40.0 per 100 000 women, 95% CI 35.0 to 45.6) and mortality (21.3 per 100 000 women, 95% CI 18.8 to 24.1) across the BRICS and had the steepest growth of CC incidence and mortality rates with increasing age.Conclusion Despite an overall decreasing trend of CC burden in BRICS, substantial heterogeneity exists across nations. Identifying country-specific priority groups and tailoring interventions is essential, and the patterns observed have implications for public health strategies applicable not just to BRICS nations but also to many other emerging economies facing substantial CC burden.
BACKGROUND:Human papillomavirus (HPV) is a common sexually transmitted infection with a substantial disease burden in China. Despite the importance of vaccinating young adults, coverage remains suboptimal. This study aims to assess the knowledge, attitude, and practice (KAP) towards HPV, HPV-related disease, and HPV vaccine among young adults in China. METHODS:A nationwide cross-sectional survey was conducted between July and August 2024, enrolling 1000 young adults aged 18-30 years through stratified sampling across seven administrative regions. Participants completed a structured electronic questionnaire assessing socio-demographics and KAP regarding HPV, HPV-related disease, and HPV vaccination. Descriptive analyses summarized KAP, and regression models identified associated factors. RESULTS:Overall, 70.4% of participants had heard of HPV and 75.2% had heard of HPV vaccine. The mean knowledge score was 5.3/10 for HPV and related diseases and 8.2/12 for HPV vaccine. Multivariable analysis demonstrated that higher knowledge levels were significantly associated with more favorable attitudes and stronger willingness to vaccinate in both sexes. There was a substantial gap between self-reported vaccination willingness (36.0% of males, 71.4% of females) and actual uptake (5.0% of males, 22.2% of females). Key barriers included insufficient knowledge about HPV vaccine, the absence of vaccinated individuals within participants' social networks, and safety concerns. CONCLUSION:KAP regarding HPV and vaccination have improved among young adults in China but still lag behind developed countries. Despite increased knowledge and vaccination willingness, a substantial gap persisted between intention and actual uptake. This requires not only strengthening HPV knowledge, reducing safety concerns, advocating universal vaccination strategies, and enhancing on-campus education, but also implementing systemic policy reforms to translate willingness into action, with the ultimate goal to reduce HPV-related disease burden.
Human papillomavirus(HPV)is the most prevalent sexually transmitted infection worldwide1.More than 200 HPV geno-types have been identified and are classified as high-risk HPV(HR-HPV)or low-risk HPV(LR-HPV)according to their onco-genic potential.
Background: High-risk human papillomavirus (HPV) infection is causally linked to multiple non-cervical cancers. In the absence of scalable screening strategies, vaccination represents the most feasible preventive approach. However, economic evaluations in China have largely focused on cervical outcomes, underestimating the broader value of HPV vaccination. Methods: We evaluate the long-term health and economic impacts of HPV vaccination in China from 2026 to 2100 using a previously developed and calibrated Chinese-adapted hybrid model. Strategies varied by vaccine type and catch-up age, and were evaluated from a societal perspective. Outcomes included health and economic burden, net monetary benefit (NNB), return on investment (ROI), and incremental cost-effectiveness ratio (ICER), with subgroup analyses by cohort, cancer type, sex, and region. One-way and probabilistic sensitivity analyses were conducted. Results: Initiating HPV vaccination in 2026 with 90% coverage would avert at least 65% of HPV-attributable non-cervical burden in vaccinated cohorts, with the greatest gains observed for anal and oropharyngeal cancers. Over 95% of this burden in unvaccinated cohorts would remain. Including non-cervical outcomes increased NNB by $1.90-$4.03 billion and ROI by 0.47-0.75, with larger gains in urban areas. The 9-valent vaccine with catch-up to age 26 yielded the highest net benefit. Interpretation: HPV vaccination could substantially reduce the burden of non-cervical cancers in China. Realizing its full benefits will require coordinated policies, supporting a shift toward a comprehensive multi-cancer prevention framework.
A comprehensive profile of immunogenicity induced by a single dose of human papillomavirus (HPV) vaccination has yet to be presented. We report interim data from an ongoing non-interventional real-world study comparing the memory cell and antibody responses following single- and two-dose regimens of the Escherichia coli-produced HPV-16/18 vaccine in Chinese girls aged 9-14 years. HPV-16/18-specific neutralizing antibodies, IgG antibodies, and memory B- and T-cell responses were assessed and compared between the single-dose and two-dose groups. The results showed that among 492 per-protocol participants (298 two-dose; 194 single-dose), the median time from Dose 1 to blood sampling was 12.07 months. Single-dose neutralizing antibody seropositivity exceeded 90% for HPV-16 and approached 80% for HPV-18. The antibody avidity index of HPV-16 IgG after a single dose was non-inferior to that after two doses (lower bound of the geometric mean avidity ratio > 0.5). Both dosing schedules induced HPV-16/18-specific memory B- and T-cell responses with similar positivity and geometric means (p > 0.05). Therefore, a single dose of the E. coli-produced HPV-16/18 vaccine elicited robust antibody quantity and quality, with memory B- and T-cell responses comparable to those induced by two doses, supporting its potential for population-level implementation and contribution to the WHO target of vaccinating 90% of girls.
OBJECTIVES:To assess the demographic and clinical characteristics, treatment and health outcome, and economic burden of juvenile-onset recurrent respiratory papillomatosis (JoRRP) in China. METHODS:We identified twelve hospitals mainly responsible for JoRRP management across China to enroll patients presenting for JoRRP between Jan 1, 2011, and Dec 31, 2021. Data were primarily extracted from medical records, and missing values were additionally collected through telephone or outpatient interviews by two researchers independently. We used counts (proportions) and median values (interquartile range, IQR) to describe data. We applied the Lorenz curve and the concentration index (C-index) to indicate the wealth-related and education-related inequalities in JoRRP. RESULTS:Of the 361 enrolled JoRRP patients, the median age at first diagnosis was 2.7 years (IQR: 1.5-5.0). During the 7.2-year median follow-up, we observed that 314 (87.0%) patients experienced relapse and 125 (38.0%) patients underwent an aggressive clinical course. The median value for the estimated total economic costs per patient was 8717.5$ (IQR: 4700.6$-15359.1$) and the occurrence of catastrophic health expenditure was concentrated in families with low incomes and less-educated parents. CONCLUSION:Chinese JoRRP patients experienced significant disease burden characterized by severe clinical symptoms and substantial economic costs. Strategic healthcare plans for JoRRP are needed for disease mitigation in China.
Background:A safe and highly efficacious Escherichia coli-produced HPV-16/18 bivalent vaccine (Cecolin®) offers a cost-effective cervical cancer prevention measure. Here, we report data on the long-term efficacy and immunopersistence up to 10 years post-vaccination. Methods:In the Phase III clinical trial (NCT01735006), 7372 women were enrolled and randomly assigned to receive the HPV or control vaccine (hepatitis E vaccine). Women from 2 sites (Xinmi City and Fengning County; N = 1986) were invited to participate in the extension study. Cervical samples were collected for ThinPrep Pap tests and HPV DNA testing. Serum samples from participants in the immune persistent subcohort (N = 300) were collected for neutralising antibody testing. The co-primary outcomes were high-grade cervical, vulvar or vaginal lesions and persistent infection (over 6 months) associated with HPV 16/18 in the per-protocol population. Findings:A total of 1648 women participated in the extension study (806 from the vaccine group and 842 from the control group). Over a median 10.2-year follow-up, vaccine efficacy was 87.5% (95% CI 6.4-99.7) against high-grade cervical, vulvar or vaginal lesions (1 case in the vaccine group and 8 cases in the control group, P = 0.0391), and 97.0% (95% CI 78.9-100.0) against persistent infection (over 6 months, 1 case in the vaccine group and 32 cases in the control group, P < 0.0001) in the per-protocol population. The GMCs of neutralising antibodies peaked by month 7, declined through month 42, with HPV-16 plateauing and HPV-18 continuing to decline thereafter. At 114 months, 98.9% (93/94) of baseline seronegative participants remained seropositive for HPV-16 with the GMC of 61.84 IU/mL and 97.0% (98/101) remained seropositive for HPV-18 with the GMC of 18.73 IU/mL. Interpretation:The E. coli-produced HPV 16/18 bivalent vaccine elicits sustained antibody responses and confers durable protection against HPV 16/18 associated high-grade cervical, vulvar or vaginal lesions and persistent infections for a minimum of 10 years post-vaccination. Funding:National Key Research and Development Program of China (2023YFC2307602), National Natural Science Foundation of China (823B2086, 82273640), Beijing Natural Science Foundation (L244091), and Fundamental Research Funds for the Central Universities (20720220005).
Table S1 shows average age and standardized average age at diagnosis for cervical cancer between 2006 to 2030.
Figure S4 age-period-cohort effect on cervical cancer mortality rates in China between 2006 to 2016.
BACKGROUND:Optimal triage option for high-risk HPV-positive (hrHPV) women remains uncertain. We aimed to utilize methylation-sensitive restriction enzyme-based quantitative PCR (MSRE-qPCR) technique and develop triple-target human gene methylation panels to improve detection of advanced cervical precancers and cancers (CIN3 +) among hrHPV women. METHODS:Eighteen candidate genes were detected by MSRE-qPCR in cervical samples from hrHPV women. All possible triple-target panels from these genes were generated by logistic regression models with repeated ten-fold cross-validation on a training set of 1223 women (180 CIN3 +; 1043 < CIN3). Panels with the top two AUCs for CIN3 + on a validation set of 937 women (69 CIN3 +; 868 < CIN3) were ultimately selected for qPCR reconstruction, retesting, and retraining. Triage performance, screening efficiency and risk stratification of the selected panels were then compared with traditional triage strategies (cytology [ASCUS as the threshold, atypical squamous cells of undetermined significance], HPV16/18 genotyping, HPV16/18 genotyping combined with cytology [ASCUS]) within the validation set. RESULTS:Two panels were finally identified and validated for CIN3 + detection. Panel 1 includes JAM3, PCDHGB7, and SORCS1; while Panel 2 consists of PAX1, ZNF671, and ASCL1. Compared to traditional triage strategies, both panels demonstrated superior AUCs (Panel 1: 0.799; Panel 2: 0.790; Cytology: 0.532; HPV16/18 genotyping: 0.589; HPV16/18 + Cytology: 0.515; all PAUC < 0.001), with substantially higher specificities (83.06%; 86.98%; 29.49%; 72.93%; 14.52%), comparable sensitivities (76.81%; 71.01%; 76.81%; 44.93%; 88.41%), and requiring fewer colposcopies per CIN3 + case (3.77; 3.31; 12.55; 8.58; 13.16). However, Panel 1 and Panel 2 were statistically indistinguishable (PAUC = 0.603; Ratiosensitivity: 0.92 [0.76-1.13]; Ratiospecificity: 1.05 [1.01-1.08]). Unlike traditional strategies (CIN3 + risks: 5.59% ~ 17.97%), women tested negative on either panel had immediate CIN3 + risks below 3% (Panel 1: 2.17%; Panel 2: 2.58%), supporting safe deferral for at least one year. CONCLUSIONS:Two triple-target human gene methylation panels were successfully developed, each integrated into a single MSRE-qPCR system for one-tube detection. Both panels outperformed current triage strategies, indicating their potential as alternatives, though external validation among diverse settings is needed before clinical application.
Table S5 shows proportion of the annual number of deaths by age group between 2006 to 2016.
Figure S3 shows age-period-cohort effect on cervical cancer incidence rates in China between 2006 to 2016.