9-valent Human Papillomavirus Vaccine Research Articles

Reduced risk of CIN2+ recurrence in women immunized with a 9-valent HPV vaccine post-excision: Retrospective cohort study

ABSTRACT The main aim of our study was to investigate the specific contribution of a 9-valent human papillomavirus vaccine (9vHPV) to the recurrence risk of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in women vaccinated post-excision. Therefore, we conducted a retrospective monocentric cohort study in women aged 22–49 years undergoing conization between 2014 and 2023. The 9vHPV-vaccinated women were matched to unvaccinated women for age and follow-up duration in a 1:2 ratio to eliminate allocation bias. The risk of CIN2+ recurrence was estimated by the incidence rate ratio using Poisson regression with adjustment for comorbidities, smoking status, nulliparity, CIN grade, positive cone margin, and HPV genotypes. The CIN2+ recurrence rates in 147 women enrolled in the analysis were 18 and 2 cases per 100,000 person-days for unvaccinated and vaccinated women, respectively, during a mean follow-up period of 30 months (±22 months). A reduction in CIN2+ recurrences by 90% (95% confidence interval: 12–99%) was documented in 9vHPV-vaccinated participants compared to women undergoing only surgical excision. Moreover, vaccinated women with a positive cone margin showed a 42% (though non-significant) reduction in relapse (p = .661). Full post-conization vaccination with the 9vHPV contributed to an additional reduction in the risk of CIN2+ recurrence. This finding is consistent with current knowledge and suggests a high adjuvant effect of the 9vHPV vaccine.

Application of seamless phase Ⅱ/Ⅲ design in vaccine clinical trials

The seamless phase Ⅱ/Ⅲ design integrates independent phase Ⅱ and phase Ⅲ clinical trials into a continuous, phased adaptive clinical trial design. Compared with traditional independent phase Ⅱ and phase Ⅲ clinical trials, the seamless design offers significant advantages in accelerating drug or vaccine development and improving clinical trial efficiency. Currently, the application of this design in anti-tumor drug research is becoming increasingly mature, and it is gradually expanding to clinical trials of vaccines, including the 9-valent human papillomavirus vaccine, sabin strain inactivated polio vaccine, and others. This paper aims to clarify the seamless phase Ⅱ/Ⅲ design concept and offer valuable insights into its implementation. It accomplishes this by presenting a clinical trial example featuring a phase Ⅱ/Ⅲ seamless design for a 9-valent human papillomavirus vaccine. The article delves into the specific considerations and potential challenges related to implementing the seamless design, aiming to provide valuable insights for optimizing vaccine clinical trials within our country.

Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147).

We report the results of a randomized phase II trial of imiquimod, a topical immune-response modulator versus imiquimod plus a 9-valent human papillomavirus (HPV) vaccine (9vHPV) versus clinical surveillance in cervical intraepithelial neoplasia (CIN2/3) patients. We randomly allocated 133 patients with untreated CIN2/3 in equal proportions to a 4-month treatment with self-applied vaginal suppositories containing imiquimod (Arm B) or imiquimod plus a 9vHPV (Arm C) versus clinical surveillance (Arm A). The main outcome was efficacy, defined as histologic regression to CIN1 or less. Secondary outcomes were HPV clearance and tolerability. Exploratory objectives included the comparison of cervical CD4/CD8 T-cell infiltration at baseline, mid-study, and posttreatment by flow cytometry among study arms. Of the 114 evaluable patients 77% and 23% harbored CIN2 and CIN3, respectively. Regression to CIN1 or less was observed in 95% of patients in the imiquimod group (Arm B) compared with 79% in the control/surveillance (Arm A); P = 0.043 and 84% in the imiquimod+9vHPV group (Arm C; P = 0.384 vs. Arm A). Neither of the treatment-arm differences from Arm A reached the prespecified α = 0.025 significance level. No significant differences were noted in the secondary outcome of rate of HPV clearance. The number of tissue-resident memory CD4/CD8 T cells in cytobrush samples demonstrated a >5-fold increase in Arm B/imiquimod when compared with Arm A/surveillance (P < 0.01). In contrast, there was no significant difference in T-cell responses among participants in Arm C when compared with Arm A. Imiquimod treatment was well tolerated. Although imiquimod induced a higher regression to CIN1 or less and significant increases in CD4/CD8 T cells infiltrating the cervix, it did not meet its prespecified statistical outcome for efficacy. A higher regression rate than expected was observed in the surveillance arm of this prospective trial. Future clinical trials with imiquimod targeting CIN3 patients are warranted.

Abstract 4104: Randomized phase II trial of imiquimod with or without 9vHPV vs observation in patients with CIN 2 and 3

Abstract Introduction: We report the results of a randomized phase II trial of imiquimod, a topical immune-response modulator, vs imiquimod plus a 9-valent human papillomavirus vaccine (9vHPV) vs surveillance in cervical intraepithelial neoplasia (CIN) 2 and 3 patients. Methods: We randomly allocated 133 patients with untreated CIN 2/3 in equal proportions to a 4-month treatment with self-applied vaginal suppositories containing imiquimod (arm B) or imiquimod plus 9vHPV (arm C) vs clinical surveillance (arm A). The main outcome was efficacy, defined as histologic regression to CIN 1 or less. Secondary outcomes were HPV clearance and treatment tolerability. Exploratory objectives included the comparison of cervical CD4/CD8 T-cell infiltration at baseline, mid-study, and post-treatment by flow-cytometry. Results: Of the 114 evaluable patients 77% and 23% had CIN2 and CIN3, respectively. Histologic regression to CIN1 or less was observed in 95% of patients in the Arm B: imiquimod group and 84% in the Arm C: imiquimod+9vHPV compared with 79% in Arm A: surveillance (p=0.043 and 0.384, respectively). The difference between either treatment arm compared with control did not reach the prespecified α=0.025. No significant differences were noted in HPV clearance. The number of tissue-resident memory CD4/CD8 T-cells in cytobrush samples demonstrated a &amp;gt;5-fold increase in Arm-B: imiquimod when compared to Arm-A: surveillance (p&amp;lt;0.01). Imiquimod treatment was well tolerated. In contrast, there was no significant difference in T-cell responses among participants in Arm-C compared to Arm-A. Imiquimod treatment was well-tolerated. Conclusions: Although imiquimod induced a higher percentage of regression to CIN1 or less and significant increases in CD4/CD8 T-cells infiltrating the cervix, it did not meet its prespecified statistical outcome for efficacy. A higher regression rate than expected was observed in the surveillance arm of this prospective trial. Future clinical trial with imiquimod targeting CIN3 patients are warranted. Citation Format: Sangini S. Sheth, Ji Eun Oh, Stefania Bellone, Eric R. Siegel, Natalia Buza, Akiko Iwasaki, Alessandro D. Santin. Randomized phase II trial of imiquimod with or without 9vHPV vs observation in patients with CIN 2 and 3 [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 4104.

Prevalence of Human Papillomavirus (HPV) and HPV Type Distribution in Penile Samples in Young Men in Denmark: Results 10 Years After Implementation of a Girls-Only HPV Vaccination Program.

In Denmark, a girls-only human papillomavirus (HPV) vaccination program was initiated in 2008-2009. The study aim was to assess the HPV prevalence and type distribution in younger men prior to HPV vaccination in men. The study population was younger men who attended information days regarding military service. At random days (2019-2020), 280 men were included. We collected questionnaire data regarding risk factors for HPV infection and a penile swab for HPV testing. We compared results in this study with those from a previous study of young men (2006-2007). The majority of participants (94%) were 18-20 years old. The median number of lifetime sexual partners was 4. Altogether, 130 men (46.4%) were HPV positive. No infections with HPV types 6, 11, 16, 18, 31, and 45 were detected. The most frequent type was HPV-51 (detected in 11.1%). Comparison showed that the odds of high-risk HPV type infection were higher in 2019-2020 (prevalence odds ratio [POR], 1.7 [95% confidence interval {CI}, 1.1-2.7]) compared with 2006-2007. In contrast, the odds were lower (POR, 0.3 [95% CI, .1-.6]) for HPV types targeted by the 9-valent HPV vaccine. The multicohort girls-only vaccination program has to a large degree protected young men against the HPV types included in the licensed vaccines. This does not speak against gender-neutral vaccination as the HPV prevalence is still high, although consisting largely of less carcinogenic HPV types.

Therapeutic Response to Treatment of a Papillomatous Ocular Surface Squamous Neoplasia With Intramuscular Human Papillomavirus Vaccine.

The purpose of this study was to describe the response of a papillomatous ocular surface squamous neoplasia (OSSN) to the intramuscular (IM) 9-valent human papillomavirus (HPV) vaccine after failed medical and surgical interventions. A 79-year-old White man with a conjunctival lesion underwent a biopsy which revealed OSSN and positivity for high-risk HPV. Initially treated with medical therapy and surgical excisions, the patient developed a recurrence and refused further surgery. He was given 4 doses of IM HPV vaccine at the 6-week interval. A dramatic reduction in lesion size and reduced epithelial thickening and hyperreflectivity was noted on slitlamp examination and high-resolution anterior segment optical coherence tomography after receiving the IM HPV vaccine. Although lesion size was markedly reduced, the therapy did not achieve total resolution, resulting in further treatment with topical 1% 5-fluorouracil (5-FU) eye drops and later 0.04% mitomycin C eye drops. The patient then elected to discontinue further treatment and solely observe. This case report adds to the growing literature demonstrating the potential therapeutic use of vaccines in cancer treatment. Although HPV vaccination is currently approved for prophylaxis, the use of HPV vaccines as a therapeutic option for various HPV-mediated diseases, including OSSN, should be further explored. The HPV vaccine yielded significant initial improvement in this patient who refused further surgical interventions. The use of IM HPV vaccine as an adjunctive treatment of papillomatous OSSN may represent a potential therapeutic option in cases refractory to standard treatment modalities.

Comparing one dose of HPV vaccine in girls aged 9–14 years in Tanzania (DoRIS) with one dose in young women aged 15–20 years in Kenya (KEN SHE): an immunobridging analysis of randomised controlled trials

The first randomised controlled trial of single-dose human papillomavirus (HPV) vaccine efficacy, the Kenya single-dose HPV-vaccine efficacy (KEN SHE) trial, showed greater than 97% efficacy against persistent HPV16 and HPV18 infection at 36 months among women in Kenya. We compared antibody responses after one dose of HPV vaccine in the Dose Reduction Immunobridging and Safety Study (DoRIS), the first randomised trial of the single- dose regimen in girls aged 9-14 years, the target age range for vaccination, with those after one dose of the same vaccine in KEN SHE. In the DoRIS trial, 930 girls aged 9-14 years in Tanzania were randomly assigned to one, two, or three doses of the 2-valent vaccine (Cervarix) or the 9-valent vaccine (Gardasil-9). The proportion seroconverting and geometric mean concentrations (GMCs) at month 24 after one dose were compared with those in women aged 15-20 years who were randomly assigned to one dose of the same vaccines at the same timepoint in KEN SHE. Batched samples were tested together by virus-like particle ELISA for HPV16 and HPV18 IgG antibodies. Non-inferiority of GMC ratios (DoRIS trial:KEN SHE) was predefined as a lower bound of the 95% CI less than 0·50. Month 24 HPV16 and HPV18 antibody GMCs in DoRIS were similar or higher than those in KEN SHE. 2-valent GMC ratios were 0·90 (95% CI 0·72-1·14) for HPV16 and 1·02 (0·78-1·33) for HPV18. 9-valent GMC ratios were 1·44 (95% CI 1·14-1·82) and 1·47 (1·13-1·90), respectively. Non-inferiority of antibody GMCs and seropositivity was met for HPV16 and HPV18 for both vaccines. HPV16 and HPV18 immune responses in young girls 24 months after a single dose of 2-valent or 9-valent HPV vaccine were comparable to those in young women who were randomly assigned to a single dose of the same vaccines and in whom efficacy had been shown. A single dose of HPV vaccine, when given to girls in the target age range for vaccination, induces immune responses that could be effective against persistent HPV16 and HPV18 infection at least two years after vaccination. The UK Department of Health and Social Care, the Foreign, Commonwealth, & Development Office, the Global Challenges Research Fund, the UK Medical Research Council and Wellcome Trust Joint Global Health Trials scheme, the Bill and Melinda Gates Foundation, the US National Cancer Institute; the US National Institutes of Health, and the Francis and Dorothea Reed Endowed Chair in Infectious Diseases. For the KiSwahili translation of the abstract see Supplementary Materials section.

Post-marketing safety surveillance study of a 9-valent human papillomavirus vaccine: Comment

Post-marketing safety surveillance study of a 9-valent human papillomavirus vaccine: Comment

Effectiveness of catch-up and routine program of the 9-valent vaccine on cervical cancer risk reduction in Japan.

In 2013, the national human papillomavirus (HPV) immunization program began. However, in June 2013, Japan's Ministry of Health, Labor and Welfare (MHLW) announced a "temporary" suspension of its recommendation for the human papillomavirus vaccine. Finally, in November 2021, the MHLW ended its suspension of the recommendation of the HPV vaccine. To address the 9-year gap in HPV vaccinations the suspension had caused, the MHLW conducted a program of catch-up vaccinations from April 2022 to March 2025. Finally, in April 2023, the 9-valent HPV vaccine was approved for both the routine and catch-up vaccination programs in Japan. In this study, we investigated the potential effects of the introduction of the 9-valent vaccine on the increased risk of cervical cancer in females born after fiscal year (FY) 2000. We estimated the lifetime relative risk of cervical cancer incidence and death using the improved routine and catch-up vaccination rates after the recent resumption of the governmental recommendation for women and girls to have the HPV vaccination. These relative risks were calculated using a lifetime risk of 1.000 for cervical cancer incidence and death for females born in FY 1993. We predicted that even if a 90% vaccination rate were to be achieved by FY 2024 with the 9-valent vaccine among women born between FY 2000 and FY 2005, the risk would remain higher than for the vaccination generation. Therefore, for women born between FY 2000 and FY 2005, it will be necessary to significantly improve the cervical cancer screening rate to compensate for this increased risk.

Listing and Comparing the Immunogenicity, Safety, and Effectiveness of 9vHPV Vaccinations for Different Age Groups: 9-15 Years Old, 16-26 Years Old, 27-45 Years Old

The effectiveness of the Human Papillomavirus (HPV) vaccination in preventing high-risk HPV infections and accompanying serious vaginal, cervical, and vulvar disorders was verified. The development of the 9-valent HPV(9vHPV) vaccine yields greater coverage versus the quadrivalent (qHPV) vaccine. This study aims to assess the 9vHPV from immunogenicity, safety, and effectiveness in three different age groups respectively: 9-15 years old, 16-26 years old, and 27-45 years old. This paper searched PubMed and Embase databases to include related clinical trials of these three age groups and ensure a large-scale study population. Immunogenicity analysis for different age groups reported that the geometric mean titers (GMTs) decreased with age but could still stimulate robust and effective immune responses. The antibody levels of the subjects significantly increased to reach protective levels and persisted for a long time after vaccination. Besides, the 9vHPV vaccine has a high protective effect against the infection of nine subtypes of HPV. Both HPV infection rates and rates of associated diseases significantly decreased versus those who did not receive the vaccine. Additionally, the outcomes also demonstrated that the safety of the 9vHPV vaccines was good across all age groups. The intensity of most reported injection-site adverse events (AEs) and vaccine-related systemic AEs were not serious. Serious adverse reactions are very rare. In total, immunogenicity, efficacy, and safety in different age groups of the 9vHPV vaccination are overall good. These findings provide scientific evidence for the immunization of the 9vHPV vaccine and recommend the optimal age for vaccination.

Post-marketing safety surveillance study of a 9-valent human papillomavirus vaccine in individuals aged 16–26 years in Chongqing, China

ABSTRACT The safety of human papillomavirus (HPV) vaccines, one of the major challenges to public vaccination, has been controversial. This study assessed the adverse reactions of 9-valent HPV (9vHPV) vaccines. This open-label, observational, multi-center, post-marketing study assessed the safety of 9vHPV administered according to local clinical practice. All post-marketing adverse events (AEs) reports received between December 2019 and November 2021 in Chongqing were analyzed. A total of 1000 individuals aged 16–26 years provided safety data post-vaccination; The most common AEs (60.1%) experienced by 9vHPV vaccine recipients were vaccination-site AEs (pain, swelling, induration) and non-vaccination-site AEs (dizzy, weak, fever). Vaccination-site AEs most were mild-to-moderate in intensity. Discontinuations and HPV 9-related serious AEs were rare (0.3% and 0.0%, respectively). Eight SAEs were reported during the study but none were considered as related to the study vaccine. The 9vHPV vaccine was generally well tolerated in subjects aged 16–26 years; Vaccination-site AEs were more common with 9vHPV.

EE286 Cost Effectiveness and Public Health Impact of Implementing Gender-Neutral Vaccination with the 9-Valent Human Papillomavirus Vaccine in Turkiye

EE286 Cost Effectiveness and Public Health Impact of Implementing Gender-Neutral Vaccination with the 9-Valent Human Papillomavirus Vaccine in Turkiye

A survey of potential acceptance of 9-valent HPV vaccine among Chinese male college students

ABSTRACT Human papillomavirus (HPV) has a great impact on world health. Vaccination is among the most important methods of preventing HPV infection. This study investigated Chinese male college students’ knowledge of, attitude toward, and acceptance of the 9vHPV vaccine and the independent predictors. An online cross-sectional study was conducted among male college students at Chinese colleges and universities from March 12 to March 23, 2022. Based on a literature review of similar studies, a self-questionnaire was designed to investigate the students’ knowledge of, attitude toward, and acceptance of the 9vHPV vaccine. Multivariate logistic regression analysis was performed to identify factors influencing their willingness to be vaccinated. In addition, the structural equation model was constructed. A total of 1,547 male college students completed the survey. Of all the students, 54.95% were unwilling to receive a 9vHPV vaccination, while only 45.05% expressed willingness. Multivariate logistic regression analysis revealed that the male college students willing to receive the vaccine included medical students, those in a romantic relationship, those whose relatives and friends had cervical cancer, those whose relatives and friends had received the 9vHPV vaccine, those supportive of promoting the vaccine for men, and those who would recommend the vaccine to their relatives and friends. Male college students exhibited high hesitancy toward the 9vHPV vaccine. Acceptance of the 9vHPV vaccine by male college students can be improved by deepening their accurate understanding of the vaccine and enhancing their positive attitude toward it.

Evaluating the cost-effectiveness of HPV vaccination for adolescent girls in Japan: A comparison of 2-valent, 4-valent, and 9-valent HPV vaccines with consideration of cross-protection

ObjectiveIn April 2023, the Japanese Health Ministry panel approved the inclusion of the 9-valent human papillomavirus (9vHPV) vaccine in the National Immunization Program, alongside the 2-valent (2vHPV) and 4-valent HPV (4vHPV) vaccines. In response to this, we evaluated the cost-effectiveness of these three vaccines for routine immunization of girls aged 12–16 in Japan, considering the cross-protection of 2vHPV and 4vHPV vaccines. MethodsWe constructed an age-structured mathematical model for HPV transmission, aiming to quantify the economic and epidemiological effects of various HPV vaccination strategies over a 70-year period in Japan. We determined incremental costs and quality-adjusted life years (QALYs) for each strategy, applying a 3% annual discount. Univariate and probabilistic sensitivity analyses were conducted to assess the uncertainty of our model results, with all evaluations done in 2023. ResultsOur projections indicate that the HPV vaccination program in Japan will significantly reduce the incidence of HPV-related diseases. All HPV vaccination strategies, using the 2vHPV, 4vHPV, and 9vHPV vaccines, were found to be cost-effective compared to no vaccination, with incremental cost-effectiveness ratios of ¥971,447/QALY, ¥1,237,297/QALY, and ¥742,084/QALY, respectively. Direct comparisons between vaccines demonstrated that the 9vHPV vaccination was more cost-effective than the 2vHPV vaccination, whereas 4vHPV vaccination was dominated by 2vHPV vaccination. ConclusionsOur study validates the cost-effectiveness of implementing the 9vHPV vaccine as the primary option over the 2vHPV or 4vHPV vaccine for girls in Japan. These findings underscore the need to improve the acceptance rate and coverage of HPV vaccinations in the country.

Immunogenicity and safety of an Escherichia coli-produced human papillomavirus (types 6/11/16/18/31/33/45/52/58) L1 virus-like-particle vaccine: a phase 2 double-blind, randomized, controlled trial

The Escherichia coli-produced human papillomavirus (HPV) 16/18 bivalent vaccine (Cecolin) has received prequalification by the World Health Organization based on its high efficacy and good safety profile. We aimed to evaluate the immunogenicity and safety of the second-generation nonavalent HPV 6/11/16/18/31/33/45/52/58 vaccine (Cecolin 9) through the randomized, blinded phase 2 clinical trial. Eligible healthy women aged 18–45 years were randomly (1:1) allocated to receive three doses of 1.0 mL (270 µg) of Cecolin 9 or placebo with a 0-1-6-month schedule. The primary endpoint was the seroconversion rate and geometric mean titer of neutralizing antibodies (nAbs) one month after the full vaccination course (month 7). The secondary endpoint was the safety profile including solicited adverse reactions occurring within 7 d, adverse events (AEs) occurring within 30 d after each dose, and serious adverse events (SAEs) occurring during the 7-month follow-up period. In total, 627 volunteers were enrolled and randomly assigned to Cecolin 9 (n = 313) or placebo (n = 314) group in Jiangsu Province, China. Almost all participants in the per-protocol set for immunogenicity (PPS-I) seroconverted for nAbs against all the nine HPV types at month 7, while two failed to seroconvert for HPV 11 and one did not seroconvert for HPV 52. The incidence rates of total AEs in the Cecolin 9 and placebo groups were 80.8% and 72.9%, respectively, with the majority of them being mild and recovering shortly. None of the SAEs were considered related to vaccination. In conclusion, the E. coli-produced 9-valent HPV (9vHPV) vaccine candidate was well tolerated and immunogenic, which warrants further efficacy studies in larger populations.

Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety.

The 9-valent human papillomavirus (9vHPV) vaccine Phase III immunogenicity study in 9- to 15-year-old boys and girls was extended to assess immunogenicity and effectiveness through 10 years after the last vaccine dose (NCT00943722). Boys (n = 301) and girls (n = 971) who received three 9vHPV vaccine doses in the base study (day 1, months 2 and 6) enrolled in the extension. Serum was collected through month 126 for antibody assessments by competitive Luminex immunoassay and immunoglobulin G-Luminex immunoassay. For effectiveness analysis starting at age 16 years, genital swabs were collected (to assess HPV DNA by polymerase chain reaction) and external genital examinations conducted every 6 months. Primary analyses were conducted in per-protocol populations. Geometric mean antibody titers peaked around month 7, decreased sharply between months 7 and 12, then gradually through month 126. Seropositivity rates remained ≥81% by competitive Luminex immunoassay and ≥95% by immunoglobin G-Luminex immunoassay at month 126 for each 9vHPV vaccine type. After up to 11.0 (median 10.0) years of follow-up postdose 3, there were no cases of HPV6/11/16/18/31/33/45/52/58-related high-grade intraepithelial neoplasia or condyloma in males or females. Incidence rates of HPV6/11/16/18/31/33/45/52/58-related 6-month persistent infection in males and females were low (54.6 and 52.4 per 10000 person-years, respectively) and within ranges expected in vaccinated cohorts, based on previous human papillomavirus vaccine efficacy trials. The 9vHPV vaccine demonstrated sustained immunogenicity and effectiveness through ∼10 years post 3 doses of 9vHPV vaccination of boys and girls aged 9 to 15 years.

Acceptability and readiness to promote human papillomavirus vaccination at ages 9–10 years: a feasibility study among North Carolina clinics

While 9-valent human papillomavirus (HPV) vaccination is approved by the US Food and Drug Administration for use in adolescents as young as age 9, providers typically recommend it at ages 11–12. Studies suggest that recommending HPV vaccination at 9 or 10 years of age could increase up-to-date vaccination by age 13, which could especially benefit rural populations with reduced access to primary health care and lower HPV vaccination coverage than urban areas. This study aimed to assess the feasibility of the age-9 recommendation of HPV vaccination in rural clinics. We conducted in-depth interviews with providers and staff from two primary care clinics in central North Carolina to understand attitudes toward recommending HPV vaccination to 9- and 10-year-olds. All interviewees agreed that HPV vaccination was important for cancer prevention and should be recommended before the onset of sexual activity, agreeing that HPV vaccination could be initiated before age 11 to improve timeliness and completion of the vaccination series. However, opinions were mixed on whether HPV vaccination should be initiated as young as 9 years old. Two key informants recruited from two university-affiliated clinics described their experiences recommending HPV vaccination to 9- and 10-year-olds, including a modified vaccination schedule that promotes HPV vaccination during routine well-child visits, prior to pubertal onset, and alongside other recommended adolescent vaccines. Age-9 recommendation and administration of HPV vaccination is possible with minimal changes to current clinical practices and could increase the convenience and acceptability of HPV vaccination in under-vaccinated settings.

Underlying background of the current trend of increasing HPV vaccination coverage in Japan.

Cervical cancer is prevalent among women, with a reported 604,127 cases in 2020 worldwide. The incidence of cervical cancer has been mitigated in most high-income countries by promoting the human papilloma virus (HPV) vaccine. However, in Japan, cervical cancer is still a leading cause of mortality and the most prevalent cancer among women aged between 15 and 39. This can be attributed to the 7-year suspension of HPV vaccination recommendations by the Japanese government. A decline in vaccination coverage followed this suspension, caused by a small number of reported adverse events, resulting in a steep decline in vaccination coverage from over 70% to less than 1%. However, there have been indications of a change in trend in Japan. In 2020, a group of volunteer doctors initiated awareness-raising activities through social networking services and other platforms, and the target population that received at least one dose of the vaccine in 2020 increased to 15.9%. Additionally, in July 2020, the Japanese government approved the updated 9-valent HPV vaccine and resumed recommendations in November 2021. As a result, 30.1% of those eligible for routine HPV vaccination received at least one dose of the vaccine from April to September, 2022. However, the HPV vaccine coverage in Japan is still far from the 90% recommended by the World Health Organization, and continued communication and education on the vaccines benefits are necessary to achieve optimal coverage.

Provision of screening services for cervical and breast cancer – A scientific study commissioned by the European Board & College of Obstetrics and Gynaecology (EBCOG)

ObjectiveCancer screening can play an important role in early detection, improving treatment outcomes and reducing morbidity and mortality. Breast and cervical cancers belong to the most common gynaecological cancers group. Countries provide different screening programmes on its eligible population basis centred on different health care policies. This scientific study aims to assess and understand the health inequalities in the member countries of the European Board & College of Obstetrics and Gynaecology (EBCOG) as regards screening programmes of gynaecological cancer, with a special focus on breast and cervical cancers’ screening strategies. Study designA descriptive questionnaire-based study was conducted, addressed to EBCOG member countries. ResultsNinety-one percent of the countries have an organized national or regional screening programme for cervical cancer. Of these, 45% of countries use both cytology and testing for Human Papilloma Virus (HPV) as screening test, 31% use cytology exclusively and 17% only perform HPV testing. Considerable differences were found regarding the interval of screening test: there are countries performing HPV detection triennially, while others perform only conventional cytology every 5 years. Sixty-nine percent of countries included in this study begin screening for cervical cancer in women aged 25 to 29 years, four of them using HPV detection as the screening test. Six countries begin cervical cancer screening before the age of 25. As regards vaccination against HPV, almost all countries have implemented national HPV vaccination programme, except in Poland and Turkey. The 9-valent HPV vaccine is the most frequently offered (77% of countries) and the majority vaccination programmes include both girls and boys. As regards breast cancer screening, all thirty-two countries have an implemented screening programme. All countries perform mammography as the screening test, 62.5% of them begin in women aged 50 to 54, with a 2-yearly interval in the majority. In five countries, screening programmes are performed biennially, starting between 45 and 49 years old. Seven countries start in women aged 41 to 44. ConclusionsThere are discrepancies around gynaecological cancer screenings provision among EBCOG member countries. It is important to establish European recommendations about screening for gynaecological cancers, in order to standardize the access to equitable better health care in gynaecological cancers within Europe.

Global impact and cost-effectiveness of one-dose versus two-dose human papillomavirus vaccination schedules: a comparative modelling analysis

BackgroundTo eliminate cervical cancer as a public health problem, the World Health Organization had recommended routine vaccination of adolescent girls with two doses of the human papillomavirus (HPV) vaccine before sexual initiation. However, many countries have yet to implement HPV vaccination because of financial or logistical barriers to delivering two doses outside the infant immunisation programme.MethodsUsing three independent HPV transmission models, we estimated the long-term health benefits and cost-effectiveness of one-dose versus two-dose HPV vaccination, in 188 countries, under scenarios in which one dose of the vaccine gives either a shorter duration of full protection (20 or 30 years) or lifelong protection but lower vaccine efficacy (e.g. 80%) compared to two doses. We simulated routine vaccination with the 9-valent HPV vaccine in 10-year-old girls at 80% coverage for the years 2021–2120, with a 1-year catch-up campaign up to age 14 at 80% coverage in the first year of the programme.ResultsOver the years 2021–2120, one-dose vaccination at 80% coverage was projected to avert 115.2 million (range of medians: 85.1–130.4) and 146.8 million (114.1–161.6) cervical cancers assuming one dose of the vaccine confers 20 and 30 years of protection, respectively. Should one dose of the vaccine provide lifelong protection at 80% vaccine efficacy, 147.8 million (140.6–169.7) cervical cancer cases could be prevented. If protection wanes after 20 years, 65 to 889 additional girls would need to be vaccinated with the second dose to prevent one cervical cancer, depending on the epidemiological profiles of the country. Across all income groups, the threshold cost for the second dose was low: from 1.59 (0.14–3.82) USD in low-income countries to 44.83 (3.75–85.64) USD in high-income countries, assuming one dose confers 30-year protection.ConclusionsResults were consistent across the three independent models and suggest that one-dose vaccination has similar health benefits to a two-dose programme while simplifying vaccine delivery, reducing costs, and alleviating vaccine supply constraints. The second dose may become cost-effective if there is a shorter duration of protection from one dose, cheaper vaccine and vaccination delivery strategies, and high burden of cervical cancer.