Nine-valent Human Papillomavirus Vaccine Research Articles

Analysis of human papillomavirus infection status and related factors among men who have sex with men in Tianjin

Objective: The status quo and related factors of human papillomavirus (HPV) infection in multiple parts of men who have sex with men (MSM) in Tianjin were analyzed. Methods: Using the cross-sectional survey method, a total of 600 MSM were recruited in Tianjin from September to December 2023, including 200 (18-26 years old), 300 (27-45 years old), and 100 (≥46 years old) stratificaed by age group. Questionnaire survey was used to collect knowledge and behavioral information related to demography and STD prevention and treatment. Exfoliated cells from genital, perianal and oral cavity were collected for HPV typing detection. Logistic regression model was used to analyze the related factors of HPV infection. Results: The infection rate of HPV was 53.67% (322/600) in MSM, with high-risk type as 41.17% (247/600), low-risk type as 27.17% (163/600). The infection rate of HPV in both multiple and single types was 26.83% (161/600).The infection rates of genotypes covered by nine-valent HPV vaccine, quadrivalent HPV vaccine and bivalent HPV vaccine were 36.83% (221/600), 25.17% (151/600) and 9.50% (57/600), respectively.The infection rates of genital HPV, high-risk or low-risk types were 24.67% (148/600), 16.67% (100/600) and 11.00% (66/600), respectively. The infection rates of perianal HPV, high-risk or low-risk types were 42.00% (252/600), 30.17% (181/600) and 20.50% (123/600), respectively. The infection rates of oral HPV high-risk and low-risk types were 3.17% (19/600), 2.33% (14/600) and 1.17% (7/600), respectively. Divorce or widowhood (aOR=2.38, 95%CI: 1.26-4.50), history of homosexual anal intercourse in the past 6 months (aOR=2.28, 95%CI: 1.00-5.50), and use of dependent drugs (including new psychoactive substances) (aOR=1.62, 95%CI: 1.02-2.58) were risk factors for genital HPV infection. College degree/university degree or above (aOR=0.36, 95%CI: 0.16-0.81) was a protective factor for perianal HPV infection, and a history of drug dependence (aOR=1.85, 95%CI: 1.19-2.88) was a risk factor. Conclusions: MSM in Tianjin was a high-risk group for HPV infection, and the HPV infection in the perianal area was more severe than in the genital area and oral area.Marital status, education level, history of homosexual anal sex in the past 6 months, and history of drug dependence were related factors of HPV infection among MSM.

Analysis of Implementation Strategies for Nationwide HPV Vaccination Programs Across European Union Countries.

Human papillomavirus (HPV) vaccination programs play a critical role in the primary prevention of HPV-related diseases, including cervical cancer. However, the principles governing the implementation of these programs vary across European Union (EU) countries. The objective of this study was to analyze and compare the strategies for implementing HPV vaccination programs across the EU, with a focus on access, vaccine selection, and procurement processes. This study utilized a comprehensive review of official websites from government bodies, public health organizations, and dedicated vaccination platforms in each of the 27 EU member states. Additionally, a search of Tenders Electronic Daily (TED) was conducted to examine the criteria used in tendering processes for vaccine suppliers involved in national HPV vaccination programs. All 27 EU countries provide public funding for HPV vaccination, with 26 countries offering free vaccination for both girls and boys. In 22 of these countries, the nine-valent HPV vaccine is the only option available for free under national programs. Estonia and Ireland are exceptions, where a single dose of Gardasil 9 is administered. Most countries adhere to the approved vaccination schedules, though slight variations exist. The predominant criterion for selecting vaccine suppliers in national tenders is the lowest price offered. HPV vaccination programs across the EU are uniformly funded through public health systems, yet access to free vaccination and specific program details vary by country. These variations reflect the diverse healthcare systems and procurement strategies in place, which can impact the systemic approach to HPV prevention. Further harmonization of vaccine procurement and implementation strategies may enhance the effectiveness and equity of HPV vaccination across Europe.

Analyzing HPV Vaccination Service Preferences among Female University Students in China: A Discrete Choice Experiment.

Despite being primary beneficiaries of human papillomavirus (HPV) vaccines, female university students in China exhibit low vaccination rates. This study aimed to assess their preferences for HPV vaccination services and evaluate the relative importance of various factors to inform vaccination strategy development. Through a literature review and expert consultations, we identified five key attributes for study: effectiveness, protection duration, waiting time, distance, and out-of-pocket (OOP) payment. A D-efficient design was used to create a discrete choice experiment (DCE) questionnaire. We collected data via face-to-face interviews and online surveys from female students across seven universities in China, employing mixed logit and latent class logit models to analyze the data. The predicted uptake and compensating variation (CV) were used to compare different vaccination service scenarios. From 1178 valid questionnaires, with an effective response rate of 92.9%, we found that effectiveness was the most significant factor influencing vaccination preference, followed by protection duration, OOP payment and waiting time, with less concern for distance. The preferred services included a 90% effective vaccine, lifetime protection, a waiting time of less than three months, a travel time of more than 60 min, and low OOP payment. Significant variability in preferences across different vaccination service scenarios was observed, affecting potential market shares. The CV analysis showed female students were willing to spend approximately CNY 5612.79 to include a hypothetical 'Service 5' (a vaccine with higher valency than the nine-valent HPV vaccine) in their prevention options. The findings underscore the need for personalized, need-based HPV vaccination services that cater specifically to the preferences of female university students to increase vaccination uptake and protect their health.

Human papillomavirus (HPV) vaccination in Japan.

To review the status of human papillomavirus (HPV) vaccination in Japan from inception to the present, focusing on past and current challenges. Published articles and website content related to HPV vaccination were reviewed. The Ministry of Health, Labor and Welfare suspended proactive recommendations for HPV vaccination in June 2013 following repeated media reports of girls experiencing adverse events, including chronic pain and walking disturbances, after receiving the HPV vaccine. Despite later recognition of these symptoms as a functional somatic syndrome, HPV vaccine coverage of target girls aged 12 to 16 years in the National Immunization Program (NIP) rapidly decreased to near zero. This suspension of the proactive HPV vaccination recommendation ceased in fiscal year (f-year) 2022, initiating a 3-year catch-up free HPV vaccination period from April 2022 to March 2025 for women born from f-years 1997 to 2005. These drastic changes were driven by established evidence of the effectiveness and safety of HPV vaccines reported from both Japan and other countries, and a nine-valent HPV vaccine has been included in the NIP since f-year 2023. However, the estimated HPV vaccination rate in the NIP remains low at ≤30%. To regain high coverage of HPV vaccination in Japan, it is essential that government, industry, and academic society work together to raise awareness and educate Japanese people about cervical cancer prevention and HPV-related diseases.

Distribution of HPV types among women with HPV-related diseases and exploration of lineages and variants of HPV 52 and 58 among HPV-infected patients in China: A systematic literature review

ABSTRACT To summarize the distribution of types of human papillomavirus (HPV) associated with HPV-related diseases and investigate the potential causes of high prevalence of HPV 52 and 58 by summarizing the prevalence of lineages, sub-lineages, and mutations among Chinese women. We searched PubMed, EMBASE, CNKI, and WanFang from January, 2012 to June, 2023 to identify all the eligible studies. We excluded patients who had received HPV vaccinations. Data were summarized in tables and cloud/rain maps. A total of 102 studies reporting HPV distribution and 15 studies reporting HPV52/HPV58 variants were extracted. Among Chinese women, the top five prevalent HPV types associated with cervical cancer (CC) were HPV16, 18, 58, 52, and 33. In patients with vaginal cancers and precancerous lesions, the most common HPV types were 16 and 52 followed by 58. For women with condyloma acuminatum (CA), the most common HPV types were 11 and 6. In Chinese women with HPV infection, lineage B was the most prominently identified for HPV52, and lineage A was the most common for HPV58. In addition to HPV types 16, which is prevalent worldwide, our findings revealed the unique high prevalence of HPV 52/58 among Chinese women with HPV-related diseases. HPV 52 variants were predominantly biased toward lineage B and sub-lineage B2, and HPV 58 variants were strongly biased toward lineage A and sub-lineage A1. Further investigations on the association between the high prevalent lineage and sub-lineage in HPV 52/58 and the risk of cancer risk are needed. Our findings underscore the importance of vaccination with the nine-valent HPV vaccine in China.

Screening for High-Risk Human Papillomavirus Reveals HPV52 and HPV58 among Pediatric and Adult Patient Saliva Samples.

Previous research has demonstrated that the human papillomavirus (HPV) can infect a wide range of human tissues, including those within the oral cavity. High-risk oral HPV strains have been associated with the development and progression of oral cancers, including oral squamous cell carcinomas. Although many studies have examined the prevalence of the high-risk strains HPV16 and HPV18, far fewer have assessed the prevalence of other high-risk HPV strains. An approved study protocol was used to identify HPV52 and HPV58 among clinical samples (n = 87) from a saliva biorepository. Quantitative polymerase chain reaction (qPCR) and validated primers for HPV52 and HPV58 were used to facilitate this screening. This screening demonstrated that a total of n = 4/45 or 8.9% of adult saliva samples harbored high-risk HPV52, and n = 2/45 or 4.4% tested positive for high-risk HPV58. In addition, a total of n = 6/42 or 14.3% of the pediatric saliva samples tested positive for high-risk HPV, including n = 5/42 or 11.9% with HPV52 and n = 3/42 or 7.1% for HPV58. These data demonstrate the presence of the high-risk oncogenic HPV52 and HPV58 strains among both adult and pediatric clinical patient samples. More detailed longitudinal research must be conducted to determine whether this prevalence may be increasing or decreasing over time. In addition, these data strongly support public health prevention efforts, such as knowledge and awareness of the nine-valent HPV vaccine covering additional high-risk strains, including HPV52 and HPV58.

Human papillomavirus genotyping in high-grade vaginal intraepithelial neoplasia: Amulticentric Italian study.

This study aimed to analyze the human papillomavirus (HPV) genotype distribution in a large cohort of high-grade vaginal intraepithelial neoplasia (VaIN) (vaginal HSIL, VaIN2/3) patients from two Italian referral centers. We included all patients with histologically confirmed VaIN2/3 from the Department of Surgical Sciences, Sant'Anna Hospital, University of Torino, Torino, Italy, and Ospedale Maggiore della Carità, Novara, Italy, between 2003 and 2022. After the histological evaluation of formalin-fixed paraffin-embedded samples, we performed HPV genotyping with VisionArray HPV Chip 1.0. We detected HPV DNA in 94.4% of VaIN2/3 (168/178), with HPV 16 as the most prevalent genotype, accounting for 51.8% of all infections, 41.2% of VaIN2and 77.6% of VaIN3 cases. Other frequent genotypes were HPV 58 (8.3%, 10.9% of VaIN2and 2.0% of VaIN3), HPV 73 (5.4%, 5.0% of VaIN2and 6.1% of VaIN3), and HPV 31 (5.4%, 6.7% of VaIN2and 2.0% of VaIN3). 73.2% of VaIN2/3 had a single HPV genotype infection and 26.8% a multiple infection (20.8% a double infection, 4.8% a triple infection, and 1.2% a quadruple infection). Single infection was more frequently present in VaIN3 than VaIN2 (81.6% vs. 69.8%). 69.1% of single infections and 73.3% of multiple infections had one or more genotypes covered by nine-valent HPV vaccine. HPV vaccination is expected to have a large impact on reducing the incidence of vaginal intraepithelial neoplasia.

Human Papillomavirus Inpatient Postpartum Vaccination: Clinical Guideline Implementation.

The nine-valent human papillomavirus (9vHPV) vaccine is highly effective at preventing cervical cancer, yet U.S. vaccination rates remain low. The objective of this study was to evaluate integration of 9vHPV inpatient vaccination into routine postpartum care. Obstetrics professionals at an academic urban referral center received an emailed protocol outlining a novel 9vHPV vaccination program of postpartum inpatients aged 26 years or younger. A retrospective evaluation from March 2021 to March 2022 was conducted to evaluate implementation. Characteristics of patients vaccinated before pregnancy compared with vaccine-eligible patients (none, unknown, or partially vaccinated status) were compared by the use of χ2, analysis of variance, and multivariable logistic regression. Similarly, analyses were performed comparing vaccine-eligible patients who did with those who did not receive an inpatient 9vHPV vaccination. Of 569 postpartum inpatients, 370 (65.0%) were already vaccinated, 70 (34.2%) were never vaccinated, 49 (24.6%) were partially vaccinated, and 80 (14.1%) had unknown status. Of vaccine-eligible patients, 46 (23.1%) received 9vHPV vaccination as an inpatient. In multivariable analysis, race and ethnicity, marital status, and primary language were significant predictors of vaccination before pregnancy. Among vaccine-eligible patients, inpatient vaccination recipients were primarily Hispanic, Spanish speaking, and publicly insured. In multivariable analysis of vaccine-eligible patients, receiving care from the certified nurse midwifery practice was the only independent predictor of vaccination (odds ratio 2.4, 95% CI 1.02-5.74, P=.04). Non-Hispanic White, Spanish-speaking, and married patients were disproportionally undervaccinated in our baseline population, but about one quarter of vaccine-eligible patients received 9vHPV vaccination postpartum. Inpatient postpartum 9vHPV vaccination may help narrow disparities in vaccination.

Human papillomavirus genotypic characteristics of 60,685 subjects under age-expansion vaccination of the nine-valent human papillomavirus vaccine: A cross-sectional study

BackgroundHuman papillomavirus (HPV) vaccination is a key initiative to promote the WHO global strategy to accelerate the elimination of cervical cancer, and this study aimed to investigate the current status of HPV infection and genotypic characteristics of the population under the impact of age-expansion of nine-valent HPV vaccination policy in China. MethodsThe clinical data of 60,685 subjects who were admitted in the Renmin Hospital of Wuhan University and underwent HPV genotyping from January 2017 to October 2022 were retrospectively analyzed. ResultsThe total number of positive HPV genotyping in the included population was 10,303, with a positivity rate of 17.0 %. The HPV positivity rate in the male and female populations increased slowly year by year, with a higher rate of positivity in men (32.7 %) than in women (16.7 %) (P < 0.001). HPV was predominantly single infection in all populations, with higher prevalence of high-risk HPV than low-risk HPV in females, while low-risk HPV infection was predominant in the male population. The age distribution of female subjects infected with HPV, with HPV52 as the most common type, showed a bimodal pattern. As for HPV infected male subjects, HPV6 was the main type, and there was no bimodal age distribution. The expanded age vaccination of the nine-valent HPV vaccine will result in 42.4 % efficiency of vaccine protection for 49.9 % of age-eligible women. If the nine-valent HPV vaccine were open to males in China, it would reduce HPV infections in men by 56.4 %. ConclusionsThe HPV positivity rate in the population remains high and tends to increase, and the age-expansion of the nine-valent HPV vaccine would contribute to reducing the threat of disease caused by HPV infection for age-eligible women. Moreover, attention should be paid to enhancing HPV screening in males and opening up vaccination when appropriate.

A retrospective analysis of human papillomavirus (HPV) prevalence and genotype distribution among 25,238 women in Shanghai, China revealed the limitations of current HPV-based screening and HPV vaccine

BackgroundTo determine the human papillomavirus (HPV) type-specific prevalence and distribution among women with various age and cervical lesions in Shanghai, China. And to evaluate the carcinogenicity of different high-risk HPV (HR-HPV) and the efficacy of HR-HPV testing and HPV vaccine. MethodsThe clinical data from 25,238 participants who received HR-HPV testing (HPV GenoArray test kit, HybriBio Ltd) at the Affiliated Hospital of Tongji University from 2016 to 2019 were reviewed and analyzed using SPSS (version 20.0, Tongji University, China). ResultsThe overall prevalence of HPV was 45.57% in the study population, of which 93.51% were found HR-HPV infection. The three most prevalent HR-HPV genotypes were HPV 52 (22.47%), 16 (16.4%) and 58 (15.93%) among HPV-positive women, and HPV 16 (43.30%), 18 (9.28%) and 58 (7.22%) in women with histologically confirmed cervical cancer (CC). 8.25% of CC were found to be HPV negative. Only 83.51% of CC cases were related to the HPV genotypes covered by nine-valent HPV vaccine. HPV prevalence and genotype distribution varied with age and cervical histology. The odds ratios (OR) of HR-HPV for CC were also different, among which the top three types were HPV 45 [OR= 40.13, 95% confidence intervals (CI) 10.37–155.38], 16 (OR=33.98, 95%CI 15.90–72.60) and 18 (OR=21.11, 95%CI 8.09–55.09). The increase in the types of HPV infection did not increase the risk of CC correspondingly. As the primary cervical screening method, HR-HPV testing showed the high sensitivity (93.97%, 95%CI 92.00–95.49) but low specificity (42.82%, 95%CI 41.81–43.84). ConclusionsOur study provide the comprehensive epidemiological data on HPV prevalence and genotype distribution among Shanghai women with various cervical histology, which can not only serve as a significant reference for clinical practice, but also implicated the need of more effective CC screening methods and HPV vaccine covering more subtypes.

HPV inpatient postpartum vaccination: evaluation of a pilot quality improvement project

The nine-valent human papilloma virus vaccine (9vHPV) is highly effective at preventing cervical cancer, yet U.S. vaccination rates remain low. The objective of this study was to evaluate integration of 9vHPV inpatient vaccination into routine postpartum care.

"If People Were Told About the Cancer, They'd Want to Get Vaccinated": Knowledge, Attitudes, and Beliefs About HPV Vaccination Among Mid-Adult Men.

In 2018, nine-valent human papillomavirus (HPV) vaccine eligibility expanded to include adults aged 27 to 45. This study aimed to identify knowledge, attitudes, and beliefs (KABs) about HPV and HPV vaccination among newly eligible mid-adult men, for whom uptake in adolescence and younger adulthood remains suboptimal. We conducted six virtual focus groups (N = 34 participants) with unvaccinated men aged 27 to 45 living in Southern California's Inland Empire. Data were systematically analyzed to identify emergent themes using the rigorous and accelerated data reduction technique. The sample of men was diverse (79% Hispanic, non-Hispanic Black, Asian, or mixed race/ethnicity; 26% gay or bisexual) and captured participants from across the socioeconomic spectrum. Eighty-eight percent of participants had never received a provider recommendation to be vaccinated against HPV. Many had unanswered questions about HPV and HPV vaccination, could not recall any HPV-related cancers that affect men, and were unaware of their current eligibility for vaccination. Embarrassment and stigma surrounding vaccination against a sexually transmitted infection, concerns about vaccine side effects and safety, and preferences for preventing HPV via "safer sex" and monogamy were salient barriers to vaccination. Nevertheless, many men were eager to learn more about HPV vaccination and engage with health care providers around that topic. Interventions aimed at improving men's knowledge, changing social norms, and supporting health providers to identify HPV vaccine-eligible patients may be especially fruitful for facilitating shared clinical decision-making between mid-adult men and their health care providers.

Geotropism and oncogenic potential of HPV infections in cohort study populations in Vojvodina, North region of Serbia

Background/Aim: Geotropism of the human papillomavirus (HPV) represents the heterogeneous distribution of different genotypes worldwide. Aim of this study was to evaluate the prevalence of the HPV infection in women from Vojvodina, Serbia, according to cytological status and pathological changes of cervix - dysplasia and cancer. Methods: The research was conducted as a retrospective study at the Oncology Institute of Vojvodina and the Institute of Public Health of Vojvodina (IPHV). Data from the medical records of female patients treated for cervical intraepithelial neoplasia or cervical cancer at the Department of Gynaecology, Clinic for Surgical Oncology, Oncology Institute of Vojvodina in Sremska Kamenica in the period from 2016 to 2021 were used, as well as the laboratory findings of the IPHV for a group of patients with normal cytological results of the Papanikolau (PAPA) smear. Results: A total of 731 women, from 20 to 82 years of age, with different cytological results were enrolled. 567 samples were classified as NILM, while 164 samples belong to a group of abnormal histopathology (LSIL/HSIL/cervical cancer). The HPV genotyping assay was performed using the EUROArray HPV test to detect 30 HPV genotypes. In the overall number with normal cytological findings, HPV infection was verified in 242 (42.7 %) patients, of which 135 (55.8 %) were verified with high risk HPV, while 76 (31.4 %) were verified with a mixed group of HPV (Low risk/High risk HPV). Most prevalent genotypes were HPV 16, 31, 53, 51 and 18 in NILM cytological status. In the samples with the abnormal histopathology, the most prevalent genotypes were HPV 16, 33, 31 and 56, while 18 and 39 were equally verified. Genotype 16 was the most prevalent in the examined sample, with a higher prevalence in higher-grade histopathological findings: 18.8 % in LSIL, 31.9 % in HSIL and 75.0 % in cervical cancer samples. Infection with multiple associated genotypes of HPV was not correlated with histopathology. By comparing histopathological diagnosis and age, older patients had higher-grade lesions. Conclusion: Based on the estimated oncogenic potential of HPV genotypes as well as their prevalence in presented sample, it can be concluded that the nine-valent HPV vaccine for genotypes 6, 11, 16, 18, 31, 33, 45, 52 and 58 would have the potential to prevent HPV infection and the incidence of precancerous lesions and cervical cancer in about 85 % of women. Observing trends in the prevalence of HPV, especially HR HPV genotypes, can be important in the further strategy of applying secondary and primary prevention, as well as the application of HPV detection as part of co-testing or considering the introduction of HPV testing in the initial screening program.

Safety of 9-valent human papillomavirus vaccine administered to males and females in routine use

BackgroundThe nine-valent human papillomavirus vaccine (HPV9, Gardasil®9) was licensed in the USA in December 2014. This study was a multiyear post-licensure study to assess HPV9 safety following routine administration. MethodsThis retrospective cohort study compared the risk of emergency department visits and hospitalizations during the interval soon after vaccination with risk during a later interval. Kaiser Permanente Northern California (KPNC) members aged ≥ 9 years who received ≥ 1 HPV9 dose between 10/1/2015–9/30/2017 were included. Outcomes were grouped into predefined diagnostic categories. We compared the odds of events in postvaccination risk intervals (days 0–14, days 1–60) with odds of events during control intervals (days 61–75, days 61–120) using conditional logistic regression. We characterized prespecified events on the day of vaccination (allergic reaction and syncope) and all deaths in the study period. ResultsThe study included 215,965 individuals receiving ≥ 1 dose of HPV9, of whom 140,628 had no prior HPV vaccination. We observed similar numbers of males and females and racial/ethnic diversity consistent with the underlying population. At first dose median age was 12–13 years and 77% received ≥ 1 concomitant vaccine. Eighteen event categories were significantly elevated, including skin disorders (odds ratio [OR] 1.88, 95% confidence interval [CI] 1.00, 3.53) and ill-defined conditions (OR 1.36, 95% CI 1.13, 1.64; category includes abdominal pain, allergic reactions, syncope, etc.). On review, most findings were previously known, preceded vaccination, or had other causes. Allergic reactions and syncope at vaccination were infrequent but many were potentially related. No deaths (n = 37) were considered related to HPV9 and were consistent with the background rate. ConclusionsWe did not identify new safety concerns related to HPV9. The results are consistent with the HPV9 safety profile as established from previous studies/surveillance. RegistrationEuropean Network of Centres for Pharmacoepidemiology and Pharmacovigilance (EUPAS13151, protocol V503-028).

Reinfection of Nine-Valent Human Papillomavirus Vaccine Types Among HIV-Negative Men Who Have Sex With Men: A Prospective Cohort Study.

ObjectivesReinfection of human papillomavirus (HPV) among men who have sex with men (MSM) after clearing the infection of HPV has not been well characterized. To understand the reinfection of HPV among human immunodeficiency virus (HIV) negative MSM without HPV vaccine, we analyzed the reinfection of nine-valent HPV vaccine (9v-HPV) types.MethodsData were acquired from a prospective cohort study among HIV-negative MSM in Urumqi of Xinjiang from 1 April 2016 to 14 July 2020. Participants were recruited through a local non-government organization using a website advertisement. Self-administered questionnaires and self-collected anal swabs were collected at baseline and every 6 months. The incidence rates of reinfection was calculated based on the number of events divided by person-months of observation of event risk. 95% confidence intervals (CIs) were calculated based on the Poisson distribution.ResultsA total of 515 HIV-negative unvaccinated MSM were included with a mean age of 30.93 years (SD 7.85), and 27.68% were reinfected with any 9v-HPV type after clearance. The reinfection incidence rate of any 9v-HPV was 14.47 per 1000 person-months (95% CI: 11.52–17.87). HPV52 was the most common type of reinfection, with a reinfection rate of 17.96 per 1,000 person months (95% CI: 11.58–26.33). Univariate analysis showed that MSM over the age of 30 had a slightly higher risk of reinfection with any 9v-HPV (Hazard ratio (HR): 1.57; 95% CI: 1.01–2.45), but no significant association was observed in multivariate analysis.ConclusionsOur study showed MSM without HPV vaccine will become reinfected following the natural clearance of specific HPV types. It is also suggested that HPV vaccination is recommended not only prior to sexual debut but also after viral clearance for MSM to reduce HPV prevalence.

Immunogenicity and safety of a nine-valent human papillomavirus vaccine in Vietnamese males and females (9 to 26 years of age): an open-label, phase 3 trial

ABSTRACT This open-label, single-center, Phase 3 study (NCT03546842) assessed the immunogenicity and safety of the nine-valent human papillomavirus (9vHPV; HPV6/11/16/18/31/33/45/52/58) vaccine in Vietnamese males and females, with the aim to support 9vHPV vaccine licensure in Vietnam. Participants aged 9–26 years received three 9vHPV vaccine doses (Day 1, Month 2, Month 6). Serum samples were obtained on Day 1 (pre-vaccination) and at Month 7 (one month post-Dose 3) for the measurement of anti-HPV antibodies. Geometric mean titers (GMTs) and seroconversion percentages were obtained using the HPV-9 competitive Luminex immunoassay. Injection-site adverse events (AEs), systemic AEs, serious AEs (SAEs), and study discontinuations due to AEs were recorded. Of 201 participants enrolled, 200 (99.5%) received ≥1 vaccine dose. All participants who received the three-dose regimen (198/200, 98.5%) seroconverted for all 9vHPV vaccine types by Month 7. Robust anti-HPV GMT responses were also observed. Half of participants (50.5%) reported ≥1 AE; the majority were injection-site-related (45.0%) and mild (43.0%). There were no deaths, vaccine-related SAEs, or discontinuations due to AEs. Administration of three 9vHPV vaccine doses was highly immunogenic and resulted in acceptable seropositivity percentages for all vaccine HPV types. The 9vHPV vaccine was generally well tolerated among this study population. Region of origin: Vietnam Trial registration: clinicaltrials.gov Identifier NCT03546842

Immunogenicity and safety of a nine-valent human papillomavirus vaccine in women 27–45 years of age compared to women 16–26 years of age: An open-label phase 3 study

BackgroundEfficacy of the nine-valent human papillomavirus (9vHPV; HPV types 6/11/16/18/31/33/45/52/58) vaccine was demonstrated in a phase 3 study in women 16–26 years of age. We present a phase 3 immunogenicity and safety study of the 9vHPV vaccine in women 27–45 versus 16–26 years of age. MethodsThis international, open-label study (NCT03158220) was conducted in women 16–45 years of age. Participants (16–26 years, n = 570 and 27–45 years, n = 642) received a three-dose 9vHPV vaccination regimen (day 1, month 2, month 6). Month 7 geometric mean titers (GMTs) and seroconversion percentages to anti-HPV 6/11/16/18/31/33/45/52/58 were assessed. Participants were followed for safety throughout the study. ResultsAt month 7, anti-HPV 6/11/16/18/31/33/45/52/58 GMTs in women 27–45 years were compared to those in women 16–26 years of age. The primary hypothesis of non-inferiority of anti-HPV 16/18/31/33/45/52/58 GMTs in older versus younger women was met. The lower bound of the GMT ratio 95% confidence interval (27–45 years to 16–26 years) was 0.60–0.67 depending on HPV type, exceeding the non-inferiority margin of 0.5 for all HPV types. Month 7 seroconversion percentages in women 27–45 years of age were >99% for all HPV types. Injection-site and vaccine-related systemic adverse events (AEs) were observed in 87.5% and 25.1% of women 16–26 years, and 85.2% and 24.1% of women 27–45 years of age, respectively; no vaccine-related serious AEs were reported and no deaths occurred during the study. ConclusionsThe 9vHPV vaccine elicited non-inferior anti-HPV GMTs in women 27–45 years compared with women 16–26 years of age for HPV 16/18/31/33/45/52/58. The vaccine was generally well tolerated with a similar AE profile across the age groups. These data support bridging 9vHPV vaccine efficacy findings in women 16–26 years to women 27–45 years of age.Clinical trial registration NCT03158220.

Public health impact and cost effectiveness of routine and catch-up vaccination of girls and women with a nine-valent HPV vaccine in Japan: a model-based study

BackgroundCombined with cancer screening programs, vaccination against human papillomavirus (HPV) can significantly reduce the high health and economic burden of HPV-related disease in Japan. The objective of this study was to assess the health impact and cost effectiveness of routine and catch-up vaccination of girls and women aged 11–26 years with a 4-valent (4vHPV) or 9-valent HPV (9vHPV) vaccine in Japan compared with no vaccination.MethodsWe used a mathematical model adapted to the population and healthcare settings in Japan. We compared no vaccination and routine vaccination of 12–16-year old girls with 1) 4vHPV vaccine, 2) 9vHPV vaccine, and 3) 9vHPV vaccine in addition to a temporary catch-up vaccination of 17–26 years old girls and women with 9vHPV. We estimated the expected number of disease cases and deaths, discounted (at 2% per year) future costs (in 2020 ¥) and discounted quality-adjusted life years (QALY), and incremental cost effectiveness ratios (ICER) of each strategy over a time horizon of 100 years. To test the robustness of the conclusions, we conducted scenario and sensitivity analyses.ResultsOver 100 years, compared with no vaccination, 9vHPV vaccination was projected to reduce the incidence of 9vHPV-related cervical cancer by 86% (from 15.24 new cases per 100,000 women in 2021 to 2.02 in 2121). A greater number of cervical cancer cases (484,248) and cancer-related deaths (50,102) were avoided through the described catch-up vaccination program. Routine HPV vaccination with 4vHPV or 9vHPV vaccine prevented 5,521,000 cases of anogenital warts among women and men. Around 23,520 and 21,400 diagnosed non-cervical cancers are prevented by catch-up vaccination among women and men, respectively. Compared with no vaccination, the ICER of 4vHPV vaccination was ¥975,364/QALY. Compared to 4vHPV, 9vHPV + Catch-up had an ICER of ¥1,534,493/QALY.ConclusionsA vaccination program with a 9-valent vaccine targeting 12 to 16 year-old girls together with a temporary catchup program will avert significant numbers of cases of HPV-related diseases among both men and women. Furthermore, such a program was the most cost effective among the vaccination strategies we considered, with an ICER well below a threshold of ¥5000,000/QALY.

14342 Clearance of recalcitrant warts in a pediatric patient following administration of the nine-valent human papillomavirus vaccine

Verruca vulgaris (common warts) are a benign neoplasm of skin and mucous membranes caused by human papillomavirus (HPV) that are especially common in school-aged children. Spontaneous resolution of warts within two years is common, but recalcitrant cases can cause considerable morbidity in pediatric and adult patients. Although many therapeutic options for warts exist, there is no definitive cure. Several cases of recalcitrant common wart clearance following use of the bivalent, quadrivalent, or 9-valent HPV vaccine have been described. We report the case of a 10-year old girl with persistent cutaneous warts lasting three years which resolved completely following 2 doses of the 9-valent HPV vaccine. No recurrence of warts was noted 9 months after clearance. To our knowledge, this is the first report of recalcitrant common wart clearance in an immunocompetent pediatric patient with the 9-valent vaccine. The mode of action for this therapy is presently unclear, but comparative homology studies of the virus’s L1 capsid protein suggest the possibility of a cross protective effect. Interestingly, an age-dependent response to HPV vaccination has also been observed. Complete resolution is frequent in younger patients, while adult patients commonly experience incomplete clearance. Evidence shows that this effect may be partially due to hormonal changes during puberty. This case contributes to the growing body of evidence showing HPV vaccination to be a good alternative to other cutaneous wart treatments for pediatric patients and adds to our understanding of potential therapeutic use of the HPV vaccine.

HPV vaccination and Native Americans: protocol for a systematic review of factors associated with HPV vaccine uptake among American Indians and Alaska Natives in the USA

IntroductionThe nine-valent human papillomavirus (HPV) vaccine could prevent an estimated 92% of the cancers attributable to HPV types targeted by the vaccine. However, uptake of the HPV vaccine among American...