Safety Assessment of Concurrent Vaccination with the HPV Vaccine and the COVID-19 Vaccine in Fujian Province, China: A Retrospective Study.

During acute respiratory infections, women may concurrently receive human papillomavirus (HPV) and respiratory vaccines, as observed during the coronavirus disease 2019 (COVID-19) pandemic in China. However, few studies have assessed the safety of such concurrent administration, which could impact HPV vaccination schedules. This study analyzes the safety and optimal sequence of concurrent HPV and COVID-19 vaccinations. For this purpose, we surveyed women with both vaccines from January to October 2023 in Fujian Province, China. During this process, we collected vaccination history and adverse event (AE) data via telephone or interviews. Participants were grouped as Before, Concurrent, or After based on their vaccination sequence. A Chi-squared test, exact Fisher tests, and logistic regression were used to analyze the incidence of AEs and factors influencing vaccine safety. Overall, 1416 eligible participants were included. Although overall AE risk with the HPV vaccine was unaffected by vaccination sequence, individual AEs varied statistically between groups, including pain at the vaccination site (p < 0.001) and prolonged menstruation duration (p = 0.003). Based on the results, the optimal sequence would be to receive the HPV vaccine after the COVID-19 vaccine (After group). This insight may guide future emergency vaccination sequences for HPV and other respiratory infectious diseases.

A comprehensive assessment of quality management methods in the SMESH study.

BACKGROUND: This paper aims to instigate discussion and publication of methodologies applied to enhance quality management through comprehensive scientific reports. It provides a detailed description of the design, implementation, and results of the quality control program employed in the SMESH study. METHODS: Cross-sectional, multicenter, national study designed to assess the prevalence of human papillomavirus in sex workers and in men who have sex with men (MSM). Respondent-driven sampling recruitment was used. An online system was developed for the study and checkpoints were defined for data entry. The system checked the quality of biological samples and performed a retest with part of the sample. RESULTS: A total of 1.598 participants (442 sex workers and 1.156 MSM) were included. Fifty-four health professionals were trained for face-to-face data collection. The retest showed Kappa values ranging between 0.3030 and 0.7663. CONCLUSION: The retest data were mostly classified as indicating a strong association. The data generated by the checkpoints showed the successful implementation of the quality control program.

Cost-effectiveness analysis of alternative screening strategies for the detection of cervical cancer among women in rural areas of Western Kenya.

While the incidence of cervical cancer has dropped in high-income countries due to organized cytology-based screening programs, it remains the leading cause of cancer death among women in Eastern Africa. Therefore, the World Health Organization (WHO) now urges providers to transition from widely prevalent but low-performance visual inspection with acetic acid (VIA) screening to primary human papillomavirus (HPV) DNA testing. Due to high HPV prevalence, effective triage tests are needed to identify those lesions likely to progress and so avoid over-treatment. To identify the optimal cost-effective strategy, we compared the VIA screen-and-treat approach to primary HPV DNA testing with p16/Ki67 dual-stain cytology or VIA as triage. We used a Markov model to calculate the budget impact of each strategy with incremental quality-adjusted life years and incremental cost-effectiveness ratios (ICER) as the main outcome. Deterministic cost-effectiveness analyses show that the screen-and-treat approach is highly cost-effective (ICER 2469 Int$), while screen, triage, and treat with dual staining is the most effective with favorable ICER than triage with VIA (ICER 9943 Int$ compared with 13,177 Int$). One-way sensitivity analyses show that the results are most sensitive to discounting, VIA performance, and test prices. In the probabilistic sensitivity analyses, the triage option using dual stain is the optimal choice above a willingness to pay threshold of 7115 Int$ being cost-effective as per WHO standards. The result of our analysis favors the use of dual staining over VIA as triage in HPV-positive women and portends future opportunities and necessary research to improve the coverage and acceptability of cervical cancer screening programs.

Human papillomavirus circulating tumor DNA assays as a mechanism for head and neck cancer equity in rural regions of the United States.

The rates of human papillomavirus-positive oropharyngeal cancer (HPV-OPC) are rising worldwide and in the United States, particularly in rural regions including Appalachia. Rural areas face unique health challenges resulting in higher cancer incidence and mortality rates, and this includes HPV-OPC. The recent advent of highly sensitive liquid biopsies for the non-invasive detection of HPV-OPC recurrence (circulating tumor HPV DNA, HPV ctDNA) has been swiftly adopted as part of surveillance paradigms. Though knowledge gaps persist regarding its use and clinical trials are ongoing, the ease of collection and cost-effectiveness of HPV ctDNA make it more accessible for HPV-OPC survivors than usual surveillance methods of frequent exams and imaging. Herein, we discuss how implementing HPV ctDNA assays in rural regions of the United States provide one poignant example of how liquid biopsies can improve cancer care equity.

An evaluation of the cost of human papilloma virus (HPV) vaccine delivery in Zambia.

BACKGROUND: Human papillomavirus (HPV) is a common sexually transmitted infection and the leading cause of cervical cancer. The HPV vaccine is a safe and effective way to prevent HPV infection. In Zambia, the vaccine is given during Child Health Week to girls aged 14 years who are in and out of school in two doses over two years. The focus of this evaluation was to establish the cost to administer a single dose of the vaccine as well as for full immunisation of two doses. METHODS: This work was part of a broader study on assessing HPV programme implementation in Zambia. For HPV costing aspect of the study, with a healthcare provider perspective and reference year of 2020, both top-down and micro-costing approaches were used for financial costing, depending on the cost data source, and economic costs were gathered as secondary data from Expanded Programme for Immunisation Costing and Financing Project (EPIC), except human resource costs which were gathered as primary data using existing Ministry of Health salary scales and reported time spent by different health cadres on activities related to HPV vaccination. Data was collected from eight districts in four provinces, mainly using a structured questionnaire, document reviews and key informant interviews with staff at national, provincial, district and health facility levels. Administrative coverage rates were obtained for each district. RESULTS: Findings show that schools made up 53.3% of vaccination sites, community outreach sites 30.9% and finally health facilities 15.8%. In terms of coverage for 2020, for the eight districts sampled, schools had the highest coverage at 96.0%. Community outreach sites were at 6.0% of the coverage and health facilities accounted for only 1.0% of the coverage. School based delivery had the lowest economic cost at USD13.2 per dose and USD 28.1 per fully immunised child (FIC). Overall financial costs for school based delivery were US$6.0 per dose and US$12.4 per FIC. Overall economic costs taking all delivery models into account were US$23.0 per dose and US$47.6 per FIC. The main financial cost drivers were microplanning, supplies, service delivery/outreach and vaccine co-financing; while the main economic cost drivers were human resources, building overhead and vehicles. Nurses, environmental health technicians and community-based volunteers spent the most time on HPV related vaccination activities compared to other cadres and represented the greatest human resource costs. CONCLUSIONS: The financial cost of HPV vaccination in Zambia aligns favourably with similar studies conducted in other countries. However, the economic costs appear significantly higher than those observed in most international studies. This discrepancy underscores the substantial strain placed on healthcare resources by the program, a burden that often remains obscured. While the vaccine costs are currently subsidized through the generous support of Gavi, the Vaccine Alliance, it's crucial to recognize that these expenses pose a considerable threat to long-term sustainability. Consequently, countries such as Zambia must proactively devise strategies to address this challenge.

HPV Vaccine Issues in Japan: A review of our attempts to promote the HPV vaccine and to provide effective evaluation of the problem through social-medical and behavioral-economic perspectives.

In Japan, subsidies from local and national government programs for HPV vaccination of girls aged 13-16 began in 2010. By 2013, HPV vaccines were being used routinely for vaccinating girls aged 12-16 as part of its national immunization program. However, in June of 2013, in response to reports of possible adverse reactions to the vaccine, Japan's Ministry of Health, Labor, and Welfare (MHLW) announced a 'temporary suspension' of its governmental recommendation for HPV vaccination. The vaccination rate quickly dropped from 70 % of age-eligible girls to almost zero. It was not until 2021 that the government's recommendation suspension finally ended. The efficacy and safety of the HPV vaccine is now well documented, yet Japan has failed to reestablish any credible level of HPV vaccination. The World Health Organization (WHO) warned that Japan's HPV vaccination debacle was likely to result in real harm to the girls who lacked its protection; something we have already demonstrated with real-world data. To reinvigorate the HPV vaccination program in Japan to its prior levels, in the face of the current high level of HPV vaccine hesitancy, we will have to address the irrationality of human decision-making pointed out by behavioral economics. The Japanese government must act expeditiously to promote stronger cervical cancer control measures.

IGSF3 tissue expression in squamous cell carcinoma of the oropharynx: a novel tool for prognosis assessment in HPV-related and HPV-unrelated disease.

Biomarkers are not broadly used in the management of head and neck cancers (HNCs). Biomarkers have been beneficial in the management of other cancers, however, not in HNCs. Therefore, we observed the immunopositivity of a novel biomarker called immunoglobulin superfamily member 3 (IGSF3) in tumor tissues in HPV-related and HPV-unrelated OPSCC. Two patient cohorts (C1 and C2) from separate time periods were available for this study (total N = 282). Both consisted of OPSCC patients treated at the Helsinki University Hospital (HUS, Helsinki, Finland) during 2000-2016. For HPV determination, HPV mRNA in situ hybridization was used. Immunohistochemistry was used to assess IGSF3 immunopositivity in cancer tissues. Overall survival (OS) was used as endpoint in the statistical analysis. In C1, stronger immunopositivity of IGSF3 in tumor-infiltrating lymphocytes (TILs) correlated with favorable OS (p = 0.005). Stronger IGSF3 immunopositivity in tumor cells (TCs) was associated with HPV negativity (p = 0.017). Stronger IGSF3 immunopositivity in TILs correlated with HPV positivity (p < 0.001). Elevated IGSF3 immunopositivity in TILs associates with HPV-related tumors and may signify favorable prognosis. The immunopositivity of IGSF3 differs between HPV-related and HPV-unrelated OPSCC.

Assessment of Cervicovaginal Smear and HPV DNA Co-Test for Cervical Cancer Screening: Implications for Diagnosis and Follow-Up Strategies.

OBJECTIVE: Cervical cancer is a major cause of cancer-related mortality, necessitating effective screening and diagnostic methods. This study aimed to assess the performance of cervicovaginal smear (CVS) and human papillomavirus (HPV)-DNA co-test. STUDY DESIGN: The pathology results of 225 female patients who underwent HPV-DNA testing with CVS between 2014 and 2022 and were subsequently diagnosed by colposcopic cervical biopsy or second CVS were retrospectively analyzed. RESULTS: CVS samples showed atypical squamous cells of undetermined significance (ASCUS), low-grade squamous intraepithelial lesion (LSIL), high-grade squamous intraepithelial lesion (HSIL), and cervical cancer. Concordance between the first and second diagnoses demonstrated moderate agreement for LSIL. ASCUS cases exhibited a significant correlation with HPV-DNA positivity and higher-grade cervical lesions. In biopsy, sensitivity and specificity for CIN1/LSIL were 87.5% and 53.3, respectively, while for CIN2-3/HSIL, they were 83.87% and 58.49%. HPV testing showed significant correlation with histopathologic results. In women over 40 years, more intraepithelial lesions were diagnosed compared to younger women (p < 0.005). The conventional smear technique proved reliable in detecting high-grade lesions. CONCLUSIONS: Despite the limitations of our study, our results emphasize the value of HPV-DNA testing to avoid unnecessary interventions and to establish appropriate follow-up strategies.

Barriers to the assessment and recommendation of HPV vaccination among healthcare providers in Texas.

Background: Healthcare providers (HCPs) recommendations for HPV vaccination plays a critical role in increasing vaccination uptake. This study assesses the prevalence of reported barriers to HPV vaccination assessment and recommendation among HCPs in Texas. Methods: Study data were obtained from a population-based survey of HCPs currently practicing in Texas. Participants were asked about their HPV vaccination assessment and recommendation practices and the reasons for not assessing or recommending the vaccine. Barriers were stratified by HCP characteristics including age, sex, race/ethnicity, location of practice, provider type, and type of facility. Results: Among the 826 HCPs included in this study, 47.3 % never, 49.6 % sometimes, and 3.0 % often/always assessed a patient's HPV vaccination status. Similarly, 36.0 % never, 36.2 % sometimes, and 27.9 % often/always recommended HPV vaccination. The most frequently reported barriers to assessment and recommendation of HPV vaccination were time constraints (22.9 %), delegating the task to others (15.0 %), lack of effective tools and information to give patients (12.0 %), and requiring additional training (9.2 %). HCPs who were female, less than 35 years old, non-Hispanic black, and nonphysician HCPs (Physician Assistant, Nurse Practitioner) most frequently reported lacking effective tools and information and a need for additional training. Conclusion: The assessment and recommendation for HPV vaccination among HCPs in Texas is suboptimal. Barriers reported varied based on the provider's characteristics. Addressing these barriers, such as by providing more effective tools and information and offering additional training to HCPs, could potentially increase HPV vaccination rates in Texas. The findings also suggest that interventions should be tailored to specific demographic groups.

Assessment of HPV Knowledge and Awareness among Students and Staff at IBB University, Niger State, Nigeria: Implications for Health Education and Prevention.

In Nigeria, statistics reveal that there is a high rate of cervical cancer among women and a significant lack of awareness surrounding Human Papillomavirus (HPV), which poses a substantial risk of HPV infection. This cross-sectional survey, conducted at Ibrahim Badamasi Babangida (IBB) University, focuses on adapting and exploring the factors that influence a 20-item scale to measure HPV knowledge, evaluating knowledge-associated patterns and HPV-associated risk factors. We examined HPV vaccination rates, infection awareness, vaccine awareness, and the impact of ethnicity on HPV knowledge. Various validated forms were adapted to measure HPV awareness and knowledge. Non-parametric tests addressed non-normality. Data were presented using median and IQR and categorical data were frequency-based. Bivariate tests (Mann-Witney, Kruskal Wallis) explored knowledge-associated factors, while quantile regression (75th percentile) examined HPV knowledge factors. Variables were considered statistically significant at p < 0.05. The adapted 20-item knowledge scale revealed strong reliability (Cronbach's alpha = 0.913), ensuring internal consistency. The median knowledge score was 0, with an interquartile range (IQR) of 0-5. Our findings revealed a significant lack of awareness and knowledge about HPV; only 34.8% of the population were aware of HPV infection and 25.0% were familiar with HPV vaccination. Furthermore, ethnicity was found to be significantly associated with knowledge of HPV. This study emphasizes the necessity for targeted interventions to enhance HPV awareness, especially within specific ethnic groups. Despite a robust knowledge scale, educational initiatives such as seminars/conferences about HPV and cervical cancer remain crucial in addressing this gap, ultimately reducing HPV infection and cervical cancer risks in Nigeria.

Expression and scale-up production of recombinant human papillomavirus type 52 L1 protein in methylotrophic yeast Hansenula polymorpha.

BACKGROUND: Human papillomavirus (HPV) vaccination is one of the crucial national vaccination programs aimed at reducing the prevalence of the diseases associated with HPV infections, which continue to pose a global health concern. However, a significant disparity exists in the distribution of HPV vaccine, particularly in low-middle income countries where the cost of HPV vaccine becomes a major obstacle. Thus, it is essential to ensure the availability of an economically feasible HPV vaccine, necessitating immediate efforts to enhance the cost-effectiveness of vaccine production. This study aimed to develop an efficient production system for the recombinant HPV type 52 L1 protein as HPV vaccine material using methylotrophic yeast Hansenula polymorpha expression system. RESULTS: This study presents an in-depth examination of the expression and scale-up production of HPV type 52 L1 protein using DASGIP® parallel bioreactor system. The pHIPX4 plasmid, which is regulated by the MOX promoter, generates stable clones that express the target protein. Cultivation employing the synthetic medium SYN6(10) with controlled parameters (e.g. temperature, pH, feeding strategy, and aeration) produces 0.15 µg/mL of HPV type 52 L1 protein, suggesting a possibility for scaling up to a higher production level. CONCLUSION: The scale-up production of HPV type 52 L1 protein using Hansenula polymorpha expression system described in this study provides an opportunity for an economical manufacturing platform for the development of the HPV vaccine.

Factors associated with parental human papillomavirus vaccination intentions among adolescents from socioeconomically advantaged versus deprived households: a nationwide, cross-sectional survey.

Background: In the USA, HPV vaccine coverage is substantially lower among adolescents from high-income households compared to their low-income counterparts. We examined and compared the factors associated with parental HPV vaccination intentions between socioeconomically divergent groups. Methods: Data from unvaccinated and not fully HPV-vaccinated adolescents from the 2017-2021 National Immunization Survey (NIS)-Teen were analyzed. Socioeconomically advantaged vs. deprived groups were identified based on dichotomized income (material capital) and education (social capital). Parental intent to initiate and complete the HPV vaccine series was compared using bivariable analysis and the factors associated with lacking intent were identified. Findings: The 2017-2021 NIS-Teen included a total of 212,643 participants; the final analytical sample consisted of 105,958 adolescents (an estimated 10.3 million adolescents) who were unvaccinated or not fully vaccinated. In the advantaged group, 64.7% of parents of unvaccinated adolescents (equating to 2.4 million US adolescents) had no intention to initiate the HPV vaccine compared to 40.9% of parents in the deprived group (equating to 0.2 million adolescents) (P < 0.0001; S > 13.29). The most frequent reason for lacking intent in the advantaged group was 'safety concerns' (25.5%). In the deprived group, 'lack of knowledge', 'not recommended', and 'not needed' were common reasons (nearly 15% each). Lack of intent to complete the HPV vaccine series was higher in the advantaged group (43.9%; 1.1 million adolescents) compared to the deprived group (25.2%; 0.08 million adolescents) (P < 0.0001; S > 13.29). More than half in the advantaged group (58.4%) and over a third (37.1%) in the deprived group cited 'already up to date' as the main reason for not completing the HPV vaccine series. Interpretation: Lack of intent to initiate and complete the HPV vaccination series, particularly among socioeconomically advantaged parents is a significant barrier to achieving the national goal in the USA. Funding: The US National Institute on Minority Health and Health Disparities, the National Center for Advancing Translational Sciences, MUSC Hollings Cancer Center Seed funding, and the US National Cancer Institutes.

Atypical glandular cells in Pap tests: cytology-histology correlation and risk assessment with human papillopmavirus (HPV) testing.

INTRODUCTION: Atypical glandular cells (AGC) represent less than 1% of Pap test cases and include a variety of lesions in both the cervix and endometrium. The study aimed to investigate the cytology-histology correlation in AGC patients and to evaluate the clinical utility of hrHPV testing in this diagnostic context. MATERIALS AND METHODS: We identified 491 atypical glandular cells (AGC) cases in our quality analysis (QA) database of 336,064 Pap tests interpreted between March 1, 2013 and July 12, 2016. Of these, 251 cases had follow-up biopsies with hrHPV tests in 148 cases. RESULTS: The most common histologic diagnosis associated with AGC was normal/benign or low-grade lesions, comprising 55% of cervical biopsies and 24% of endometrial biopsies. High-grade lesions were identified in 21% of follow-up biopsies. In patients with AGC cytology, a positive hrHPV test significantly increased the likelihood of cervical HSIL or above lesions on biopsy by 26.4 times (OR = 26.4, 95% CI: 5.8-119.4, P < 0.0001). A positive genotyping result for HPV 16 dramatically increased the likelihood of cervical HSIL or above lesions on biopsy (OR = 84, 95% CI: 12.0-590.5, P < 0.0001). The HPV test had a negative predictive value of 97% (CI: 85%-100%). CONCLUSIONS: Our study confirms that AGC is a significant diagnosis with an overall risk for high-grade cervical or endometrial lesions as high as 21%. hrHPV testing with genotyping is an effective tool for identifying high-risk individuals within the AGC population, with excellent positive and negative predictive values. This approach is valuable for clinical risk stratification and differential diagnosis in patients with AGC cytology.

Human papillomavirus (HPV) vaccination program in Sri Lanka: Ongoing costs and operational context of a routinized program.

Existing evidence on the cost of human papillomavirus (HPV) vaccination programs has focused on pilot and demonstration projects or initial introductions, which resulted in a perceived high cost. We aimed to study the ongoing cost and operational context of an established HPV vaccination program in Sri Lanka. We conducted a retrospective operational research and microcosting study focusing on 2019. We collected data from 30 divisional health units, 10 districts, and the central level. We then evaluated financial and economic costs, reported by level of the health system, program activity, cost types, and per dose delivered. In 2019, Sri Lanka delivered a total of 314,815 doses of HPV vaccine. In our study sample, 95 % of the HPV vaccination sessions took place at schools, with peaks of delivery in February-March and September-October. The weighted mean financial cost per dose delivered was $0.27 (95 % confidence interval [CI]: $0.15-$0.39) and the economic cost per dose was $3.88 (95 % CI: $2.67-$5.10), excluding the cost of vaccines and supplies. Most of the cost was borne by the divisional health unit level. Service delivery and social mobilization were major contributors to overall costs at the divisional health unit level, and vaccine collection or distribution and storage were the most costly activities at the district and central levels. Cost drivers included the opportunity cost of health worker and non-health worker time at the divisional health unit level and capital costs for vehicles and equipment, along with fuel, maintenance, and energy, at the district and central levels. This study provides new evidence on the cost and cost drivers of a routinized HPV vaccination program. Results can be used for financial planning purposes in Sri Lanka and may inform other countries as they consider use of HPV vaccines.

Evaluation of an HPV vaccine toolkit to improve OB/GYN discussion of HPV vaccination.

Background: HPV (Human Papillomavirus) vaccination is a safe, effective method to prevent HPV-associated disease. Racial-ethnic disparities in HPV vaccination exist, which could lead to widening gaps in cervical cancer mortality. Provider discussion of HPV vaccination has been shown to be a primary factor for increasing vaccination rates. The objective of this study is to assess provider discussion of HPV vaccination pre and post implementation of an intervention, named the HPV Vaccine Toolkit, in an Obstetrics and Gynecology (OB/GYN) clinic in Boyle Heights, Los Angeles. Study design and methods: This quality improvement study occurred over four cycles of development. Its design was guided by the Theory of Planned Behavior. The toolkit components included dot phrases (pre-written phrases to speed documentation), educational posters, electronic health record prompts, HPV vaccine referral guides, and educational sessions. Chart audits and pre- and post-providers surveys were performed between 2019 and 2021 to assess for an increase in provider discussion of the HPV vaccine, as well as to evaluate the various components of the toolkit. Results: Provider discussion increased over the four cycles of this intervention, with HPV vaccination discussion documented in 15 % of patients in 2019, 19 % of patients in 2020 and 47 % of patients in 2021. Gaps identified included limited discussion of vaccination at postpartum visits. Provider uncertainty of where to refer patients for the HPV vaccine decreased following the intervention. Conclusion: Discussion of HPV vaccination is an important preventative strategy that can be overlooked in OB/GYN clinics. Implementation of multicomponent strategies can increase provider discussion of HPV vaccination status, although barriers to discussion remain. Improved counseling on HPV vaccination could have significant impacts on reducing HPV-related disease.

Cost-effectiveness of nonavalent HPV vaccination in the Netherlands.

BACKGROUND: A bivalent human papillomavirus vaccine (2vHPV) is currently used in the Netherlands; a nonavalent vaccine (9vHPV) is also licensed. RESEARCH DESIGN AND METHODS: We compared the public health and economic benefits of 2vHPV- and 9vHPV-based vaccination strategies in the Netherlands over 100 years using a validated deterministic dynamic transmission metapopulation model. RESULTS: Compared to 2vHPV, the 9vHPV strategy averted an additional 3,245 cases of and 825 deaths from 9vHPV-strain-attributable cancers, 4,247 cases of and 190 deaths from recurrent respiratory papillomatosis (RRP), and 1,009,637 cases of anogenital warts (AGWs), with an incremental cost-effectiveness ratio (ICER) of €4,975 per quality-adjusted life year (QALY) gained. The ICER increased in a scenario with increased HPV vaccination coverage rates and was relatively robust to one-way deterministic sensitivity analyses, with variation in the disease utility parameter having the most impact. When catch-up vaccination for individuals ≤26 years of age was added to the model, vaccinating with 9vHPV averted additional cancers and AGWs compared to 2vHPV vaccination. CONCLUSION: Our analyses predict that transitioning from a 2vHPV- to a 9vHPV-based vaccination strategy would be cost-effective in the Netherlands.

A validated polyclonal antiserum-based immunoassay for assessment of HPV 16 L1 relative potency.

Vaccine potency is typically evaluated using an assay that acts as a surrogate for biological activity. Although in vivo vaccines better represent human immunological responses, in vitro assays are preferred due to lower variability, higher throughput, easier validation and ethical considerations. In in vitro determination of Human Papillomavirus (HPV), Virus-like particle (VLP) vaccine potency currently depends on monoclonal antibody assays. However, these reagents are hard to obtain and currently are not available commercially. In this work, a polyclonal antiserum-based immunoassay was developed to evaluate the relative potency of Alhydrogel formulated HPV 16 VLPs. The repeatability and specificity were evaluated, and found that the assay was sensitive to small amounts of non-VLP HPV 16 L1 proteins. Finally, the assay was tested in comparison to the mouse effective dose 50 (ED50) assay on a limited number of batches. The agreement between these results suggests this test as a suitable surrogate for the in vivo test.

A Systematic Review of the Effectiveness of Cervical Cancer Screening and Prevention Interventions for African American Women: Implications for Promoting Health Equity.

African American women suffer under the burden of cervical cancer as they are first in mortality, diagnosed at later stages, and have a survivorship rate that is lower than the national average. The aim of our review is to evaluate the effectiveness of cervical cancer screening and prevention interventions for African American women living in the United States and to assess their commitment to health equity. A literature search was conducted using PubMed, Embase, CINAHL, and Scopus using MeSH terms related to cervical cancer, human papillomavirus (HPV), screening and prevention, and African Americans. This resulted in 1970 articles. Studies were included if they promoted cervical screening or prevention, sampled African American women aged 18 and over, and evaluated interventions. Among the 23 articles that met inclusion criteria, there were a wide variety of intervention strategies, that is, community health workers, patient navigation, patient reminders, self-sampling collection, and HPV vaccination. Health education interventions, when coupled with patient navigation or community health workers, were effective in promoting screening participation (odds ratio: 2.43, 95% confidence interval: 1.47-4.02). There were mixed results regarding the incorporation of health equity principles. This review supports the importance of incorporating health equity principles and community based methods in screening and prevention interventions. Future research and practice should incorporate African American women's perspectives in intervention development and implementation.

Males' Access to Human Papillomavirus Vaccination in Resource-Limited Settings.

The human papillomavirus is known to cause cervical and anogenital cancer and benign anogenital and cutaneous warts. Both males and females can contract the virus during sexual intercourse and skin-to-skin contact. Communities in low- and middle-income countries, including Africa, are particularly suffering from human papillomavirus-related diseases, mainly cervical cancer. Vaccination is the most economical and efficient prevention strategy to control human papillomavirus-related diseases. Undoubtedly, to control all types of human papillomavirus-related morbidity and mortality, the entire at-risk, sexually active population needs to be vaccinated regardless of their sex. However, the vaccination program, particularly in Africa, the world's most resource-limited region, is habitually limited to the female population, considering only the burden of cervical cancer. We think that it is impossible to fully mitigate the human papillomavirus infection by vaccinating only the female population, while males can carry and pass the virus. In addition, marginalizing males from this program seems to violate gender inequality and their sexual and reproductive health rights. Hence, we voice the need for global and local governments to consider and customize human papillomavirus vaccination programs for the male population. Also, it is better to consider the male population in different research studies regarding human papillomavirus-related malignant and benign conditions.