Hepatitis A antibody persistence 8 and 10 years after 1-dose and 2-dose vaccination in children from Panama

BackgroundHepatitis A virus (HAV) remains a global public health concern, which is potentially growing in Latin America, due to an expected shift from high to intermediate endemicity levels. The use of HAV vaccines in pediatric national immunization programs (NIPs), either as a 2-dose or a 1-dose schedule, has been explored in Latin American countries; however, evidence demonstrating long-term protection in this population is limited in the region. We evaluated long-term antibody persistence following a 1-dose partial series and the recommended 2-dose schedule used in Panama’s pediatric NIP.MethodsTwo independent cross-sectional serological surveys were conducted at year 8 (Y8) and Y10 following vaccination under the NIP with 1 or 2 doses of an inactivated HAV vaccine (Havrix, GSK). Seropositivity (anti-HAV antibody concentration ≥ 15 mIU/mL) rates and antibody geometric mean concentrations (GMCs) were assessed at each serosurvey. Non-inferiority of 1 dose versus 2 doses was also explored.ResultsThis study (NCT02712359) included 600 and 599 children at Y8 and Y10 post-vaccination, respectively. Seropositivity rates were 74.3% (95% confidence interval [CI]: 69.0; 79.2) and 97.7% (95% CI: 95.3; 99.1) at Y8 and 71.9% (95% CI: 66.4; 76.9) and 96.3% (95% CI: 93.5; 98.2) at Y10, in the 1-dose and 2-dose groups, respectively. Antibody GMCs were lower in the 1-dose versus the 2-dose group in both surveys. Non-inferiority was not demonstrated since the lower limit of the 2-sided 95% CI for the between-group difference in seropositivity rates (1-dose minus 2-dose) was < ?10%.ConclusionAnti-HAV antibody persistence was observed in lower percentages of children receiving 1 dose versus 2 doses of Havrix, at 8 and 10 years post-vaccination in Panama. Further investigations are needed to confirm antibody persistence and conclude on the protection afforded beyond 10 years in the pediatric population in Latin America.     

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

BackgroundThe 9-valent human papillomavirus (9vHPV; HPV6/11/16/18/31/33/45/52/58) vaccine was approved for use in Chinese women aged 16–26 years in 2018. This phase 3, open-label study (NCT03903562) compared 9vHPV vaccine immunogenicity and safety in Chinese females aged 9–19 years and 27–45 years with Chinese females aged 20–26 years; we report results from day 1 through 1 month post-Dose 3. The study will continue through 54 months post-Dose 3 to assess antibody persistence in Chinese girls aged 9–19 years.MethodsParticipants aged 9–45 years received three doses of the 9vHPV vaccine. Geometric mean titers (GMTs) and seroconversion percentages for anti-HPV6/11/16/18/31/33/45/52/58 antibodies were determined by competitive Luminex immunoassay in serum samples obtained at day 1 and 1 month post-Dose 3. Adverse events (AEs) within 30 days post-vaccination and serious AEs (SAEs) occurring at any time were recorded.ResultsIn total, 1990 participants (690 aged 9–19 years; 650 aged 20–26 years; 650 aged 27–45 years) were enrolled. At 1 month post-Dose 3, >99% of participants in the per-protocol immunogenicity population seroconverted to each vaccine HPV type. Anti-HPV6/11/16/18/31/33/45/52/58 antibody GMTs in the 9–19-year age group were non-inferior to those in participants aged 20–26 years. Anti-HPV6/11/16/18/31/33/45/52/58 seroconversion percentages in the 27–45-year age group were non-inferior to those in participants aged 20–26 years. Injection-site and systemic AEs were reported by 43.3% and 50.9%, 50.5% and 57.1%, and 43.8% and 43.4% of participants aged 9–19, 20–26, and 27–45 years, respectively. There were no vaccine-related SAEs, discontinuations due to AEs, and deaths.ConclusionAntibody responses induced by 9vHPV vaccination in Chinese females aged 9–19 years and 27–45 years were non-inferior to those in Chinese females aged 20–26 years. The vaccine was generally well tolerated.ClinicalTrials.gov Identifier: NCT03903562.     

Socioeconomic disadvantage and human papillomavirus (HPV) vaccination uptake

ImportanceDespite availability of safe and effective human papillomavirus (HPV) vaccines, vaccination uptake remains low in the U.S. Research examining the impact of neighborhood socioeconomic status on HPV vaccination may help target interventions.ObjectiveTo examine the association between area deprivation and HPV vaccine initiation and completion.Design, setting, participantsRetrospective cohort study of individuals aged 11–18 years residing in the upper Midwest region. Receipt of HPV vaccination was examined over a three-year follow-up period (01/01/2016–12/31/2018).Main outcomes and measuresOutcomes of interest were initiation and completion of HPV vaccination. Demographic data were collected from the Rochester Epidemiology Project (REP). Area-level socioeconomic disadvantage was measured by calculating an Area Deprivation Index (ADI) score for each person, a measure of socioeconomic disadvantage derived from American Community Survey data. Multivariable mixed effect Cox proportional hazards models were used to examine the association of ADI quartiles (Q1-Q4) with HPV vaccine series initiation and completion, given initiation.ResultsIndividuals residing in census block groups with higher deprivation had significantly lower likelihood of HPV vaccine initiation (Q2: HR = 0.91, 0.84–0.99 Q3: HR = 0.83, 0.76–0.90; Q4: HR = 0.84, 0.74–0.96) relative to those in the least-deprived block groups (Q1). Similarly, those living in block groups with higher deprivation had significantly lower likelihood of completion (Q2: HR = 0.91, 0.86–0.97; Q3: HR = 0.87, 0.81–0.94; Q4: HR = 0.82, 0.74–0.92) compared to individuals in the least-deprived block groups (Q1).Conclusions and relevanceLower probability of both HPV vaccine-series initiation and completion were observed in areas with greater deprivation. Our results can inform allocation of resources to increase HPV vaccination rates in our primary care practice and provide an example of leveraging public data to inform similar efforts across diverse health systems.     

Cost-effectiveness of human papillomavirus vaccination in girls living in Latin American countries: A systematic review and meta-analysis

BackgroundCervical cancer is a major public health problem in Latin America. Cost-effectiveness studies help stakeholders with decisions regarding human papillomavirus (HPV) vaccination programs, one of the main prevention measures. Our objective was to synthesize the results of cost-effectiveness studies of HPV vaccination in girls, to understand factors influencing cost-effectiveness in the region.MethodsWe systematically searched databases as well as repositories from conferences, Ministries of Health and Health Technology Assessment offices. Incremental cost-effectiveness ratios (ICERs) were extracted, with data converted to international dollars (I$) and inflated to 2019 values. We used the gross domestic product per capita as threshold for judging the cost-effectiveness of vaccination. We calculated the geometric mean ICER by type of vaccine, whether screening (cytology or HPV test) was used as comparator, effectiveness measure, perspective, source of funding, year of cost, and country.ResultsWe found 24 studies. Despite the methodological differences, most studies concluded that HPV vaccination of girls in Latin American countries was either cost-saving or cost-effective. The mean ICER was I$ 3,804 for the bivalent vaccine, I$ 640 for the quadrivalent and I$ 358 for a generic HPV-16/18 vaccine. The mean ICER was lower in the studies that used HPV DNA test instead of cytology (I$ 122 vs I$ 1,841) as comparator; used the societal perspective (I$ 235 vs. I$ 1,986); were funded by non-profit sources instead of by pharmaceutical industry (I$ 421 vs. I$ 2,676); and used costs obtained prior to 2008 (I$ 365 vs I$ 1,415). We observed great variation in the mean ICERs by effectiveness measure (I$ 402 for per disability adjusted life years, I$ 461 for life year saved, and I$ 1,795 for quality adjusted life years).ConclusionsMost studies concluded that HPV vaccination of girls in Latin America countries was cost-saving or cost-effective, despite heterogeneity between models.     

Exploring socio-demographic and geospatial variation in human papillomavirus vaccination uptake in Virginia

Significant variation in human papillomavirus (HPV) vaccine coverage exists across the United States. A closer look at state and region-specific coverage is necessary to identify potentially modifiable disparities. Using ArcGIS software, we identify geospatial variation in HPV vaccine coverage in the state of Virginia and examine the relationship between various socio-demographic indicators and HPV vaccination uptake. HPV vaccination rates among adolescents 11 to 17 years as of 07/01/2018 were retrieved at the zip-code level from the Virginia Immunization Information System and chloropleth maps produced. The ArcGIS Hot Spot Analysis tool identified spatial clusters of zip codes with high and low vaccination rates. Population characteristics and socioeconomic indicators were retrieved from the 2010 United States Census and compared between statistically significant clusters of higher or lower than expected vaccination rates. Regions with significantly lower initiation rates were less populated, less educated, and had a lower median household income (MHI) with higher rates of poverty and unemployment. Among male adolescents, these areas had a significantly lower density of primary care providers and smaller African American and Hispanic populations. In contrast, regions with significantly lower series completion were more populated and had a higher MHI, but there was no difference in provider density or minority population. Ultimately, regional socioeconomic indicators are significant predictors of HPV vaccination, but have contrasting implications for series initiation and completion. Targeted interventions and safety net programs have traditionally focused on the socioeconomically disadvantaged, however it is the more affluent communities that may be struggling with series completion.     

Disparities in human papillomavirus vaccination coverage in the United States,National Health and Nutrition Examination Survey,January 2017–March 2020

BackgroundWe assessed disparities in HPV vaccination coverage by sociodemographic characteristics in the United States.MethodsUsing 2017-March 2020 National Health and Nutrition Examination Survey data, we estimated vaccination coverage of ≥ 1 dose of HPV vaccine by race/ethnicity and poverty, insurance, and nativity status for females and males aged 9–14, 15–19, and 20–29 years.ResultsAmong those aged 9–14 years, coverage among non-Hispanic Black (NHB), Hispanic, and non-Hispanic Asian (NHA) females (40.0%, 33.6%, 34.0%) and males (27.1%, 35.3%, 30.9%) was higher than non-Hispanic White (NHW) females (26.5%) and males (25.2%). Among those aged 15–19 and 20–29 years, coverage varied among NHB, Hispanic, and NHA compared to NHW females and was lower among NHB, Hispanic, and NHA than NHW males. Coverage was lower among uninsured than insured in most comparisons.ConclusionsHPV vaccination coverage varied by race/ethnicity and other characteristics. Efforts are needed to increase HPV vaccination coverage in all populations.     

Pneumococcal vaccination in older adults: An initial analysis of social determinants of health and vaccine uptake

ObjectivesTo examine the potential influence of social determinants of health on pneumococcal vaccination in older American adults.MethodsThis study used nationwide, US Medicare claims data from 2013 to 2016 to assess uptake of pneumococcal vaccination among adults in the first year after turning age 65. Patients were followed from the point of being 65 years of age and initially enrolled in traditional fee-for-service Medicare or a Medicare Advantage plan through the subsequent year and observed for pneumococcal vaccination in outpatient clinics and pharmacies. Publicly-available data on select social determinants of health were incorporated and guided by the World Health Organization vaccine hesitancy matrix. Logistic regression determined predictors of vaccination while controlling clinical and demographic characteristics.ResultsA total of 307,488 and 74,995 adults aged 65 years were identified from Medicare Advantage and Medicare fee-for-service claims, respectively, and 21.1% of Medicare Advantage and 38.2% of Medicare fee-for-service patients received a pneumococcal vaccine in the first year after turning 65. Those residing in urban areas had a higher likelihood of pneumococcal vaccination in both the Medicare Advantage (OR: 1.31; 95% CI: 1.267–1.344) and Medicare fee-for-service (OR: 1.53; 95% CI: 1.450–1.615) cohorts. Additionally, residing in areas of higher health literacy or communities with more democratic voters were consistently associated with a higher odds of pneumococcal vaccination regardless of Medicare type. Results also pointed to a synergistic relationship between receiving the influenza vaccine and also being vaccinated against pneumococcal disease.ConclusionSocial determinants of health, including local health literacy, poverty, residing in more liberal areas, and access to information, may be influencing the pneumococcal vaccine-related decisions of older adults. However, additional factors associated with the vaccine hesitancy matrix and more granular data (e.g., zip code-level) are needed to fully determine the impact in this and other vaccines recommended in older adults.     

An innovative housing-related measure for individual socioeconomic status and human papillomavirus vaccination coverage: A population-based cross-sectional study

BackgroundHuman papillomavirus (HPV) is a known cause of anogenital (eg, cervical) and oropharyngeal cancers. Despite availability of effective HPV vaccines, US vaccination-completion rates remain low. Evidence is conflicting regarding the association of socioeconomic status (SES) and HPV vaccination rates. We assessed the association between SES, defined by an individual validated Housing-based Index of Socioeconomic Status (HOUSES), and HPV vaccination status.MethodsWe conducted a cross-sectional study of children/adolescents 9–17 years as of December 31, 2016, living in southeastern Minnesota by using a health-record linkage system to identify study-eligible children/adolescents, vaccination dates, and home addresses matched to HOUSES data. We analyzed the relationship between HPV vaccination status and HOUSES using multivariable Poisson regression models stratifying by age, sex, race, ethnicity, and county.ResultsOf 20,087 study-eligible children/adolescents, 19,363 (96.4%) were geocoded and HOUSES measures determined. In this cohort, 57.9% did not receive HPV vaccination, 15.8% initiated (only), and 26.3% completed the series. HPV vaccination-initiation and completion rates increased over higher SES HOUSES quartiles (P < .001). Rates of HPV vaccination initiation versus unvaccinated increased across HOUSES quartiles in multivariable analysis adjusted for age, sex, race, ethnicity, and county (1st quartile, referent; 2nd quartile, 0.97 [0.87–1.09]; 3rd quartile, 1.05 [0.94–1.17]; 4th quartile, 1.15 [1.03–1.28]; test for trend, P = .002). HOUSES was a stronger predictor of HPV vaccination completion versus unvaccinated (1st quartile referent; 2nd quartile, 1.06 [0.96–1.16]; 3rd quartile, 1.12 [1.03–1.23]; 4th quartile, 1.32 [1.21–1.44]; test for trend, P < .001). Significant interactions were shown for HPV vaccination initiation by HOUSES for sex (P = .009) and age (P = .006).ConclusionThe study showed disparities in HPV vaccination by SES, with the highest HOUSES quartiles associated with increased rates of initiating and even greater likelihood of completing the series. HOUSES data may be used to target and tailor HPV vaccination interventions to undervaccinated populations.     

Anal human papillomavirus among men who have sex with men in three metropolitan cities in southern China: implications for HPV vaccination

IntroductionMen who have sex with men (MSM), especially those infected with human immunodeficiency virus (HIV), are at disproportionate risk for human papillomavirus (HPV) infection. Data about anal HPV prevalence among MSM in southern China are limited.MethodsMSM were recruited between January 1 and August 31, 2017 in three metropolitan cities: Guangzhou, Shenzhen and Wuxi. A self-completed tablet-based questionnaire was used to collect information about socio-demographic/sexual behavioral characteristics, history of sexually transmitted infections (STIs) and recreational drug use. An anal brush was used to collect exfoliated cells for HPV DNA testing and genotyping, and a blood sample was taken for HIV testing. Penile/anal warts were checked by a clinician.ResultsA total of 536 MSM were enrolled, including 39 HIV-positive and 497 HIV-negative individuals. Compared with HIV-negative MSM, prevalence of any HPV genotype (79.5% vs 46.7%), any high-risk genotype (64.1% vs 36.6%) and any nonavalent vaccine-preventable genotype (53.9% vs 31.6%) was significantly higher in HIV-positive MSM, with all P < 0.01. HIV infection (adjusted odds ratio [AOR], 4.28; 95% confidence interval [CI], 1.87–9.80), using recreational drugs (AOR, 1.87; 95% CI, 1.22–2.87), having ≥ 3 years of sexual experience (AOR, 1.52; 95% CI, 1.01–2.28), having ≥ 6 lifetime male partners (AOR, 1.92; 95% CI, 1.29–2.86), and engaging receptive anal intercourse (AOR, 2.30; 95% CI, 1.48–3.57) were associated with higher anal HPV prevalence. Any HPV prevalence increased with age, from 24.5% at < 20 years to 55.8% at ≥ 40 years.ConclusionsAnal HPV prevalence was high among MSM in southern China, significantly associated with HIV status and sexual experience. HPV prevalence increased with age among MSM. A targeted HPV vaccination program for teenage MSM might be necessary. Our findings will inform targeted HPV modelling among MSM in China.     

Identification of subgroups in the Danish population for targeted human papillomavirus vaccination efforts

BackgroundIn the Danish childhood vaccination program, the human papillomavirus (HPV) vaccination coverage is lower than for other vaccines. To tailor a targeted HPV vaccination effort, we aimed to identify girls in Denmark with lower first dose HPV vaccination coverage than girls in general.MethodsA population-based retrospective cohort study was performed of girls born in 2001–2004, residing in Denmark in September 2019 (N = 128,351). Data from the Danish Vaccination Register was linked to sociodemographic data from the Danish Civil Registration System and Statistics Denmark. Cox's proportional hazard regression models were used to compare vaccination uptake rates between subgroups of girls.ResultsHPV vaccination coverage at 14 years of age varied widely by municipality (53.4–80.6%). Girls living with neither of their parents had a lower chance of being vaccinated compared to girls living with both their parents (HR 0.43; 95% CI 0.41–0.46), likewise for girls attending special need education compared with girls attending public schools (HR 0.50; 95% CI 0.42–0.59). The vaccination uptake among immigrants was lower compared to Danish-born girls (HR 0.51; 95% CI 0.49–0.54), especially among immigrant girls whose parents had not passed any Danish exams. Finally, girls who were DTaP-IPV revaccinated had a 50% greater chance of being HPV vaccinated compared to girls who were not (HR 1.61; 95% CI 1.58–1.64).ConclusionTo increase the HPV vaccination uptake, we recommend vaccination efforts targeting girls living without any of their parents, girls attending special need education, immigrants, and girls who are not DTaP-IPV revaccinated. When targeting immigrants, the effort should focus on disseminating sufficient and understandable information about the Danish childhood vaccination program to the parents.     

The adult vaccination landscape in the United States during the Affordable Care Act era: Results from a large retrospective database analysis

BackgroundEarly provisions of the Affordable Care Act (ACA) reduced financial barriers to preventive care, including routinely recommended vaccines; however, vaccination coverage remains suboptimal. This study examined characteristics of routine adult vaccinations and potential missed opportunities for vaccinations through the lens of healthcare resource utilization among adults in the ACA era.MethodsThis was a retrospective analysis of healthcare claims from the Truven Health MarketScan Commercial Claims and Encounters (CCAE), Medicare Supplemental (MS), and Multi-State Medicaid databases among adults aged 19 years or older. Influenza, Tdap (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis), herpes zoster (HZ), and pneumococcal vaccinations were identified between 2011 and 2016. Potential missed opportunities were defined as well-visits at which individuals were age-eligible for vaccination but did not receive it, assessed during recommended windows for each vaccine. Missed encounters were defined as having no well-visits. Multivariable logistic regression was used to identify factors associated with vaccination and potential missed opportunities.ResultsFamily/internal medicine and unknown/other providers administered most influenza, Tdap, and pneumococcal vaccinations, for the CCAE/MS and Medicaid cohorts, respectively. HZ vaccinations were primarily administered through pharmacies. The proportion of vaccination events increased in the pharmacy setting between 2011 and 2016. Having preventive care visits, non-well-visits, and receiving most care from a family/internal medicine practitioner were associated with increased odds of vaccination. Missed encounters were common in Medicaid enrollees. Potential missed opportunities were more prevalent in the CCAE/MS cohort than among Medicaid enrollees. Having non-well-visits was associated with a reduced likelihood of having a missed opportunity.ConclusionSince the ACA implementation, preventive care among adults was sporadic. Many adults had limited opportunities for vaccination. The large prevalence of missed opportunities suggests vaccination uptake could be improved. Better support for vaccination or referrals for providers who may not traditionally vaccinate could improve vaccine uptake.     

Cost-effectiveness analysis of the implementation of a National Immunization Program for rotavirus vaccination in a country with a low rotavirus gastroenteritis-related mortality: A South Korean study

Rotavirus is a leading cause of severe gastroenteritis among children younger than 5 years in South Korea. Two rotavirus vaccines (RVs), pentavalent human-bovine reassortant vaccine (Rotateq®; RV5) and attenuated human strain originated monovalent vaccine (Rotarix®; RV1), have been available for voluntary vaccination using out-of-pocket payment since 2007 and 2008, respectively. Yet, RVs are not included in the National Immunization Program (NIP), partly because of the low associated mortality rate. We assessed the cost-effectiveness of RVs to assist the evidence-based decision-making process for NIP implementation in South Korea. Using a transparent age-structured static cohort model, we simulated the experience of ten annual birth cohorts of South Korean children from 2018 to 2027. Model inputs included rotavirus gastroenteritis (RVGE) incidence and mortality rates, RVGE treatment costs, vaccine coverage and timeliness, and vaccine effectiveness and price. The incremental costs of including RVs in the NIP compared to no vaccination were 59,662,738 USD and 152,444,379 USD for RV1 and RV5, respectively. The introduction of RV1 and RV5 can prevent 4799 disability-adjusted life years (DALYs) and 5068 DALYs. From the societal perspective, the incremental cost-effectiveness ratios (ICERs) for adopting RV into the NIP versus no vaccination were 12,432 USD per DALY averted for RV1 and 30,081 USD per DALY averted for RV 5. The weighted average for the ICERs of the two vaccines computed using the market share of each vaccine in the current voluntary use as a weight, was 21,698 USD per DALY averted. The estimated ICER was below 1 × gross domestic product per capita (30,000 USD), which has been a commonly used willingness-to-pay threshold for health care technology assessment in South Korea, suggesting that introducing RVs into the NIP would be cost-effective.     

Importance of human papillomavirus vaccination leaflets focusing on the safety profile targeted pediatricians in Japan

ObjectivesTo investigate the association between providing leaflets to support pediatricians in explaining the safety of the human papillomavirus (HPV) vaccine and mother’s decision to vaccinate their daughters in Japan.MethodsIn this cross-sectional study, we conducted a survey of mothers to evaluate the effect of leaflets that were created to support pediatricians in explaining the safety profile of the HPV vaccine. Mothers who provided consent for vaccination before receiving an explanation were excluded from the study. The primary outcome was the mother’s decision to vaccinate their daughters with the HPV vaccine after receiving an explanation from pediatricians using our leaflets.ResultsAmong 161 eligible mothers, 101 decided on HPV vaccination (decided group) and 60 did not (decided against group). There was no difference in the maternal background between the 2 groups. The decided group had a significantly more positive impression of the leaflets than the undecided group. In multivariable logistic regression analysis, a detailed explanation for possible adverse events and specific solutions to them was associated with the mother's decision to have their daughters vaccinated (odds ratio 2.35, 95% confidence interval 1.02–5.44), but not the pathology of cervical cancer and the HPV vaccination process.ConclusionLeaflets emphasizing an explanation of adverse events may contribute to mothers’ decision making for HPV vaccination.     

Cost-effectiveness analysis of quadrivalent and nonavalent human papillomavirus vaccines in Ethiopia

BackgroundIn Ethiopia, cervical cancer is the second most common cancer among women of the reproductive age group. Since 2018, the quadrivalent human papillomavirus (4vHPV) vaccine targeting four HPV types (6/11/16/18) has been introduced in the national immunization program in Ethiopia. Currently, however, a nonavalent HPV (9vHPV) vaccine which provides broader protection against nine HPV types (?6/11/16/18/31/33/45/52/58) is available for global use. Our study, therefore, aims to estimate the cost-effectiveness of 9vHPV vaccine compared to the current HPV vaccination program in Ethiopia.MethodA static Markov cohort model was used to simulate the progression of HPV infection to cervical cancer for a cohort of 12-years-old girls (N = 100,000) in Ethiopia. The model ran up to the age of 100 years, with a cycle length of 1 year. One-way and probabilistic sensitivity analyses were used to explore the robustness of the model and uncertainties around the parameters included in the model. Cost-effectiveness thresholds of one and three times gross domestic product (GDP) per quality-adjusted life-year (QALY) gained were considered.ResultsAt a price of US$ 6.9, the incremental cost-effectiveness ratio (ICER) per QALY gained for the 9vHPV vaccine was US$ 454 compared to the 4vHPV vaccine, which is less than one times GDP per capita of Ethiopia. The ICER was most sensitive to the change in the discount rate of QALYs. Compared to 4vHPV vaccine, for 9vHPV vaccine to remain very cost-effective and cost-effective, its price per dose should not exceed US$ 8.4 and US$ 15, respectively, at a threshold of one and three times GDP per capita.ConclusionCompared to the 4vHPV vaccine, the 9vHPV vaccine is a cost-effective option in Ethiopia, given that its price per dose does not exceed US$15.     

Distribution of serotypes causing invasive pneumococcal disease in older adults from high-income countries and impact of pediatric and adult vaccination policies

BackgroundNeither indirect protection through use of 13-valent and 10-valent pneumococcal conjugate vaccines (PCV13 and PCV10) in pediatric National Immunization Programs (NIPs) nor direct vaccination with the 23-valent polysaccharide vaccine have eliminated vaccine serotype invasive pneumococcal disease (IPD) in older adults. Vaccinating older adults with higher-valency PCV15 and PCV20 could address remaining IPD due to pediatric PCV serotypes plus additional IPD due to serotypes included in these vaccines.MethodsWe collected serotype-specific IPD data in older adults (≥65 years in most countries), from national or regional surveillance systems or hospital networks of 33 high-income countries. Data were from official government websites, online databases, surveillance system reports, published literature, and personal communication with in-country investigators. Average percentages of IPD serotypes were calculated.ResultsAmong 52,905 cases of IPD with a serotype identified, PCV13 serotypes accounted for 33.7% of IPD (55.8% and 30.6% for countries with PCV10 and PCV13 in the pediatric NIP), most commonly serotypes 3 (14.9%) and 19A (7.0%). PCV15 and PCV20 would cover an additional 10.4% and 32.9% of older adult IPD beyond PCV13 serotypes (PCV10 countries: 7.7% and 23.3%; PCV13 countries: 10.6% and 34.6%). The most common of these additional serotypes were 8 (9.9%), 22F (7.9%), 12F (4.6%), and 11A (3.3%). PPSV23 policies for older adults were not correlated with lower IPD percentages due to PPSV23 serotypes.ConclusionsVaccinating older adults with higher-valency PCVs, especially PCV20, could substantially reduce the remaining IPD burden in high-income countries, regardless of current PCV use in pediatric NIPs and adult PPSV23 policies.     

Safety and immunogenicity of a pichia pastoris-expressed bivalent human papillomavirus (types 16 and 18) L1 virus-like particle vaccine in healthy Chinese women aged 9–45 years: A randomized,double-blind,placebo-controlled phase 1 clinical trial

BackgroundWe evaluated the safety and immunogenicity of high and low doses of a novel pichia pastoris-expressed bivalent (types 16 and 18) human papillomavirus (HPV) virus-like particle vaccine.MethodsIn this randomized, double-blind, placebo-controlled phase 1 trial, we enrolled 160 healthy females aged 9–45 years in Guangxi, China who were randomized (1:1:2) to receive either low (0.5 mL) or high (1.0 mL) dosages of bivalent HPV vaccine, or placebo (aluminum adjuvant) in a 0, 2, 6 months schedule. Adverse events and other significant conditions that occurred within 30 days after each vaccination were recorded throughout the trial. Sera were collected at days 0, 60, 180 and 210 to measure anti-HPV 16/18 neutralizing antibodies.ResultsA total of 160 participants received at least one dose of the HPV vaccine and 152 completed the three dose vaccination series. Reporting rates of adverse events in placebo, low dose (0.5 mL) and high dose (1.0 mL) groups were 47.5 %, 55.0 % and 55.0 %, respectively. No serious adverse events occurred during this trial. 100 % of the participants who received three doses of the HPV vaccine produced neutralizing antibodies against HPV 16/18 vaccine. For HPV 16 and HPV 18, the geometric mean titers (GMTs) were similar between the low dose group (GMT_{HPV 16} = 10816 [95 % CI: 7824–14953]), GMT_{HPV 18} = 3966 [95 % CI: 2693–5841]) and high dose group (GMT _{HPV 16} = 14482 [95 % CI: 10848–19333], GMT _{HPV 18} = 3428 [95 % CI: 2533–4639]).ConclusionThe pichia pastoris-expressed bivalent HPV vaccine was safe and immunogenic in Chinese females aged 9–45 years. The low dosage (0.5 mL) was selected for further immunogenicity and efficacy study.     

Burden of pneumococcal disease due to serotypes covered by the 13-valent and new higher-valent pneumococcal conjugate vaccines in the United States

The addition of pneumococcal conjugate vaccines (PCVs) to the United States (US) national immunization program led to significant reductions in incidence, mortality, and associated sequelae caused by pneumococcal disease (PD) in children and adults through direct and indirect protection. However, there remains clinical and economic burden due to PD caused by serotypes not included in the current 13-valent PCV (PCV13) formulation. To address this unmet need, 15-valent PCV (PCV15) and 20-valent PCV (PCV20), containing additional serotypes to PCV13, were recently approved in the US for adults and are anticipated for pediatrics in the near future. The study objective was to estimate the annual number of cases, deaths, and economic burden of PD due to serotypes included in PCV13, PCV15, and PCV20 for both US pediatric and adult populations. An Excel-based model was developed to calculate clinical and economic outcomes using published age-group specific serotype coverage; incidence of invasive PD, community-acquired pneumonia, and acute otitis media; case fatality rates; and disease-related costs. The results showed that across all age groups, the estimated annual PD cases and associated deaths covered by PCV13 serotypes were 914,199 and 4320, respectively. Compared with PCV13 serotypes, the additional 2 and 7 serotypes covered by PCV15 and PCV20 were attributed with 550,475 and 991,220 annual PD cases, as well as 1425 and 3226 annual deaths, respectively. This clinical burden translates into considerable economic costs ranging from $903 to $1,928 million USD that could be potentially addressed by PCV15 and PCV20. The additional serotypes included in PCV20 contribute substantially to the clinical and economic PD burden in the US pediatric and adult populations. Despite the success of the PCV13 pediatric national immunization program and increased adult uptake of PCV13 and 23-valent polysaccharide vaccine, broader PCV serotype coverage is needed across all ages to further reduce pneumococcal disease burden.     

Public health impact and cost-effectiveness of a nine-valent gender-neutral HPV vaccination program in France

ObjectivesIn France, 9-valent HPV vaccination is recommended routinely for 11–14-years-old girls and as catch-up for 15–19-years-old girls. Recently, recommendation for gender-neutral vaccination (GNV) has been approved. The objectives of the study were to assess the public health impact and cost-effectiveness of a 9-valent GNV compared with girls-only vaccination program (GOV).MethodsA published HPV disease transmission dynamic model accounting for herd protection effects with a 100-year time horizon was adapted and calibrated to French data. Epidemiological and economic outcomes included disease cases averted and quality-adjusted life years (QALY). Costs and incremental cost-effectiveness ratio (ICER) were measured in 2018 Euros (€). A coverage rate of 26.2% among girls and boys was assumed for the GNV program based on the current female coverage rate in France. The base case included genital warts, cervical, vulvar, vaginal, and anal cancers. Scenario analyses included all HPV-related diseases and considered higher vaccination coverage rate (60%). Deterministic sensitivity analyses on key inputs were performed.ResultsOver 100 years, GNV resulted in an additional reduction of 9,519 and 3,037 cervical cancer cases and deaths; 6,901 and 1,166 additional anal cancer cases and deaths; and a reduction of additional 1,284,077 genital warts compared with current GOV and an ICER of 24,763€/QALY. When including all HPV-related diseases, the ICER was 15,184€/QALY. At a higher coverage rate (60%), GNV would prevent 17,430 and 4,334 additional anogenital cancer cases and deaths and over two million genital warts compared with GOV with an ICER of 40,401€/QALY. Results were sensitive to a higher discount rate (6% versus 4%) and a shorter duration of protection (20 years versus lifetime).ConclusionsIn France, GNV has a significant impact in terms of public health benefits and may be considered cost-effective compared with GOV at low and high coverage rates.     

Human papillomavirus vaccination coverage among men who have sex with men—National HIV Behavioral Surveillance,United States, 2017

Men who have sex with men (MSM) are at high risk for infections and diseases caused by human papillomavirus (HPV), many of which are vaccine-preventable. In the United States, routine HPV vaccination has been recommended for adolescent males since 2011. This analysis evaluated self-reported receipt of ≥ 1 HPV vaccine dose by age group and HIV status among adult MSM using 2017 data from National HIV Behavioral Surveillance (NHBS) and compared the proportion vaccinated to prior years. Among 10,381 MSM aged ≥ 18 years, 17.9% of MSM overall and 28.4% of MSM living with HIV reported any HPV vaccination. Among 2,482 MSM aged 18–26 years, 32.8% overall and 51.3% living with HIV reported HPV vaccination. Since 2011, the proportion of MSM aged 18–26 years reporting HPV vaccination has increased over six-fold. As vaccinated adolescents age into young adults, coverage will continue to increase overall, including among MSM.     

Meningococcal vaccination in patients with newly diagnosed asplenia in the United States

BackgroundPatients with asplenia are recommended to receive meningococcal ACWY (MenACWY) and B (MenB) vaccines in the United States (US).ObjectivesTo examine uptake and time to receipt of meningococcal vaccines in newly diagnosed asplenia patients, and identify factors associated with vaccination.MethodsFor this retrospective database analysis, patients were identified from 1/1/2010 (MenACWY) or 1/1/2015 (MenB) through 3/31/2018 from an administrative claims database including commercially insured US patients with ≥1 inpatient or ≥2 outpatient claims with evidence of a new asplenia diagnosis (sickle cell disease was excluded); continuous enrollment for ≥12 months before and ≥6 months after the index date; and age ≥2 (MenACWY) or ≥10 (MenB) years. Co-primary outcomes were uptake and time to receipt of ≥1 dose, separately for MenACWY and MenB, by Kaplan–Meier analysis. Cox proportional hazards regression models were used to identify characteristics associated with vaccination.ResultsAmong 2,273 and 741 patients eligible for the MenACWY and MenB analyses, respectively, 28.1% and 9.7% received MenACWY and MenB in the first 3 years after a new asplenia diagnosis. Patients were more likely to receive meningococcal vaccines if they had received pneumococcal vaccines (MenACWY: hazard ratio [HR] 26.02; 95% confidence interval [CI] 21.01–32.22; MenB: HR 3.89; 95% CI 2.07–7.29) or attended ≥1 well-care visit (MenACWY: HR 6.63; 95% CI 4.84–9.09; MenB: HR 11.17; 95% CI 3.02–41.26).ConclusionsMeningococcal vaccination rates among newly diagnosed asplenia patients were low, highlighting the need to educate providers about the recommendations for high-risk conditions and ensure healthcare access for vulnerable patients.