Association of functional disability and treatment modalities with perceived effectiveness of treatment among adults with depression: a cross-sectional study

BackgroundApproximately 17.3 million US adults had at least one major depressive episode (MDE) in 2017. Of those, about two-thirds received mental health services from health professionals. Persons with disabilities (PWD) have higher risks of depression and may face more challenges in seeking treatment.ObjectiveExamined whether the presence of disabilities affected the perceived effectiveness of treatment for people with MDE who received outpatient mental health care.MethodsWe obtained MDE status, functional disability, modality of treatment (i.e., medication only, counseling only, medication plus counseling), self-reported effectiveness of treatment, and covariates from a nationally representative sample of US adults aged ≥18 years in the 2015–2019 National Survey on Drug Use and Health. We used multivariable logistic regression models with recommended survey weighting to examine associations between disability and perceived effectiveness of treatment.ResultsThe study population comprised 9992 respondents, representing 9.53 million US adults who had MDE and received outpatient mental health care in the past year. Overall, 58.9% had at least one functional limitation. A higher proportion of PWDs received medication plus counseling treatment compared to persons without disabilities (79.2% vs. 67.9%, P < .001). PWDs were significantly less likely to rate treatment as effective (OR = 0.77; 95% CI: 0.66–0.91). Odds ratios decreased as the number of limitations increased, and this association was moderated by treatment modality.ConclusionPWDs have poorer perceived outcomes of outpatient mental health care for depression, especially for treatment modalities involving counseling. These findings call for focused attention to depression treatment efforts for PWD that accommodate their needs.     

Fine particulate matter and body weight status among older adults in China: Impacts and pathways

BackgroundPopulation ageing and air pollution have become two major public health concerns in China. Longitudinal evidence on the body weight impacts of air pollution among older adults is rare. This study aims to investigate the impacts of ambient particulate matter with aerodynamic diameters ≤2.5 μm (PM_2.5) on weight status of older adults in China and the potential behavioral and metabolic pathways through which PM_2.5 influences weight status.MethodsThe longitudinal data from the China Health and Retirement Longitudinal Study (body mass index—BMI, n = 9053; waist/height ratio—WHR, n = 9064) were linked to the air pollution data at the city-level with a rural-urban distinction. We used mixed-effects linear models to evaluate the impacts of PM_2.5 on individual weight status and multiple mediation analysis to examine potential pathways.ResultsAfter adjusting for relevant socioeconomic and city-level risk factors, significant and robust positive impacts of PM_2.5 on BMI (0.025, 95%CI: 0.018, 0.031) and WHR*100 (0.058, 95%CI: 0.044, 0.072) were found among older adults in China. The PM_2.5-weight status relationship among older adults may be mediated through metabolic and inflammatory dysfunction pathways particularly HbA1c and C-reactive protein (CRP). As PM_2.5 deteriorates, the detrimental impacts tend to be more severe for rural-urban migrants and rural residents, compared to their urban counterparts. The worsening rural PM_2.5 profiles in some areas, such as the northern parts of the Central and the Eastern, may leave them particularly vulnerable to air pollution.ConclusionsPM_2.5 has an independent and significant detrimental impact on weight status including BMI and WHR of older adults in China, especially among rural adults and rural-urban migrants. PM_2.5 may affect weight status of older adults through biomarkers such as HbA1c and CRP. More research is needed to confirm our findings.     

Safety,reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized,double-blind,placebo-controlled COVID-19 vaccine trial in Japan

BackgroundThis study evaluated safety, reactogenicity, and immunogenicity of a 2-month homologous booster regimen of Ad26.COV2.S in Japanese adults.MethodsIn this multicenter, placebo-controlled, Phase 1 trial, adults (Cohort 1, aged 20–55 years, N = 125; Cohort 2, aged ≥ 65 years, N = 125) were randomized 2:2:1 to receive Ad26.COV2.S 5 × 10¹⁰ viral particles (vp), Ad26.COV2.S 1 × 10¹¹ vp, or placebo, followed by a homologous booster 56 days later. Safety, reactogenicity, and immunogenicity were assessed.ResultsTwo hundred participants received Ad26.COV2.S and 50 received placebo. The most frequent solicited local adverse event (AE) was vaccination-site pain, and the most frequent solicited systemic AEs were fatigue, myalgia, and headache. After primary vaccination, neutralizing and binding antibody levels increased through Day 57 (post-prime) in both cohorts. Fourteen days after boosting (Day 71), neutralizing antibody geometric mean titers (GMTs) had almost reached their peak value in Cohort 1 (5 × 10¹⁰ vp: GMT = 1049; 1 × 10¹¹ vp: GMT = 1470) and peaked in Cohort 2 (504; 651); at Day 85, GMTs had declined minimally in Cohort 2. For both cohorts, binding antibody levels peaked at Day 71 with minimal decline at Day 85.ConclusionA single dose and homologous Ad26.COV2.S booster increased antibody responses with an acceptable safety profile in Japanese adults (ClinicalTrials.gov Identifier: NCT04509947).     

Perceived impacts of COVID-19 on wellbeing among US working-age adults with ADL difficulty

BackgroundThe COVID-19 pandemic has disproportionately impacted people with disabilities. Working-age adults with ADL difficulty may face unique challenges and heightened health risks because of the pandemic. It is critical to better understand the impacts of COVID-19 on social, financial, physical, and mental wellbeing among people with disabilities to inform more inclusive pandemic response policies.ObjectiveThis study compares perceived COVID-19 physical and mental health, social, and financial impacts for US working-age adults with and without ADL difficulty.MethodsWe analyzed data from a national survey of US working-age adults (aged 18–64) conducted in February and March 2021 (N = 3697). We used logistic regression to compare perceived COVID-19-related impacts on physical and mental health, healthcare access, social relationships, and financial wellbeing among those with and without ADL difficulty.ResultsAdults with ADL difficulty were more likely to report negative COVID-19 impacts for many but not all outcomes. Net of covariates, adults with ADL difficulty had significantly greater odds of reporting COVID-19 infection (OR = 2.1) and hospitalization (OR = 6.7), negative physical health impacts (OR = 2.0), and negative impacts on family relationships (OR = 1.6). However, they had significantly lower odds of losing a friend or family member to COVID-19 (OR = 0.7). There were no significant differences in perceived impacts on mental health, ability to see a doctor, relationships with friends, or financial wellbeing.ConclusionsWorking-age adults with ADL difficulty experienced disproportionate health and social harm due to the COVID-19 pandemic. To address these disparities, public health response efforts and social policies supporting pandemic recovery must include disability perspectives.     

Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials

BackgroundAd26.COV2.S is a well-tolerated and effective vaccine against COVID-19. We evaluated durability of anti-SARS-CoV-2 antibodies elicited by single-dose Ad26.COV2.S and the impact of boosting.MethodsIn randomized, double-blind, placebo-controlled, phase 1/2a and phase 2 trials, participants received single-dose Ad26.COV2.S (5 × 10¹⁰ viral particles [vp]) followed by booster doses of 5 × 10¹⁰ vp or 1.25 × 10¹⁰ vp. Neutralizing antibody levels were determined by a virus neutralization assay (VNA) approximately 8–9 months after dose 1. Binding and neutralizing antibody levels were evaluated by an enzyme-linked immunosorbent assay and pseudotyped VNA 6 months after dose 1 and 7 and 28 days after boosting.ResultsData were analyzed from phase 1/2a participants enrolled from 22 July–18 December 2020 (Cohort 1a, 18–55 years [y], N = 25; Cohort 2a, 18–55y, N = 17; Cohort 3, ≥65y, N = 22), and phase 2 participants from 14 to 22 September 2020 (18–55y and ≥ 65y, N = 73). Single-dose Ad26.COV2.S elicited stable neutralizing antibodies for at least 8–9 months and stable binding antibodies for at least 6 months, irrespective of age. A 5 × 10¹⁰ vp 2-month booster dose increased binding antibodies by 4.9- to 6.2-fold 14 days post-boost versus 28 days after initial immunization. A 6-month booster elicited a steep and robust 9-fold increase in binding antibody levels 7 days post-boost. A 5.0-fold increase in neutralizing antibodies was observed by 28 days post-boost for the Beta variant. A 1.25 × 10¹⁰ vp 6-month booster elicited a 3.6-fold increase in binding antibody levels at 7 days post-boost versus pre-boost, with a similar magnitude of post-boost responses in both age groups.ConclusionsSingle-dose Ad26.COV2.S elicited durable antibody responses for at least 8 months and elicited immune memory. Booster-elicited binding and neutralizing antibody responses were rapid and robust, even with a quarter vaccine dose, and stronger with a longer interval since primary vaccination.Trial Registration: ClinicalTrials.gov Identifier: NCT04436276, NCT04535453.     

Immunogenicity and safety of a single booster dose of NVX-CoV2373 (TAK-019) in healthy Japanese adults who had previously received a primary series of COVID-19 mRNA vaccine: Primary analysis report of a phase 3 open-label trial

BackgroundWe evaluated the immunogenicity and safety of a booster dose of NVX-CoV2373 in Japanese adults who had completed a primary series of COVID-19 mRNA vaccine 6–12 months previously.MethodsThis single-arm, open-label, phase 3 study, conducted at two Japanese centres, enrolled healthy adults ≥ 20 years old. Participants received a booster dose of NVX-CoV2373. The primary immunogenicity endpoint was non-inferiority (lower limit of the 95 % confidence interval [CI] ≥ 0.67) of the geometric mean titre (GMT) ratio of titres of serum neutralizing antibodies (nAbs) against the SARS-CoV-2 ancestral strain 14 days after booster vaccination (day 15) in this study, compared with those 14 days after the second primary NVX-CoV2373 vaccination (day 36) in the TAK-019-1501 study (NCT04712110). Primary safety endpoints included local and systemic solicited adverse events (AEs) up to day 7 and unsolicited AEs up to day 28.ResultsBetween 15 April 2022 and 10 May 2022, 155 participants were screened and 150, stratified by age (20–64 years old [n = 135] or ≥ 65 years old [n = 15]), received an NVX-CoV2373 booster dose. The GMT ratio between titres of serum nAbs against the SARS-CoV-2 ancestral strain on day 15 in this study and those on day 36 in the TAK-019-1501 study was 1.18 (95 % CI, 0.95–1.47), meeting the non-inferiority criterion. Following vaccination, the proportion of participants who reported local and systemic solicited AEs up to day 7 was 74.0 % and 48.0 %, respectively. The most common local and systemic solicited AEs were tenderness (102 participants [68.0 %]) and malaise (39 participants [26.0 %]), respectively. Seven participants (4.7 %) reported unsolicited AEs between vaccination and day 28; all were severity grade ≤ 2.DiscussionA single heterologous NVX-CoV2373 booster induced rapid and robust anti-SARS-CoV-2 immune responses, addressing waning immunity in healthy Japanese adults, and had an acceptable safety profile.ClinicalTrials.gov identifier: NCT05299359.     

Long-term immunogenicity and safety of the hepatitis B vaccine HepB-CpG (HEPLISAV-B) compared with HepB-Eng (Engerix-B) in adults with chronic kidney disease

BackgroundHepatitis B virus (HBV) infection remains a significant global burden, especially for patients with chronic kidney disease (CKD) receiving hemodialysis. Three doses of HepB–CpG (HEPLISAV-B® vaccine) induced a superior immune response compared with 4 double doses of HepB–Eng (Engerix-B®) in a phase 3 trial (HBV-17) in adults with CKD. Here we report the long-term immunogenicity and safety of HepB-CpG and HepB–Eng in eligible participants of HBV-17 who enrolled in this optional 34-month follow-up trial (HBV-19).MethodsHBV-19 is a multicenter, open-label, phase 3b trial of adults with CKD who previously received a complete series of HepB-CpG or HepB-Eng in the HBV-17 trial. Participants were assigned to seroprotection categories at enrollment on the basis of their antibody response to hepatitis B surface antigen (anti-HBs) in HBV-17. The objective was to evaluate the durability of seroprotection (defined as an anti-HBs concentration ≥ 10 mIU/mL) induced by HepB-CpG and HepB-Eng. Participants whose anti-HBs concentration was below 10 mIU/mL received additional HepB-CpG or HepB-Eng doses.Results147 participants were enrolled; 66.7 % were men, median age was 65.0 years, and 83.7 % were white. The durability of seroprotection in participants with CKD was similar in those who received HepB-CpG and those who received HepB-Eng. Antibody concentrations ≥ 100 mIU/mL persisted for longer in HepB-CpG than HepB-Eng recipients, among those with anti-HBs ≥ 100 mIU/mL post vaccination. The geometric mean anti-HBs concentration in the HepB-CpG group was significantly higher than in the HepB-Eng group over time (P ≤ 0.0001). The safety profiles were similar between the vaccine groups.ConclusionsDue to the higher antibody levels induced by HepB-CpG in participants with CKD, seroprotection against HBV may be expected to persist longer than that induced by HepB-Eng. ClinicalTrials.gov: NCT01282762.     

Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia

BackgroundFour-component meningococcal B (4CMenB) vaccine is licensed in many countries but has had limited use in adolescents despite this age group being at increased risk of meningococcal disease.ObjectivesTo assess the safety profile of two doses of 4CMenB in adolescents.MethodsCluster randomised controlled trial of senior school students in South Australia (SA) with participating schools randomised to intervention (4CMenB) or control. Vaccine safety was monitored using the South Australian Vaccine Safety Surveillance System (SAVSS), a spontaneous reporting system for adverse events following immunisation (AEFI) with enhanced follow-up of AEFI.Results58,637 doses of 4CMenB vaccine were administered to 30,522 students (median age 16 years) during 2017–2018. Of 18,348 and 12,174 students vaccinated in 2017 and 2018, 97.3% and 84.3%, respectively, received both scheduled doses (N = 28,115). 193 AEFI in 187 students were reported with a reporting rate of 0.32% (95%CI: 0.28–0.39%). Seventy individuals sought medical review, including nine serious adverse events. 98% (166/169) of those who were contactable for AEFI follow-up (87.6% 169/193) reported resolution of the event. Most common AEFI were injection site reaction (126/193), headache (99/193) and nausea (61/193). AEFI were more frequently reported in females (aOR = 1.409 (95%CI: 1.002, 1.980)), schools with high level of educational advantage (adjusted Odds Ratio (aOR) = 1.515 (95%CI: 1.005, 2.284)), following first dose (aOR = 1.619 (95%CI: 1.168, 2.244)), and in 2017 (aOR = 1.437 (95%CI: 1.001, 2.064)). Reported AEFI declined with increasing age (aOR = 0.771 (95%CI: 0.673, 0.883)).ConclusionIn this largest post-licensure use of 4CMenB in adolescents, the low AEFI reporting rate provides real-world evidence of 4CMenB safety in this age group.(ClinicalTrials.gov number: NCT03089086).     

Residential mobility and chronic disease among World Trade Center Health Registry enrollees, 2004–2016

Residential mobility is hypothesized to impact health through changes to the built environment and disruptions in social networks, and may vary by neighborhood deprivation exposure. However, there are few longitudinal investigations of residential mobility in relation to health outcomes. This study examined enrollees from the World Trade Center Health Registry, a longitudinal cohort of first responders and community members in lower Manhattan on September 11, 2001. Enrollees who completed ≥2 health surveys between 2004 and 2016 and did not have diabetes (N = 44,089) or hypertension (N = 35,065) at baseline (i.e., 2004) were included. Using geocoded annual home addresses, residential mobility was examined using two indicators: moving frequency and displacement. Moving frequency was defined as the number of times someone was recorded as living in a different neighborhood; displacement as any moving to a more disadvantaged neighborhood. We fit adjusted Cox proportional hazards models with time-dependent exposures (moving frequency and displacement) and covariates to evaluate associations with incident diabetes and hypertension. From 2004 to 2016, the majority of enrollees never moved (54.5%); 6.5% moved ≥3 times. Those who moved ≥3 times had a similar hazard of diabetes (hazard ratio (HR) = 0.78; 95% Confidence Interval (CI): 0.40, 1.53) and hypertension (HR = 0.99; 95% CI: 0.68, 1.43) compared with those who never moved. Similarly, displacement was not associated with diabetes or hypertension. Residential mobility was not associated with diabetes or hypertension among a cohort of primarily urban-dwelling adults.     

Duration of influenza vaccine effectiveness in the elderly in Japan: A retrospective cohort study using large-scale population-based registry data

BackgroundThe immune response to influenza vaccination in the elderly is likely to be lower than that in young adults. Clinical protection may not persist year-round in the elderly. However, the effectiveness of influenza vaccine in the elderly has not been adequately studied, especially in terms of the duration of effectiveness.MethodsWe used a linked database of healthcare administrative claims data and vaccination records maintained by the municipality of a city in Kanto region of Japan. We studied individuals who were aged 65 years or older at baseline and were followed up between April 1, 2014 to March 31, 2020. The duration of influenza vaccine effectiveness by age category was analyzed using a time-dependent piecewise Cox proportional hazard model with time-dependent vaccine status, prior season vaccination and covariates confirmed in the baseline period (age, sex, cancer, diabetes, chronic obstructive pulmonary diseases, asthma, chronic kidney diseases, and cardiovascular diseases).ResultsWe identified an analysis population of 83,146 individuals, of which 7,401 (8.9%) had experienced influenza and 270 (0.32%) underwent influenza-related hospitalization. Individuals who were vaccinated during the first season (n = 47,338) were older than non-vaccinated individuals (n = 35,808) (average age, 75.8 vs. 74.1 years, respectively). The multivariable analysis showed a lower incidence of influenza in vaccinated individuals (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.43–0.51; P < 0.001), while the incidence of hospitalization for influenza did not differ significantly by vaccination status (HR, 0.79; 95% CI, 0.53–1.18; P = 0.249). Protective effectiveness against incidence was maintained for 4 or 5 months after vaccination in those aged 65–69 and 80-years, 5 months in 70–79 years.ConclusionsOur study identified moderate vaccine effectiveness in preventing the incidence of influenza in the Japanese elderly. Vaccine effectiveness showed a trend of gradual attenuation. Clinicians should suspect influenza infection even in those vaccinated, especially in elderly individuals who had received vaccination more than 4 or 5 months previously.     

Post-COVID conditions and healthcare utilization among adults with and without disabilities—2021 Porter Novelli FallStyles survey

BackgroundAdults with disabilities are at increased risk for SARS-CoV-2 infection and severe disease; whether adults with disabilities are at an increased risk for ongoing symptoms after acute SARS-CoV-2 infection is unknown.ObjectivesTo estimate the frequency and duration of long-term symptoms (>4 weeks) and health care utilization among adults with and without disabilities who self-report positive or negative SARS-CoV-2 test results.MethodsData from a nationwide survey of 4510 U.S. adults administered from September 24, 2021–October 7, 2021, were analyzed for 3251 (79%) participants who self-reported disability status, symptom(s), and SARS-CoV-2 test results (a positive test or only negative tests). Multivariable models were used to estimate the odds of having ≥1 COVID-19–like symptom(s) lasting >4 weeks by test result and disability status, weighted and adjusted for socio-demographics.ResultsRespondents who tested positive for SARS-CoV-2 had higher odds of reporting ≥1 long-term symptom (with disability: aOR = 4.50 [95% CI: 2.37, 8.54] and without disability: aOR = 9.88 [95% CI: 7.13, 13.71]) compared to respondents testing negative. Among respondents who tested positive, those with disabilities were not significantly more likely to experience long-term symptoms compared to respondents without disabilities (aOR = 1.65 [95% CI: 0.78, 3.50]). Health care utilization for reported symptoms was higher among respondents with disabilities who tested positive (40%) than among respondents without disabilities who tested positive (18%).ConclusionsOngoing symptoms among adults with and without disabilities who also test positive for SARS-CoV-2 are common; however, the frequency of health care utilization for ongoing symptoms is two-fold among adults with disabilities.     

The low carriage prevalence of pneumococcus among community-dwelling older people: A cross-sectional study in Japan

BackgroundThe carriage prevalence of pneumococcus among community-dwelling older adults is not fully understood, especially in superaged societies. Our purpose was to elucidate the carriage prevalence of pneumococcus in the upper respiratory tract among Japanese community-dwelling adults aged ≥65 years.MethodsWe conducted a cross-sectional study of generally healthy community-dwelling adults aged ≥65 years in Nagasaki city, Japan. Demographic and clinical data and nasopharyngeal, oropharyngeal and saliva samples were collected from February 21st, 2018, to December 17th, 2018. The specimens were tested by culture and molecular methods.ResultsAmong a total of 504 enrolled participants, none were positive for pneumococcus by culture, and 22 were positive by PCR. The overall carriage prevalence was 4.4% (95% CI: 2.8–6.5%). The prevalence was highest in saliva samples, followed by oropharyngeal and nasopharyngeal samples. No demographic characteristics were associated with carriage prevalence, including age (4.7% among participants aged 65–74 years and 4.1% among those 75 years and older). Among the pneumococcal-positive participants, 18.2% were PCV13-covered serotypes.ConclusionsOur data suggest a low carriage prevalence of S. pneumoniae among community-dwelling older people in Japan.     

Associations of influenza and pneumococcal vaccinations with burdens of older family caregivers: The Japan Gerontological Evaluation study (JAGES) cross-sectional study

BackgroundInfluenza and pneumonia tend to be severe in older adults; thus, vaccination is necessary to prevent these illnesses. Vaccination is especially important for older family caregivers (OFCs) not only to prevent them from becoming ill, but also to prevent secondary infections in the family care receivers (FCRs), who are mostly frail older adults and have a higher risk of severe illness. Thus, we investigated whether caregiving burdens were associated with the vaccinations among older adults.MethodsWe used cross-sectional data from the Japan Gerontological Evaluation Study (JAGES), which was conducted in 64 Japanese municipalities from November 2019 to January 2020. The target population consisted of 26,177 individuals aged 65 years or older who were independent and did not need public long-term care. The primary outcome was the uptakes of either or both influenza and pneumococcal vaccinations. Multinomial logistic regressions were performed, setting those who underwent neither vaccinations as the reference group.ResultsAmong the participants, 23.3 %, 25.8 %, 9.4 %, or 41.5 % underwent neither, only influenza, only pneumococcal, or the both vaccinations, respectively. The caregiving frequency, time length in a day, or dementia of FCR were negatively associated with influenza vaccination (caregiving almost every day: relative risk ratio {RRR}: 0.39, 95 % confident interval {95 % CI} [0.24–0.63]; caregiving almost all day: 0.44, 95 % CI: 0.23–0.85; caregiving for FCR: RRR:0.55, 95 % CI: 0.34–0.91). On the other hand, those caregiving burdens were not associated with pneumococcal only or the both vaccinations. Having a family physician mitigated all the negative effect of the caregiving burdens on the vaccinations.ConclusionOur results suggest that the caregiving burden is a barrier to influenza vaccination but not to pneumococcal vaccination and that having a physician mitigates the negative effect regardless of the burden kind.     

Motivational interviewing and vaccine acceptance in children: The MOTIVE study

Background and ObjectiveVaccine coverage have been less than desired in young children in part due to parental vaccine hesitancy. Addressing health beliefs through patient-centered communication approaches such as motivational interviewing (MI) may improve vaccine confidence. Thus, the objective of this study was to determine the difference in paediatric vaccination coverage rates based on the Advisory Committee on Immunization Practices (ACIP) and Centers for Disease Control and Prevention (CDC) recommended schedule in children 0–6 years of age after an educational intervention for providers and integration of an MI-based communication tool, MOTIVE (MOtivational Interviewing Tool to Improve Vaccine AcceptancE).MethodsPaediatric and family practice providers in a federally qualified health center in the United States completed an educational intervention regarding vaccine hesitancy and use of the MOTIVE tool. Providers then implemented the MOTIVE tool to address common health beliefs using strong, presumptive vaccine recommendations and an MI framework during encounters with patients 0–6 years of age. Data were collected from 1-year pre-educational intervention (July 2018-June 2019, N = 2504) and post-intervention (July 2019-March 2020, N = 1954) to examine differences in vaccination coverage rates and documented vaccine refusals.ResultsUse of the MOTIVE tool was associated with a statistically significant increase in IIV vaccination coverage rate in children 6 months to 6 years of age (32.4% versus 43.9%, p < 0.01). A significantly increased Hib vaccination coverage rate was observed in children 0–18 months of age. Patients with commercial insurance also had significantly higher vaccination coverage rates for the DTaP, IPV, and VAR vaccines during the intervention period. Use of the MOTIVE tool was associated with a decrease in documented vaccine refusals per 100 patients in children 0–6 years of age (31.5 versus 17.6, p < 0.01).ConclusionUse of an MI-based communication tool may decrease vaccine refusals and improve childhood vaccination coverage rates, particularly for IIV.Clinical Trial Registration: ClinicalTrials.gov, NCT03934008, https://clinicaltrials.gov/ct2/show/NCT03934008, deidentified individual participant data will not be made available.     

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.     

Epidemiology of community-acquired pneumonia in the era of extended serotype-covering multivalent pneumococcal conjugate vaccines

BackgroundSouth Korea has been providing 10-valent pneumococcal conjugate vaccine/(PCV10)/13-valent pneumococcal conjugate vaccine (PCV13) to children and 23-valent pneumococcal polysaccharide vaccine (PPSV23) to older adults as part of a national immunization program.MethodsFrom September 2015 to August 2017, a prospective cohort study was conducted for adults aged ≥19 years with community-acquired pneumonia (CAP) at four university hospitals. All-cause and pneumococcal CAP incidence and mortality rates were evaluated on the basis of hospital catchment population. Serotype distribution of pneumococcal CAP was also evaluated.ResultsAmong 2669 patients with CAP, 252 cases (9.4%) were pneumococcal CAP cases. The annual incidences of all-cause and pneumococcal CAP were 194.3 cases and 18.3 cases respectively, per 100,000 persons. Serotyped Streptococcus pneumoniae was identified in 107 cases (42.5%) through culture or a serotype-specific urinary antigen detection assay. Pneumococcal CAP caused by the PCV13 and PPSV23 serotypes were 50 cases (46.7% of serotyped pneumococcal CAP and 19.8% of pneumococcal CAP), and 83 cases (77.6% of serotyped pneumococcal CAP and 32.9% of pneumococcal CAP), respectively. The most prevalent serotype was 3 (n = 21, 19.6% of serotyped pneumococcal CAP), followed by 19A (n = 10, 9.3% of serotyped pneumococcal CAP) and 11A (n = 10, 9.3% of serotyped pneumococcal CAP). Compared with non-pneumococcal CAP patients, pneumococcal CAP patients were more likely to have a higher CURB-65 scores (P = 0.002). The overall 30-day mortality rate of pneumococcal CAP was higher than that of non-pneumococcal CAP (6.3% versus 5.6%; odds ratio [OR], 1.15; 95% confidence interval [CI], 0.67–1.96), but this trend was reversed in patients aged 65–74 years (4.2% versus 8.6%; OR, 0.47; 95% CI, 0.14–1.54).ConclusionsThe disease burden of PCV13-serotype pneumococcal CAP remains significantly high in Korean adults, particularly among elderly people, even after a high uptake of pediatric PCVs.     

Association between health insurance coverage and uptake of seasonal influenza vaccine in Brazos County,Texas

BackgroundLack of health insurance may limit access to influenza vaccination, resulting in higher risk of infection.MethodsThe Brazos County Health Department obtained medical records summarizing vaccination and health insurance status of all influenza cases occurring in December 2017 (n = 417). The odds of influenza vaccination were estimated for those with public or private health insurance as compared to uninsured individuals using multivariate logistic regression analysis adjusted for age and race.ResultsHealth insurance coverage among Brazos County residents with influenza was 62.4%. Public and private health insurance was associated with higher odds of influenza vaccination compared to no insurance (aOR: 2.05; 95% CI: 1.00–4.21 and aOR: 1.77; 95% CI: 1.07–2.92, respectively), particularly among adults 18–64 years of age.ConclusionsInfluenza vaccination is strongly associated with health insurance. Expansion of programs that facilitate access to health services or provide free influenza vaccines may improve influenza prevention among the uninsured.     

Willingness to vaccinate children against COVID-19 declined during the pandemic

ObjectivesTo document the level of vaccine hesitancy in caregivers’ of children younger than 12 years of age over the course of the pandemic in Pediatric Emergency Departments (ED).Study designOngoing multicenter, cross-sectional survey of caregivers presenting to 19 pediatric EDs in the USA, Canada, Israel, and Switzerland during first months of the pandemic (phase1), when vaccines were approved for adults (phase2) and most recently when vaccines were approved for children (phase3).ResultsWillingness to vaccinate rate declined over the study period (59.7%, 56.1% and 52.1% in the three phases). Caregivers who are fully vaccinated, who have higher education, and those worried their child had COVID-19 upon arrival to the ED, were more likely to plan to vaccinate in all three phases. Mothers were less likely to vaccinate early in the pandemic, but this hesitancy attenuated in later phases. Older caregivers were more willing to vaccinate, and caregivers of older children were less likely to vaccinate their children in phase 3. During the last phase, willingness to vaccinate was lowest in those who had a primary care provider but did not rely on their advice for medical decisions (34%). Those with no primary care provider and those who do and rely on their medical advice, had similar rates of willingness to vaccinate (55.1% and 52.1%, respectively).ConclusionsCOVID-19 vaccine hesitancy is widespread and growing over time, and public health measures should further try to leverage identified factors associated with hesitancy in order to enhance vaccination rates among children.     

Serologic response to sequential vaccination with enhanced influenza vaccines: Open label randomized trial among adults aged 65–74 years

BackgroundThe effects of sequential vaccination with enhanced influenza vaccines are poorly understood. We conducted an exploratory open-label study to assess serologic response to sequential vaccination in older adults.Methods160 adults aged 65 through 74 years were randomized (1:1:1) to receive trivalent inactivated standard dose (SD), high-dose (HD), or MF59-adjuvanted (AD) vaccine in 2016/17. In 2017/18, HD and AD recipients received the same vaccine; SD recipients were re-randomized to HD or AD. Hemagglutination inhibition assays were performed using turkey erythrocytes against A/California/7/2009(H1N1)-like and B/Brisbane/60/2008(B/Victoria)-like in both seasons, and A/Michigan/45/2015(H1N1)-like in season 2. Microneutralization assays were performed against cell-propagated A/Hong Kong/4801/2014(H3N2)-like using MDCK-SIAT1 cells. Postvaccination geometric mean titer (GMT), percent with titer ≥ 40, and mean fold rise (MFR, ratio of postvaccination versus prevaccination titer) in season 2 were compared across groups, and ratio of MFR in season 2 versus season 1 was assessed for each strain.ResultsAnalysis included 152 participants (55 HD → HD, 58 AD → AD, 19 SD → HD, and 20 SD → AD). Season 2 postvaccination GMTs and percent with titer ≥ 40 did not differ between HD → HD and AD → AD recipients for vaccine strains examined. However, a higher percent of HD → HD and AD → AD recipients had postvaccination titer ≥ 40 than SD → AD recipients for A/H1N1 (86%-89% versus 60%) and SD → AD and SD → HD recipients for A/H3N2 (83%-87% versus 40%-53%). GMTs were higher in AD → AD versus SD → AD recipients for A/H1N1 (p = .01) and A/H3N2 (p = .002). MFRs in season 2 were low in all groups for A/H3N2 (1.5–2.2) and B/Victoria (1.7–2.3). MFR was lower in season 2 versus 1 for HD → HD and AD → AD recipients for all vaccine strains (1.6–3.7 versus 2.6–6.2).ConclusionsSequential vaccination with enhanced vaccines did not reduce immunogenicity in adults aged 65 through 74 years. Serologic response to cell-propagated A/H3N2 was suboptimal for all vaccines.ClinicalTrials.gov identifier. NCT02872311