It is not yet clear to what extent SARS-CoV-2 infection rates in children reflect community transmission, nor whether infection rates differ between primary schoolchildren and young teenagers. A ...cross-sectional serosurvey compared the SARS-CoV2 attack-rate in a sample of 362 children recruited from September 21 to October 6, 2020, in primary (ages 6–12) or lower secondary school (ages 12–15) in a municipality with low community transmission (Pelt) to a municipality with high community transmission (Alken) in Belgium. Children were equally distributed over grades and regions. Blood samples were tested for the presence of antibodies to SARS-CoV-2 with an enzyme-linked immunosorbent assay. We found anti-SARS-CoV-2 antibodies in 4.4% of children in the low transmission region and in 14.4% of children in the high transmission region. None of the primary schoolchildren were seropositive in the low transmission region, whereas the seroprevalence among primary and secondary schoolchildren did not differ significantly in the high transmission region. None of the seropositive children suffered from severe disease. Children who were in contact with a confirmed case (RR 2.9; 95%CI 1.6–4.5), who participated in extracurricular activities (RR 5.6; 95%CI 1.2–25.3), or whose caregiver is a healthcare worker who had contact with COVID-19 patients (RR 2.2; 95%CI 1.0–4.6) were at higher risk of seropositivity. If SARS-CoV2 circulation in the community is high, this will be reflected in the pediatric population with similar infection rates in children aged 6–12 years and 12–15 years.
What is Known:
•Children are generally less affected by COVID-19 than adults but SARS-CoV2 infection rates among children are not well known.
•There were large regional differences in infection rates during the first wave of the SARS-CoV2 pandemic.
What is New:
•None of the primary schoolchildren (6–12 years) were seropositive for SARS-CoV2 in an area with a low community transmission, but infection rates were higher in adolescents (12–15 years).
•In an area with high community transmission, seroprevalence rates in younger children were more comparable to those in adolescents.
Abstract
Background
The aim of this study was to investigate safety and immunogenicity of vaccine formulations against respiratory syncytial virus (RSV) containing the stabilized prefusion ...conformation of RSV fusion protein (RSVPreF3).
Methods
This phase 1/2, randomized controlled, observer-blind study enrolled 48 young adults (YAs; aged 18–40 years) and 1005 older adults (OAs; aged 60–80 years) between January and August 2019. Participants were randomized into equally sized groups to receive 2 doses of unadjuvanted (YAs and OAs) or AS01-adjuvanted (OAs) vaccine or placebo 2 months apart. Vaccine safety and immunogenicity were assessed until 1 month (YAs) or 12 months (OAs) after second vaccination.
Results
The RSVPreF3 vaccines boosted humoral (RSVPreF3-specific immunoglobulin G IgG and RSV-A neutralizing antibody) responses, which increased in an antigen concentration-dependent manner and were highest after dose 1. Compared to prevaccination, the geometric mean frequencies of polyfunctional CD4+ T cells increased after each dose and were significantly higher in adjuvanted than unadjuvanted vaccinees. Postvaccination immune responses persisted until end of follow-up. Solicited adverse events were mostly mild to moderate and transient. Despite a higher observed reactogenicity of AS01-containing vaccines, no safety concerns were identified for any assessed formulation.
Conclusions
Based on safety and immunogenicity profiles, the AS01E-adjuvanted vaccine containing 120 μg of RSVPreF3 was selected for further clinical development.
Clinical Trials Registration
NCT03814590.
Vaccine formulations against respiratory syncytial virus (RSV) containing the stabilized prefusion conformation of RSV fusion protein (RSVPreF3) were well tolerated and immunogenic. Based on safety/immunogenicity profiles, the AS01E-adjuvanted vaccine containing 120 μg of RSVPreF3 was selected for further clinical development.
Seasonal influenza is an annually recurring threat to residents of long-term care facilities (LTCFs) since high age and chronic disease diminish immune response following vaccination. Although ...immunization of healthcare workers (HCWs) has proven to be an added value, coverage rates remain low. A ready-to-use instruction manual was designed to facilitate the implementation of interventions known to increase vaccination coverage in healthcare institutions. It includes easy-access vaccination, role model involvement, personalized promotional material, education and extensive communication. We evaluated this manual during the 2017-vaccination campaign in 11 LTCFs in Belgium. Vaccination coverage before and after the campaign was recorded by the LTCFs and the usefulness of the manual was assessed by interviewing the organizers of the local campaigns. Attitudes toward vaccination and reasons for vaccination were evaluated with a quantitative survey in HCWs before and after the campaign. The mean vaccination coverage reported by the LTCFs was 54% (range: 35-72%) in 2016 and 68% (range: 45-81%) in 2017. After the campaign, HCWs were less likely to expect side effects after influenza vaccination (OR (95%CI): 0.4 (0.2-0.9)) or to oppose vaccination (OR (95%CI): 0.3 (0.1-0.9)). The majority (>60%) indicated to be well informed about the risks of influenza and the efficacy of the vaccine. The main reason for vaccination in those who previously refused it was resident protection. The manual was found useful by the organizers of the campaigns. We conclude that the use of an intervention manual may support vaccination uptake and decrease perceived barriers toward influenza vaccination in countries without mandatory vaccination in HCWs.
Background. To date, there is no commercially available vaccine to prevent infectious mononucleosis, a disease frequently induced by Epstein-Barr virus (EBV) infection in adolescents or adults devoid ...of preexisting immunity to the virus. Methods. A total of 181 EBV-seronegative, healthy, young adult volunteers were randomized in a double-blind fashion to receive either placebo or a recombinant EBV subunit glycoprotein 350 (gp350)/aluminum hydroxide and 3-O-desacyl-4′-monophosphoryl lipid A (AS04) candidate vaccine in a 3-dose regimen. Results. The vaccine had demonstrable efficacy (mean efficacy rate, 78.0% 95% confidence interval {CI}, 1.0%–96.0%) in preventing the development of infectious mononucleosis induced by EBV infection, but it had no efficacy in preventing asymptomatic EBV infection. One month after receipt of the final dose of gp350 vaccine, 98.7% of subjects showed seroconversion to anti-gp350 antibodies (95% CI, 85.5%–97.9%), and they remained anti-gp350 antibody positive for >18 months. Furthermore, there were no concerns regarding the safety or reactogenicity of the gp350/AS04 vaccine. Conclusion. These data support the clinical feasibility of using an EBV vaccine to prevent infectious mononucleosis. Trial registration. ClinicalTrials.gov identifier: NCT00430534.
In Flanders, Belgium, pertussis vaccination is recommended since 2013 and available free-of-charge in every pregnancy between 24 and 32 weeks of gestation. Influenza vaccination is recommended for ...more than 10 years with a co-payment system in the second or third trimester of pregnancy, when pregnancy coincides with the influenza season. This study aims to estimate the coverage of pertussis and influenza vaccination during pregnancy in 2016 and to determine predictors for missing vaccination.
Postpartum women were visited at home for a vaccination coverage survey using an Expanded Program on Immunization (EPI)-based two-stage cluster sampling design. Predictors for missed vaccination were identified using a multiple logistic regression model.
Among 481 participating women, 69.3% were vaccinated against pertussis and 47.2% were vaccinated against influenza. Moreover, 65.3% of pertussis vaccine recipients and 96.9% of influenza vaccine recipients were vaccinated within the recommended gestational window.
Surprisingly, among women who were completely informed (i.e. on disease-associated risks, maternal vaccination costs and recommendations), still 12.4% were unvaccinated against pertussis and 23.9% against influenza.
In the final models, the only common predictor of missing maternal pertussis and influenza vaccination was multiparity. Significant predictors of maternal pertussis vaccination were family income (less likely if unknown or low (< €3000) than if moderate (€3001-€4000)) and hospital of delivery (less likely if >800 annual deliveries than <800). Significant predictors of maternal influenza vaccination, though with less straight-forward associations, were maternal ethnicity and educational level, involvement of a gynaecologist in pregnancy follow-up, and characteristics of the hospital of delivery.
In Flanders, more than two-third of pregnant women receives pertussis vaccination but less than half of them receives the influenza vaccine. Further improvement for both maternal vaccination programs can be achieved by targeting the underserved populations and diminishing vaccination hurdles.
Despite the increasing importance of teamwork in healthcare, medical education still puts great emphasis on individual achievements. The purpose of this study is to examine medical students' team ...role preferences, including the association with gender and specialty; and to provide implications for policy makers and medical educators.
We used an exploratory methodology, following a cross-sectional design. Data was collected from first year master students in medicine (n = 2293) during five consecutive years (2016-2020). The Belbin Team Role Self Perception Inventory (BTRSPI) was used to measure medical students' self-perceptions of their team role.
The Team Worker was the most preferred team role among medical students (35.8%), regardless of gender or specialty. Female and male students had similar team role patterns, although female students scored higher on Team Worker (40.4% vs. 29.1%, P < .001) and Completer-Finisher (14.0% vs. 8.0%, P < .001). With regard to specialties, the Team Worker role was more often chosen by general practitioners than by person-centered and technique-oriented specialties (47.1% vs. 41.8% vs. 29.1%, P < .001).
Our findings contribute to an increased scientific understanding of how medical students perceive their own team role, and how this is related to gender and specialty. This is valuable due to the increased importance of interdisciplinary teamwork in healthcare. Medical schools should prioritize stimulating teamwork skills through the implementation of different interventions at all stages (i.e. from the admission process to curricula to residency) and all levels (i.e. explicit and implicit curricula).
Calcitonin gene-related peptide (CGRP) is pivotal in the pathophysiology of migraine headaches and represents a promising target for migraine treatment. The humanized monoclonal antibody galcanezumab ...(LY2951742) binds to CGRP and may be effective in migraine prophylaxis.
The primary objective was to evaluate the safety and tolerability of single and multiple doses of galcanezumab in humans. Secondary objectives included assessing the pharmacokinetics and evaluating target engagement.
A double-blind, randomized, placebo-controlled study (NCT 01337596) with single escalating and multiple subcutaneous (SC) doses of galcanezumab was performed in healthy male volunteers. Single doses of 1, 5, 25, 75, 200, and 600 mg of galcanezumab (
= 7/dose) or placebo (
= 2/dose) were injected SC in six consecutive cohorts of nine subjects each. One cohort of nine subjects received multiple (4) 150 mg doses of galcanezumab or placebo every other week. Target engagement was evaluated by measuring inhibition of capsaicin-induced increase in dermal blood flow (DBF).
Sixty-three subjects were randomized and included in the safety analyses. Galcanezumab was well tolerated in single doses (1-600 mg SC) and consecutive doses (150 mg SC). There was no dose-dependent difference in type or frequency of treatment-emergent adverse events, and no clinically meaningful difference when compared with placebo. Pharmacokinetics were linear. Galcanezumab induced a robust, dose-dependent, and durable inhibition of capsaicin-induced increase in DBF, supporting the continued clinical development of galcanezumab for prophylaxis in migraine patients.
Upon exposure to vaccine-preventable diseases, certain individuals are at increased risk for complications due to preexisting diseases, age or immunosuppressive treatment. Vaccination against ...influenza, pneumococcal disease and hepatitis B (for some groups) is advised in addition to standard vaccination against diphtheria, tetanus and pertussis. We estimated the vaccination coverage and determinants of recommended vaccinations in patients with diabetes mellitus type 1 (n = 173) and type 2 (n = 177), chronic kidney disease (CKD) (n = 138), heart failure (n = 200), chronic obstructive pulmonary disease (COPD) (n = 187), HIV (n = 201) or solid organ transplantation (SOT) (n = 201) in a monocentric study. Vaccination data were retrieved from documents provided by patients and general practitioners, and from the Flemish vaccination register. Less than 10% had received all recommended vaccines. Overall, 29% of subjects were vaccinated against diphtheria-tetanus, 10% against pertussis, 44% against influenza, 32% against pneumococcal disease and 24% of HIV patients and 31% of CKD patients against hepatitis B. Age was positively associated with vaccination against influenza (OR:2.0, p < .01) and pneumococcal disease (OR:2.6, p < .001). Patients with COPD, HIV and SOT were more likely to be vaccinated against influenza (OR:2.8, p < .001, OR:1.8, p < .05; OR:2.0, p < .001, respectively) and pneumococcal disease (OR:2.9, p < .001, OR:25.0, p < .001; OR:2.6, p < .001, respectively) than patients with heart failure. Reason for non-vaccination were concerns about effectiveness, necessity and side effects of influenza vaccines, and not being aware of the recommendation for pneumococcal disease. Initiatives to monitor the vaccination status of vulnerable patients are needed, which is why we advocate systematic vaccination registration and frequent communication about vaccination.
In addition to more narrow criteria such as safety, effectiveness and cost-effectiveness, vaccines can also be evaluated based on broader criteria such as their economic impact, contribution to ...disease eradication objectives, caregiver aspects, financial protection offered, equity or social acceptability. We summarize a survey executed in a sample of the population (
= 1000) in Flanders, Belgium, in which we investigated support for using these broader criteria to evaluate vaccines for funding decisions. By means of both favourable and unfavourable framings of a hypothetical vaccine across 40 value dimensions, we find support for the view that people indeed consider a broad range of medical and socio-economic criteria relevant. Several of these are not incorporated in standard evaluation frameworks for vaccines. The different results we find for different framings highlight the importance of developing a consistent a priori value framework for vaccine evaluation, rather than evaluating vaccines on an ad hoc basis.
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