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2.
researchsquare; 2023.
Preprint in English | PREPRINT-RESEARCHSQUARE | ID: ppzbmed-10.21203.rs.3.rs-3054644.v1

ABSTRACT

Background:  Germ Defence (www.germdefence.org) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19 the intervention needed to be implemented at scale rapidly. Methods: With the approval of NHS England, we implemented an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via GP practices across England, UK, compared with usual care. GP practices randomised to the intervention arm (n=3292) were emailed and asked to disseminate the Germ Defence intervention to all adult patients via mobile phone text, email or social media. GP practices randomised to the usual care arm (n=3287) maintained standard management for the 4-month trial period after and then asked to share Germ Defence with their adult patients.  The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses, suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage, hospital admissions.  The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of intervention by GP practice, and by patients were measured via website analytics. Results: Germ Defence was used 310,731 times. The average satisfaction score after using the website was 7.52 (0-10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95%CI 0.96, 1.06, p=0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0- 48% of a practice list. Practices with high levels of intervention uptake (>11%) had a lower proportion of minority ethnic groups. Conclusions:  We demonstrated that rapid large-scale implementation of a digital behavioural intervention can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment. Trial registration: This trial was registered in the ISRCTN registry (14602359) on 12 August 2020.


Subject(s)
COVID-19 , Respiratory Tract Infections , Gastrointestinal Diseases
3.
Journal of Cystic Fibrosis ; 21(Supplement 2):S55-S56, 2022.
Article in English | EMBASE | ID: covidwho-2314477

ABSTRACT

Background: As a quality service improvement response since elexacaftor/ tezacaftor/ivacaftor (ELX/TEZ/IVA) became available and the yearly average number of cystic fibrosis (CF) pregnancies (n = 7 pre-2020, n = 33 in 2021) increased significantly at an adult CF center (~600 people with CF), a monthly multidisciplinary CF-maternal health virtual clinic was established with antenatal virtual CF exercise classes dedicated to providing adaptive, specialist support to this cohort, aswell as outreach guidance and education to local obstetric teams. Method(s): This was a single-center retrospective reviewof Royal Brompton Hospital CF-Maternal Health multidisciplinary team clinic records and a patient survey from March 2020 to March 2022. Result(s): Of 47 pregnancies in 41 women (median age 30;) eligible for ELX/ TEZ/IVA at start of pregnancy, 40% (n = 19) were unplanned, and 19% (n = 9) used assisted conception. Three women with a history of infertility conceived naturally, having required assisted conception for previous pregnancies, and five women had multiple pregnancies during the study period. ELX/TEZ/IVA was continued in 60% (n = 28), delayed in 28% (n = 13), and stopped in 13% (n = 6) of pregnancies through maternal choice and careful clinical counselling. Pre-pregnancy pulmonary status was poorer in women who continued than in those who delayed or stopped (Table 1). Of those who stopped, 85% (n = 5) restarted because of pulmonary deterioration by the third trimester. Prenatal CF complications included at least one episode of minor hemoptysis in 21% (n = 9/41) of women, at least one infective exacerbation in 55% of pregnancies (n = 26/47), and noninvasive ventilation in one woman. Other pregnancy-associated complications included one case of ovarian hyperstimulation syndrome, one case of sub-segmental pulmonary embolism, and two cases of pregnancy-induced hypertension. Excluding 10 first trimester terminations, 10 current pregnancies, and one patient relocation, obstetric outcomes available for 26 pregnancies confirmed a live birth rate of 85% (n = 22/26) and a 15% first-trimester miscarriage rate (n = 4). Obstetric complications included preterm delivery rate of 23% (n = 6/26), including two cases of COVID infection resulting in two neonatal intensive care unit admissions, one case of endometritis after cesarean section, and a fourthdegree perineal tear. There were no ectopic pregnancies, maternal or neonatal deaths, or reports of infant cataracts or congenital malformations. Median gestational age was 37/40 weeks (range 29-40). Mode of delivery was via cesarean section in 45% (n = 10/22, of which twowere emergency) and vaginal in 55% (n = 12/22), of which 83% (n = 10/12) were via induction of labor for diabetes (CF or gestational) indication. Deliveries were supported and occurred equally at local obstetric units and in tertiarycare obstetric hospital settings (50%, n = 11/22). Patient-experience survey responses cited high levels of confidence in health optimization and prioritization during pregnancy and praised excellent inter-health care provider communication and peer-to-peer emotional support provided among expectant mothers in the virtual prenatal exercise groups. Table 1. Baseline demographic and clinical characteristics of elexacaftor/tezacaftor/ivacaftoreligible expectant mothers according to therapeutic decision (Table Presented) Conclusion(s): In the absence of clinical trial safety data, the novel approach of a dedicated CF-maternal health multidisciplinary team clinic with local obstetric outreach support has ensured regular specialist clinical and emotional peer-to-peer support for this cohort of women eligible for ELX/ TEZ/IVA to ensure optimal outcomes and experiences of their pregnancies, where appropriate, close to home.Copyright © 2022, European Cystic Fibrosis Society. All rights reserved

4.
J Clin Psychopharmacol ; 43(3): 239-245, 2023.
Article in English | MEDLINE | ID: covidwho-2313996

ABSTRACT

PURPOSE/BACKGROUND: A recent article in this journal presented a US perspective regarding the modernization of clozapine prescription and proposed an escape from the long shadow cast by agranulocytosis. METHODS: Here, an international group of collaborators discusses a point of view complementary to the US view by focusing on worldwide outcomes of clozapine usage that may be uneven in terms of frequency of clozapine adverse drug reactions. FINDINGS/RESULTS: Studies from the Scandinavian national registries (Finland and Denmark) did not find increased mortality in clozapine patients or any clear evidence of the alleged toxicity of clozapine. Data on clozapine-associated fatal outcomes were obtained from 2 recently published pharmacovigilance studies and from the UK pharmacovigilance database. A pharmacovigilance study focused on physician reports to assess worldwide lethality of drugs from 2010 to 2019 found 968 clozapine-associated fatal outcomes in the United Kingdom. Moreover, the United Kingdom accounted for 55% (968 of 1761) of worldwide and 90% (968 of 1073) of European fatal clozapine-associated outcomes. In a pharmacovigilance study from the UK database (from 2008 to 2017), clozapine was associated with 383 fatal outcomes/year including all reports from physicians and nonphysicians. From 2018 to 2021, UK clozapine-associated fatal outcomes increased to 440/year. IMPLICATIONS/CONCLUSIONS: The interpretation of fatal outcomes in each country using pharmacovigilance databases is limited and only allows gross comparisons; even with those limitations, the UK data seem concerning. Pneumonia and myocarditis may be more important than agranulocytosis in explaining the uneven distribution of fatal outcomes in clozapine patients across countries.


Subject(s)
Agranulocytosis , Antipsychotic Agents , Clozapine , Humans , Clozapine/adverse effects , Antipsychotic Agents/adverse effects , Pharmacovigilance , Agranulocytosis/chemically induced , United Kingdom
5.
Circ Res ; 132(10): 1338-1357, 2023 05 12.
Article in English | MEDLINE | ID: covidwho-2312458

ABSTRACT

SARS-CoV-2 vaccine-associated myocarditis/myocardial injury should be evaluated in the contexts of COVID-19 infection, other types of viral myocarditis, and other vaccine-associated cardiac disorders. COVID-19 vaccine-associated myocardial injury can be caused by an inflammatory immune cell infiltrate, but other etiologies such as microvascular thrombosis are also possible. The clinical diagnosis is typically based on symptoms and cardiac magnetic resonance imaging. Endomyocardial biopsy is confirmatory for myocarditis, but may not show an inflammatory infiltrate because of rapid resolution or a non-inflammatory etiology. Myocarditis associated with SARS-COVID-19 vaccines occurs primarily with mRNA platform vaccines, which are also the most effective. In persons aged >16 or >12 years the myocarditis estimated crude incidences after the first 2 doses of BNT162b2 and mRNA-1273 are approximately 1.9 and 3.5 per 100 000 individuals, respectively. These rates equate to excess incidences above control populations of approximately 1.2 (BNT162b2) and 1.9 (mRNA-1273) per 100 000 persons, which are lower than the myocarditis rate for smallpox but higher than that for influenza vaccines. In the studies that have included mRNA vaccine and SARS-COVID-19 myocarditis measured by the same methodology, the incidence rate was increased by 3.5-fold over control in COVID-19 compared with 1.5-fold for BNT162b2 and 6.2-fold for mRNA-1273. However, mortality and major morbidity are less and recovery is faster with mRNA vaccine-associated myocarditis compared to COVID-19 infection. The reasons for this include vaccine-associated myocarditis having a higher incidence in young adults and adolescents, typically no involvement of other organs in vaccine-associated myocarditis, and based on comparisons to non-COVID viral myocarditis an inherently more benign clinical course.


Subject(s)
COVID-19 Vaccines , COVID-19 , Heart Injuries , Myocarditis , Adolescent , Humans , Young Adult , 2019-nCoV Vaccine mRNA-1273 , BNT162 Vaccine , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Heart Injuries/etiology , Myocarditis/epidemiology , Myocarditis/etiology , SARS-CoV-2 , Vaccination/adverse effects
6.
J Nurses Prof Dev ; 39(3): E27-E31, 2023.
Article in English | MEDLINE | ID: covidwho-2314761

ABSTRACT

This article will describe the creation and implementation of a remote learning failure to rescue (FTR) class with remote experiential simulation technology into a nurse residency program. The COVID-19 pandemic impacted traditional delivery methods for education within nurse residency programs. Following is the background of this hospital's nurse residency program and FTR curriculum and a description of the creation and implementation of a remote FTR class using internally developed remote experiential simulation technology.


Subject(s)
COVID-19 , Internship and Residency , Humans , Pandemics , Curriculum , Learning
7.
J ECT ; 2023 Apr 05.
Article in English | MEDLINE | ID: covidwho-2299181

ABSTRACT

OBJECTIVES: Electroconvulsive therapy (ECT) is an essential procedure for a range of psychiatric conditions. Multiple single-center studies have documented reduction in ECT administration in 2020 because of the coronavirus disease 2019 pandemic, but there have been little nationally representative data from the United States. The aim of this study was to examine the demographics of patients receiving ECT in 2019 and 2020 and to characterize temporal and regional variations in ECT utilization. METHODS: The 2019 and 2020 National Inpatient Sample, an administrative database of inpatient hospitalizations in the United States, was queried for hospitalizations involving the delivery of ECT based on procedural codes. Overall number of ECT procedures was calculated based on the overall number of ECT procedural claims. RESULTS: In the 2019 NIS, 14,230 inpatient hospitalizations (95% confidence interval, 12,936-15,524) involved the use of ECT, with a cumulative 52,450 inpatient ECT procedures administered. In 2020, the number of inpatient hospitalizations with ECT decreased to 12,055 (95% confidence interval, 10,878-13,232), with a 10.0% reduction in overall procedures to 47,180. Whereas January and February ECT hospitalizations were comparable in both years, ECT hospitalizations decreased by more than 25% in March through May 2020 relative to 2019 volume. There was regional variability in the change in ECT utilization between 2019 and 2020. CONCLUSIONS: Electroconvulsive therapy use among general hospital inpatients declined between 2019 and 2020, with regional variability in the magnitude of change. Further study is warranted into the root causes and optimal responses to these changes.

8.
Technol Soc ; 73: 102241, 2023 May.
Article in English | MEDLINE | ID: covidwho-2302521

ABSTRACT

Although several studies have explored the effects of the pandemic on aviation, little remains known about whether members of the public are willing to fly again after they have been vaccinated. The current study uses the Health Belief Model (HBM) to fill this missing gap by manipulating the following variables: 1) whether or not the participant is vaccinated; 2) whether or not airlines require that all passengers and crew receive vaccinations; 3) length of flight; 4) destination; and 5) the number of passengers. The data from 678 participants revealed that willingness to fly is much higher if the participants themselves have been vaccinated, if the airlines require all passengers to be vaccinated, if the flight is short, if the destination is domestic, and if the number of passengers is low. These findings did not appear to differ as a function of flying business versus pleasure. We discuss the practical implications of these data as airlines struggle to bring back their customer base.

10.
Nat Chem Biol ; 2022 Sep 29.
Article in English | MEDLINE | ID: covidwho-2274727

ABSTRACT

Prevention of infection and propagation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a high priority in the Coronavirus Disease 2019 (COVID-19) pandemic. Here we describe S-nitrosylation of multiple proteins involved in SARS-CoV-2 infection, including angiotensin-converting enzyme 2 (ACE2), the receptor for viral entry. This reaction prevents binding of ACE2 to the SARS-CoV-2 spike protein, thereby inhibiting viral entry, infectivity and cytotoxicity. Aminoadamantane compounds also inhibit coronavirus ion channels formed by envelope (E) protein. Accordingly, we developed dual-mechanism aminoadamantane nitrate compounds that inhibit viral entry and, thus, the spread of infection by S-nitrosylating ACE2 via targeted delivery of the drug after E protein channel blockade. These non-toxic compounds are active in vitro and in vivo in the Syrian hamster COVID-19 model and, thus, provide a novel avenue to pursue therapy.

12.
J Acad Consult Liaison Psychiatry ; 64(3): 199-208, 2023.
Article in English | MEDLINE | ID: covidwho-2239062

ABSTRACT

BACKGROUND: In 2010, the Academy of Consultation-Liaison (then Academy of Psychosomatic Medicine) surveyed US residency programs to understand training in consultation-liaison (CL) psychiatry, leading to recommendations in 2014. Since then, residency training in CL has evolved in the context of competing training demands, increased prioritization of electives, and reactions to coronavirus 2019. OBJECTIVE: To determine the current state of residency training in CL across the United States, including the structure of core and elective resident rotations in CL, attending physician staffing, presence of fellows and other trainees, didactic curriculum, and impact of coronavirus 2019. METHODS: Members of the Academy of Consultation-Liaison Residency Education Subcommittee designed and piloted an 81-question survey tool that was sent to program directors of 269 US general psychiatry training programs for voluntary completion. RESULTS: One hundred three of 269 programs responded to the survey, yielding a response rate of 38.3%. Responding programs were larger and more likely to have a CL fellowship than nonresponding programs. Of the 103 responding programs, 82.5% have more than the minimally required time on CL, with 46.6% reporting an increase in total CL time in the past decade. Since 2010, 18.4% of responding programs changed the placement of the CL rotation, with 43.7% now adherent to the 2014 Academy of Psychosomatic Medicine recommendation to include core CL training in the second half of residency. Thirty-five percent of responding programs require residents to rotate on more than 1 CL service, and 19.4% have a required outpatient CL component. Faculty full-time equivalent varies widely. Of all services included, 33.8% report that all CL faculty are board-certified in CL psychiatry, whereas 18.7% have no board-certified faculty. Of the 103 responding programs, 36.9% offer a CL fellowship, but 31.1% report no residency graduates pursuing CL fellowships in the past 5 years. Of the included programs, 77.7% have a formal CL curriculum for residents, with 34.0% reporting a separate didactic series during the CL rotation. CONCLUSIONS: Among the responding programs, the amount of time spent on core CL rotations has increased in the past decade, but programs have also shifted CL training earlier in the course of residency. Residency programs are increasingly challenged to provide an optimal CL experience, and updated guidance from Academy of Consultation-Liaison may be appreciated.


Subject(s)
Internship and Residency , Psychiatry , United States , Follow-Up Studies , Psychiatry/education , Curriculum , Referral and Consultation
13.
J Acad Consult Liaison Psychiatry ; 2022 Aug 08.
Article in English | MEDLINE | ID: covidwho-2239073

ABSTRACT

BACKGROUND: Delirium is common in the setting of infection with severe acute respiratory syndrome coronavirus 2. Anecdotal evidence and case reports suggest that patients with delirium in the setting of Coronavirus 2019 (COVID-19) may exhibit specific features, including increased tone, abulia, and alogia. OBJECTIVE: To determine whether differences exist in sociodemographic and medical characteristics, physical examination findings, and medication use in delirious patients with and without COVID-19 infection referred for psychiatric consultation. METHODS: We undertook an exploratory, retrospective chart review of 486 patients seen by the psychiatry consultation service at a tertiary care hospital from March 10 to May 15, 2020. Delirious patients were diagnosed via clinical examination by a psychiatric consultant, and these patients were stratified by COVID-19 infection status. The strata were described and compared using bivariate analyses across sociodemographic, historical, objective, and treatment-related variables. RESULTS: A total of 109 patients were diagnosed with delirium during the study period. Thirty-six were COVID-19+. Median age was 63 years and did not differ between groups. COVID-19+ patients with delirium were more likely to present from nursing facilities (39% vs 11%; Fisher's exact test; P = 0.001) and have a history of schizophrenia (11% vs 0%; Fisher's exact test; P = 0.011). Myoclonus (28% vs 4%; P = 0.002), hypertonia (36% vs 10%; P = 0.003), withdrawal (36% vs 15%; P = 0.011), akinesia (19% vs 6%; P = 0.034), abulia (19% vs 3%; P = 0.004), and alogia (25% vs 8%; P = 0.012) were more common in COVID-19+ patients. COVID-19+ delirious patients were significantly more likely to have received ketamine (28% vs 7%; P = 0.006), alpha-adrenergic agents besides dexmedetomidine (36% vs 14%; P = 0.014), and enteral antipsychotics (92% vs 66%; P = 0.007) at some point. CONCLUSIONS: Patients with COVID-19 delirium referred for psychiatric consultation are more likely to reside in nursing facilities and have a history of schizophrenia than delirious patients without COVID-19. Patients with delirium in the setting of COVID-19 may exhibit features consistent with akinetic mutism. Psychiatrists must assess for such features, as they may influence management choices and the risk of side effects with agents commonly used in the setting of delirium.

14.
J Acad Consult Liaison Psychiatry ; 64(3): 209-217, 2023.
Article in English | MEDLINE | ID: covidwho-2232754

ABSTRACT

BACKGROUND: COVID-19 is associated with a range of neuropsychiatric manifestations. While case reports and case series have reported catatonia in the setting of COVID-19 infection, its rate has been poorly characterized. OBJECTIVE: This study reports the co-occurrence of catatonia and COVID-19 diagnoses among acute care hospital discharges in the United States in 2020. METHODS: The National Inpatient Sample, an all-payors database of acute care hospital discharges, was queried for patients of any age discharged with a diagnosis of catatonia and COVID-19 in 2020. RESULTS: Among 32,355,827 hospitalizations in the 2020 National Inpatient Sample, an estimated 15,965 (95% confidence interval: 14,992-16,938) involved a diagnosis of catatonia without COVID-19 infection, 1,678,385 (95% confidence interval: 1,644,738-1,712,022) involved a diagnosis of COVID-19 without a co-occurring catatonia diagnosis, and 610 (95% confidence interval: 578-642) involved both catatonia and COVID-19 infection. In an adjusted model, a diagnosis of COVID-19, but not a diagnosis of catatonia or the combination of catatonia and COVID-19, was associated with increased mortality. Patients with catatonia and COVID-19 were frequently diagnosed with encephalopathy and delirium codes. CONCLUSIONS: Catatonia and COVID-19 were rarely co-diagnosed in 2020, and catatonia diagnosis was not associated with increased mortality in patients with COVID-19. Further research is needed to better characterize the phenomenology of catatonia in the setting of COVID-19 infection and its optimal treatment.


Subject(s)
Brain Diseases , COVID-19 , Catatonia , Humans , United States/epidemiology , Catatonia/diagnosis , Catatonia/epidemiology , Inpatients , COVID-19/complications , Hospitalization , Brain Diseases/complications
15.
Clin Infect Dis ; 2022 Jun 10.
Article in English | MEDLINE | ID: covidwho-2236904

ABSTRACT

We enrolled arriving international air travelers in SARS-CoV-2 genomic surveillance, using molecular testing of pooled nasal swabs, and sequencing positive samples for viral sublineage. Traveler-based genomic surveillance provided early warning variant detection; we reported the first U.S. Omicron BA.2 and first BA.3 in North America, weeks before next reported detection.

16.
Am J Surg ; 225(5): 934-936, 2023 05.
Article in English | MEDLINE | ID: covidwho-2220423

ABSTRACT

BACKGROUND: Modifications to practice during COVID pandemic impacted health maintenance and treatment of cancer patients. METHODS: We conducted a retrospective cohort study of all consecutive patients presenting to our institution with a new diagnosis of colorectal cancer pre-COVID (January 2017 to December 2019) and post-COVID (January to December 2020). RESULTS: The total number of patients with a new diagnosis of CRC was 2196. The pre-COVID period had 1891 patients whereas post-COVID period had 305. The median number of patients diagnosed with CRC per month was 50 and 35.5 pre and post-COVID, respectively. Time to treatment initiation was similar with no difference in stage at presentation for the pre and post-COVID periods. CONCLUSION: There was a significant decrease in colorectal cancer diagnosis number and rate (p < 0.01) during the COVID era with no difference in staging at diagnosis or time to treatment initiation.


Subject(s)
COVID-19 , Colorectal Neoplasms , Humans , Pandemics , Retrospective Studies , Cognition , Colorectal Neoplasms/therapy
17.
Genet Med ; 25(2): 100324, 2023 02.
Article in English | MEDLINE | ID: covidwho-2178938

ABSTRACT

PURPOSE: People with pre-existing conditions may be more susceptible to severe COVID-19 when infected by SARS-CoV-2. The relative risk and severity of SARS-CoV-2 infection in people with rare diseases such as neurofibromatosis type 1 (NF1), neurofibromatosis type 2 (NF2), or schwannomatosis (SWN) is unknown. METHODS: We investigated the proportions of people with NF1, NF2, or SWN in the National COVID Cohort Collaborative (N3C) electronic health record data set who had a positive test result for SARS-CoV-2 or COVID-19. RESULTS: The cohort sizes in N3C were 2501 (NF1), 665 (NF2), and 762 (SWN). We compared these with N3C cohorts of patients with other rare diseases (98-9844 individuals) and the general non-NF population of 5.6 million. The site- and age-adjusted proportion of people with NF1, NF2, or SWN who had a positive test result for SARS-CoV-2 or COVID-19 (collectively termed positive cases) was not significantly higher than in individuals without NF or other selected rare diseases. There were no severe outcomes reported in the NF2 or SWN cohorts. The proportion of patients experiencing severe outcomes was no greater for people with NF1 than in cohorts with other rare diseases or the general population. CONCLUSION: Having NF1, NF2, or SWN does not appear to increase the risk of being SARS-CoV-2 positive or of being a patient with COVID-19 or of developing severe complications from SARS-CoV-2.


Subject(s)
COVID-19 , Neurofibromatoses , Neurofibromatosis 1 , Neurofibromatosis 2 , Humans , Neurofibromatosis 2/complications , Neurofibromatosis 2/epidemiology , Neurofibromatosis 1/complications , Neurofibromatosis 1/epidemiology , Rare Diseases , COVID-19/complications , SARS-CoV-2 , Neurofibromatoses/complications , Neurofibromatoses/epidemiology
18.
Open Forum Infectious Diseases ; 9(Supplement 2):S775, 2022.
Article in English | EMBASE | ID: covidwho-2189964

ABSTRACT

Background. COVID-19 continues to cause substantial morbidity and mortality globally. It is likely that booster vaccinations will be needed in future years to protect older adults and those with chronic medical conditions. We present interim topline results of a phase 1/2 study of IVX-411 [ACTRN12621000738820.;ACTRN12621000882820], an investigational VLP protein subunit SARS-CoV-2 vaccine, in adults aged 18-69 years (Figure 1). Methods. In Part 1, 84 SARS-CoV-2-naive adults were randomized to receive two doses on Days 0 and 28 of either IVX-411 (5, 25, or 125mug) +/- adjuvant, or placebo (Figure 2a). In Part 2, 84 subjects received a single dose of either IVX-411 +/- adjuvant or placebo 3-6 months after completion of a primary licensed vaccine regimen (Figure 2b). Solicited adverse events (AEs) were collected for 7 days after each dose, with immunogenicity assessed on Days 0, 28, and 49 [(Part 1) and on Days 0, 7 and 28 (Part 2). Primary outcomes in both parts were solicited and unsolicited AEs, neutralizing antibody titers, and spike protein-specific IgG antibody titers. Results. Demographics were similar in the IVX-411 groups vs placebo. In Part 1 and Part 2, local reactogenicity was mild-to-moderate, with higher rates of AEs with increasing doses and addition of adjuvant (Figure 3a). Rates of systemic AEs were similar to placebo across groups (Figure 3b). No vaccine-related severe or serious AEs were noted. IVX-411 was immunogenic in both primary and booster vaccination: in SARS-CoV-2-naive subjects, a limited dose effect was seen, with significantly higher antibody titers in the groups receiving adjuvanted IVX-411 vaccine (p< 0.01;Figure 4a). The magnitude of antibody responses was similar to, or below, Human Convalescent Sera levels. In previously vaccinated subjects, IVX-411 boosted baseline antibody titers, with no conclusive dose or adjuvant effect (Figure 4b). Immunogenicity was observed across all variants of concern (beta, delta, and omicron) in both parts, with up to 7- fold rises from baseline (Figure 5). Conclusion. The study met all primary safety and immunogenicity objectives, with acceptable tolerability profiles in primary and booster vaccination. A clear adjuvant effect was observed in SARS-CoV-2-naive subjects.

20.
United European Gastroenterology Journal ; 10(Supplement 8):268, 2022.
Article in English | EMBASE | ID: covidwho-2115266

ABSTRACT

Introduction: The COVID-19 pandemic led to the suspension of all faceto- face teaching for gastroenterology trainees in the UK. From June 2020, we organised and delivered a weekly webinar, mapped to the UK higher speciality training (HST) gastroenterology curriculum, comprising a 40-minute lecture, delivered by an international multi-disciplinary faculty, followed by 10-20 minutes of moderated discussion via Microsoft Teams. Webinars were coordinated and moderated live by East Midlands Gastroenterology trainees and made available on demand for attendees to view in between commitments. Any professional in Gastroenterology, including trainees, consultants and allied health professionals, not limited to geographical location, was allowed to request access to the platform. Aims & Methods: We aimed to perform a multi-modal evaluation of the webinar series. First, we reviewed participants' demographics and weekly webinar attendance data. Second, we conducted a curriculum-mapping exercise of the programme to identify the breadth of topics covered. Third, we conducted two web-based feedback surveys in June 2021 and April 2022 to assess participants' satisfaction with the webinar series. Finally, since the webinar series has substituted face-to-face training for East Midlands trainees, we performed a projected calculation of CO2 emission saving based on the cessation of face-to-face teaching within the East Midlands region. Result(s): Between June 2020 and April 2022, a total of 84 webinars were delivered by 68 consultants, 13 senior trainees and two allied health care professionals. 47.6% of the speakers were from outside East Midlands. A total of 746 participants were registered on the online platform, of whom 85.6% were from the UK and 14.4% were from abroad. Live attendance data were available for 33 sessions (mean 55 +/- 13 attendees). The webinar series has, so far, covered over 80% of the UK HST gastroenterology curriculum. Fifty-nine participants and 20 participants completed the first and second feedback surveys, respectively. 98% of the first survey respondents felt that the webinars fulfilled their educational goals and 100% rated the programme's quality as good/very good. This positive feedback was sustained during the second survey with 100% reporting that the webinars fulfilled their educational goals and 90% rating the programme's quality as good/very good. 97% of the first survey respondents and 100% of the second survey respondents wanted the webinar series to continue, even when face-to-face teaching resumes. Using the East Midlands region as an example, we estimate a saving of >2.9 metric tons in CO2 emission/region, equivalent to the recycling of one ton of waste/year from the replacement of face-to-face with web-based teaching. Conclusion(s): We have demonstrated that the East Midlands Gastroenterology webinar series is a greener, highly valued, and sustainable trainee-led innovation, bringing together an international community of gastroenterology practitioners. A significant proportion of the UK HST curriculum can be delivered online. Future evaluations should aim to evaluate the scalability of such innovation across different programmes in different settings.

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