scholarly journals Immunogenicity of COVID-19 Vaccination in Immunocompromised Patients: An Observational, Prospective Cohort Study Interim Analysis

2021 ◽  
Author(s):  
Ghady Haidar ◽  
Mounzer Agha ◽  
Amy Lukanski ◽  
Kelsey Linstrum ◽  
Rachel Troyan ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Interim Analysis ◽  
Healthcare Workers ◽  
Hematological Malignancies ◽  
Solid Organ ◽  
Immunocompromised Patients ◽  
Observational Prospective Cohort Study ◽  
Antibody Levels

Objectives: Immunocompromised patients were excluded from COVID-19 vaccine clinical trials. The objectives of the study were to measure antibody responses, levels, and neutralization capability after COVID-19 vaccination among immunocompromised patients and compare these variables to those of immunocompetent healthcare workers. Methods This is an interim analysis of an ongoing observational, prospective cohort study which launched on April 14, 2021 across Western Pennsylvania. Participants were healthy healthcare workers (HCW) and immunocompromised patients who had completed their COVID-19 vaccination series. Individuals with a history of COVID-19 were not eligible. Serum was collected to measure for the presence of IgG against the SARS-CoV-2 Spike protein using a semi-quantitative assay; antibody levels were available for comparisons. A quasi-random subset of patients was selected for pseudovirus neutralization assays. Seropositivity with 95% Clopper-Pearson exact confidence intervals and distribution of antibody levels were measured. To identify risk factors for seronegativity, clinical characteristics were univariately compared between antibody reactive and non-reactive individuals within the immunocompromised group. Results: 107 HCW and 489 immunocompromised patients were enrolled. Compared to HCWs, seropositivity was significantly lower (p<.001) among immunocompromised patients with Solid organ transplant (SOT), autoimmune, hematological malignancies, and solid tumors (HCW=98.1%; SOT=37.2%; autoimmune=83.8%; hematological malignancies=54.7%; and solid tumor=82.4%, p < 0.05). Over 94% of patients with Human Immunodeficiency Virus were seropositive. Among seropositive patients, antibody levels were much lower among SOT (4.5 [2.1,13.1], p=.020). Neutralization titers tightly correlated with antibody levels (Spearman r = 0.91, p < 0.0001). Conclusion: Our findings demonstrate the heterogeneity of the humoral immune response to COVID-19 vaccines based on underlying immunosuppressive condition and highlight an urgent need to optimize and individualize COVID-19 prevention in these patients. These findings also have implications on public health guidance, particularly given revised Centers for Disease Control and Prevention recommendations permitting vaccinated individuals to abandon masking and social distancing in most settings. Future studies are warranted to determine assessment of cellular immunity, longitudinal measurement of immune responses, and the safety and efficacy of revaccination.

Risk stratification in men with a negative prostate biopsy: An interim analysis of a prospective cohort study

2021 ◽  
Author(s):  
Mads Sandahl ◽  
Bodil Ginnerup Pedersen ◽  
Benedicte Parm Ulhøi ◽  
Michael Borre ◽  
Karina Dalsgaard Sørensen
Keyword(s):  
Cohort Study ◽  
Risk Stratification ◽  
Prospective Cohort Study ◽  
Prostate Biopsy ◽  
Prospective Cohort ◽  
Interim Analysis ◽  
Negative Prostate Biopsy

scholarly journals Increased Mortality in Elderly Patients Admitted with Hyponatremia: A Prospective Cohort Study

2021 ◽  
Vol 10 (14) ◽  
pp. 3059
Author(s):  
Petros Ioannou ◽  
Symeon Panagiotakis ◽  
Emmanouela Tsagkaraki ◽  
Constantinos Tsioutis ◽  
Konstantinos Fragkiadakis ◽  
...  
Keyword(s):  
Cohort Study ◽  
Elderly Patients ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Total Mortality ◽  
University Hospital ◽  
Electrolyte Disorder ◽  
Admission Rates ◽  
Observational Prospective Cohort Study ◽  
Current Guidelines

Hyponatremia is the most common electrolyte disorder, commonly affecting older hospitalized individuals; however, the literature is not clear regarding its effect on mortality. The aim of this 2-year observational prospective cohort study was to evaluate the mortality and re-admission rates, the clinical and laboratory characteristics and the causes of hyponatremia in patients older than 65 years admitted with a corrected serum sodium of 130 mEq/L or less in an internal medicine ward of a tertiary Greek university hospital. During the observation period, 138 patients (mean age 80.5 years, 36.2% male) fulfilled the inclusion criteria and were prospectively followed for 1 year after admission. Symptoms of hyponatremia were present in 59.4% of patients. Hypovolemia was the main sole cause of hyponatremia, but in about one third of patients, hyponatremia was multifactorial. Only a low proportion of patients (12.3%) fulfilled the criteria of the syndrome of inappropriate antidiuresis (SIAD) at admission according to the current guidelines. The re-admission rates at 3- and 12-months following discharge was 34.2% and 51.8%, respectively. Mortality during hospitalization was 17.4% and was higher compared to non-hyponatremic admitted older patients, while the total mortality at 1 year after admission was 28.3%, indicating that hyponatremia at admission is a marker of significant mortality during and after hospitalization in elderly patients.

scholarly journals COVID-19 vaccine impact on rates of SARS-CoV-2 cases and post vaccination strain sequences among healthcare workers at an urban academic medical center: a prospective cohort study

2021 ◽  
Author(s):  
Tara C. Bouton ◽  
Sara Lodi ◽  
Jacquelyn Turcinovic ◽  
Sarah E. Weber ◽  
Emily Quinn ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Healthcare Workers ◽  
Positive Impact ◽  
Medical Center ◽  
Academic Medical Center ◽  
Post Vaccination ◽  
Unvaccinated Control ◽  
Rate Ratios

AbstractBackgroundCOVID-19 vaccine trials and post-implementation data suggest vaccination decreases SARS-CoV-2 infections. We examine COVID-19 vaccination’s impact on SARS-CoV-2 case rates and viral diversity among healthcare workers (HCW) during a high community prevalence period.MethodsA prospective cohort study from Boston Medical Center (BMC)’s HCW vaccination program, where staff received two doses of BNT162b2 or mRNA-1273. We included PCR-confirmed SARS-CoV-2 cases among HCWs from December 09, 2020 to February 23, 2021. Weekly SARS-CoV-2 rates per 100,000 person-day overall and by time from first injection (1-14 and >14 days) were compared with surrounding community rates. Viral genomes were sequenced from SARS CoV-2 positive samples.ResultsSARS-CoV-2 cases occurred in 1.4% (96/7109) of HCWs given at least a first dose and 0.3% (17/5913) of HCWs given both vaccine doses. Adjusted SARS-CoV-2 infection rate ratios were 0.73 (95% CI 0.53-1.00) 1-14 days and 0.18 (0.10-0.32) >14 days from first dose. HCW SARS-CoV-2 cases >14 days from initial dose compared to within 14 days were more often older (46 versus 38 years, p=0.007), Latinx (10% versus 8%, p=0.03), and asymptomatic (48% versus 11%, p=0.0002). SARS-CoV-2 rates among HCWs fell below those of the surrounding community, with a 18% versus 11% weekly decrease respectively (p=0.14). Comparison of 48 SARS-CoV-2 genomes sequenced from post-first dose cases did not indicate selection pressure towards known spike-antibody escape mutations.ConclusionsOur results indicate a positive impact of COVID-19 vaccines on SARS-CoV-2 case rates. Post-vaccination isolates did not show unusual genetic diversity or selection for mutations of concern.Main PointCases of SARS-CoV-2 among health care workers dropped rapidly with COVID-19 vaccination. Sequencing 48 breakthrough infections (overwhelmingly in 14 days after 1st dose) showed no clear sign of any differences in spike protein compared with time-matched, unvaccinated control sequences.

A(H1N1)v2009: A controlled observational prospective cohort study on vaccine safety in pregnancy

Vaccine ◽  
2012 ◽  
Vol 30 (30) ◽  
pp. 4445-4452 ◽  
Author(s):  
Marc Oppermann ◽  
Juliane Fritzsche ◽  
Corinna Weber-Schoendorfer ◽  
Brigitte Keller-Stanislawski ◽  
Arthur Allignol ◽  
...  
Keyword(s):  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Vaccine Safety ◽  
Observational Prospective Cohort Study ◽  
In Pregnancy

scholarly journals The MYRACLE protocol study: a multicentric observational prospective cohort study of patients with multiple myeloma

BMC Cancer ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Lina Benaniba ◽  
Benoit Tessoulin ◽  
Sabrina Trudel ◽  
Catherine Pellat-Deceunynck ◽  
Martine Amiot ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Observational Prospective Cohort Study ◽  
Protocol Study

scholarly journals Study protocol for resolution of organ injury in acute pancreatitis (RESORP): an observational prospective cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040200
Author(s):  
Ahmed E Sherif ◽  
Rory McFadyen ◽  
Julia Boyd ◽  
Chiara Ventre ◽  
Margaret Glenwright ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Diabetes Mellitus ◽  
Acute Pancreatitis ◽  
Cohort Study ◽  
Prospective Cohort Study ◽  
Prospective Cohort ◽  
Observational Prospective Cohort Study ◽  
New Onset

IntroductionSurvivors of acute pancreatitis (AP) have shorter overall survival and increased incidence of new-onset cardiovascular, respiratory, liver and renal disease, diabetes mellitus and cancer compared with the general population, but the mechanisms that explain this are yet to be elucidated. Our aim is to characterise the precise nature and extent of organ dysfunction following an episode of AP.Methods and analysisThis is an observational prospective cohort study in a single centre comprising a University hospital with an acute and emergency receiving unit and clinical research facility. Participants will be adult patient admitted with AP. Participants will undergo assessment at recruitment, 3 months and 3 years. At each time point, multiple biochemical and/or physiological assessments to measure cardiovascular, respiratory, liver, renal and cognitive function, diabetes mellitus and quality of life. Recruitment was from 30 November 2017 to 31 May 2020; last follow-up measurements is due on 31 May 2023. The primary outcome measure is the incidence of new-onset type 3c diabetes mellitus during follow-up. Secondary outcome measures include: quality of life analyses (SF-36, Gastrointestinal Quality of Life Index); montreal cognitive assessment; organ system physiological performance; multiomics predictors of AP severity, detection of premature cellular senescence. In a nested cohort within the main cohort, individuals may also consent to multiparameter MRI scan, echocardiography, pulmonary function testing, cardiopulmonary exercise testing and pulse-wave analysis.Ethics and disseminationThis study has received the following approvals: UK IRAS Number 178615; South-east Scotland Research Ethics Committee number 16/SS/0065. Results will be made available to AP survivors, caregivers, funders and other researchers. Publications will be open-access.Trial registration numbersClinicalTrials.gov Registry (NCT03342716) and ISRCTN50581876; Pre-results.

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