scholarly journals 489. SARS-CoV-2 Seroprevalence and Antibody Response Among Pregnant People in Seattle, WA

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S345-S345
Author(s):  
Sylvia LaCourse ◽  
Alisa Kachikis ◽  
Kelsey L Kinderknecht ◽  
Romeo R Galang ◽  
Lauren B Zapata ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Antibody Response ◽  
Antenatal Care ◽  
Medical Records ◽  
Rt Pcr ◽  
Research Support ◽  
Initial Testing ◽  
Igg Index ◽  
Research Grant

Abstract Background Antenatal care is a unique opportunity to assess SARS-CoV-2 seroprevalence and antibody response in pregnant people, including those with previously unknown infection. Methods Pregnant people were screened for SARS-CoV-2 IgG during antenatal care or delivery in Seattle, Washington with Abbott Architect chemiluminescent immunoassay which provides quantitative index (positive ≥1.4). Participants with IgG+ results or identified with RT-PCR+ results via medical records were invited to enroll in a longitudinal evaluation of antibody responses. We report preliminary results of an ongoing seroprevalence and longitudinal study with planned 18-month follow-up. Results Between September 9, 2020–May 7, 2021, we screened 1304 pregnant people; 62 (4.8%) tested SARS-CoV-2 IgG+, including 28 (45%) with known prior SARS-CoV-2 infection. Among participants testing IgG+, median age was 32 years (interquartile range [IQR] 26–35) and median gestational age was 21 weeks (IQR 12–38) at screening; median IgG index was 3.2 (IQR 2.1–4.9, range 1.4–9.9), including 3.9 (IQR 2.3–5.8) among those with vs. 2.7 (IQR 1.9–4.2) among those without prior RT-PCR+ results (p=0.05 by Wilcoxon rank-sum). Of 30 longitudinal study participants enrolled, 24 tested IgG+ at baseline (75% with prior RT-PCR+ result) and 6 tested IgG- on enrollment but were identified as previously RT-PCR+ via medical records; 24/30 (80%) reported previous symptoms. Of 24 participants testing IgG+ at baseline, 14 (58%) had first follow-up IgG results at median of 66 days (IQR 42–104) since initial testing, with median IgG index of 2.0 (IQR 1.0–3.8). 9/14 (64%) participants with repeat IgG testing remained IgG+ at first follow-up (≤280 days after first RT-PCR+ result for those with and ≥104 days after first IgG detection for those without prior RT-PCR+ results), while 5/14 (26%) had a negative Abbott IgG test at a median of 81 days (IQR 75–112) since initial testing. Conclusion Nearly half of pregnant people testing SARS-CoV-2 IgG+ reported no known prior SARS-CoV-2 diagnosis or symptoms. SARS-CoV-2 IgG antibody response and durability in pregnancy has implications for maternal and neonatal protection and susceptibility and highlights potential benefits of vaccination in this population. Disclosures Sylvia LaCourse, MD, Merck (Grant/Research Support) Alisa Kachikis, MD, MS, GlaxoSmithKline (Consultant)Pfizer (Consultant) Alexander L. Greninger, MD, PhD, Abbott (Grant/Research Support)Gilead (Grant/Research Support)Merck (Grant/Research Support) Janet A. Englund, MD, AstraZeneca (Consultant, Grant/Research Support)GlaxoSmithKline (Research Grant or Support)Meissa Vaccines (Consultant)Pfizer (Research Grant or Support)Sanofi Pasteur (Consultant)Teva Pharmaceuticals (Consultant) Alison Drake, PhD, MPH, Merck (Grant/Research Support)

scholarly journals Factors associated with preterm birth at Wachemo University Nigist Eleni Mohammed memorial hospital, southern Ethiopia: case-control study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Negeso Gebeyehu Gejo ◽  
Melaku Tesfaye W/mariam ◽  
Biruk Assefa Kebede ◽  
Ritbano Ahmed Abdo ◽  
Abebe Alemu Anshebo ◽  
...  
Keyword(s):  
Preterm Birth ◽  
Antenatal Care ◽  
Medical Records ◽  
Case Control Study ◽  
Southern Ethiopia ◽  
Preterm Neonates ◽  
Factors Associated ◽  
Induced Hypertension ◽  
Control Study

Abstract Background Preterm birth is defined as the birth of a baby before 37 completed weeks of gestation. Worldwide, prematurity is the second foremost cause of death in children under the age of 5 years. Preterm birth also gives rise to short and long term complications. Therefore, the primary aim of this study was to identify the factors associated with preterm birth in Wachemo University Nigist Eleni Mohammed Memorial referral hospital, Hadiya Zone, Southern Ethiopia. Methods An institution-based unmatched case-control study was conducted from July 01, 2018 to June 30, 2019 among mothers who gave birth in Wachemo University Nigest Eleni Mohammed Memorial referral hospital. A retrospective one-year data was retrieved from medical records of mothers with their index neonates. Simple random sampling technique was employed to recruit study participants. SPSS version 20 software was used for data entry and computing statistical analysis. Both bivariable and multivariable logistic regression analyses were used to determine the association of each independent variable with the dependent variable. Odds ratio with their 95% confidence intervals was computed to identify the presence and strength of association, and statistical significance was affirmed if p < 0.05. Result The current study evaluated 213 medical records of mothers with index neonates (71 cases and 142 controls). Urban residency [AOR = 0.48; 95% Cl; 0.239, 0.962], antenatal care follow up [AOR = 0.08; 95 Cl; 0.008, 0.694], premature rupture of membranes [AOR = 3.78; 95% Cl; 1.467, 9.749], pregnancy induced hypertension [AOR = 3.77; 95% Cl; 1.408, 10.147] and multiple pregnancies [AOR = 5.53; 95% Cl; 2.467, 12.412] were the factors associated with preterm birth. More than one-third (36.6%) preterm neonates died in the present study. Conclusions The present study found that urban residency, antenatal care follow up, premature rupture of membranes, pregnancy induced hypertension and multiple pregnancies were factors associated with preterm birth. The mortality among preterm neonates is high. Enhancing antenatal care follow up and early detection and treatment of disorders among pregnant women during antenatal care and undertaking every effort to improve outcomes of preterm birth and reduce neonatal mortality associated with prematurity is decisive.

scholarly journals More rapid, robust and sustainable antibody responses to mRNA COVID-19 vaccine in convalescent COVID-19 individuals

2021 ◽  
Author(s):  
Sabrina E Racine-Brzostek ◽  
Jim Yee ◽  
Ashley Sukhu ◽  
Yuqing Qiu ◽  
Sophie Rand ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Antibody Response ◽  
Real World ◽  
Neutralizing Antibodies ◽  
Vaccine Dose ◽  
Antibody Responses ◽  
Antibody Levels

Longitudinal studies are needed to evaluate the SARS-CoV-2 mRNA vaccine antibody response under real-world conditions. This longitudinal study investigated the quantity and quality of SARS-CoV-2 antibody response in 846 specimens from 350 subjects: comparing BNT162b2-vaccinated individuals (19 previously diagnosed with COVID-19 [RecoVax]; 49 never been diagnosed [NaiveVax]) to 122 hospitalized unvaccinated (HospNoVax) and 160 outpatient unvaccinated (OutPtNoVax) COVID-19 patients. NaiveVax experienced a delay in generating SARS-CoV-2 total antibody levels (TAb) and neutralizing antibodies (SNAb) after the 1st vaccine dose (D1), but a rapid increase in antibody levels was observed after the 2nd dose (D2). However, these never reached the robust levels observed in RecoVax. In fact, NaiveVax TAb and SNAb levels decreased 4-weeks post-D2 (p=0.003;p<0.001). For the most part, RecoVax TAb persisted throughout this study, after reaching maximal levels 2-weeks post-D2; but SNAb decreased significantly ~6-months post-D1 (p=0.002). Although NaiveVax avidity lagged behind that of RecoVax for most of the follow-up periods, NaiveVax did reach similar avidity by ~6-months post-D1. These data suggest that one vaccine dose elicits maximal antibody response in RecoVax and may be sufficient. Also, despite decreasing levels in TAb and SNAb overtime, long-term avidity maybe a measure worth evaluating and possibly correlating to vaccine efficacy.

scholarly journals 814. Successful Treatment of Cutibacterium acnes (CA) Prosthetic Device Infection (PDI) with Oral Linezolid and Rifampin (LR)

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S500-S500
Author(s):  
Ronald G Nahass ◽  
Maalikat Esquivel ◽  
Krystle Smith ◽  
Danielle Heinemann ◽  
Kathleen H Seneca
Keyword(s):  
Low Cost ◽  
Oral Treatment ◽  
Prosthetic Device ◽  
Research Support ◽  
Duration Of Treatment ◽  
Slime Layer ◽  
Device Infection ◽  
Cutibacterium Acnes ◽  
Research Grant

Abstract Background CA PDI is increasingly recognized. CA is felt to create a slime layer that makes infection more likely and treatment more difficult in this setting. Traditional management has included prosthetic device explantation (PDE), prolonged antibiotic treatment, and delayed reimplantation. Recent interest in the use of oral treatment regimens and single stage procedures with long duration antibiotic therapy led us to treat a series of patients with oral treatment and retained prosthesis after debridement. We report those results. Methods Sequential patients with CA PDI treated with oral therapy were identified. All patients underwent debridement of the tissue, exchange of components and/or reimplantation of the prosthetic device. Only patients with exchanges were included. PDE was excluded. MIC testing for CA isolates was obtained when possible. Initial treatment was recorded at time of surgery. LR was the treatment of choice unless toxicity developed. A minimum of a 3-month follow-up post treatment was required to be included. 6 and 12 month follow up were obtained for all patients but 1 at this time. Results 10 patients were treated (Table 1). Shoulder joint infections were most common. All patients were treated with LR. All completed a minimum of 42 days of treatment (Table 2). The medication was well tolerated. The most common adverse events were nausea. 9/10 patients with 12 month follow up had no evidence of relapse. 1/10 had no relapse at 3 months. Typical for CA infection laboratory markers for infection were not markedly elevated. Notably thrombocytopenia did not occur (Table 3). Table 1. Distribution of Prosthetic Device Infections Table 2. Duration of Treatment Table 3. Selected Laboratory Results Conclusion We demonstrated the ability to successfully treat 10/10 patients with CA PDI without explantation using prolonged oral treatment with LR after debridement. This combination should be considered a treatment option and explored further as a low cost, well tolerated, high value treatment approach to this difficult infection. Disclosures Ronald G. Nahass, MD, Abbvie (Grant/Research Support, Speaker’s Bureau)Alkermes (Grant/Research Support)Gilead (Grant/Research Support, Speaker’s Bureau)Merck (Grant/Research Support, Speaker’s Bureau) Kathleen H. Seneca, MSN, Abbvie (Research Grant or Support)Alkermes (Research Grant or Support)Gilead (Speaker’s Bureau)

scholarly journals P280 Clinical burden of concomitant joint disease in psoriasis: a US-linked claims and electronic medical records database analysis

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
William Tillett ◽  
Michelle Skornicki ◽  
Patricia Prince ◽  
Robert Suruki ◽  
Edward Lee ◽  
...  
Keyword(s):  
Metabolic Disease ◽  
Electronic Medical Records ◽  
Medical Records ◽  
Well Being ◽  
Skin Condition ◽  
Joint Disease ◽  
Research Support ◽  
Clinical Burden

Abstract Background Psoriasis (PSO) is an inflammatory skin condition, impacting physical and psychological well-being. PSO patients may develop psoriatic arthritis (PsA), a painful joint disease that further impacts quality of life. The objective was to examine rates of metabolic disease and depression in patients with PSO and PsA. Methods Claims data linked to electronic medical records were examined (Jan-2007-Mar-2018). Prevalent PSO patients were followed until end of data collection and categorized based on development of PsA (PSO+PsA cohort; defined by ICD9/10 codes in patients without PsA at baseline). Follow-up rates of comorbidities, including metabolic disease and depression, were compared for those with/without PsA, presented as cases per 1,000 patient-years (1000PY). Results Progression to PsA occurred in 2,311 (12%) patients. Follow-up rates of hyperlipidemia, hypertension, diabetes, and cardiovascular disease in the PSO+PsA cohort were 1.4-times (326 vs 234/1000PY), 1.6-times (357 vs 228/1000PY), 1.7-times (119 vs 72/1000PY), and 1.4-times (71 vs 50/1000PY) that observed in the PSO-only cohort, respectively. In patients without baseline metabolic disease, higher rates in PSO+PsA vs PSO-only remained (approximately 1.5-times and 1.3-times higher rates of hypertension and hyperlipidemia, respectively). The rate of depression was 140 vs 92/1000PY in the PSO+PsA vs PSO-only cohort; when examined in patients without baseline depression, rates were about half that observed in the overall population (72 vs 49/1000PY). Conclusion PSO+PsA patients had a substantial clinical burden, characterized by 40-70% higher rates of metabolic disease and depression than for patients who did not progress to PsA. Disclosures W. Tillett: Consultancies; AbbVie, Celgene, Janssen, Lilly, Novartis, Pfizer and UCB Pharma. Grants/research support; AbbVie, Celgene and Lilly. M. Skornicki: Other; Employee of Aetion. P. Prince: Other; Employee of Aetion. R. Suruki: Other; Employee of UCB Pharma. E. Lee: Other; Employee of UCB Pharma. A. Louder: Other; Employee of Aetion.

scholarly journals The fall in antibody response to SARS-CoV-2: a longitudinal study of asymptomatic to critically ill patients up to 10 months after recovery

2021 ◽  
Author(s):  
Maddalena Peghin ◽  
Maria De Martino ◽  
Martina Fabris ◽  
Alvisa Palese ◽  
Erica Visintini ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Antibody Response ◽  
Seroconversion Rate ◽  
Disease Onset ◽  
Acute Onset ◽  
Serological Response ◽  
Prospective Longitudinal Study ◽  
Prospective Longitudinal

Background. The aim was to assess long-term dynamics and factors associated with the serological response against the Severe Acute Respiratory Syndrome Coronavirus 2 after primary infection. Methods. A prospective longitudinal study with monthly serological follow-up during the first 4 months, and then at 6, 8 and 10 months after the disease onset of all recovered adult in- and out-patients with Coronavirus Disease 2019 (COVID-19) attending Udine Hospital (Italy) during the first wave (from March to May 2020). Results. 542 individuals were included (289 female, mean age 53.1 years), mostly with mild COVID-19 (370, 68.3%). Patients were followed for a median of 302 days (Interquartile Range, 186-311). Overall seroconversion rate within two months was 32% for IgM and 90% for IgG. Seroreversion was observed in 90% of patients for IgM at 4 months and in 47% for IgG at 10 months. older age, number of symptoms at acute onset, severity of acute COVID-19, were all independent predictors of long-term immunity both for IgM (β, linear regression coefficient, 1.10, p=0.001; β 5.15 p=0.014; β 43.84 p=0.021, respectively) and for IgG (β 1.43 p<0.001; β 10.46 p<0.001; β 46.79 p<0.001, respectively), whereas the initial IgG peak was associated only with IgG duration (β 1.12, p <0.001). Conclusions. IgM antibodies disappeared at four months and IgG antibodies declined in about half of patients 10 months after acute COVID-19. These effects varied depending on the intensity of the initial antibody response, age and burden of acute COVID-19.

scholarly journals 127. Development of a Kinetic ELISA (kELISA) and Reactive B-cell Frequency (RBF) Assay to Detect Respiratory Syncytial Virus (RSV) Pre-Fusion F Protein-Specific Immune Responses in Infants

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S77-S78
Author(s):  
Stephanie L Rolsma ◽  
Sandy M Yoder ◽  
Rachel S Nargi ◽  
Eric Brady ◽  
Natalia Jimenez-Truque ◽  
...  
Keyword(s):  
Panel Member ◽  
Multiple Time ◽  
Research Support ◽  
Review Panel ◽  
Cell Frequency ◽  
Material Support ◽  
F Protein ◽  
Multiple Time Points ◽  
Research Grant

Abstract Background RSV is a major cause of pediatric respiratory disease. Antibodies to the prefusion conformation of the RSV fusion (pre-F) protein are needed for virus neutralization. Methods We measured RSV-specific responses in two groups of children &lt; 3 years of age; subjects with laboratory-confirmed RSV (RSV-infected) or infants born in the period May to September and enrolled prior to their first RSV season (RSV-uninfected). RSV-infected infants had blood samples obtained at 1, 6, 9, and 12 months after infection. RSV-uninfected infants had blood samples obtained at enrollment, at the end of their first RSV season, and 6 months later. A kELISA to measure RSV pre-F-specific antibodies and an RBF assay to identify RSV F-specific B cells were developed. Results 102 subjects were enrolled; 11 were excluded due to missed visits or withdrawal. Of the 65 subjects in the RSV-uninfected group, all were kELISA positive at enrollment, consistent with maternal antibody transfer. 53 subjects had sufficient samples for analysis at multiple time points; 29 became seronegative and 24 remained seropositive. In the seronegative group, the kELISA value decreased rapidly to &lt; 0.25 by 6 months after the RSV season in 27/29 (93%), (Figure 1a). In the persistently seropositive group, all 24 subjects maintained a positive kELISA value, with some developing higher values over time, consistent with asymptomatic infection (Figure 1b). An RBF assay was used to determine whether antibodies were due to persistent maternal antibodies or endogenous production (Figure 2). In the seronegative group, 24/29 (80%) had a negative RBF; in the seropositive group, 23/24 (96%) had a positive RBF during follow-up. There were 26 subjects in the RSV-infected group; 22 had sufficient samples for analysis at multiple time points. All were seropositive by kELISA at one month post-infection with variable kELISA values during follow-up (Figure 3). 17/22 (77%) had a positive RBF, although 4 of the subjects without a positive RBF had indeterminate results at ≥ 1 visit. Figure 1. kELISA values of baseline RSV-negative subjects, by subject age at time of sample. Panel A: Subjects classified as seronegative (n=29). Panel B: Subjects without known RSV classified as persistently seropositive (n=24). Figure 2. Reactive B-cell frequency assay. The first step in the RBF assay is growth of Lymphoblastoid Cell Lines (LCLs), as shown over days 1-3 (Left-Day 1, Middle-Day 2, Right-Day 3, magnification 200X). The cells circled in the figure indicate a single LCL’s growth over time. LCL supernatant is used to detect RSV F-protein specific antibodies using traditional ELISA, resulting in a positive, indeterminate, or negative result. Indeterminate results occur due to a lack of cell viability and/or failure to form LCLs, resulting in failure to exceed an optical density of 5x background. Figure 3. kELISA values of RSV-infected subjects, by subject age at time of sample. First sample was obtained at approximately one month after laboratory-confirmed RSV. Conclusion Assays measuring F-specific immune responses in infants will be critical for RSV vaccine development. A kELISA targeting RSV pre-F epitopes, with an RBF assay targeting RSV F-specific B cells, may allow discrimination for maternal and infant-derived antibodies. Disclosures Isaac Thomsen, MD, MSCI, Horizon Therapeutics (Individual(s) Involved: Self): Consultant James E. Crowe, Jr., MD, Astra Zeneca (Grant/Research Support)IDBiologics (Board Member, Grant/Research Support, Shareholder)Luna Biologics (Consultant)Meissa Vaccines (Advisor or Review Panel member)Takeda Vaccines (Grant/Research Support) Kathryn M. Edwards, MD, Bionet (Individual(s) Involved: Self): Consultant; CDC (Individual(s) Involved: Self): Research Grant or Support; IBM (Individual(s) Involved: Self): Consultant; Merck (Individual(s) Involved: Self): member DSMC, Other Financial or Material Support; Moderna (Individual(s) Involved: Self): member DSMC, Other Financial or Material Support; NIH (Individual(s) Involved: Self): Research Grant or Support; Pfizer (Individual(s) Involved: Self): member DSMC, Other Financial or Material Support; Roche (Individual(s) Involved: Self): member of DSMB, Other Financial or Material Support; Sanofi Pasteur (Individual(s) Involved: Self): member DSMB, Other Financial or Material Support; Sequiras (Individual(s) Involved: Self): Member DSMB, Other Financial or Material Support; X4 Pharmaceuticals (Individual(s) Involved: Self): Consultant Buddy Creech, MD, MPH, Altimmune (Consultant)Astellas (Other Financial or Material Support, Data and Safety Monitoring Committee)Diotheris (Consultant)GSK (Consultant)Horizon (Consultant)Merck (Scientific Research Study Investigator)Premier Healthcare (Advisor or Review Panel member)Vir (Consultant)

scholarly journals Treatment of Six COVID-19 Patients with Convalescent Plasma

2020 ◽  
Author(s):  
Can Jin ◽  
Juan Gu ◽  
Youshu Yuan ◽  
Qinying Long ◽  
Qi Zhang ◽  
...  
Keyword(s):  
Plasma Treatment ◽  
Electronic Medical Records ◽  
Medical Records ◽  
Throat Swab ◽  
Rapid Progression ◽  
Chest Imaging ◽  
Rt Pcr ◽  
Plasma Therapy ◽  
Key Points

AbstractObjectiveTo describe the efficacy of convalescent plasma transfusion for COVID-19 patients.MethodsThis is a retrospective study of 6 COVID-19 patients with convalescent plasma at Guizhou Provincial Jiangjunshan Hospital – a tertial hospital, in Guiyang, Guizhou, China, from January 29, to April 30, 2020; final data of follow-up was May 12, 2020. Through the review of the electronic medical records of Guizhou Jiangjunshan Hospital, clinical data of 6 patients were obtained. Three patients with worsening symptoms after empirical treatment with antivirals were transfused convalescent plasma therapy for the first treatment, while the other three severe or critical COVID-19 patients with rapid progression were transfused. The efficacy of convalescent plasma depends on the relief of symptoms, changes in laboratory indicators and chest imaging abnormalities.ResultsThe PaO2 / FiO2 and lymphocyte count of patients 1, 2 and 3 treated with convalescent plasma treatment for the first treatment period were changed from abnormal to normal. The levels of inflammation markers CRP and IL-6 of the patients decreased significantly. Chest imaging examination showed that the lung lesions gradually subsided. The relapsed patients (No. 4 and No. 6), after using convalescent plasma therapy, turned negative on two consecutive throat swab tests on Day 24 and Day 3, respectively.ConclusionsConvalescent plasma treatment of COVID-19 is beneficial for those patients with be difficult to turn to negative or re-positive RT-PCR.Key PointsConvalescent plasma treatment of COVID-19 is beneficial for those patients with be difficult to turn to negative or re-positive RT-PCR.

scholarly journals 67. SARS-CoV-2 Transmission: Preliminary Findings from a Household-based Study

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S165-S165
Author(s):  
Carlos G Grijalva ◽  
Yuwei Zhu ◽  
Natasha B Halasa ◽  
Ahra Kim ◽  
Melissa A Rolfes ◽  
...  
Keyword(s):  
Disease Onset ◽  
Median Number ◽  
Household Member ◽  
Research Support ◽  
Nasal Swabs ◽  
Household Members ◽  
Index Cases ◽  
Support Research ◽  
Research Grant

Abstract Background Social distancing measures, such as shelter-in-place or stay-at-home orders, are recommended for control of community transmission of SARS-CoV-2. Few studies, however, have characterized the transmission of SARS-CoV-2 infections in households. Methods We conducted a case-ascertained study of household transmission in Nashville, TN starting in April 2020, after recommendations to stay at home were enacted. Index cases were ambulatory patients identified through clinical RT-PCR testing at Vanderbilt walk-in-clinics dispersed across the Nashville metropolitan area. For this study, the index case was the first person presenting with respiratory or compatible symptoms in a household and who lived with at least one other household member. After informed consent was obtained, household members were remotely trained in the self-collection of nasal swabs and use of REDCap electronic questionnaires. Household members completed daily symptom diaries and collected daily nasal swabs for 14 days. Contact patterns within households before and after disease onset were ascertained. Nasal swab samples were tested using RT-PCR at an academic research laboratory. Results At the time of writing, 18 families were enrolled (including 18 index cases and 34 household members) with at least 1 follow-up nasal swab tested. The median age of index cases and household members was 37 years (IQR: 26–46) and 27 years (15–39), respectively. The median number of days from index patient onset of symptoms to first sample collected in the household was 4 (2–5). Before onset of symptoms, 83% of index cases spent &gt;4 hours in the same room with at least one other household member, whereas after disease onset and diagnosis, 44% did. Among 34 non-index household members, 18 (53%) had a positive test during follow-up; the median number of days from index case’s symptoms onset to first positive detection in a household member was 4.5 (3–5) days. Interestingly, 13 (72%) of 18 secondary infections were detected within the first 3 days of follow-up, whereas 5 (28%) were detected during subsequent days. Conclusion These observations suggest that transmission of SARS-CoV-2 within households is high, with many infections detected during the initial days of study follow-up. Disclosures Carlos G. Grijalva, MD, MPH, AHRQ (Grant/Research Support)Campbell Alliance (Grant/Research Support)CDC (Grant/Research Support)FDA (Grant/Research Support)Merck (Consultant)NIH (Scientific Research Study Investigator)Pfizer (Consultant)Sanofi (Consultant)Sanofi (Grant/Research Support) Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures - it’s a education grant, supported by genetech)Karius (Consultant)Moderna (Consultant)Quidel (Grant/Research Support, Research Grant or Support)Sanofi (Grant/Research Support, Research Grant or Support)

scholarly journals 358. Sociodemographic and clinical features of children and adolescents with SARS-CoV-2 infection in Nashville, Tennessee

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S248-S249
Author(s):  
Leigh Howard ◽  
Kathryn Garguilo ◽  
Jessica Gillon ◽  
Steven Webber ◽  
Natasha B Halasa ◽  
...  
Keyword(s):  
Children And Adolescents ◽  
Research Support ◽  
Full Spectrum ◽  
Duration Of Symptoms ◽  
Healthcare Settings ◽  
Asymptomatic Children ◽  
Asymptomatic Patients ◽  
Support Research ◽  
Research Grant

Abstract Background Little is known regarding the full spectrum of illness among children with SARS-CoV-2 infection across integrated healthcare settings, as many published pediatric cohorts focus on hospitalized patients with SARS-CoV-2 infection. Methods Active surveillance was performed for SARS-CoV-2 detections among symptomatic and asymptomatic children and adolescents ≤18 years of age in a quaternary care academic hospital laboratory in the Southeastern U.S. For symptomatic patients with a positive respiratory specimen for SARS-CoV-2 by polymerase chain reaction (PCR), and for neonates born to SARS-CoV-2-positive mothers, we performed phone follow-up and medical record review at days 2, 7, and 30 after diagnosis. Testing was initiated 3/12/20 for symptomatic patients and 5/4/20 for screening asymptomatic patients. Results By 6/14/20, SARS-CoV-2 tests were positive in 193/5306 (3.6%) specimens from unique patients ≤18 (Table 1), compared to 2653/36503 (7.2%) specimens in patients &gt;18 years. Specimens from 181/2638 (6.8%) symptomatic and 12/2768 (0.4%) asymptomatic children were positive. Nine infants born to SARS-CoV-2 infected mothers had negative PCR tests at birth; 1 infant subsequently acquired SARS-CoV-2 infection at 5 weeks of age. Sociodemographic and clinical data for 181 SARS-CoV-2-positive symptomatic children are displayed in Table 2 and Figure 1. The most common symptoms were cough (59%), fever (50%), and rhinorrhea (39%). Nine/181 symptomatic patients (5%) were hospitalized, primarily for respiratory symptoms. Symptom resolution occurred by follow-up day 2 in 82/178 (46%) and day 7 in 128/164 (78%) patients with complete assessments to date. 131/181 (72%) of children had known SARS-CoV-2 positive contacts. We observed no cases of multisystem inflammatory syndrome in children. Conclusion In our community, pediatric SARS-CoV-2 prevalence was low, but was much higher among symptomatic than asymptomatic children. Symptoms were mild, and the duration of symptoms brief, in the majority of these patients captured within an integrated ambulatory and hospital-based healthcare system, capturing the full spectrum of the disease profile in this age group. Disclosures Natasha B. Halasa, MD, MPH, Genentech (Other Financial or Material Support, I receive an honorarium for lectures - it’s a education grant, supported by genetech)Karius (Consultant)Moderna (Consultant)Quidel (Grant/Research Support, Research Grant or Support)Sanofi (Grant/Research Support, Research Grant or Support)

scholarly journals LB13. The Efficacy and Impact in Heathy Infants of Nirsevimab on Medically Attended RSV Lower Respiratory Tract Infection

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S811-S812
Author(s):  
Laura Hammitt ◽  
Laura Hammitt ◽  
Ron Dagan ◽  
Yuan Yuan ◽  
Manuel Baca Cots ◽  
...  
Keyword(s):  
Research Study ◽  
Scientific Research ◽  
Panel Member ◽  
Research Support ◽  
Review Panel ◽  
Term Infants ◽  
Study Investigator ◽  
Support Research ◽  
Research Grant

Abstract Background Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) in infants. Nirsevimab is a single-dose monoclonal antibody with extended half-life that was shown to protect preterm infants 29 to &lt; 35 weeks gestation against RSV LRTI. However, most medically attended (MA) cases occur in otherwise healthy, term infants for whom there is currently no effective RSV prevention strategy. We report the primary analysis of efficacy and safety, along with the impact of nirsevimab in late preterm and term infants (≥ 35 weeks gestation) in the phase 3 MELODY study (NCT03979313). Methods Infants were randomized 2:1 to receive one intramuscular injection of nirsevimab (50 mg if &lt; 5 kg; 100 mg if ≥ 5 kg at dosing) or placebo entering their first RSV season. The primary endpoint was the incidence of MA RSV LRTI over 150 days postdose. Cases met predefined clinical criteria of disease severity and were confirmed by real-time reverse-transcriptase PCR. Safety was evaluated through 360 days postdose. Enrollment started on 23 July 2019 and was suspended following the declaration of the COVID-19 pandemic by the WHO on 11 March 2020. Results Overall, 1490 infants were randomized and included in the intent-to-treat population; 1465 (98%) completed the 150-day efficacy follow-up, and 1367 (92%) completed the 360-day safety follow-up. The incidence of MA RSV LRTI was 1.2% (n=12/994) in the nirsevimab group and 5.0% (n=25/496) in the placebo group, giving nirsevimab an efficacy of 74.5% (95% confidence interval [CI]: 49.6, 87.1; p&lt; 0.0001). Nirsevimab averted 93.6 (95% CI 63.0, 124.0) MA LRTIs per 1000 infants dosed. Nirsevimab was well tolerated, with similar rates of adverse events (87.4% nirsevimab; 86.8% placebo) and serious adverse events (6.8% nirsevimab; 7.3% placebo) between groups. Conclusion In this phase 3 study, a single dose of nirsevimab protected late preterm and term infants against MA RSV LRTI over an RSV season with a favorable safety profile. Approximately 11 infants need to be immunized to prevent 1 case of LRTI; nirsevimab has the potential to be an important intervention to reduce the burden of RSV LRTI in healthy infants. Disclosures Laura Hammitt, MD, MedImmune (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)Merck & Co., Inc. (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)Novavax (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)Pfizer (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support) Laura Hammitt, MD, MedImmune (Individual(s) Involved: Self): Grant/Research Support, Research grant to my institution; Merck (Individual(s) Involved: Self): Grant/Research Support, Research grant to my institution; Pfizer (Individual(s) Involved: Self): Grant/Research Support, Research grant to my institution Ron Dagan, MD, Medimmune/AstraZeneca (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)MSD (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau)Pfizer (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau) Yuan Yuan, PhD, AstraZeneca (Employee, Shareholder) Shabhir A. Mahdi, PhD, BMGF (Research Grant or Support)EDCTP (Research Grant or Support)GlaxoSmithKline (Research Grant or Support)Melody (Research Grant or Support)Minervax (Research Grant or Support)Novavax (Research Grant or Support)SAMRC (Research Grant or Support) William J. Muller, MD, PhD, Ansun (Scientific Research Study Investigator)Astellas (Scientific Research Study Investigator)AstraZeneca (Scientific Research Study Investigator)Genentech (Scientific Research Study Investigator)Gilead (Scientific Research Study Investigator)Janssen (Scientific Research Study Investigator)Karius (Scientific Research Study Investigator)Melinta (Scientific Research Study Investigator)Merck (Scientific Research Study Investigator)Nabriva (Scientific Research Study Investigator)Seqirus (Scientific Research Study Investigator)Tetraphase (Scientific Research Study Investigator) William J. Muller, MD, PhD, Ansun (Individual(s) Involved: Self): Grant/Research Support; Astellas (Individual(s) Involved: Self): Research Grant or Support; AstraZeneca (Individual(s) Involved: Self): Grant/Research Support; BD (Individual(s) Involved: Self): Research Grant or Support; Eli Lilly (Individual(s) Involved: Self): Grant/Research Support; Gilead (Individual(s) Involved: Self): Grant/Research Support; Karius, Inc. (Individual(s) Involved: Self): Grant/Research Support, Scientific Research Study Investigator; Melinta (Individual(s) Involved: Self): Grant/Research Support; Merck (Individual(s) Involved: Self): Grant/Research Support; Moderna (Individual(s) Involved: Self): Grant/Research Support; Nabriva (Individual(s) Involved: Self): Grant/Research Support; Seqirus (Individual(s) Involved: Self): Consultant; Tetraphase (Individual(s) Involved: Self): Grant/Research Support Heather J. Zar, PhD, AstraZeneca (Grant/Research Support)Novavax (Grant/Research Support)Pfizer (Grant/Research Support, Advisor or Review Panel member) Dennis Brooks, MD, AstraZeneca (Employee) Amy Grenham, MSc, AstraZeneca (Employee, Shareholder) Ulrika Wählby Hamrén, PhD, AstraZeneca R&D (Employee, Shareholder) Vaishali S. Mankad, MD, AstraZeneca (Employee) Therese Takas, BSc, AstraZeneca (Employee, Other Financial or Material Support, Own stock in AstraZeneca) Jon Heinrichs, PhD, AstraZeneca (Shareholder)Bristol Myers Squibb (Shareholder)J&J (Shareholder)Merck (Shareholder)Organon (Shareholder)Procter & Gamble (Shareholder)Sanofi (Shareholder)Sanofi Pasteur (Employee) Amanda Leach, MRCPCH, AstraZeneca (Employee, Shareholder) M. Pamela Griffin, MD, AstraZeneca (Employee) Tonya L. Villafana, PhD, AstraZeneca (Employee)

Sign in / Sign up

Export Citation Format

Share Document