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  • 1
    In: The Journal of Infectious Diseases, Oxford University Press (OUP), ( 2024-03-27)
    Abstract: Establishing the safety and immunogenicity of a hepatitis E virus vaccine in multiple populations could facilitate broader access and prevent maternal and infant mortality. Methods We conducted a phase 1, randomized, double-blinded, placebo-controlled (4:1 vaccine: placebo) trial of 30 µg HEV-239 (Hecolin®, Xiamen Innovax Biotech Company Limited, China) administered intramuscularly in healthy US adults aged 18-45 years. Participants were vaccinated on days 1, 29, and 180. Participants reported solicited local and systemic reactions for 7 days following vaccination and were followed through 12 months after enrollment for safety and immunogenicity (IgG, IgM). Results Solicited local and systemic reactions between treatment and placebo group were similar and overall mild. No participants experienced serious adverse events related to HEV-239. All participants receiving HEV-239 seroconverted at one month following the first dose and remained seropositive throughout the study. HEV-239 elicited a robust hepatitis E IgG response that peaked one month following the second dose (Geometric Mean Concentration (GMC) 6.16; 95% CI 4.40-8.63), was boosted with the third dose (GMC 11.50; 95% CI 7.90-16.75) and persisted through 6 months. Conclusions HEV-239 is safe and elicits a durable immune response through at least 6 months after the third dose in healthy US adults. Clinical Trials Registration NCT03827395. Safety Study of Hepatitis E Vaccine (HEV239) - Full Text View - ClinicalTrials.gov
    Type of Medium: Online Resource
    ISSN: 0022-1899 , 1537-6613
    RVK:
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2024
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  • 2
    In: Pediatric Transplantation, Wiley, Vol. 24, No. 6 ( 2020-09)
    Abstract: Posaconazole is a broad‐spectrum antifungal used for prophylaxis and treatment of invasive fungal diseases. There are limited data on the optimal dosing, safety, and efficacy of the DRT and IV formulations in immunocompromised pediatric and adolescent patients. We describe our experience including dosing, plasma trough concentrations, safety, and tolerability. Plasma concentrations ≥.7 µg/mL were considered therapeutic for prophylaxis and ≥1.0 µg/mL for treatment. Fifty‐four patients (median age of 16 years) received DRT or IV formulations of posaconazole. Thirty‐one (57%) patients received posaconazole for treatment and 23 (43%) for prophylaxis. Overall, 36 (67%) patients achieved targeted initial plasma trough concentrations (median 1.3 µg/mL) (Figure  1 ). The median daily dose among patients 〈 13 years of age who achieved the targeted initial concentrations was 7.3 mg/kg/day for the DRT formulation and 9.8 mg/kg/day for the IV formulation. The median daily dose among patients ≥13 years of age who achieved the targeted initial concentrations was 4.9 mg/kg/day for the DRT formulation and 5.6 mg/kg/day for the IV formulation. Thirty‐six patients (67%) developed transaminitis, mostly grade 1. Our observations show that DRT and IV formulations are safe and effective in immunocompromised children, adolescents, and young adults. Higher dosing per body weight of DRT and IV posaconazole may be required in patients 〈 13 years of age compared with patients 13 years of age and older to achieve therapeutic plasma concentrations. Distribution of posaconazole plasma trough levels by indication groups image
    Type of Medium: Online Resource
    ISSN: 1397-3142 , 1399-3046
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2020
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  • 3
    Online Resource
    Online Resource
    Oxford University Press (OUP) ; 2021
    In:  Journal of the Pediatric Infectious Diseases Society Vol. 10, No. Supplement_1 ( 2021-03-26), p. S1-S1
    In: Journal of the Pediatric Infectious Diseases Society, Oxford University Press (OUP), Vol. 10, No. Supplement_1 ( 2021-03-26), p. S1-S1
    Abstract: Posaconazole is a broad-spectrum antifungal used for prophylaxis and treatment of invasive fungal infections. There are limited data on the optimal dosing, safety, and effectiveness of the delayed-released tablets (DRT) and intravenous (IV) formulations in immunocompromised pediatric and adolescent patients. Methods A retrospective chart review was performed to study all immunocompromised patients who received DRT or IV formulations of posaconazole at our institution from January 1, 2014, to July 31, 2019, and had at least one plasma trough concentration. Plasma concentrations ≥0.7 µg /mL were considered therapeutic for prophylaxis, and ≥1.0 µg/mL for treatment. We describe our experience including dosing, plasma trough concentrations, safety, and tolerability. Results We identified 54 patients (28 males/26 females) who received DRT or IV formulations of posaconazole. The median age was 14 years (range 2–21 years). Thirty-one (57%) patients received posaconazole for treatment and 23 (43%) for prophylaxis. The most common underlying condition was hematological malignancies (66%) and 19 patients (35%) had received an allogeneic HSCT and were receiving immunosuppressive therapy. Overall, 36 (67%) patients achieved targeted initial plasma trough concentrations (median 1.3 µg/mL, IQR 0.758–1.760 µg/mL) (Figure). The median daily dose among patients & lt;13 years of age who achieved the targeted initial plasma trough concentrations was 7.3 mg/kg/day (IQR 6.8–11.0) for the DRT formulation and 9.8 mg/kg/day (IQR 7.4–11.7) for the IV formulation. The median daily dose among patients ≥ 13 years of age who achieved the targeted initial plasma trough concentrations was 4.9 mg/kg/day (IQR 4.1–6.5) for the DRT formulation and 5.6 mg/kg/day (IQR 3.9–5.8) for the IV formulation. Concomitant use of H2-receptor blockers (H2RA) and/or proton pump inhibitors (PPI) medications were not associated with failure to achieve target trough levels (P = 0.96). Thirty-six patients (67%) developed transaminitis, mostly grade 1. Conclusions Our results show that DRT and IV formulations are safe and effective in immunocompromised children, adolescents, and young adults. Higher dosing per body weight of DRT and IV posaconazole may be required in patients & lt;13 years of age compared with patients 13 years of age and older to achieve therapeutic plasma concentrations. It appears that neither a PPI nor an H2RA has an effect on the plasma exposure of the DRT.
    Type of Medium: Online Resource
    ISSN: 2048-7207
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 4
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: Studies show that past SARS-CoV-2 infection provides a protective immune response against subsequent COVID-19, but the degree of protection from prior infection has not been determined. History of previous SARS-COV-2 Infection and Current SARS-COV-2 Infection Status at Admission. *Adjusted for chronic respiratory disease and prior COVID-19 vaccination Methods From May 2021 through Feb 2022, adults (≥ 18 years of age) hospitalized at Emory University Hospital and Emory University Hospital Midtown with acute respiratory infection (ARI) symptoms, who were PCR tested for SARS-CoV-2 were enrolled. A prior history of SARS-CoV-2 infection was obtained from patient interview and medical record review. Previous infection was defined as a self-reported prior SARS-CoV-2 infection or previous evidence of a positive SARS-CoV-2 PCR test ≥ 90 days before ARI hospital admission. We performed a test negative design to evaluate the protection provided by prior SARS-CoV-2 infection against subsequent COVID-19-related hospitalization. Effectiveness was determined using logistic regression analysis adjusted for patient sociodemographic and clinical characteristics and COVID-19 vaccination status. Results Of 1152 adults hospitalized for ARI, 704/1152 (61%) were SARS-CoV-2 positive. 96/1152 (8%) had a prior SARS-CoV-2 infection before hospital admission. Patients with a previous history of SARS-CoV-2 infection were less likely to test positive for SARS-CoV-2 upon admission for ARI compared to those who did not have evidence of prior infection (31/96 [32%] vs 673/1056 [64%] ; adjusted OR: 0.25 [0.15, 0.41] (Table). Conclusion Reinfections represented a small proportion ( & lt; 10%) of COVID-19-related hospitalizations. Prior SARS-CoV-2 infection provided meaningful protection against subsequent COVID-19-related hospitalization. The durability of this infection-induced immunity, variant-specific estimates, and the additive impact of vaccination are needed to further elucidate these findings. Disclosures Laura A. Puzniak, PhD. MPH, Merck & Co., Inc.: Stocks/Bonds|Pfizer, Inc.: Stocks/Bonds Robin Hubler, MS, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds Srinivas Valluri, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Benjamin Lopman, PhD, Epidemiological Research and Methods, LLC: Advisor/Consultant Satoshi Kamidani, MD, NIH: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine.|Pfizer: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine. Christina A. Rostad, MD, BioFire Inc, GSK, MedImmune, Micron, Merck, Novavax, PaxVax, Pfizer, Regeneron, Sanofi-Pasteur.: Grant/Research Support|Meissa Vaccines, Inc.: Co-inventor of RSV vaccine technology licensed to Meissa Vaccines, Inc.|NIH (Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines): Grant/Research Support John M. McLaughlin, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Evan J. Anderson, MD, GSK: Advisor/Consultant|GSK: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Kentucky Bioprocessing, Inc: Data Safety Monitoring Board|MedImmune: Grant/Research Support|Medscape: Advisor/Consultant|Merck: Grant/Research Support|Micron: Grant/Research Support|NIH: Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines|PaxVax: Grant/Research Support|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Regeneron: Grant/Research Support|Sanofi Pasteur: Advisor/Consultant|Sanofi Pasteur: Grant/Research Support|Sanofi Pasteur: Data Adjudication and Data Safety Monitoring Boards|WCG and ACI Clinical: Data Adjudication Board.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 5
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. 7 ( 2022-07-04)
    Abstract: Vaccines may play a role in controlling the spread of antibiotic resistance. However, it is unknown if rotavirus vaccination affects antibiotic use in the United States (US). Methods Using data from the IBM MarketScan Commercial Database, we conducted a retrospective cohort of US children born between 2007 and 2018 who were continuously enrolled for the first 8 months of life (N = 2 136 136). We followed children through 5 years of age and compared children who completed a full rotavirus vaccination series by 8 months of age to children who had not received any doses of rotavirus vaccination. We evaluated antibiotic prescriptions associated with an acute gastroenteritis (AGE) diagnosis and defined the switching of antibiotics as the prescription of a second, different antibiotic within 28 days. Using a stratified Kaplan-Meier approach, we estimated the cumulative incidence for each study group, adjusted for receipt of pneumococcal conjugate vaccine, provider type, and urban/rural status. Results Overall, 0.8% (n = 17 318) of participants received an antibiotic prescription following an AGE diagnosis. The 5-year adjusted relative cumulative incidence of antibiotic prescription following an AGE diagnosis was 0.793 (95% confidence interval [CI], .761–.827) among children with complete rotavirus vaccination compared to children without rotavirus vaccination. Additionally, children with complete vaccination were less likely to switch antibiotics (0.808 [95% CI, .743–.887] ). Rotavirus vaccination has averted an estimated 67 045 (95% CI, 53 729–80 664) antibiotic prescriptions nationally among children born between 2007 and 2018. Conclusions These results demonstrate that rotavirus vaccines reduce antibiotic prescribing for AGE, which could help reduce the growth of antibiotic resistance.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 6
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: Whether receipt of COVID-19 vaccine associates with receipt of other routinely-recommended adult vaccines such as, influenza and pneumococcal vaccines is not well described. We evaluated this relationship in a population of adults who were hospitalized for acute respiratory infection (ARI). *Odds ratio describing odds of receiving at least one COVID-19 vaccine (vs not) by influenza vaccination status adjusted for race, employment status, chronic cardiac diseases, cancer, solid organ transplant, and chronic kidney disease.**Odds ratio describing odds of receiving at least one COVID-19 vaccine (vs not) by pneumococcal vaccination status adjusted for race and chronic kidney disease. Methods We enrolled adults (≥ 18 years of age) who were hospitalized at Emory University Hospital and Emory University Hospital Midtown with symptoms consistent with ARI. Participants were interviewed and medical records abstracted to gather demographic information, including social behaviors during the pandemic, medical history, and prior vaccination history (i.e., COVID-19, influenza, and pneumococcal). Using two separate logistic regression analyses, we determined the association between i) receipt of influenza vaccine in the prior year among adults ≥ 18 years and ii) receipt of any pneumococcal vaccine in the prior 5 years among adults ≥ 65 years on the receipt of at least one COVID-19 vaccine≥ 14 days prior to admission. Adjusted models included demographic information (e.g., age, sex, race/ethnicity, employment status), social behaviors, and history of chronic medical conditions. Results Overall, 1056 participants were enrolled and had vaccination records available. Of whom, 509/1056 (48.2%) had received at least one dose of COVID-19 vaccine. Adults ≥ 18 years who received influenza vaccine were more likely to have received ≥1 dose of COVID-19 vaccine compared to those who did not (267/373 [71.6%] vs 242/683 [35.4%] P= & lt; .0001; adjusted odds ratio [OR]: 3.3 [95%CI: 2.4, 4.4] ). Similarly, adults ≥65 years who received pneumococcal vaccine were more likely to have received ≥ 1 dose of COVID-19 vaccine compared to those who did not (195/257 [75.9%] vs 41/84 [48.8%] P= & lt; .0001; adjusted odds ratio [OR]: 3.0 [95%CI: 1.8, 5.1] ). Conclusion In this study of adults hospitalized for ARI, receipt of influenza and pneumococcal vaccination strongly correlated with receipt of COVID-19 vaccination. Continued efforts are needed to reach adults who remain hesitant to not only receive COVID-19 vaccines, but also other vaccines that lessen the burden of respiratory illness. Disclosures Laura A. Puzniak, PhD. MPH, Merck & Co., Inc.: Stocks/Bonds|Pfizer, Inc.: Stocks/Bonds Robin Hubler, MS, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds Srinivas Valluri, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Benjamin Lopman, PhD, Epidemiological Research and Methods, LLC: Advisor/Consultant Satoshi Kamidani, MD, NIH: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine.|Pfizer: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine. Christina A. Rostad, MD, BioFire Inc, GSK, MedImmune, Micron, Merck, Novavax, PaxVax, Pfizer, Regeneron, Sanofi-Pasteur.: Grant/Research Support|Meissa Vaccines, Inc.: Co-inventor of RSV vaccine technology licensed to Meissa Vaccines, Inc.|NIH (Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines): Grant/Research Support John M. McLaughlin, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Evan J. Anderson, MD, GSK: Advisor/Consultant|GSK: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Kentucky Bioprocessing, Inc: Data Safety Monitoring Board|MedImmune: Grant/Research Support|Medscape: Advisor/Consultant|Merck: Grant/Research Support|Micron: Grant/Research Support|NIH: Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines|PaxVax: Grant/Research Support|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Regeneron: Grant/Research Support|Sanofi Pasteur: Advisor/Consultant|Sanofi Pasteur: Grant/Research Support|Sanofi Pasteur: Data Adjudication and Data Safety Monitoring Boards|WCG and ACI Clinical: Data Adjudication Board.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 7
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 8, No. Supplement_1 ( 2021-12-04), p. S757-S758
    Abstract: Acute respiratory tract infections (ARIs) are a significant cause of morbidity in adults. Influenza is associated with about 490,600 hospitalizations and 34,200 deaths in the US in the 2018-2019 season. The burden of rhinovirus among adults hospitalized with ARI is less well known. We compared the burden of influenza and rhinovirus from 2 consecutive winter respiratory viral seasons in hospitalized adults and healthy controls pre-COVID-19 and one season mid-COVID-19 to determine the impact of rhinovirus as a pathogen. Methods From Oct 2018 to Apr 2021, prospective surveillance of adults ≥50 years old admitted with ARI or COPD/CHF exacerbations at any age was conducted at two Atlanta hospitals. Adults were eligible if they lived within an eight-county region around Atlanta and if their symptom duration was & lt; 14 days. In the seasons from Oct 2018 to Mar 2020, asymptomatic adults ≥50 years old were enrolled as controls. Standard of care test results were included and those enrolled contributed nasopharyngeal swabs that were tested for respiratory pathogens using BioFire® FilmArray® Respiratory Viral Panel (RVP). Results During the first two seasons, 1566 hospitalized adults were enrolled. Rhinovirus was detected in 7.5% (118) and influenza was detected in 7.7% (121). Rhinovirus was also detected in 2.2% of 466 healthy adult controls while influenza was detected in 0%. During Season 3, the peak of the COVID-19 pandemic, influenza declined to 0% of ARI hospitalizations. Rhinovirus also declined (p=0.01) but still accounted for 5.1% of all ARIs screened (Figure 1). Rhinovirus was detected at a greater rate in Season 3 than in asymptomatic controls in the first 2 seasons (p=0.008). In the first two seasons, Influenza was detected in 8.6% (24/276) of those admitted to the ICU. Rhinovirus was detected in 6.1% (17/276) of those admitted to the ICU but declined to 3.1% (8/258) in Season 3. Figure 1. Percent Positive Cases of Influenza and Rhinovirus between Season 1 & 2 (hospitalized and healthy controls) vs Season 3 (hospitalized) Conclusion Dramatic declines occurred in influenza in adults hospitalized with ARI, CHF, or COPD in Atlanta during the COVID-19 pandemic and with enhanced public health measures. Although rhinovirus declined during the COVID-19 pandemic, it continued to be identified at a rate higher than in historical controls. Additional data are needed to understand the role of rhinovirus in adult ARI, CHF, and COPD exacerbations. Disclosures David L. Swerdlow, MD, Pfizer Vaccines (Employee) Robin Hubler, MS, Pfizer Inc. (Employee) Christina A. Rostad, MD, BioFire Inc, GSK, MedImmune, Micron, Janssen, Merck, Moderna, Novavax, PaxVax, Pfizer, Regeneron, Sanofi-Pasteur. (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)Meissa Vaccines (Other Financial or Material Support, Co-inventor of patented RSV vaccine technology unrelated to this manuscript, which has been licensed to Meissa Vaccines, Inc.) Larry Anderson, MD, ADVI (Consultant)Bavarian Nordic (Consultant)Novavax (Consultant)Phizer (Grant/Research Support, Scientific Research Study Investigator)Sciogen (Research Grant or Support) Nadine Rouphael, MD, pfizer, sanofi, lily, quidel, merck (Grant/Research Support) Nadine Rouphael, MD, Lilly (Individual(s) Involved: Self): Emory Study PI, Grant/Research Support; Merck (Individual(s) Involved: Self): Emory study PI, Grant/Research Support; Pfizer: I conduct as co-PI the RSV PFIZER study at Emory, Research Grant; Pfizer (Individual(s) Involved: Self): Grant/Research Support, I conduct as co-PI the RSV PFIZER study at Emory; Quidel (Individual(s) Involved: Self): Emory Study PI, Grant/Research Support; Sanofi Pasteur (Individual(s) Involved: Self): Chair phase 3 COVID vaccine, Grant/Research Support Evan J. Anderson, MD, GSK (Scientific Research Study Investigator)Janssen (Consultant, Scientific Research Study Investigator, Advisor or Review Panel member)Kentucky Bioprocessing, Inc (Advisor or Review Panel member)MedImmune (Scientific Research Study Investigator)Medscape (Consultant)Merck (Scientific Research Study Investigator)Micron (Scientific Research Study Investigator)PaxVax (Scientific Research Study Investigator)Pfizer (Consultant, Grant/Research Support, Scientific Research Study Investigator)Regeneron (Scientific Research Study Investigator)Sanofi Pasteur (Consultant, Scientific Research Study Investigator)
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 8
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: During the COVID-19 pandemic, social interventions such as social distancing and mask wearing have been encouraged. Social risk factors for SARS-CoV-2 infection and subsequent hospitalization remain uncertain. Methods Adult patients were eligible if admitted to Emory University Hospital or Emory University Hospital Midtown with acute respiratory infection (ARI) symptoms (≤ 14 days) or an admitting ARI diagnosis from May 2021 – Feb 2022. After enrollment, an in-depth interview identified demographic and social factors (e.g., employment status, smoking history, alcohol use), household characteristics, and pandemic social behaviors. All patients were tested for SARS-CoV-2 using PCR. We evaluated whether these demographic and social factors were related to a positive SARS-CoV-2 test upon admission to hospital with ARI using a logistic regression model. Results 1141 subjects were enrolled and had SARS-CoV-2 PCR results available (700 positive and 441 negative). The median age was greater in the SARS-CoV-2 negative cohort than in the positive cohort (60 and 53 years, respectively; P & lt; .0001). Those who tested positive were more likely to have had at least some college education compared to those who tested negative (64.3% vs 52.3%, P & lt; .0001; adjusted odds ratio [aOR]: 1.4 [95%CI: 1.1, 2.0] ). Compared to those who tested negative, those who were SARS-CoV-2 positive were also more likely to be employed (48.9% vs 26.5%, P & lt; .0001; aOR: 1.7 [95%CI: 1.1, 2.3]), have children 5-17 yo at home (27.6% vs 17.9%, P=.0002; aOR: 1.5 [95%CI: 1.1, 2.1] ). Those with COVID-19 were less likely to receive home healthcare (6.2% vs 13.3%, P & lt; .0001; aOR: 0.5 [95%CI: 0.4, 0.9]) and to be a current or previous smoker (7.6% vs 17.7%, P & lt; .0001; aOR: 0.3 [95%CI: 0.2, 0.5]). Conclusion Among adults admitted to the hospital for ARI, those who tested positive for SARS-CoV-2 were typically younger, more likely to care for school-aged children, more likely to work outside the home, but were less likely to receive home healthcare or smoke. Personal and public health strategies to mitigate COVID-19 should take into consideration modifiable social risk factors. Disclosures Laura A. Puzniak, PhD. MPH, Merck & Co., Inc.: Stocks/Bonds|Pfizer, Inc.: Stocks/Bonds Robin Hubler, MS, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds Srinivas Valluri, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Benjamin Lopman, PhD, Epidemiological Research and Methods, LLC: Advisor/Consultant Satoshi Kamidani, MD, NIH: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine.|Pfizer: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine. Christina A. Rostad, MD, BioFire Inc, GSK, MedImmune, Micron, Merck, Novavax, PaxVax, Pfizer, Regeneron, Sanofi-Pasteur.: Grant/Research Support|Meissa Vaccines, Inc.: Co-inventor of RSV vaccine technology licensed to Meissa Vaccines, Inc.|NIH (Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines): Grant/Research Support John M. McLaughlin, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Evan J. Anderson, MD, GSK: Advisor/Consultant|GSK: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Kentucky Bioprocessing, Inc: Data Safety Monitoring Board|MedImmune: Grant/Research Support|Medscape: Advisor/Consultant|Merck: Grant/Research Support|Micron: Grant/Research Support|NIH: Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines|PaxVax: Grant/Research Support|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Regeneron: Grant/Research Support|Sanofi Pasteur: Advisor/Consultant|Sanofi Pasteur: Grant/Research Support|Sanofi Pasteur: Data Adjudication and Data Safety Monitoring Boards|WCG and ACI Clinical: Data Adjudication Board.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 9
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 6, No. Supplement_2 ( 2019-10-23), p. S793-S794
    Abstract: Data are limited about the burden of respiratory syncytial virus (RSV)-related hospitalizations in older adults and those with COPD or CHF. Methods We conducted prospective surveillance at two hospitals from October 2018 to March 2019 for adults ≥50 years of age admitted with acute respiratory infections (ARI) and adults of any age with COPD or CHF-related admissions. Adults were eligible if they were residents of an 8 county region in Atlanta, Georgia. Asymptomatic adults ≥50 years of age were enrolled as controls. Nasopharyngeal and oropharyngeal swabs were tested for RSV and influenza (Flu) using BioFire® FilmArray® Respiratory Viral Panel (RVP) and acute/convalescent serology was obtained for RSV antibodies detection by enzyme immunoassay against RSV lysate. Standard of care results were included for enrollees. We compare the number of RSV+, Flu+ and RSV−/Flu− cases along with demographic features and outcomes. Results We screened 12,453 patients to identify 1,515 eligible adults of which 617 (41%) were enrolled. The most common reasons for failing to enroll were refusal (676, 75%) and inability to obtain informed consent (221, 25%). Of the 617, 36 (6%) were RSV+ and 41 (7%) were Flu+. RSV was detected in 1/126 (0.8%) and Flu in 0/126 healthy controls. RSV+ occurred earlier in surveillance and peaked at a higher frequency (figure). Clinical characteristics and outcomes are in the table. In a convenience sample, a four-fold rise in RSV antibody titer was detected among 8/15 RSV+, 0/42 RSV−/Flu−, and 0/42 healthy controls. Conclusion The burden and outcomes for RSV are similar to Flu in adults admitted to the hospital with ARI, CHF, or COPD. A vaccine for RSV would be beneficial. Disclosures Nadine Rouphael, MD, Merck: I conduct as Emory PI the PNEUMO MERCK study at Emory, Research Grant; Pfizer: I conduct as co-PI the RSV PFIZER study at Emory, Research Grant; Sanofi-Pasteur: I conducted as Emory PI the CDIFFENSE trial at Emory, Research Grant.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 10
    In: Clinical Infectious Diseases, Oxford University Press (OUP), Vol. 73, No. 10 ( 2021-11-16), p. 1759-1767
    Abstract: Vaccination is the primary strategy to reduce influenza burden. Influenza vaccine effectiveness (VE) can vary annually depending on circulating strains. Methods We used a test-negative case-control study design to estimate influenza VE against laboratory-confirmed influenza-related hospitalizations among children (aged 6 months–17 years) across 5 influenza seasons in Atlanta, Georgia, from 2012–2013 to 2016–2017. Influenza-positive cases were randomly matched to test-negative controls based on age and influenza season in a 1:1 ratio. We used logistic regression models to compare odds ratios (ORs) of vaccination in cases to controls. We calculated VE as [100% × (1 – adjusted OR)] and computed 95% confidence intervals (CIs) around the estimates. Results We identified 14 596 hospitalizations of children who were tested for influenza using the multiplex respiratory molecular panel; influenza infection was detected in 1017 (7.0%). After exclusions, we included 512 influenza-positive cases and 512 influenza-negative controls. The median age was 5.9 years (interquartile range, 2.7–10.3), 497 (48.5%) were female, 567 (55.4%) were non-Hispanic Black, and 654 (63.9%) children were unvaccinated. Influenza A accounted for 370 (72.3%) of 512 cases and predominated during all 5 seasons. The adjusted VE against influenza-related hospitalizations during 2012–2013 to 2016–2017 was 51.3% (95% CI, 34.8% to 63.6%) and varied by season. Influenza VE was 54.7% (95% CI, 37.4% to 67.3%) for influenza A and 37.1% (95% CI, 2.3% to 59.5%) for influenza B. Conclusions Influenza vaccination decreased the risk of influenza-related pediatric hospitalizations by  & gt;50% across 5 influenza seasons.
    Type of Medium: Online Resource
    ISSN: 1058-4838 , 1537-6591
    RVK:
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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