Influenza Virus Vaccines Commons^™

Research Support Infrastructure: Implementing A Clinical Research Coordinating Center, Julio A. Ramirez, Paula Peyrani, William A. Mattingly, Forest W. Arnold, Timothy L. Wiemken, Robert R. Kelley, Leslie A. Wolf, Ruth M. Carrico, Andrea Reyes-Vega

Faculty and Staff Scholarship

Insufficient infrastructure is one of the challenges facing investigators in the field of clinical research. At the University of Louisville (UofL) Division of Infectious Diseases, we developed a multidisciplinary coordinating center with the aim to support investigators in all aspects of the clinical research process. The objective of this article is to describe the composition and the role of the different units of the UofL Clinical Research Coordinating Center. The different components of the Center can serve as a template for institutions interested in developing a clinical research support infrastructure.

Seroprevalence Of Anti-Polio Antibodies In Children From Polio High Risk Area Of Afghanistan: A Cross Sectional Survey 2017, Imtiaz Hussain, Ondrej Mach, Nasir A. Hamid, Zaid Bhatti, Deborah D. Moore, Shahid Khan, Hasan Khan, William C. Weldon, Zulfiqar Ahmed Bhutta, Sajid Bashir Soofi

Department of Paediatrics and Child Health

Background: Afghanistan is one of the remaining wild-poliovirus (WPV) endemic countries. We conducted a seroprevalence survey of anti-poliovirus antibodies in Kandahar Province.
Methods: Children in two age groups (6–11 months and 36–48 months) visiting Mirwais hospital in Kandahar for minor ailments unrelated to polio were enrolled. After obtaining informed consent, we collected venous blood and conducted neutralization assay to detect poliovirus neutralizing antibodies.
Results: A total of 420 children were enrolled and 409/420 (97%) were analysed. Seroprevalence to poliovirus type 1 (PV1) was 97% and 100% in the younger and older age groups respectively; it was 71% and 91% for …

Vaccine Epidemiology And Decision-Making: A Bryant Student Focus, Hannah Coburn

Honors Projects in Science and Technology

The Centers for Disease Control and Prevention estimate that influenza has resulted in between 9.2 and 35.6 million illnesses and between 12,000 and 56,000 deaths annually since 2010 (1). Annual influenza vaccination remains to be the most effective way in controlling the spread and symptom severity of influenza infections (1). Influenza infections are especially virulent on college campuses as a dense population of students interact in close quarters such as shared housing, bathrooms, dining halls, classrooms, and social activities (2). Despite influenza vaccinations being safe, effective, easily accessible to Bryant University students, and free of cost, many students choose not …

Associations Between Nurse Experience, Clinical Specialty Setting, And Level Of Nursing Education With Adherence To Clinical Practice Guidelines For Inpatient Influenza And Pneumococcal Vaccination Administration, Amy C. Alsante, Dnp, Ms, Rn, Ne-Bc, Chep

Doctor of Nursing Practice Projects

Background: This research project examines associations between years of nursing practice and compliance with clinical practice guidelines for inpatient influenza/pneumococcal vaccination administration. Previous research demonstrates novice nurses are at higher risk for errors of omission and face challenges with critical thinking.

Objectives: 1) Identify associations between years of practice and compliance with clinical practice guidelines for inpatient influenza/pneumococcal vaccination administration and 2) to identify associations among independent variables including levels of education, and specialty setting.

Methods: A retrospective chart review was conducted to identify associations between years of practice and compliance with clinical practice guidelines for inpatient influenza/pneumococcal vaccination administration. …

Evaluation Of Vaccine Derived Poliovirus Type 2 Outbreak Response Options: A Randomized Controlled Trial, Karachi, Pakistan, Ali Faisal Saleem Dr, Mohammad Tahir Yousafzai, Ondrej Mach, Asia Khan, Farheen Quadri, William C. Weldon, M. Steven Oberste, Syed S. Zaidi, Muhammad M. Alam, Anita K. M. Zaidi

Department of Paediatrics and Child Health

Background: Outbreaks of circulating vaccine derived polioviruses type 2 (cVDPV2) remain a risk to poliovirus eradication in an era without live poliovirus vaccine containing type 2 in routine immunization. We evaluated existing outbreak response strategies recommended by the World Health Organization (WHO) for control of cVDPV2 outbreaks.
Methods: Seronegative children for poliovirus type 2 (PV2) at 22 weeks of life were assigned to one of four study groups and received respectively (1) one dose of trivalent oral poliovirus vaccine (tOPV); (2) monovalent OPV 2 (mOPV2); (3) tOPV together with a dose of inactivated poliovirus vaccine (IPV); or (4) mOPV2 with …

Tanzania: Hiv/Aids, Francis Faasen

Global Public Health

Tanzania has a lot of issues going on in the community, but HIV/AIDS is the number one issue they are facing. Over 5% of their population has the HIV/Aids virus. There are many interventions that have been tried in Tanzania. In the last year there have been over 50,000 new cases of HIV/Aids in Tanzania. The goal is to main those numbers go down dramatically in the coming years. The two most common interventions are trying to educate this subject at a young age and provide condoms to the population. They tried giving condoms out to the people of Tanzania …

A Comparison Of Three Diagnostic Platforms For The Detection Of Influenza A And B In Children, Furqan Kabir, Marvi Tariq, Fatima Aziz, Syed Imran Rizvi, Shahida Qureshi, Syed Asad Ali, Najeeha Talat Iqbal

Department of Paediatrics and Child Health

Background: Viral flu is the predominant cause of hospitalization in young children, which invariably leads to enhanced morbidity and mortality in children in developing countries. Initial treatment of viral flu is based on presumptive diagnosis. Bedside testing is not common in clinical settings because of variable sensitivity and specificity of rapid tests in different settings.
Methods: To address this issue, we evaluated the performance of Binax influenza A/B rapid testing kit against two robust molecular platforms (quantitative real-time polymerase chain reaction [qRT-PCR] and TaqMan array card [TAC]) in 24 nasopharyngeal (NP) swabs, collected from children under 5 years of age. …

Six-Year Experience Of Influenza Vaccination As A Condition Of Employment For A Large Regional Health Care System, John R. Brill, Mark Hermanoff, Angela Tonozzi, Mary Jo Capodice, Jennifer Farrar, Zarina Dawoodbhai

Journal of Patient-Centered Research and Reviews

Background: Influenza remains a significant contributor to morbidity and mortality in the United States. Health care workers (HCW) can be both victims and vectors of influenza. Influenza vaccination of HCW is protective for both caregivers and patients, but voluntary programs generally fail to achieve rates recommended by the Centers for Disease Control and Prevention. Despite a complex, multifaceted influenza program initiated in 1996 that included significant education and promotion as well as free on-site vaccination, annual Aurora Health Care caregiver immunization rates remained in the mid-70s until adoption of a “condition of employment” strategy in 2011.

Purpose: Discuss the annual …

When Is Affect Variability Bad For Health? The Association Between Affect Variability And Immune Response To The Influenza Vaccination, Brooke N. Jenkins, John F. Hunter, Marie P. Cross, Amanda M. Acevedo, Sarah D. Pressman

Psychology Faculty Articles and Research

Objectives—This study addresses methodological and theoretical questions about the association between affect and physical health. Specifically, we examine the role of affect variability and its interaction with mean levels of affect to predict antibody (Ab) levels in response to an influenza vaccination.

Methods—Participants (N = 83) received the vaccination and completed daily diary measures of affect four times a day for 13 days. At one and four months post-vaccination, blood was collected from the participants to assess Ab levels.

Results—Findings indicate that affect variability and its interaction with mean levels of affect predict an individual’s immune response. …

Preliminary Evaluation Of An Lyta Pcr Assay For Detection Of Streptococcus Pneumoniae In Urine Specimens From Hospitalized Patients With Community-Acquired Pneumonia, Subathra Marimuthu, James T. Summersgill, Kuldeep Ghosh, Leslie A Wolf

The University of Louisville Journal of Respiratory Infections

Community acquired pneumonia (CAP) due to Streptococcus pneumoniae still occurs in at risk populations, despite the availability of effective vaccines. Laboratory confirmation of S. pneumoniae remains challenging in cases of CAP despite advances in blood culture techniques and the availability of nucleic acid amplification tests such as PCR-based methods. Urine specimens are an attractive sample type because they are non-invasive compared to bronchial washes or whole blood specimens for patients with CAP. While urine specimens have been used successfully in antigen detection assays, they have not been extensively evaluated for PCR-based assays. In this preliminary study, we evaluated the potential …

Distributing Data And Analysis Software Containers For Better Data Sharing In Clinical Research, William A. Mattingly Phd, Stephen Furmanek, Christopher M. Sinclair, Timothy L. Wiemken Phd

The University of Louisville Journal of Respiratory Infections

Introduction: Data sharing in clinical research is critical for increasing knowledge discovery. Data and software tools should be FAIR: Findable, Accessible, Inter-operable and Re-usable. Many bottlenecks exist in the process of a clinical investigator using shared data including data acquisition and statistical analysis. The objective of this project is to develop a structure for sharing data and providing rapid automated statistical analysis through creation of a pre-packaged, open-source software container.

Methods: We use the open source software container technologies VirtualBox and Vagrant to create a template for sharing clinical data and analysis scripts as a single container. We use …

Streptococcus Pneumoniae Antigen, Missing Opportunities Of A Promising Point Of Care Diagnostic Test, Magdelina Słomka, Ruby Gupta, Baltej Singh, Venkatesh Gondhi, Siddartha Bhandary, Ekezie Francis, Jose Bordon

The University of Louisville Journal of Respiratory Infections

Background: The etiologic diagnosis of community acquired pneumonia (CAP) and community-acquired meningitis (CAM) are still far from optimal accuracy and turnaround time. The most common bacterial pathogen identified in both CAP and CAM is Streptococcus pneumoniae.

Methods: We reviewed the literature on S. pneumoniae antigen to highlight opportunities to optimize its use as a point of care diagnostic test to maximize quality of patient care, antimicrobial stewardship outcomes and cost saving. A PubMed search was performed using key words “S. pneumoniae antigen; rapid diagnostic tests for S. pneumoniae”. We selected articles in English and sorted into randomized …

Level Of Recall Bias Regarding Pneumococcal Vaccination History Among Adults Hospitalized With Community-Acquired Pneumonia: Results From The University Of Louisville Pneumonia Study, Sarah Van Heiden, Ruth Carrico, Timothy L. Wiemken, Ronika Alexander, John M. Mclaughlin, Qin Jiang, Paula Peyrani, William A. Mattingly, Stephen P. Furmanek, Connor L. English, Senen Pena, Raul Isturiz, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

Background: Recall bias is likely to occur in vaccine effectiveness studies using self-reported vaccination history. The validity of patient-reported vaccination status for adults is not well defined. The objective of this study was to evaluate the validity of self-reported pneumococcal vaccination history among patients hospitalized with community-acquired pneumonia (CAP).

Methods: Prospective ancillary study of a population-based observational study of hospitalized patients with CAP in the city of Louisville. To be included in the analysis, patients had to (i) be reached by phone 30-days after discharge from the hospital and (ii) report that they remembered whether or not they received a …

One-Year Mortality In Patients With Community-Acquired Pneumonia, Paula Peyrani, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

Pneumonia remains a common cause of morbidity and mortality in the US. Although, communityacquired pneumonia (CAP) has traditionally been considered an acute process, more recently, data have emerged showing that patients surviving an episode of CAP are at increased risk of death long after hospital discharged. In this descriptive review, we examine the current knowledge of long-term mortality and propose a hypothesis explaining the pathogenesis of long-term mortality in patients with CAP.

Most Common Statistical Methodologies In Recent Clinical Studies Of Community-Acquired Pneumonia, Stephen Furmanek, Connor L. English, Thomas Chandler, Timothy L. Wiemken Phd

The University of Louisville Journal of Respiratory Infections

Background: Training new individuals in pneumonia research is imperative to produce a new generation of clinical investigators with the expertise necessary to fill gaps in knowledge. Clinical investigators are often intimidated by their unfamiliarity with statistics. The objective of this study is to define the most common statistical methodologies in recent clinical studies of CAP to inform teaching approaches in the field.

Methods: Articles met inclusion criteria if they were clinical research with an emphasis on incidence, epidemiology, or patient outcomes, searchable via PubMed or Google Scholar, published within the timeframe of January 1st 2012 to August 1st 2017, …

Antimicrobial Stewardship In Hospitalized Patients With Respiratory Infections: Ten-Year Experience From The Robley Rex Louisville Va Medical Center, Leslie A. Beavin, Forest W. Arnold, Paula Peyrani, Anupama Raghuram, David Newman, Ronald Smith, Carmen Sciortino, Stephen P. Furmanek, Ruth M. Carrico, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

Rationale: Antibiotic stewardship has been defined as coordinated interventions designed to improve and measure the appropriate use of antibiotic agents. Respiratory infections are the most common infectious reason for hospitalization in the United States. Therefore, one could extrapolate that respiratory infections are then also the most common reason for hospital antibiotic use and possess the highest potential for hospital antibiotic misuse. The primary objective of this article was to evaluate the role of antimicrobial stewardship on improving antibiotic use for respiratory infections in hospitalized patients on intravenous (IV) antibiotics at the Robley Rex Louisville VAMC over a 10-year period.

Methods: …

Rationale And Methods Of The Study Protocol: Streptococcus Pneumoniae Serotypes In Adults 18 Years And Older With Radiographically-Confirmed Community-Acquired Pneumonia (Cap), Ronika Alexander, Paula Peyrani, Julio A. Ramirez, Wesley H. Self Md, Mph, Carlos Grijalva, Francis Counselman, Gregory A. Volturo, Heidi Kabler, Luis Ostrosky-Zeichner, Richard Wunderink, Robert L. Sherwin, Senen Pena, Thomas File, Timothy L. Wiemken, Sharon Gray, Michael Pride, Kimbal D. Ford, Qin Jiang, Raul Isturiz

The University of Louisville Journal of Respiratory Infections

This study was an active, prospective surveillance study of adults 18 years and older hospitalized with community-acquired pneumonia (CAP) due to Streptococcus pneumoniae conducted at 21 hospitals in ten cities across the United States. This report describes the surveillance methodology applied between October 7, 2013 and September 30, 2016, including the identification and description of surveillance areas and populations at-risk for CAP hospitalization for estimation of incidence rates for selected study sites.

Pneumonia Pathogenesis And The Lung Microbiome: Back To The Drawing Board, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

No abstract provided.

Lung Cytokines And Systemic Inflammation In Patients With Copd, Alessandra Morello Gearhart, Rodrigo Cavallazzi, Paula Peyrani, Timothy L. Wiemken, Stephen P. Furmanek, Andrea Reyes-Vega, Umair Gauhar, Hiram Rivas-Perez, Jesse Roman, Julio A. Ramirez, Rafael Fernandez-Botran

The University of Louisville Journal of Respiratory Infections

Rationale: Chronic obstructive pulmonary disease (COPD) is characterized by lung and systemic inflammation. The role of cytokines in local and systemic inflammation in COPD is not well understood. This study aimed to compare plasma and bronchoalveolar lavage (BAL) fluid cytokine levels in COPD and non-COPD subjects with the intent of better understand their potential roles in driving local and systemic inflammation.

Methods: This cross-sectional study analyzed data from 65 subjects: 31 with COPD confirmed by spirometry and 34 non-COPD controls. All subjects underwent spirometry, plasma sample collection, and bronchoscopy/BAL. Levels of 21 inflammatory cytokines were measured in the plasma (systemic …

Using Steroids In Patients With Community-Acquired Pneumonia At The University Of Louisville Hospital: Who, What, And When, Rodrigo Cavallazzi, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

No abstract provided.

Lung Cytokines And Systemic Inflammation In Patients With Copd., Alessandra Morello Gearhart, Rodrigo Cavallazzi, Paula Peyrani, Timothy L. Wiemken, Stephen P. Furmanek, Andrea Reyes-Vega, Umair Gauhar, Hiram Rivas-Perez, Jesse Roman, Julio A. Ramirez, Rafael Fernandez-Botran

Faculty and Staff Scholarship

Rationale: Chronic obstructive pulmonary disease (COPD) is characterized by lung and systemic inflammation. The role of cytokines in local and systemic inflammation in COPD is not well understood. This study aimed to compare plasma and bronchoalveolar lavage (BAL) fluid cytokine levels in COPD and non-COPD subjects with the intent of better understand their potential roles in driving local and systemic inflammation.

Methods: This cross-sectional study analyzed data from 65 subjects: 31 with COPD confirmed by spirometry and 34 non-COPD controls. All subjects underwent spirometry, plasma sample collection, and bronchoscopy/BAL. Levels of 21 inflammatory cytokines were measured in the plasma (systemic …

Case-Control Vaccine Effectiveness Studies: Data Collection, Analysis And Reporting Results, Jennifer R. Verani, Abdullah H. Baqui, Claire V. Broome, Thomas Cherian, Cheryl Cohen, Jennifer L. Farrar, Daniel R. Feikin, Michelle J. Groome, Rana A. Hajjeh, Anita K. M. Zaidi

Department of Paediatrics and Child Health

The case-control methodology is frequently used to evaluate vaccine effectiveness post-licensure. The results of such studies provide important insight into the level of protection afforded by vaccines in a 'real world' context, and are commonly used to guide vaccine policy decisions. However, the potential for bias and confounding are important limitations to this method, and the results of a poorly conducted or incorrectly interpreted case-control study can mislead policies. In 2012, a group of experts met to review recent experience with case-control studies evaluating vaccine effectiveness; we summarize the recommendations of that group regarding best practices for data collection, analysis, …

Case-Control Vaccine Effectiveness Studies: Preparation, Design, And Enrollment Of Cases And Control, Jennifer R. Verani, Abdullah H. Baqui, Claire V. Broome, Thomas Cherian, Cheryl Cohen, Jennifer L. Farrar, Daniel R. Feikin, Michelle J. Groome, Rana A. Hajjeh, Anita K. M. Zaidi

Department of Paediatrics and Child Health

Case-control studies are commonly used to evaluate effectiveness of licensed vaccines after deployment in public health programs. Such studies can provide policy-relevant data on vaccine performance under 'real world' conditions, contributing to the evidence base to support and sustain introduction of new vaccines. However, case-control studies do not measure the impact of vaccine introduction on disease at a population level, and are subject to bias and confounding, which may lead to inaccurate results that can misinform policy decisions. In 2012, a group of experts met to review recent experience with case-control studies evaluating the effectiveness of several vaccines; here we …

Pneumonia Research And The Omics Revolution: It Is Time For Pneumomics, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

No abstract provided.

A New Journal Section: Patient Management, Forest W. Arnold, Rodrigo Cavallazzi

The University of Louisville Journal of Respiratory Infections

No abstract provided.

Impact Of Obesity On Mortality In Hospitalized Patients With Pneumonia Due To 2009 H1n1 Influenza A Virus Versus Other Etiologies, Martin A. Espinosa-Ginic, Ryan T. Hurt, Stephen P. Furmanek, Paula Peyrani, Julio A. Ramirez, Timothy Lee Wiemken, The Capo Investigators

The University of Louisville Journal of Respiratory Infections

Background: Reports from the 2009 H1N1 influenza A virus (2009 H1N1) pandemic indicate increased mortality in obese patients hospitalized with pneumonia. However, articles published prior to the pandemic have suggested that obesity may be a protective factor for mortality in these patients. The objective of this study was to compare the impact of obesity on mortality in hospitalized patients with pneumonia due to the 2009 H1N1 versus pneumonia due to other etiologies.

Methods: This was a secondary analysis of the CAPO international cohort study. Study groups were defined as follows: Group One, pneumonia due to 2009 H1N1: Patients hospitalized with …

Short Duration Of Antibiotic Therapy In Hospitalized Patients With Community-Acquired Pneumonia: Results From The Capo International Cohort Study, Alejandro Chirino Navarta, Paula Peyrani, Timothy L. Wiemken, Marcos I. Restrepo, James D. Chalmers, Carlos M. Luna, Francesco Blasi, Julio A. Ramirez, Stefano Aliberti

The University of Louisville Journal of Respiratory Infections

Introduction: Experts suggest a short duration of antibiotic therapy (DOT) in responding patients with community-acquired pneumonia (CAP). The aim of this study was to evaluate clinical outcomes after hospital discharge among patients treated with short-course antibiotic therapy (SCT) vs. long-course antibiotic therapy (LCT) for CAP.

Methods: A secondary analysis of the Community-Acquired Pneumonia Organization (CAPO) database from January 2007 to June 2013 was performed, including hospitalized CAP patients who reached clinical stability within 5 days. Two groups were identified: patients who were treated with antibiotic therapy for a total duration of 5 days or less (SCT Group) vs. …

The Community-Acquired Pneumonia Organization (Capo) Cloud-Based Research Platform (The Capo-Cloud): Facilitating Data Sharing In Clinical Research, William A. Mattingly, Timothy L. Wiemken, Stephen P. Furmanek, Paula Peyrani, Robert R. Kelley, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

Background: Pneumonia is a costly and deadly respiratory disease that afflicts millions every year. Advances in pneumonia care require significant research investment and collaboration among pneumonia investigators. Despite the importance of data sharing for clinical research it remains difficult to share datasets with old and new investigators. We present CAPOCloud, a web-based pneumonia research platform intended to facilitate data sharing and make data more accessible to new investigators.

Methods: We establish the first two use cases for CAPOCloud to be the automatic subsetting and constraining of the CAPO database and the automatic summarization of the database in aggregate. We use …

A 49-Year-Old Woman With Chronic Skin Lesions, Acute Mental Status Changes And New Pulmonary Infiltrate: Case Discussion From The University Of Louisville Hospital, Bhavani Puskur, Youssef Khafateh, Srikant Ramachandruni, Veronica Corcino, Mark Burns, Forest W. Arnold

The University of Louisville Journal of Respiratory Infections

No abstract provided.

Clinical Research: Educational Videos - The Process Of Clinical Research: Step-By-Step From Idea To Publication, Julio A. Ramirez

The University of Louisville Journal of Respiratory Infections

Clinical research can be defined as the creation and dissemination of new knowledge with the goal to improve outcomes in patients with a particular health problem. In this short video, Dr. Julio Ramirez, from the University of Louisville, offers an overview of the process of clinical research and describe how an investigator moves from the generation of an idea to the publication of study findings.