C. Buddy Creech
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View article: Inclusion of Women, Children, the Elderly, and Individuals With Underlying Medical Conditions: Prioritizing Vulnerable Populations in Clinical Research
Inclusion of Women, Children, the Elderly, and Individuals With Underlying Medical Conditions: Prioritizing Vulnerable Populations in Clinical Research Open
For over 60 years, the National Institutes of Health (NIH)-funded Vaccine and Treatment Evaluation Units (VTEUs) have led national efforts in vaccine development, evaluation of novel treatment of infectious diseases, and pandemic preparedn…
View article: Clinical immunization safety assessment (CISA) project: COVID-19 vaccine consultations and case reviews
Clinical immunization safety assessment (CISA) project: COVID-19 vaccine consultations and case reviews Open
Despite low participation rate in satisfaction and patient follow-up surveys, the CISA consultation service provided timely COVID-19 vaccine safety evaluations for HCPs through comprehensive clinical case consultations and vaccine safety g…
View article: Immunologic profiling of the infant immune response to whole-cell and acellular pertussis vaccines
Immunologic profiling of the infant immune response to whole-cell and acellular pertussis vaccines Open
Despite robust antibody responses, immunity induced by acellular pertussis vaccine (DTaP) wanes over time and risk of pertussis seems to be lower in children who receive whole-cell vaccine (DTP) as their first dose. To interrogate the earl…
View article: Systems biology-based assessment of immune responses to whole cell and acellular pertussis vaccines
Systems biology-based assessment of immune responses to whole cell and acellular pertussis vaccines Open
View article: Evolution of strain diversity and virulence factor repertoire in pediatric Staphylococcus aureus isolates
Evolution of strain diversity and virulence factor repertoire in pediatric Staphylococcus aureus isolates Open
Background Invasive Staphylococcus aureus infections cause high morbidity and mortality in children and adults. With rising antimicrobial resistance, optimal prevention strategies and novel therapeutics are needed. As an effective vaccine …
View article: Longitudinal Meta-cohort study protocol using systems biology to identify vaccine safety biomarkers
Longitudinal Meta-cohort study protocol using systems biology to identify vaccine safety biomarkers Open
The International Network of Special Immunization Services (INSIS) was established to investigate the causes and risk factors of rare adverse events following immunizations (AEFIs) and develop immunization strategies for mitigating or prev…
View article: Evaluation of Cellular Immune Responses After mRNA-1273 Vaccination in Children 6 Months to 11 Years of Age
Evaluation of Cellular Immune Responses After mRNA-1273 Vaccination in Children 6 Months to 11 Years of Age Open
Background Cell-mediated immunity (CMI) may help protect against emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that are less susceptible to neutralizing antibodies. We present CMI data after the mRNA-1273 p…
View article: Structural mapping of polyclonal IgG responses to HA after influenza virus vaccination or infection
Structural mapping of polyclonal IgG responses to HA after influenza virus vaccination or infection Open
Cellular and molecular characterization of immune responses elicited by influenza virus infection and seasonal vaccination have informed efforts to improve vaccine efficacy, breadth, and longevity. Here, we use negative stain electron micr…
View article: 579. Safety and Immunogenicity of Mpox Vaccination in Adolescents
579. Safety and Immunogenicity of Mpox Vaccination in Adolescents Open
Background Monkeypox (Mpox) is a global public health threat. In the current Democratic Republic of Congo (DRC) mpox outbreak, children < 15 years of age comprise 70% of cases and 88% of deaths. Modified Vaccinia Ankara-Bavarian Nordic …
View article: P-1854. Children with Congenital Heart Disease and PICS (Persistent Inflammation, Immunosuppression, and Catabolism Syndrome) Demonstrate Both Pro- and Anti-Inflammatory Cytokine Profiles
P-1854. Children with Congenital Heart Disease and PICS (Persistent Inflammation, Immunosuppression, and Catabolism Syndrome) Demonstrate Both Pro- and Anti-Inflammatory Cytokine Profiles Open
Background Patients with chronic critical illness have variable recovery from acute events, such as surgery or sepsis, and experience dysregulated inflammation, blunted immune responses, and recurrent infections. The development of persist…
View article: Systems Biology-Based Assessment of Immune Responses to Whole Cell and Acellular Pertussis Vaccines: Rationale, Methodology and Enrollment Procedures for Omics Workflows
Systems Biology-Based Assessment of Immune Responses to Whole Cell and Acellular Pertussis Vaccines: Rationale, Methodology and Enrollment Procedures for Omics Workflows Open
Given the local and systemic adverse reactions associated with whole cell pertussis vaccines combined with diphtheria and tetanus toxoids (DTP), acellular pertussis vaccines combined with the same toxoids (DTaP) were developed in the 1990s…
View article: Utilizing an Opportunistic Clinical Study and Population‐Based Pharmacokinetic Models to Identify Rational Empiric Dosing Regimens for Piperacillin–Tazobactam in Critically Ill Patients
Utilizing an Opportunistic Clinical Study and Population‐Based Pharmacokinetic Models to Identify Rational Empiric Dosing Regimens for Piperacillin–Tazobactam in Critically Ill Patients Open
Determining an effective dosing regimen for piperacillin–tazobactam in critically ill patients is challenging due to substantial pharmacokinetic variability caused by complex pathophysiological changes. To address this need, a prospective …
View article: Transcriptomic Biomarkers Associated With Microbiological Etiology and Disease Severity in Childhood Pneumonia
Transcriptomic Biomarkers Associated With Microbiological Etiology and Disease Severity in Childhood Pneumonia Open
Background Challenges remain in discerning microbiologic etiology and disease severity in childhood pneumonia. Defining host transcriptomic profiles during illness may facilitate improved diagnostic and prognostic approaches. Methods Using…
View article: Population Pharmacokinetic Modeling of Cefepime, Meropenem, and Piperacillin-Tazobactam in Patients With Cystic Fibrosis
Population Pharmacokinetic Modeling of Cefepime, Meropenem, and Piperacillin-Tazobactam in Patients With Cystic Fibrosis Open
Background Patients with cystic fibrosis (CF) experience recurrent bacterial pulmonary exacerbations. Management of these infections is increasingly challenging due to decreased antimicrobial susceptibility to β-lactam antibiotics. The pha…
View article: Safety and Immunogenicity of an mRNA-1273 Booster in Children
Safety and Immunogenicity of an mRNA-1273 Booster in Children Open
Background A 2-dose mRNA-1273 primary series in children aged 6 months–5 years (25 µg) and 6–11 years (50 µg) had an acceptable safety profile and was immunogenic in the phase 2/3 KidCOVE study. We present data from KidCOVE participants wh…
View article: Structural Mapping of Polyclonal IgG Responses to HA After Influenza Virus Vaccination or Infection
Structural Mapping of Polyclonal IgG Responses to HA After Influenza Virus Vaccination or Infection Open
Cellular and molecular characterization of immune responses elicited by influenza virus infection and seasonal vaccination have informed efforts to improve vaccine efficacy, breadth, and longevity. Here, we use negative stain electron micr…
View article: SARS-CoV-2 RNA and Nucleocapsid Antigen Are Blood Biomarkers Associated With Severe Disease Outcomes That Improve in Response to Remdesivir
SARS-CoV-2 RNA and Nucleocapsid Antigen Are Blood Biomarkers Associated With Severe Disease Outcomes That Improve in Response to Remdesivir Open
Background Although antivirals remain important for the treatment COVID-19, methods to assess treatment efficacy are lacking. Here, we investigated the impact of remdesivir on viral dynamics and their contribution to understanding antivira…
View article: Overview of U.S. COVID-19 vaccine safety surveillance systems
Overview of U.S. COVID-19 vaccine safety surveillance systems Open
The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal gover…
View article: Metabolomic Signatures Differentiate Immune Responses in Avian Influenza Vaccine Recipients
Metabolomic Signatures Differentiate Immune Responses in Avian Influenza Vaccine Recipients Open
Background Avian influenza viruses pose significant risk to human health. Vaccines targeting the hemagglutinin of these viruses are poorly immunogenic without the use of adjuvants. Methods Twenty healthy men and women (18–49 years of age) …
View article: Utilizing Opportunistic Clinical Study and Population-Based Pharmacometric Models to Identify Rational Empiric Dosing Regimens for Piperacillin-Tazobactam in Critically Ill Patients
Utilizing Opportunistic Clinical Study and Population-Based Pharmacometric Models to Identify Rational Empiric Dosing Regimens for Piperacillin-Tazobactam in Critically Ill Patients Open
View article: Clinical Practice Guideline by the Pediatric Infectious Diseases Society (PIDS) and the Infectious Diseases Society of America (IDSA): 2023 Guideline on Diagnosis and Management of Acute Bacterial Arthritis in Pediatrics
Clinical Practice Guideline by the Pediatric Infectious Diseases Society (PIDS) and the Infectious Diseases Society of America (IDSA): 2023 Guideline on Diagnosis and Management of Acute Bacterial Arthritis in Pediatrics Open
This clinical practice guideline for the diagnosis and treatment of acute bacterial arthritis (ABA) in children was developed by a multidisciplinary panel representing the Pediatric Infectious Diseases Society (PIDS) and the Infectious Dis…
View article: Evolution of Invasive and Colonizing Pediatric <i>Staphylococcus aureus</i> Isolates
Evolution of Invasive and Colonizing Pediatric <i>Staphylococcus aureus</i> Isolates Open
Background Staphylococcus aureus is the most common bacterial pathogen isolated in children with invasive bloodstream and musculoskeletal infections. A major barrier to vaccine and novel therapeutic development against S. aureus is its con…
View article: Are We Dosing Correctly? Population Pharmacokinetic Modeling of Cefepime, Piperacillin-Tazobactam, and Meropenem in Individuals with Cystic Fibrosis
Are We Dosing Correctly? Population Pharmacokinetic Modeling of Cefepime, Piperacillin-Tazobactam, and Meropenem in Individuals with Cystic Fibrosis Open
Background Patients with cystic fibrosis (CF) experience recurrent bacterial pulmonary exacerbations. The management of these infections becomes increasingly complex due to decreased antimicrobial susceptibility and inadequate pharmacokine…
View article: Priorities and Progress in Gram-positive Bacterial Infection Research by the Antibacterial Resistance Leadership Group: A Narrative Review
Priorities and Progress in Gram-positive Bacterial Infection Research by the Antibacterial Resistance Leadership Group: A Narrative Review Open
The Antibacterial Resistance Leadership Group (ARLG) has prioritized infections caused by gram-positive bacteria as one of its core areas of emphasis. The ARLG Gram-positive Committee has focused on studies responding to 3 main identified …
View article: Model-Guided Decision-Making for Thromboprophylaxis and Hospital-Acquired Thromboembolic Events Among Hospitalized Children and Adolescents
Model-Guided Decision-Making for Thromboprophylaxis and Hospital-Acquired Thromboembolic Events Among Hospitalized Children and Adolescents Open
Importance Rates of hospital-acquired venous thromboembolism (HA-VTE) are increasing among pediatric patients. Identifying at-risk patients for whom prophylactic interventions should be considered remains challenging. Objective To determin…
View article: Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial
Safety and Immunogenicity of a Delayed Heterologous Avian Influenza A(H7N9) Vaccine Boost Following Different Priming Regimens: A Randomized Clinical Trial Open
Background Influenza A (H7N9) has caused multiple disease waves with evidence of strain diversification. Optimal influenza A (H7N9) prime-boost vaccine strategies are unknown. Methods We recruited participants who had received monovalent i…
View article: Population pharmacokinetics and target attainment analyses to identify a rational empirical dosing strategy for cefepime in critically ill patients
Population pharmacokinetics and target attainment analyses to identify a rational empirical dosing strategy for cefepime in critically ill patients Open
Objectives We aimed to identify rational empirical dosing strategies for cefepime treatment in critically ill patients by utilizing population pharmacokinetics and target attainment analysis. Patients and methods A prospective and opportun…
View article: Development of a Kinetic ELISA and Reactive B Cell Frequency Assay to Detect Respiratory Syncytial Virus Pre-Fusion F Protein-Specific Immune Responses in Infants
Development of a Kinetic ELISA and Reactive B Cell Frequency Assay to Detect Respiratory Syncytial Virus Pre-Fusion F Protein-Specific Immune Responses in Infants Open
Background Respiratory syncytial virus (RSV) is a major cause of respiratory disease in infants, making vaccination an attractive preventive strategy. Due to earlier reports of vaccine-enhanced disease in RSV-naive children, assessing prio…
View article: Surveillance for Multisystem Inflammatory Syndrome in US Children Aged 5–11 Years Who Received Pfizer-BioNTech COVID-19 Vaccine, November 2021 through March 2022
Surveillance for Multisystem Inflammatory Syndrome in US Children Aged 5–11 Years Who Received Pfizer-BioNTech COVID-19 Vaccine, November 2021 through March 2022 Open
Multisystem inflammatory syndrome in children (MIS-C) is a complication of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; in the United States, reporting of MIS-C after coronavirus disease 2019 (COVID-19) vaccinati…
View article: Evaluation of Empirical Dosing Regimens for Meropenem in Intensive Care Unit Patients Using Population Pharmacokinetic Modeling and Target Attainment Analysis
Evaluation of Empirical Dosing Regimens for Meropenem in Intensive Care Unit Patients Using Population Pharmacokinetic Modeling and Target Attainment Analysis Open
In the present study, population pharmacokinetic (PK) analysis was performed based on meropenem data from a prospective study conducted in 114 critically ill patients with a wide range of renal functions and various disease conditions. The…