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Article ; Online: Metabolomic Signatures Differentiate Immune Responses in Avian Influenza Vaccine Recipients.

Howard, Leigh M / Jensen, Travis L / Goll, Johannes B / Gelber, Casey E / Bradley, Matthew D / Sherrod, Stacy D / Hoek, Kristen L / Yoder, Sandra / Jimenez-Truque, Natalia / Edwards, Kathryn / Creech, C Buddy

The Journal of infectious diseases

2024

Abstract: 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) were ... ...

Abstract	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) were randomized to receive two doses of inactivated influenza A/H5N1 vaccine alone (IIV) or with AS03 adjuvant (IIV-AS03) one month apart. Urine and serum samples were collected on day 0 and on days 1, 3, and 7 following first vaccination and subjected to metabolomics analyses to identify metabolites, metabolic pathways, and metabolite clusters associated with immunization. Results: Seventy-three differentially abundant (DA) serum and 88 urine metabolites were identified for any post-vaccination day comparison. Pathway analysis revealed enrichment of tryptophan, tyrosine and nicotinate metabolism in urine and serum among IIV-AS03 recipients. Increased urine abundance of 4-vinylphenol sulfate on Day 1 was associated with serologic response based on hemagglutination inhibition responses. In addition, 9 DA urine metabolites were identified in participants with malaise compared to those without. Conclusions: Our findings suggest that tryptophan, tyrosine, and nicotinate metabolism are upregulated among IIV-AS03 recipients compared with IIV alone. Metabolites within these pathways may serve as measures of immunogenicity and may provide mechanistic insights for adjuvanted vaccines.
Language	English
Publishing date	2024-01-05
Publishing country	United States
Document type	Journal Article
ZDB-ID	3019-3
ISSN	1537-6613 ; 0022-1899
ISSN (online)	1537-6613
ISSN	0022-1899
DOI	10.1093/infdis/jiad611
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Article ; Online: Risk Factors for Adverse Events in Children Receiving Outpatient Parenteral Antibiotic Therapy.

Townsley, Elizabeth / Gillon, Jessica / Jimenez-Truque, Natalia / Katz, Sophie / Garguilo, Kathryn / Banerjee, Ritu

Hospital pediatrics

2021 Volume 11, Issue 2, Page(s) 153–159

Abstract: Background: Outpatient parenteral antibiotic therapy (OPAT) can decrease length of hospital stay but is associated with adverse events (AEs). The purpose of this study was to quantify and identify risk factors for OPAT-associated AEs in children.: ... ...

Abstract	Background: Outpatient parenteral antibiotic therapy (OPAT) can decrease length of hospital stay but is associated with adverse events (AEs). The purpose of this study was to quantify and identify risk factors for OPAT-associated AEs in children. Methods: Retrospective single-center study of children ≤21 years old discharged on OPAT from January 2016 to April 2019 with infectious diseases follow-up. Demographic and clinical factors and medication and central venous catheter (CVC)-associated AEs were assessed through chart review. Univariable and multivariable analyses were performed. Results: Among 181 OPAT courses, an AE occurred in 70 (39%). Medication AEs occurred in 30 of 181 courses (16.6%). Children residing in an urban area had a 4.5 times higher risk of having a medication-related AE compared with those in a rural area (odds ratio: 4.51; 95% confidence interval: 1.60-12.77; Conclusions: In this cohort, 39% of children experienced an OPAT-associated AE, and CVC AEs were more common than medication AEs. Longer duration of intravenous therapy and urban residence were independently associated with OPAT-associated AEs, highlighting the importance of converting to oral antibiotic therapy as soon as feasible to reduce OPAT-associated AEs.
MeSH term(s)	Adolescent ; Anti-Bacterial Agents/adverse effects ; Central Venous Catheters ; Child ; Child, Preschool ; Humans ; Infant ; Outpatients ; Retrospective Studies ; Risk Factors ; Young Adult
Chemical Substances	Anti-Bacterial Agents
Language	English
Publishing date	2021-01-14
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2154-1671
ISSN (online)	2154-1671
DOI	10.1542/hpeds.2020-001388
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Article: Incidence of Acute Kidney Injury Among Infants in the Neonatal Intensive Care Unit Receiving Vancomycin With Either Piperacillin/Tazobactam or Cefepime.

Bartlett, Jenna W / Gillon, Jessica / Hale, Jennifer / Jimenez-Truque, Natalia / Banerjee, Ritu

The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG

2020 Volume 25, Issue 6, Page(s) 521–527

Abstract: Objectives: To determine whether combination therapy with vancomycin and TZP is associated with a higher incidence of acute kidney injury (AKI) compared with vancomycin with cefepime in infants admitted to the NICU.: Methods: This retrospective ... ...

Abstract	Objectives: To determine whether combination therapy with vancomycin and TZP is associated with a higher incidence of acute kidney injury (AKI) compared with vancomycin with cefepime in infants admitted to the NICU. Methods: This retrospective cohort study included infants in the NICU who received vancomycin/cefepime or vancomycin/TZP for at least 48 hours. The primary outcome was incidence of AKI, which was defined by the neonatal modified Kidney Disease Improving Global Outcomes AKI criteria. Results: Forty-two infants who received vancomycin with cefepime and 58 infants who received vancomycin with TZP were included in the analysis. The median gestational age at birth, birth weight, and dosing weight were lower in the TZP group, but other baseline characteristics were comparable, including corrected gestational age. Two patients (3%) receiving vancomycin/TZP versus 2 patients (5%) receiving vancomycin/cefepime met criteria for AKI during their antibiotic course (p = 1.00). There were no clinically significant changes in serum creatinine or urine output from baseline to the end of combination antibiotic treatment in either group. Conclusions: Among infants admitted to our NICU, AKI incidence associated with vancomycin and either TZP or cefepime therapy was low and did not differ by antibiotic combination.
Language	English
Publishing date	2020-08-20
Publishing country	United States
Document type	Journal Article
ZDB-ID	3028543-4
ISSN	1551-6776
ISSN	1551-6776
DOI	10.5863/1551-6776-25.6.521
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Article ; Online: Evaluation of Empirical Dosing Regimens for Meropenem in Intensive Care Unit Patients Using Population Pharmacokinetic Modeling and Target Attainment Analysis.

An, Guohua / Creech, C Buddy / Wu, Nan / Nation, Roger L / Gu, Kenan / Nalbant, Demet / Jimenez-Truque, Natalia / Fissell, William / Rolsma, Stephanie / Patel, Pratish C / Watanabe, Amy / Fishbane, Nicholas / Kirkpatrick, Carl M J / Landersdorfer, Cornelia B / Winokur, Patricia

Antimicrobial agents and chemotherapy

2023 Volume 67, Issue 1, Page(s) e0131222

Abstract: 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 final model ... ...

Abstract	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 final model was a one-compartment model with linear elimination, with creatinine clearance and continuous renal replacement therapy affecting clearance, and total bodyweight impacting the volume of distribution. Our model is a valuable addition to the existing meropenem population PK models, and it could be particularly useful during implementation of a therapeutic drug monitoring program combined with Bayesian forecasting. Based on the final model developed, comprehensive Monte Carlo simulations were performed to evaluate the probability of target attainment (PTA) of 16 different dosing regimens. Simulation results showed that 2 g administered every 8 h with 3-h prolonged infusion (PI) and 4 g/day by continuous infusion (CI) appear to be two empirical dosing regimens that are superior to many other regimens when both target attainment and potential toxicity are considered and renal function information is not available. Following a daily CI dose of 6 g or higher, more than 30% of the population with a creatinine clearance of <60 mL/min is predicted to have neurotoxicity. With the availability of institution- and/or unit-specific meropenem susceptibility patterns, as well as an individual patient's renal function, our PTA results may represent useful references for physicians to make dosing decisions.
MeSH term(s)	Humans ; Meropenem/pharmacokinetics ; Anti-Bacterial Agents/pharmacokinetics ; Prospective Studies ; Creatinine ; Bayes Theorem ; Intensive Care Units ; Critical Illness/therapy ; Monte Carlo Method ; Microbial Sensitivity Tests
Chemical Substances	Meropenem (FV9J3JU8B1) ; Anti-Bacterial Agents ; Creatinine (AYI8EX34EU)
Language	English
Publishing date	2023-01-09
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	217602-6
ISSN	1098-6596 ; 0066-4804
ISSN (online)	1098-6596
ISSN	0066-4804
DOI	10.1128/aac.01312-22
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Article ; Online: 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.

Rolsma, Stephanie L / Yoder, Sandra M / Nargi, Rachel S / Brady, Eric / Jimenez-Truque, Natalia / Thomsen, Isaac / Kontos, Marissa / Carnahan, Robert H / Sutton, Rachel E / Armstrong, Erica / Dally, Len / Crowe, James E / Edwards, Kathryn M / Creech, C Buddy

Journal of the Pediatric Infectious Diseases Society

2023 Volume 12, Issue 5, Page(s) 298–305

Abstract: 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 prior RSV ... ...

Abstract	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 prior RSV infection is critical for determining eligibility for future infant vaccine trials. However, this is complicated by the presence of maternally transferred maternal antibodies. We sought to develop assays that measure immune responses to RSV pre-fusion (F) protein that discriminates between maternal and infant responses. Methods: We measured RSV-specific responses in two groups of children <3 years of age; those with laboratory-confirmed RSV (RSV-infected) and those enrolled prior to their first RSV season (RSV-uninfected). Serial blood samples were obtained and recent infections with RSV and other respiratory viruses were assessed during follow-up. An RSV pre-F-specific kinetic enzyme-linked immunosorbent assay (kELISA) and an F-specific reactive B cell frequency (RBF) assay were developed. Results: One hundred two young children were enrolled between July 2015 and April 2017; 74 were in the RSV-uninfected group and 28 were in the RSV-infected group. Participants were asked to provide sequential blood samples over time, but only 53 participants in the RSV-uninfected group and 22 participants in the RSV-infected groups provided multiple samples. In the RSV-infected group, most had positive kELISA and RBF during the study. In the RSV-uninfected group, two patterns emerged: declining kELISA values without reactive B cells, due to maternal transplacental antibody transfer, and persistently positive kELISA with reactive B cells, due to asymptomatic undiagnosed RSV infection. Conclusions: A kELISA targeting RSV pre-F epitopes and an RBF assay targeting RSV F-specific B cells generally allow discrimination between maternally and infant-derived antibodies.
MeSH term(s)	Child ; Infant ; Humans ; Child, Preschool ; Antibodies, Neutralizing ; Antibodies, Viral ; Viral Fusion Proteins ; Respiratory Syncytial Virus, Human ; Respiratory Syncytial Virus Infections ; Immunity ; Enzyme-Linked Immunosorbent Assay
Chemical Substances	Antibodies, Neutralizing ; Antibodies, Viral ; Viral Fusion Proteins
Language	English
Publishing date	2023-04-07
Publishing country	England
Document type	Journal Article
ZDB-ID	2668791-4
ISSN	2048-7207 ; 2048-7193
ISSN (online)	2048-7207
ISSN	2048-7193
DOI	10.1093/jpids/piad019
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Article ; Online: Population pharmacokinetics and target attainment analyses to identify a rational empirical dosing strategy for cefepime in critically ill patients.

An, Guohua / Creech, C Buddy / Wu, Nan / Nation, Roger L / Gu, Kenan / Nalbant, Demet / Jimenez-Truque, Natalia / Fissell, William / Patel, Pratish C / Fishbane, Nicholas / Watanabe, Amy / Rolsma, Stephanie / Kirkpatrick, Carl M J / Landersdorfer, Cornelia B / Winokur, Patricia

The Journal of antimicrobial chemotherapy

2023 Volume 78, Issue 6, Page(s) 1460–1470

Abstract: 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 opportunistic ... ...

Abstract	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 opportunistic pharmacokinetic (PK) study was conducted in 130 critically ill patients in two ICU sites. The plasma concentrations of cefepime were determined using a validated LC-MS/MS method. All cefepime PK data were analysed simultaneously using the non-linear mixed-effects modelling approach. Monte Carlo simulations were performed to evaluate the PTA of cefepime at different MIC values following different dose regimens in subjects with different renal functions. Results: The PK of cefepime in critically ill patients was best characterized by a two-compartment model with zero-order input and first-order elimination. Creatinine clearance and body weight were identified to be significant covariates. Our simulation results showed that prolonged 3 h infusion does not provide significant improvement on target attainment compared with the traditional intermittent 0.5 h infusion. In contrast, for a given daily dose continuous infusion provided much higher breakpoint coverage than either 0.5 h or 3 h intermittent infusions. To balance the target attainment and potential neurotoxicity, cefepime 3 g/day continuous infusion appears to be a better dosing regimen than 6 g/day continuous infusion. Conclusions: Continuous infusion may represent a promising strategy for cefepime treatment in critically ill patients. With the availability of institution- and/or unit-specific cefepime susceptibility patterns as well as individual patients' renal function, our PTA results may represent useful references for physicians to make dosing decisions.
MeSH term(s)	Humans ; Cefepime ; Anti-Bacterial Agents/therapeutic use ; Chromatography, Liquid ; Prospective Studies ; Critical Illness ; Tandem Mass Spectrometry ; Monte Carlo Method ; Microbial Sensitivity Tests
Chemical Substances	Cefepime (807PW4VQE3) ; Anti-Bacterial Agents
Language	English
Publishing date	2023-04-18
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	191709-2
ISSN	1460-2091 ; 0305-7453
ISSN (online)	1460-2091
ISSN	0305-7453
DOI	10.1093/jac/dkad106
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Article ; Online: Safety of Live Attenuated Influenza Vaccine in Children With Asthma.

Sokolow, Andrew G / Stallings, Amy P / Kercsmar, Carolyn / Harrington, Theresa / Jimenez-Truque, Natalia / Zhu, Yuwei / Sokolow, Katherine / Moody, M Anthony / Schlaudecker, Elizabeth P / Walter, Emmanuel B / Staat, Mary Allen / Broder, Karen R / Creech, C Buddy

Pediatrics

2022 Volume 149, Issue 4

Abstract: Background and objectives: Asthma is considered a precaution for use of quadrivalent live attenuated influenza vaccine (LAIV4) in persons aged ≥5 years because of concerns for wheezing events. We evaluated the safety of LAIV4 in children with asthma, ... ...

Abstract	Background and objectives: Asthma is considered a precaution for use of quadrivalent live attenuated influenza vaccine (LAIV4) in persons aged ≥5 years because of concerns for wheezing events. We evaluated the safety of LAIV4 in children with asthma, comparing the proportion of children with asthma exacerbations after LAIV4 or quadrivalent inactivated influenza vaccine (IIV4). Methods: We enrolled 151 children with asthma, aged 5 to 17 years, during 2 influenza seasons. Participants were randomly assigned 1:1 to receive IIV4 or LAIV4 and monitored for asthma symptoms, exacerbations, changes in peak expiratory flow rate (PEFR), and changes in the asthma control test for 42 days after vaccination. Results: We included 142 participants in the per-protocol analysis. Within 42 days postvaccination, 18 of 142 (13%) experienced an asthma exacerbation: 8 of 74 (11%) in the LAIV4 group versus 10 of 68 (15%) in the IIV4 group (LAIV4-IIV4 = -0.0390 [90% confidence interval -0.1453 to 0.0674]), meeting the bounds for noninferiority. When adjusted for asthma severity, LAIV4 remained noninferior to IIV4. There were no significant differences in the frequency of asthma symptoms, change in PEFR, or childhood asthma control test/asthma control test scores in the 14 days postvaccination between LAIV4 and IIV4 recipients. Vaccine reactogenicity was similar between groups, although sore throat (P = .051) and myalgia (P <.001) were more common in the IIV4 group. Conclusions: LAIV4 was not associated with increased frequency of asthma exacerbations, an increase in asthma-related symptoms, or a decrease in PEFR compared with IIV4 among children aged 5 to 17 years with asthma.
MeSH term(s)	Adolescent ; Asthma ; Child ; Child, Preschool ; Humans ; Influenza Vaccines/adverse effects ; Influenza, Human/diagnosis ; Influenza, Human/prevention & control ; Vaccines, Attenuated/adverse effects ; Vaccines, Inactivated
Chemical Substances	Influenza Vaccines ; Vaccines, Attenuated ; Vaccines, Inactivated
Language	English
Publishing date	2022-03-27
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	207677-9
ISSN	1098-4275 ; 0031-4005
ISSN (online)	1098-4275
ISSN	0031-4005
DOI	10.1542/peds.2021-055432
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Article ; Online: Safety and immunogenicity of live, attenuated intranasal Bordetella pertussis vaccine (BPZE1) in healthy adults.

Buddy Creech, C / Jimenez-Truque, Natalia / Kown, Naomi / Sokolow, Katherine / Brady, Eric J / Yoder, Sandra / Solovay, Ken / Rubin, Keith / Noviello, Stephanie / Hensel, Elizabeth / Selamawi, Semhal / Bakare, Adetunji / Makowski, Mat / Lu, Kristina

Vaccine

2022 Volume 40, Issue 47, Page(s) 6740–6746

Abstract: Background: BPZE1 is a live, attenuated pertussis vaccine derived from B. pertussis strain Tohama I modified by genetic removal or inactivation of 3 B. pertussis toxins: pertussis toxin, dermonecrotic toxin, and tracheal cytotoxin. This Phase 2a study ... ...

Abstract	Background: BPZE1 is a live, attenuated pertussis vaccine derived from B. pertussis strain Tohama I modified by genetic removal or inactivation of 3 B. pertussis toxins: pertussis toxin, dermonecrotic toxin, and tracheal cytotoxin. This Phase 2a study evaluated the safety and immunogenicity of liquid or lyophilized BPZE1 vaccine administered intranasally by needleless tuberculin syringe or mucosal atomization device (VaxINator Methods: Fifty healthy male and non-pregnant female participants 18-49 years of age were enrolled. Participants were randomized 3:3:3:1 to a single lyophilized dose of 10 Results: Across all groups, 35/50 (70 %) experienced at least one local adverse event (AE) and 31/50 (62 %) experienced at least one systemic AE, with similar AE frequencies observed between the highest 10 Discussion: Lyophilized BPZE1 vaccine was well tolerated and immunogenic at the highest dose (10
MeSH term(s)	Adult ; Male ; Female ; Humans ; Pertussis Vaccine/adverse effects ; Bordetella pertussis ; Whooping Cough/prevention & control ; Tuberculin ; Administration, Intranasal ; Vaccines, Attenuated ; Immunogenicity, Vaccine
Chemical Substances	Pertussis Vaccine ; Tuberculin ; Vaccines, Attenuated
Language	English
Publishing date	2022-10-08
Publishing country	Netherlands
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.09.075
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Article ; Online: Maternal pertussis immunization: can it help infants?

Jiménez-Truque, Natalia / Edwards, Kathryn M

JAMA

2014 Volume 311, Issue 17, Page(s) 1736–1737

MeSH term(s)	Diphtheria-Tetanus-Pertussis Vaccine/immunology ; Diphtheria-Tetanus-acellular Pertussis Vaccines/immunology ; Female ; Humans ; Infant, Newborn/immunology ; Pregnancy ; Whooping Cough/prevention & control
Chemical Substances	Diphtheria-Tetanus-Pertussis Vaccine ; Diphtheria-Tetanus-acellular Pertussis Vaccines
Language	English
Publishing date	2014-05-07
Publishing country	United States
Document type	Comment ; Editorial
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2014.3555
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Article: Balanced Cellular and Humoral Immune Responses Targeting Multiple Antigens in Adults Receiving a Quadrivalent Inactivated Influenza Vaccine.

Yu, Esther Dawen / Grifoni, Alba / Sutherland, Aaron / Voic, Hannah / Wang, Eric / Frazier, April / Jimenez-Truque, Natalia / Yoder, Sandra / Welsh, Sabrina / Wooden, Stacey / Koff, Wayne / Creech, Buddy / Sette, Alessandro / da Silva Antunes, Ricardo

Vaccines

2021 Volume 9, Issue 5

Abstract: The role of T cell immunity has been acknowledged in recent vaccine development and evaluation. We tested the humoral and cellular immune responses to ... ...

Abstract	The role of T cell immunity has been acknowledged in recent vaccine development and evaluation. We tested the humoral and cellular immune responses to Flucelvax
Language	English
Publishing date	2021-04-23
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines9050426
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