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Article ; Online: Host immune responses to influenza infection and vaccines: Lessons learned for all viral pandemic challenges.

Engler, Renata J M / Nelson, Michael R

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology

2020 Volume 125, Issue 1, Page(s) 2–3

MeSH term(s)	Betacoronavirus/immunology ; COVID-19 ; Coronavirus Infections/immunology ; Coronavirus Infections/prevention & control ; Humans ; Influenza Vaccines/immunology ; Influenza, Human/immunology ; Pandemics/prevention & control ; Pneumonia, Viral/immunology ; Pneumonia, Viral/prevention & control ; SARS-CoV-2
Chemical Substances	Influenza Vaccines
Keywords	covid19
Language	English
Publishing date	2020-06-12
Publishing country	United States
Document type	Editorial
ZDB-ID	1228189-x
ISSN	1534-4436 ; 0003-4738 ; 1081-1206
ISSN (online)	1534-4436
ISSN	0003-4738 ; 1081-1206
DOI	10.1016/j.anai.2020.05.008
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Article: Lipoprotein(a) Elevation: A New Diagnostic Code with Relevance to Service Members and Veterans.

Engler, Renata J M / Brede, Emily / Villines, Todd / Vernalis, Marina N

Federal practitioner : for the health care professionals of the VA, DoD, and PHS

2019 Volume 36, Issue Suppl 7, Page(s) S19–S31

Abstract: Newly recognized as a clinical diagnosis, Lp(a) elevation is a major contributor to cardiovascular disease risk should be considered for patients with advanced premature atherosclerosis on imaging or a family history of premature cardiovascular disease, ... ...

Abstract	Newly recognized as a clinical diagnosis, Lp(a) elevation is a major contributor to cardiovascular disease risk should be considered for patients with advanced premature atherosclerosis on imaging or a family history of premature cardiovascular disease, particularly when there are few traditional risk factors.
Language	English
Publishing date	2019-06-13
Publishing country	United States
Document type	Journal Article
ISSN	1078-4497
ISSN	1078-4497
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Article: Insufficient Anthrax Lethal Toxin Neutralization Is Associated with Antibody Subclass and Domain Specificity in the Plasma of Anthrax-Vaccinated Individuals.

Smith, Kenneth / Garman, Lori / Norris, Kathleen / Muther, Jennifer / Duke, Angie / Engler, Renata J M / Nelson, Michael R / Collins, Limone C / Spooner, Christina / Guthridge, Carla / James, Judith A

Microorganisms

2021 Volume 9, Issue 6

Abstract: Anthrax vaccine adsorbed (AVA) is a significant line of defense against bioterrorist attack ... ...

Abstract	Anthrax vaccine adsorbed (AVA) is a significant line of defense against bioterrorist attack from
Language	English
Publishing date	2021-06-02
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms9061204
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Article ; Online: Myocarditis and pericarditis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data.

Sexson Tejtel, S Kristen / Munoz, Flor M / Al-Ammouri, Iyad / Savorgnan, Fabio / Guggilla, Rama K / Khuri-Bulos, Najwa / Phillips, Lee / Engler, Renata J M

Vaccine

2022 Volume 40, Issue 10, Page(s) 1499–1511

Abstract: Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, ... ...

Abstract	Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including acute heart failure, sudden death, and chronic dilated cardiomyopathy. Possible undiagnosed and/or subclinical acute myocarditis, with undefined potential for delayed manifestations, presents further challenges for diagnosing an acute disease and may go undetected in the setting of infection as well as adverse drug/vaccine reactions. The most common causes of MPC are viral, with non-infectious, drug/vaccine associated hypersensitivity and/or autoimmune causes being less well defined and with potentially different inflammatory mechanisms and treatment responses. Potential cardiac adverse events following immunization (AEFIs) encompass a larger scope of diagnoses such as triggering or exacerbating ischemic cardiac events, cardiomyopathy with potential heart failure, arrhythmias and sudden death. The current published experience does not support a potential causal association with vaccines based on epidemiologic evidence of relative risk increases compared with background unvaccinated incidence. The only evidence supporting a possible causal association of MPC with a vaccine comes from case reports. Hypersensitivity MPC as a drug/vaccine induced cardiac adverse event has long been a concern for post-licensure safety surveillance, as well as safety data submission for licensure. Other cardiac adverse events, such as dilated cardiomyopathy, were also defined in the CDC definitions for adverse events after smallpox vaccination in 2006. In addition, several groups have attempted to develop and improve the definition and adjudication of post-vaccination cardiovascular events. We developed the current case definitions for myocarditis and pericarditis as an AEFI building on experience and lessons learnt, as well as a comprehensive literature review. Considerations of other etiologies and causal relationships are outside the scope of this document.
MeSH term(s)	Humans ; Incidence ; Myocarditis/chemically induced ; Myocarditis/diagnosis ; Myocarditis/epidemiology ; Pericarditis/diagnosis ; Pericarditis/epidemiology ; Pericarditis/etiology ; Vaccination/adverse effects
Language	English
Publishing date	2022-01-31
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.11.074
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Article: Myocarditis and pericarditis: Case definition and guidelines for data collection, analysis, and presentation of immunization safety data

Sexson Tejtel, S. Kristen / Munoz, Flor M. / Al-Ammouri, Iyad / Savorgnan, Fabio / Guggilla, Rama K. / Khuri-Bulos, Najwa / Phillips, Lee / Engler, Renata J.M.

Vaccine. 2022 Mar. 01, v. 40, no. 10

2022

Abstract	Myocarditis and/or pericarditis (also known as myopericarditis) are inflammatory diseases involving the myocardium (with non-ischemic myocyte necrosis) and/or the pericardial sac. Myocarditis/pericarditis (MPC) may present with variable clinical signs, symptoms, etiologies and outcomes, including acute heart failure, sudden death, and chronic dilated cardiomyopathy. Possible undiagnosed and/or subclinical acute myocarditis, with undefined potential for delayed manifestations, presents further challenges for diagnosing an acute disease and may go undetected in the setting of infection as well as adverse drug/vaccine reactions. The most common causes of MPC are viral, with non-infectious, drug/vaccine associated hypersensitivity and/or autoimmune causes being less well defined and with potentially different inflammatory mechanisms and treatment responses. Potential cardiac adverse events following immunization (AEFIs) encompass a larger scope of diagnoses such as triggering or exacerbating ischemic cardiac events, cardiomyopathy with potential heart failure, arrhythmias and sudden death. The current published experience does not support a potential causal association with vaccines based on epidemiologic evidence of relative risk increases compared with background unvaccinated incidence. The only evidence supporting a possible causal association of MPC with a vaccine comes from case reports. Hypersensitivity MPC as a drug/vaccine induced cardiac adverse event has long been a concern for post-licensure safety surveillance, as well as safety data submission for licensure. Other cardiac adverse events, such as dilated cardiomyopathy, were also defined in the CDC definitions for adverse events after smallpox vaccination in 2006. In addition, several groups have attempted to develop and improve the definition and adjudication of post-vaccination cardiovascular events. We developed the current case definitions for myocarditis and pericarditis as an AEFI building on experience and lessons learnt, as well as a comprehensive literature review. Considerations of other etiologies and causal relationships are outside the scope of this document.
Keywords	acute course ; cardiomyopathy ; data collection ; death ; heart failure ; hypersensitivity ; monitoring ; myocarditis ; myocardium ; necrosis ; pericarditis ; pericardium ; relative risk ; smallpox ; vaccination ; vaccines
Language	English
Dates of publication	2022-0301
Size	p. 1499-1511.
Publishing place	Elsevier Ltd
Document type	Article
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2021.11.074
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Article ; Online: Myocarditis and pericarditis recovery following smallpox vaccine 2002-2016: A comparative observational cohort study in the military health system.

PloS one

2023 Volume 18, Issue 5, Page(s) e0283988

Abstract: Objectives: (1) Characterize the initial clinical characteristics and long-term outcomes of smallpox vaccine-associated hypersensitivity myocarditis and pericarditis (MP) in United States service members. (2) Describe the process of case identification ... ...

Abstract	Objectives: (1) Characterize the initial clinical characteristics and long-term outcomes of smallpox vaccine-associated hypersensitivity myocarditis and pericarditis (MP) in United States service members. (2) Describe the process of case identification and adjudication using the 2003 CDC nationally defined myocarditis/pericarditis epidemiologic case definitions to include consideration of case-specific diversity and evolving evidence. Background: Between 2002 and 2016, 2.546 million service members received a smallpox Vaccinia vaccine. Acute MP is associated with vaccinia, but the long-term outcomes have not been studied. Methods: Records of vaccinia-associated MP reported to the Vaccine Adverse Event Reporting System by vaccination date were adjudicated using the 2003 MP epidemiologic case definitions for inclusion in a retrospective observational cohort study. Descriptive statistics of clinical characteristics, presentation, cardiac complications, and time course of clinical and cardiac recovery were calculated with comparisons by gender, diagnosis and time to recovery. Results: Out of over 5000 adverse event reports, 348 MP cases who survived the acute illness, including 276 myocarditis (99.6% probable/confirmed) and 72 pericarditis (29.2% probable/confirmed), were adjudicated for inclusion in the long-term follow-up. Demographics included a median age of 24 years (IQR 21,30) and male predominance (96%). Compared to background military population, the myocarditis and pericarditis cohort had a higher percentage of white males by 8.2% (95% CI: 5.6, 10.0) and age <40 years by 4.2% (95% CI: 1.7,5.8). Long-term follow-up documented full recovery in 267/306 (87.3%) with 74.9% recovered in less than a year (median ~3 months). Among patients with myocarditis, the percentage who had a delayed time to recovery at time of last follow-up was 12.8% (95% CI: 2.1,24.7) higher in those with an acute left ventricular ejection fraction (EF) of ≤50% and 13.5% (95% CI: 2.4,25.7) higher in those with hypokinesis. Patient complications included 6 ventricular arrhythmias (2 received implanted defibrillators) and 14 with atrial arrhythmias (2 received radiofrequency ablation). Three of 6 patients (50%) diagnosed with cardiomyopathy had clinical recovery at their last follow-up date. Conclusions: Hypersensitivity myocarditis/pericarditis following the smallpox vaccine is associated with full clinical and functional ventricular recovery in over 87% of cases (74.9% <1 year). A minority of MP cases experienced prolonged or incomplete recovery beyond 1 year.
MeSH term(s)	Humans ; Male ; United States ; Adult ; Female ; Smallpox Vaccine/adverse effects ; Myocarditis/epidemiology ; Myocarditis/etiology ; Myocarditis/diagnosis ; Vaccinia/prevention & control ; Retrospective Studies ; Military Health Services ; Stroke Volume ; Ventricular Function, Left ; Vaccination ; Pericarditis/epidemiology ; Pericarditis/etiology ; Pericarditis/diagnosis ; Smallpox/prevention & control ; Vaccinia virus
Chemical Substances	Smallpox Vaccine
Language	English
Publishing date	2023-05-08
Publishing country	United States
Document type	Observational Study ; Journal Article
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0283988
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Article ; Online: Insufficient Anthrax Lethal Toxin Neutralization Is Associated with Antibody Subclass and Domain Specificity in the Plasma of Anthrax-Vaccinated Individuals

Kenneth Smith / Lori Garman / Kathleen Norris / Jennifer Muther / Angie Duke / Renata J. M. Engler / Michael R. Nelson / Limone C. Collins / Christina Spooner / Carla Guthridge / Judith A. James

Microorganisms, Vol 9, Iss 1204, p

2021 Volume 1204

Abstract: Anthrax vaccine adsorbed (AVA) is a significant line of defense against bioterrorist attack from Bacillus anthracis spores. However, in a subset of individuals, this vaccine may produce a suboptimal quantity of anti-protective antigen (PA), antibodies ... ...

Abstract	Anthrax vaccine adsorbed (AVA) is a significant line of defense against bioterrorist attack from Bacillus anthracis spores. However, in a subset of individuals, this vaccine may produce a suboptimal quantity of anti-protective antigen (PA), antibodies that are poorly neutralizing, and/or antibody titers that wane over time, necessitating annual boosters. To study individuals with such poor responses, we examine the properties of anti-PA in a subset of vaccinated individuals that make significant quantities of antibody but are still unable to neutralize toxin. In this cohort, characterized by poorly neutralizing antibody, we find that increased IgG4 to IgG1 subclass ratios, low antibody avidity, and insufficient antibody targeting domain 4 associate with improper neutralization. Thus, future vaccines and vaccination schedules should be formulated to improve these deficiencies.
Keywords	anthrax ; vaccine ; antibody ; subclass ; domain ; toxin ; Biology (General) ; QH301-705.5
Language	English
Publishing date	2021-06-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Adverse events following pandemic influenza A (H1N1) 2009 monovalent and seasonal influenza vaccinations during the 2009-2010 season in the active component U.S. military and civilians aged 17-44years reported to the Vaccine Adverse Event Reporting System.

Bardenheier, Barbara H / Duderstadt, Susan K / Engler, Renata J M / McNeil, Michael M

Vaccine

2016 Volume 34, Issue 37, Page(s) 4406–4414

Abstract: Background: No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season among U.S. military personnel has been published.!## ...

Abstract	Background: No comparative review of Vaccine Adverse Event Reporting System (VAERS) submissions following pandemic influenza A (H1N1) 2009 and seasonal influenza vaccinations during the pandemic season among U.S. military personnel has been published. Methods: We compared military vs. civilian adverse event reporting rates. Adverse events (AEs) following vaccination were identified from VAERS for adults aged 17-44years after pandemic (monovalent influenza [MIV], and seasonal (trivalent inactivated influenza [IIV3], live attenuated influenza [LAIV3]) vaccines. Military vaccination coverage was provided by the Department of Defense's Defense Medical Surveillance System. Civilian vaccination coverage was estimated using data from the National 2009 H1N1 Flu Survey and the Behavioral Risk Factor Surveillance System survey. Results: Vaccination coverage was more than four times higher for MIV and more than twenty times higher for LAIV3 in the military than in the civilian population. The reporting rate of serious AE reports following MIV in service personnel (1.19 per 100,000) was about half that reported by the civilian population (2.45 per 100,000). Conversely, the rate of serious AE reports following LAIV3 among service personnel (1.32 per 100,000) was more than twice that of the civilian population. Although fewer military AEs following MIV were reported overall, the rate of Guillain-Barré Syndrome (GBS) (4.01 per million) was four times greater than that in the civilian population. (1.04 per million). Conclusions: Despite higher vaccination coverage in service personnel, the rate of serious AEs following MIV was about half that in civilians. The rate of GBS reported following MIV was higher in the military.
MeSH term(s)	Adolescent ; Adult ; Adverse Drug Reaction Reporting Systems ; Female ; Guillain-Barre Syndrome/chemically induced ; Humans ; Influenza A Virus, H1N1 Subtype ; Influenza Vaccines/adverse effects ; Influenza, Human/prevention & control ; Male ; Military Personnel ; Retrospective Studies ; United States ; Vaccination/adverse effects ; Vaccination/statistics & numerical data ; Young Adult
Chemical Substances	Influenza Vaccines
Language	English
Publishing date	2016-07-19
Publishing country	Netherlands
Document type	Comparative Study ; Journal Article ; Research Support, U.S. Gov't, P.H.S.
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2016.07.019
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Article: Insufficient Anthrax Lethal Toxin Neutralization Is Associated with Antibody Subclass and Domain Specificity in the Plasma of Anthrax-Vaccinated Individuals

Smith, Kenneth / Garman, Lori / Norris, Kathleen / Muther, Jennifer / Duke, Angie / Engler, Renata J. M. / Nelson, Michael R. / Collins, Limone C. / Spooner, Christina / Guthridge, Carla / James, Judith A.

Microorganisms. 2021 June 02, v. 9, no. 6

2021

Abstract	Anthrax vaccine adsorbed (AVA) is a significant line of defense against bioterrorist attack from Bacillus anthracis spores. However, in a subset of individuals, this vaccine may produce a suboptimal quantity of anti-protective antigen (PA), antibodies that are poorly neutralizing, and/or antibody titers that wane over time, necessitating annual boosters. To study individuals with such poor responses, we examine the properties of anti-PA in a subset of vaccinated individuals that make significant quantities of antibody but are still unable to neutralize toxin. In this cohort, characterized by poorly neutralizing antibody, we find that increased IgG4 to IgG1 subclass ratios, low antibody avidity, and insufficient antibody targeting domain 4 associate with improper neutralization. Thus, future vaccines and vaccination schedules should be formulated to improve these deficiencies.
Keywords	Bacillus anthracis ; anthrax ; anthrax vaccines ; antibody affinity ; antigens ; immunoglobulin G ; neutralization ; toxins ; vaccination
Language	English
Dates of publication	2021-0602
Publishing place	Multidisciplinary Digital Publishing Institute
Document type	Article
ZDB-ID	2720891-6
ISSN	2076-2607
ISSN	2076-2607
DOI	10.3390/microorganisms9061204
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: Complementary and alternative medicine education: Need for expanded educational resources for American Academy of Allergy, Asthma & Immunology members.

Engler, Renata J M / Silvers, William S / Bielory, Leonard

The Journal of allergy and clinical immunology

2009 Volume 123, Issue 2, Page(s) 511–512

MeSH term(s)	Academies and Institutes ; Asthma/therapy ; Complementary Therapies/education ; Complementary Therapies/statistics & numerical data ; Data Collection ; Health Resources ; Humans ; Hypersensitivity/therapy ; Surveys and Questionnaires ; United States
Language	English
Publishing date	2009-02
Publishing country	United States
Document type	Letter
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2008.11.020
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