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Vacinas contra Influenza/imunologia , Influenza Humana/imunologia , Pandemias , Betacoronavirus/imunologia , COVID-19 , Infecções por Coronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/imunologia , Pneumonia Viral/prevenção & controle , SARS-CoV-2RESUMO
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.
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Serviços de Saúde Militar , Miocardite , Pericardite , Vacina Antivariólica , Varíola , Vacínia , Humanos , Masculino , Estados Unidos , Adulto , Feminino , Vacina Antivariólica/efeitos adversos , Miocardite/epidemiologia , Miocardite/etiologia , Miocardite/diagnóstico , Vacínia/prevenção & controle , Estudos Retrospectivos , Volume Sistólico , Função Ventricular Esquerda , Vacinação , Pericardite/epidemiologia , Pericardite/etiologia , Pericardite/diagnóstico , Varíola/prevenção & controle , Vaccinia virusRESUMO
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.
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Miocardite , Pericardite , Vacinação , Humanos , Incidência , Miocardite/induzido quimicamente , Miocardite/diagnóstico , Miocardite/epidemiologia , Pericardite/diagnóstico , Pericardite/epidemiologia , Pericardite/etiologia , Vacinação/efeitos adversosRESUMO
Bacillus anthracis remains a serious bioterrorism concern, and the currently licensed vaccine remains an incomplete solution for population protection from inhalation anthrax and has been associated with concerns regarding efficacy and safety. Thus, understanding how to generate long-lasting protective immunity with reduced immunizations or provide protection through postexposure immunotherapeutics are long-sought goals. Through evaluation of a large military cohort, we characterized the levels of antibodies against protective antigen and found that over half of anthrax vaccinees had low serum levels of in vitro toxin neutralization capacity. Using solid-phase epitope mapping and confirmatory assays, we identified several neutralization-associated humoral epitopes and demonstrated that select antipeptide responses mediated protection in vitro. Finally, passively transferred antibodies specific for select epitopes provided protection in an in vivo lethal toxin mouse model. Identification of these antigenic regions has important implications for vaccine design and the development of directed immunotherapeutics.
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Antraz/imunologia , Anticorpos Antibacterianos/imunologia , Bacillus anthracis/imunologia , Adulto , Sequência de Aminoácidos , Animais , Antraz/epidemiologia , Anticorpos Antibacterianos/sangue , Anticorpos Antibacterianos/química , Anticorpos Antibacterianos/genética , Antígenos de Bactérias/toxicidade , Toxinas Bacterianas/toxicidade , Bioterrorismo , Linhagem Celular , Ensaio de Imunoadsorção Enzimática , Epitopos/imunologia , Feminino , Humanos , Imunização/métodos , Imunoglobulina G/sangue , Macrófagos/efeitos dos fármacos , Macrófagos/imunologia , Masculino , Pessoa de Meia-Idade , Dados de Sequência Molecular , Oklahoma , Peptídeos/análise , Peptídeos/química , Grupos Raciais , Vacinação/métodosRESUMO
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.
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Complementary and alternative medicine (CAM) therapies present a growing information management challenge for physicians because nearly 40% of their patients may be using and another 50% may be considering use of CAM as part of their healthcare regimen. The National Health Statistics Reports for 2007 described the most commonly used nonvitamin, nonmineral therapy as natural products (eg, herbals at 17.7%). More than 5% of children under the age of 18 years used CAM for allergic conditions including asthma. The amount and quality of information available and concerns about liability risk represent a challenge for most physicians. This review focuses on considerations for approaching a CAM-related consultation, incorporating legal and logistic factors affecting how such an encounter should be approached. A 10-step process is presented that addresses different components of CAM consultations and what should be documented. Access to timely, high-quality information regarding product specific efficacy and safety data, as found in the Natural Medicines Comprehensive Database, is needed to support CAM consultation efficiently. Understanding of serious adverse events associated with CAM is limited; an international need exists for improved safety surveillance and information sharing. Allergy-immunology, as a specialty with expertise in adverse drug reaction evaluation and management, has a unique opportunity to support enhanced CAM-related adverse events evaluations, reporting, and research.
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Produtos Biológicos/efeitos adversos , Terapias Complementares/efeitos adversos , Necessidades e Demandas de Serviços de Saúde/ética , Hipersensibilidade/terapia , Produtos Biológicos/uso terapêutico , Terapias Complementares/ética , Terapias Complementares/legislação & jurisprudência , Pessoal de Saúde/ética , Necessidades e Demandas de Serviços de Saúde/legislação & jurisprudência , Interações Ervas-Drogas , Humanos , Hipersensibilidade/imunologia , Preparações de Plantas/efeitos adversos , Preparações de Plantas/uso terapêutico , Plantas Medicinais , Resultado do TratamentoRESUMO
We report the second case of severe postvaccinial encephalitis with acute disseminated encephalomyelitis since smallpox vaccination was reintroduced in 2002. Both affected patients responded dramatically with early intervention of intravenous immunoglobulin. Our patient, who also received concurrent vaccinia immunoglobulin and corticosteroids, demonstrated full recovery.
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Encefalomielite Aguda Disseminada/tratamento farmacológico , Imunoglobulinas Intravenosas/uso terapêutico , Fatores Imunológicos/uso terapêutico , Vacina Antivariólica/efeitos adversos , Esteroides/uso terapêutico , Vacínia/complicações , Vacínia/tratamento farmacológico , Adulto , Encefalomielite Aguda Disseminada/induzido quimicamente , Humanos , Masculino , Resultado do Tratamento , Adulto JovemRESUMO
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.
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A major difference between two currently licensed anthrax vaccines is presence (United Kingdom Anthrax Vaccine Precipitated, AVP) or absence (United States Anthrax Vaccine Adsorbed, AVA) of quantifiable amounts of the Lethal Toxin (LT) component Lethal Factor (LF). The primary immunogen in both vaccine formulations is Protective Antigen (PA), and LT-neutralizing antibodies directed to PA are an accepted correlate of vaccine efficacy; however, vaccination studies in animal models have demonstrated that LF antibodies can be protective. In this report we compared humoral immune responses in cohorts of AVP (n=39) and AVA recipients (n=78) matched 1:2 for number of vaccinations and time post-vaccination, and evaluated whether the LF response contributes to LT neutralization in human recipients of AVP. PA response rates (≥95%) and PA IgG concentrations were similar in both groups; however, AVP recipients exhibited higher LT neutralization ED50 values (AVP: 1464.0±214.7, AVA: 544.9±83.2, p<0.0001) and had higher rates of LF IgG positivity (95%) compared to matched AVA vaccinees (1%). Multiple regression analysis revealed that LF IgG makes an independent and additive contribution to the LT neutralization response in the AVP group. Affinity purified LF antibodies from two independent AVP recipients neutralized LT and bound to LF Domain 1, confirming contribution of LF antibodies to LT neutralization. This study documents the benefit of including an LF component to PA-based anthrax vaccines.
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Vacinas contra Antraz/uso terapêutico , Antraz/prevenção & controle , Anticorpos Antibacterianos/imunologia , Anticorpos Neutralizantes/imunologia , Antígenos de Bactérias/imunologia , Toxinas Bacterianas/imunologia , Adulto , Vacinas contra Antraz/classificação , Anticorpos Antibacterianos/sangue , Anticorpos Neutralizantes/sangue , Feminino , Humanos , Imunidade Humoral , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Masculino , Pessoa de Meia-Idade , Testes de Neutralização , Fatores Sexuais , Adulto JovemRESUMO
Edema toxin (ET), composed of edema factor (EF) and protective antigen (PA), is a virulence factor of Bacillus anthracis that alters host immune cell function and contributes to anthrax disease. Anthrax vaccine precipitated (AVP) contains low but detectable levels of EF and can elicit EF-specific antibodies in human recipients of AVP. Active and passive vaccination of mice with EF can contribute to protection from challenge with Bacillus anthracis spores or ET. This study compared humoral responses to ET in recipients of AVP (n = 33) versus anthrax vaccine adsorbed (AVA; n = 66), matched for number of vaccinations and time postvaccination, and further determined whether EF antibodies elicited by AVP contribute to ET neutralization. AVP induced higher incidence (77.8%) and titer (229.8 ± 58.6) of EF antibodies than AVA (4.2% and 7.8 ± 8.3, respectively), reflecting the reported low but detectable presence of EF in AVP. In contrast, PA IgG levels and ET neutralization measured using a luciferase-based cyclic AMP reporter assay were robust and did not differ between the two vaccine groups. Multiple regression analysis failed to detect an independent contribution of EF antibodies to ET neutralization in AVP recipients; however, EF antibodies purified from AVP sera neutralized ET. Serum samples from at least half of EF IgG-positive AVP recipients bound to nine decapeptides located in EF domains II and III. Although PA antibodies are primarily responsible for ET neutralization in recipients of AVP, increased amounts of an EF component should be investigated for the capacity to enhance next-generation, PA-based vaccines.
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Vacinas contra Antraz/imunologia , Antraz/prevenção & controle , Anticorpos Antibacterianos/biossíntese , Anticorpos Neutralizantes/biossíntese , Antígenos de Bactérias/imunologia , Bacillus anthracis/imunologia , Toxinas Bacterianas/imunologia , Adulto , Animais , Antraz/imunologia , Vacinas contra Antraz/química , Anticorpos Antibacterianos/sangue , Anticorpos Antibacterianos/imunologia , Anticorpos Neutralizantes/sangue , Anticorpos Neutralizantes/imunologia , Feminino , Humanos , Imunoglobulina G/sangue , Imunoglobulina G/imunologia , Masculino , Camundongos , Pessoa de Meia-Idade , Testes de Neutralização , Adulto JovemRESUMO
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.
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Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Vacinação/efeitos adversos , Adolescente , Adulto , Sistemas de Notificação de Reações Adversas a Medicamentos , Feminino , Síndrome de Guillain-Barré/induzido quimicamente , Humanos , Vírus da Influenza A Subtipo H1N1 , Masculino , Militares , Estudos Retrospectivos , Estados Unidos , Vacinação/estatística & dados numéricos , Adulto JovemRESUMO
Although the U.S. National Academy of Sciences concluded that anthrax vaccine adsorbed (AVA) has an adverse event (AE) profile similar to those of other adult vaccines, 30 to 70% of queried AVA vaccinees report AEs. AEs appear to be correlated with certain demographic factors, but the underlying immunologic pathways are poorly understood. We evaluated a cohort of 2,421 AVA vaccinees and found 153 (6.3%) reported an AE. Females were more likely to experience AEs (odds ratio [OR] = 6.0 [95% confidence interval {CI} = 4.2 to 8.7]; P < 0.0001). Individuals 18 to 29 years of age were less likely to report an AE than individuals aged 30 years or older (OR = 0.31 [95% CI = 0.22 to 0.43]; P < 0.0001). No significant effects were observed for African, European, Hispanic, American Indian, or Asian ancestry after correcting for age and sex. Additionally, 103 AEs were large local reactions (LLRs), whereas 53 AEs were systemic reactions (SRs). In a subset of our cohort vaccinated 2 to 12 months prior to plasma sample collection (n = 75), individuals with LLRs (n = 33) had higher protective-antigen (PA)-specific IgE levels than matched, unaffected vaccinated individuals (n = 50; P < 0.01). Anti-PA IgE was not associated with total plasma IgE, hepatitis B-specific IgE, or anti-PA IgG in individuals who reported an AE or in matched, unaffected AVA-vaccinated individuals. IP-10 was also elevated in sera of individuals who developed LLRs (P < 0.05). Individuals reporting SRs had higher levels of systemic inflammation as measured from C-reactive protein (P < 0.01). Thus, LLRs and SRs are mediated by distinct pathways. LLRs are associated with a vaccine-specific IgE response and IP-10, whereas SRs demonstrate increased systemic inflammation without a skewed cytokine profile.
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Vacinas contra Antraz/efeitos adversos , Anticorpos Antibacterianos/sangue , Antígenos de Bactérias/imunologia , Toxinas Bacterianas/imunologia , Proteína C-Reativa/análise , Quimiocina CXCL10/sangue , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/patologia , Imunoglobulina E/sangue , Adolescente , Adulto , Fatores Etários , Vacinas contra Antraz/administração & dosagem , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Etnicidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores Sexuais , Estados Unidos/epidemiologia , Adulto JovemRESUMO
BACKGROUND: Routine immunization, one of the most effective public health interventions, has effectively reduced death and morbidity due to a variety of infectious diseases. However, allergic reactions to vaccines occur very rarely and can be life threatening. Given the large numbers of vaccines administered worldwide, there is a need for an international consensus regarding the evaluation and management of allergic reactions to vaccines. METHODS: Following a review of the literature, and with the active participation of representatives from the World Allergy Organization (WAO), the European Academy of Allergy and Clinical Immunology (EAACI), the American Academy of Allergy, Asthma, and Immunology (AAAAI), and the American College of Allergy, Asthma, and Immunology (ACAAI), the final committee was formed with the purpose of having members who represented a wide-range of countries, had previously worked on vaccine safety, and included both allergist/immunologists as well as vaccinologists. RESULTS: Consensus was reached on a variety of topics, including: definition of immediate allergic reactions, including anaphylaxis, approaches to distinguish association from causality, approaches to patients with a history of an allergic reaction to a previous vaccine, and approaches to patients with a history of an allergic reaction to components of vaccines. CONCLUSIONS: This document provides comprehensive and internationally accepted guidelines and access to on-line documents to help practitioners around the world identify allergic reactions following immunization. It also provides a framework for the evaluation and further management of patients who present either following an allergic reaction to a vaccine or with a history of allergy to a component of vaccines.
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OBJECTIVES: The purpose of this study was to assess the follow-up of patients with vaccinia-associated myocarditis. BACKGROUND: With the threat of biological warfare, the U.S. Department of Defense resumed a program for widespread smallpox vaccinations on December 13, 2002. One-year afterwards, there has been a significant increase in the occurrence of myocarditis and pericarditis among those vaccinated. METHODS: Cases were identified through sentinel reporting to military headquarters, systematic surveillance, and spontaneous reports. RESULTS: A total of 540,824 military personnel were vaccinated with a New York City Board of Health strain of vaccinia from December 2002 through December 2003. Of these, 67 developed myopericarditis at 10.4 +/- 3.6 days after vaccination. The ST-segment elevation was noted in 57%, mean troponin on admission was 11.3+/- 22.7 ng/dl, and peak cardiac enzymes were noted within 8 h of presentation. On follow-up of 64 patients (96%) at a mean of 32 +/- 16 weeks, all patients had objective normalization of echocardiography, electrocardiography, laboratory testing, graded exercise testing, and functional status; 8 (13%) reported atypical, non-limiting persistent chest discomfort. CONCLUSIONS: Post-vaccinial myopericarditis should be considered in patients with chest pain within 30 days after smallpox vaccination. Normalization of echocardiography, electrocardiography, and treadmill testing is expected, and nearly all patients have resolution of chest pain on follow-up.
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Miocardite/induzido quimicamente , Vacina Antivariólica/efeitos adversos , Biomarcadores/sangue , Creatina Quinase/sangue , Sistema de Condução Cardíaco/fisiopatologia , Humanos , Incidência , Miocardite/diagnóstico , Miocardite/epidemiologia , Miocardite/fisiopatologia , Pericardite/induzido quimicamente , Pericardite/diagnóstico , Pericardite/epidemiologia , Troponina I/sangue , Troponina T/sangue , Pressão Ventricular/fisiologiaRESUMO
OBJECTIVE: To examine relationships between weight loss through changes in lifestyle and peripheral blood gene expression profiles. METHODS: A prospective nonrandomized trial was conducted over 1 year in participants undergoing intensive lifestyle modification to reverse or stabilize progression of coronary artery disease. Cardiovascular risk factors, inflammatory biomarkers, and gene expression as a function of weight loss were assessed in 89 lifestyle participants and 71 retrospectively matched controls undergoing usual care. RESULTS: Substantial weight loss (-15.2 ± 3.8%) in lifestyle participants (n = 33) was associated with improvement in selected cardiovascular risk factors and significant changes in peripheral blood gene expression from pre- to post-intervention: 132 unique genes showed significant expression changes (false discovery rate corrected P-value <0.05 and fold-change ≥1.4). Altered molecular pathways were related to immune function and inflammatory responses involving endothelial activation. In contrast, participants losing minimal weight (-3.1 ± 2.5%, n = 32) showed only minor changes in cardiovascular risk factors and markers of inflammation and no changes in gene expression compared to non intervention controls after 1 year. CONCLUSIONS: Weight loss (≥10%) during lifestyle modification is associated with down-regulation of genetic pathways governing interactions between circulating immune cells and the vascular endothelium and may be required to successfully reduce CVD risk.
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Reabilitação Cardíaca , Doenças Cardiovasculares/genética , Expressão Gênica , Estilo de Vida , Comportamento de Redução do Risco , Redução de Peso/genética , Idoso , Comportamento Alimentar , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Medição de RiscoRESUMO
BACKGROUND: Although myocarditis/pericarditis (MP) has been identified as an adverse event following smallpox vaccine (SPX), the prospective incidence of this reaction and new onset cardiac symptoms, including possible subclinical injury, has not been prospectively defined. PURPOSE: The study's primary objective was to determine the prospective incidence of new onset cardiac symptoms, clinical and possible subclinical MP in temporal association with immunization. METHODS: New onset cardiac symptoms, clinical MP and cardiac specific troponin T (cTnT) elevations following SPX (above individual baseline values) were measured in a multi-center prospective, active surveillance cohort study of healthy subjects receiving either smallpox vaccine or trivalent influenza vaccine (TIV). RESULTS: New onset chest pain, dyspnea, and/or palpitations occurred in 10.6% of SPX-vaccinees and 2.6% of TIV-vaccinees within 30 days of immunization (relative risk (RR) 4.0, 95% CI: 1.7-9.3). Among the 1081 SPX-vaccinees with complete follow-up, 4 Caucasian males were diagnosed with probable myocarditis and 1 female with suspected pericarditis. This indicates a post-SPX incidence rate more than 200-times higher than the pre-SPX background population surveillance rate of myocarditis/pericarditis (RR 214, 95% CI 65-558). Additionally, 31 SPX-vaccinees without specific cardiac symptoms were found to have over 2-fold increases in cTnT (>99th percentile) from baseline (pre-SPX) during the window of risk for clinical myocarditis/pericarditis and meeting a proposed case definition for possible subclinical myocarditis. This rate is 60-times higher than the incidence rate of overt clinical cases. No clinical or possible subclinical myocarditis cases were identified in the TIV-vaccinated group. CONCLUSIONS: Passive surveillance significantly underestimates the true incidence of myocarditis/pericarditis after smallpox immunization. Evidence of subclinical transient cardiac muscle injury post-vaccinia immunization is a finding that requires further study to include long-term outcomes surveillance. Active safety surveillance is needed to identify adverse events that are not well understood or previously recognized.
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Vacinas contra Influenza/efeitos adversos , Miocardite/epidemiologia , Pericardite/epidemiologia , Vacina Antivariólica/efeitos adversos , Vacinação/efeitos adversos , Adulto , Estudos de Coortes , Demografia , Feminino , Humanos , Incidência , Masculino , Estudos Prospectivos , Resultado do Tratamento , Troponina T/metabolismo , Estados Unidos/epidemiologia , Vacinas de Produtos Inativados/imunologiaRESUMO
(The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense.) Immunization healthcare is becoming increasingly complex as the number and types of vaccines have continued to expand. Like all prescription drugs, vaccines may be associated with adverse events. The majority of these reactions are self-limited and not associated with prolonged disability. The media, Internet and public advocacy groups have focused on potentially serious vaccine-associated adverse events with questions raised about causal linkages to increasing frequencies of diseases such as autism and asthma. Despite a lack of evidence of a causal relationship to a variety of vaccine safety concerns, including extensive reviews by the Institute of Medicine, questions regarding vaccine safety continue to threaten the success of immunization programs. Risk communication arid individual risk assessment is further challenged by the public health success of vaccine programs creating the perception that certain vaccines are no longer necessary or justified because of the rare reaction risk. There is a need for improved understanding of true vaccine contraindications and precautions as well as host factors and disease threat in order to develop a patient specific balanced risk communication intervention. When they occur, vaccine related adverse events must be treated, documented and reported through the VAERS system. The increasing complexity of vaccination health care has led the Center of Disease Control and Prevention (CDC) to identify Vaccine Safety Assessment and Evaluation as a potential new specialty.
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Hipersensibilidade a Drogas/etiologia , Vacinas/efeitos adversos , Hipersensibilidade a Drogas/epidemiologia , Humanos , Programas de Imunização/normas , Incidência , Vigilância da População , Saúde Pública , Fatores de Risco , Vacinas/classificaçãoRESUMO
Anthrax Vaccine Adsorbed (AVA) generates short-lived protective antigen (PA) specific IgG that correlates with in vitro toxin neutralization and protection from Bacillus anthracis challenge. Animal studies suggest that when PA-specific IgG has waned, survival after spore challenge correlates with an activation of PA-specific memory B cells. Here, we characterize the quantity and the longevity of AVA-induced memory B cell responses in humans. Peripheral blood mononuclear cells (PBMCs) from individuals vaccinated ≥3 times with AVA (n = 50) were collected early (3-6 months, n = 27) or late after their last vaccination (2-5 years, n = 23), pan-stimulated, and assayed by ELISPOT for total and PA-specific memory B cells differentiated into antibody secreting cells (ASCs). PA-specific ASC percentages ranged from 0.02% to 6.25% (median: 1.57%) and did not differ between early and late post-vaccination individuals. PA-specific ASC percentages correlated with plasma PA-specific IgG (r = 0.42, p = 0.03) and toxin neutralization (r = 0.52, p = 0.003) early post vaccination. PA-specific ASC percentages correlated with supernatant anti-PA both early (r = 0.60, p = 0.001) and late post vaccination (r = 0.71, p < 0.0001). These data suggest PA-specific memory B cell responses are long-lived and can be estimated after recent vaccination by the magnitude and neutralization capacity of the humoral response.
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Vacinas contra Antraz , Anticorpos Antibacterianos/imunologia , Antígenos de Bactérias/imunologia , Linfócitos B/imunologia , Bacillus anthracis/imunologia , Toxinas Bacterianas/imunologia , Imunoglobulina G/imunologia , Adulto , Humanos , Imunidade Humoral , Leucócitos Mononucleares , Masculino , Pessoa de Meia-Idade , Adulto JovemRESUMO
OBJECTIVES: We studied military health care provider (HCP) practices regarding reporting of adverse events following immunization (AEFI). METHODS: A convenience sample of HCP was surveyed to assess familiarity with Vaccine Adverse Event Reporting System (VAERS), AEFI they were likely to report, methods used and preferred for reporting, and perceived barriers to reporting. We analyzed factors associated with HCP reporting AEFI to VAERS. RESULTS: A total of 547 surveys were distributed with 487 completed and returned for an 89% response rate. The percentage of HCP aware of VAERS (54%) varied by occupation. 47% of respondents identified knowledge of at least one AEFI with only 34% of these indicating that they had ever reported to VAERS. More serious events were more likely to be reported. Factors associated with HCP reporting AEFIs in bivariate analysis included HCP familiarity with filing a paper VAERS report, HCP familiarity with filing an electronic VAERS report, HCP familiarity with VAERS, and time spent on immunization tasks. In a multivariable analysis, only HCP familiarity with filing a paper VAERS report was statistically significant (Odds ratio = 115.3; p < 0.001). CONCLUSIONS: Specific educational interventions targeted to military HCP likely to see AEFIs but not currently filing VAERS reports may improve vaccine safety reporting practices.