A Prospective Study of the Incidence of Myocarditis/Pericarditis and New Onset Cardiac Symptoms following Smallpox and Influenza Vaccination

被引：121

作者：

Engler, Renata J. M. ^{[1
,2
]}

Nelson, Michael R. ^{[2
,3
]}

Collins, Limone C., Jr. ^{[1
]}

Spooner, Christina ^{[1
]}

Hemann, Brian A. ^{[4
,5
]}

Gibbs, Barnett T. ^{[4
,5
]}

Atwood, J. Edwin ^{[4
,5
]}

Howard, Robin S. ^{[6
]}

Chang, Audrey S. ^{[6
]}

Cruser, Daniel L. ^{[7
]}

Gates, Daniel G. ^{[8
]}

Vernalis, Marina N. ^{[9
]}

Lengkeek, Marguerite S. ^{[10
]}

McClenathan, Bruce M. ^{[11
]}

Jaffe, Allan S. ^{[12
]}

Cooper, Leslie T. ^{[12
]}

Black, Steve ^{[13
]}

Carlson, Christopher ^{[14
]}

Wilson, Christopher ^{[15
]}

Davis, Robert L. ^{[16
,17
]}

机构：

[1] Walter Reed Natl Mil Med Ctr, Immunizat Healthcare Branch, Def Hlth Agcy, Mil Vaccine Agcy Vaccine Healthcare Ctr Network, Bethesda, MD 20889 USA

[2] Uniformed Serv Univ Hlth Sci, Dept Med & Pediat, Bethesda, MD 20814 USA

[3] Walter Reed Natl Mil Med Ctr, Allergy Immunol Immunizat, Bethesda, MD USA

[4] Walter Reed Natl Mil Med Ctr, Dept Med, Serv Cardiol, Bethesda, MD USA

[5] Uniformed Serv Univ Hlth Sci, Dept Med, Bethesda, MD 20814 USA

[6] Walter Reed Natl Mil Med Ctr, Dept Res Programs, Bethesda, MD USA

[7] Vassar Bros Med Ctr, Dept Pathol, Poughkeepsie, NY USA

[8] Ft Belvoir Community Hosp, Serv Cardiol, Ft Belvoir, VA USA

[9] Walter Reed Natl Mil Med Ctr, Integrated Cardiac Hlth Project, Bethesda, MD USA

[10] Allergy & Asthma Care Ctr, Chantilly, VA USA

[11] Womack Army Med Ctr, Def Hlth Agcy, Immunizat Healthcare Branch, Mil Vaccine Agcy Vaccine Healthcare Ctr Network, Ft Bragg, NC USA

[12] Mayo Clin, Div Cardiovasc Dis, Rochester, MN USA

[13] Cincinnati Childrens Hosp Ctr Global Hlth, Cincinnati, OH USA

[14] Fred Hutchinson Canc Res Ctr, Div Publ Hlth Sci, Seattle, WA 98104 USA

[15] Univ Washington, Dept Immunol, Seattle, WA 98195 USA

[16] Univ Tennessee, Ctr Hlth Sci, Ctr Biomed Informat, Memphis, TN 38163 USA

[17] Oak Ridge Natl Lab, Oak Ridge, TN USA

来源：

PLOS ONE | 2015年 / 10卷 / 03期

基金：

美国国家卫生研究院;

关键词：

INDUCED MYOCARDIAL-ISCHEMIA; LONG-TERM MORTALITY; TROPONIN-T; ADVERSE EVENTS; UNITED-STATES; GENERAL-POPULATION; RISK; ELEVATION; EXERCISE; RECOMMENDATIONS;

D O I：

10.1371/journal.pone.0118283

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

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.

引用

页数：18

共 50 条

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