Prospective Surveillance for Cardiac Adverse Events in Healthy Adults Receiving Modified Vaccinia Ankara Vaccines: A Systematic Review
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{"title"=>"Prospective Surveillance for Cardiac Adverse Events in Healthy Adults Receiving Modified Vaccinia Ankara Vaccines: A Systematic Review", "type"=>"journal", "authors"=>[{"first_name"=>"Marnie L.", "last_name"=>"Elizaga", "scopus_author_id"=>"6506202106"}, {"first_name"=>"Sandhya", "last_name"=>"Vasan", "scopus_author_id"=>"6603855768"}, {"first_name"=>"Mary A.", "last_name"=>"Marovich", "scopus_author_id"=>"6602570248"}, {"first_name"=>"Alicia H.", "last_name"=>"Sato", "scopus_author_id"=>"13204311900"}, {"first_name"=>"Dale N.", "last_name"=>"Lawrence", "scopus_author_id"=>"7402207014"}, {"first_name"=>"Bernard R.", "last_name"=>"Chaitman", "scopus_author_id"=>"35372145900"}, {"first_name"=>"Sharon E.", "last_name"=>"Frey", "scopus_author_id"=>"34975079200"}, {"first_name"=>"Michael C.", "last_name"=>"Keefer", "scopus_author_id"=>"56803548900"}], "year"=>2013, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-84872578653", "pui"=>"368149980", "doi"=>"10.1371/journal.pone.0054407", "sgr"=>"84872578653", "pmid"=>"23349878", "issn"=>"19326203"}, "id"=>"3e6d89c4-ff85-3273-92a4-d64f92d0b030", "abstract"=>"BACKGROUND: Vaccinia-associated myo/pericarditis was observed during the US smallpox vaccination (DryVax) campaign initiated in 2002. A highly-attenuated vaccinia strain, modified vaccinia Ankara (MVA) has been evaluated in clinical trials as a safer alternative to DryVax and as a vector for recombinant vaccines. Due to the lack of prospectively collected cardiac safety data, the US Food and Drug Administration required cardiac screening and surveillance in all clinical trials of MVA since 2004. Here, we report cardiac safety surveillance from 6 phase I trials of MVA vaccines. METHODS: Four clinical research organizations contributed cardiac safety data using common surveillance methods in trials administering MVA or recombinant MVA vaccines to healthy participants. 'Routine cardiac investigations' (ECGs and cardiac enzymes obtained 2 weeks after injections of MVA or MVA-HIV recombinants, or placebo-controls), and 'Symptom-driven cardiac investigations' are reported. The outcome measure is the number of participants who met the CDC-case definition for vaccinia-related myo/pericarditis or who experienced cardiac adverse events from an MVA vaccine. RESULTS: Four hundred twenty-five study participants had post-vaccination safety data analyzed, 382 received at least one MVA-containing vaccine and 43 received placebo; 717 routine ECGs and 930 cardiac troponin assays were performed. Forty-five MVA recipients (12%) had additional cardiac testing performed; 22 for cardiac symptoms, 19 for ECG/laboratory changes, and 4 for cardiac symptoms with an ECG/laboratory change. No participant had evidence of symptomatic or asymptomatic myo/pericarditis meeting the CDC-case definition and judged to be related to an MVA vaccine. CONCLUSIONS: Prospective surveillance of MVA recipients for myo/pericarditis did not detect cardiac adverse reactions in 382 study participants. TRIAL REGISTRATION: ClinicalTrials.gov NCT00082446 NCT003766090 NCT00252148 NCT00083603 NCT00301184 NCT00428337.", "link"=>"http://www.mendeley.com/research/prospective-surveillance-cardiac-adverse-events-healthy-adults-receiving-modified-vaccinia-ankara-va", "reader_count"=>14, "reader_count_by_academic_status"=>{"Researcher"=>5, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>2, "Other"=>1, "Student > Master"=>1, "Student > Bachelor"=>1, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor > Associate Professor"=>1}, "reader_count_by_user_role"=>{"Researcher"=>5, "Student > Doctoral Student"=>1, "Student > Ph. D. Student"=>2, "Other"=>1, "Student > Master"=>1, "Student > Bachelor"=>1, "Lecturer"=>1, "Lecturer > Senior Lecturer"=>1, "Professor > Associate Professor"=>1}, "reader_count_by_subject_area"=>{"Nursing and Health Professions"=>1, "Medicine and Dentistry"=>10, "Agricultural and Biological Sciences"=>2, "Immunology and Microbiology"=>1}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>10}, "Immunology and Microbiology"=>{"Immunology and Microbiology"=>1}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>2}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}}, "reader_count_by_country"=>{"United States"=>1, "United Kingdom"=>1}, "group_count"=>2}

Scopus | Further Information

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Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/276100"], "description"=>"<div><h3>Background</h3><p>Vaccinia-associated myo/pericarditis was observed during the US smallpox vaccination (DryVax) campaign initiated in 2002. A highly-attenuated vaccinia strain, modified vaccinia Ankara (MVA) has been evaluated in clinical trials as a safer alternative to DryVax and as a vector for recombinant vaccines. Due to the lack of prospectively collected cardiac safety data, the US Food and Drug Administration required cardiac screening and surveillance in all clinical trials of MVA since 2004. Here, we report cardiac safety surveillance from 6 phase I trials of MVA vaccines.</p> <h3>Methods</h3><p>Four clinical research organizations contributed cardiac safety data using common surveillance methods in trials administering MVA or recombinant MVA vaccines to healthy participants. ‘Routine cardiac investigations’ (ECGs and cardiac enzymes obtained 2 weeks after injections of MVA or MVA-HIV recombinants, or placebo-controls), and ‘Symptom-driven cardiac investigations’ are reported. The outcome measure is the number of participants who met the CDC-case definition for vaccinia-related myo/pericarditis or who experienced cardiac adverse events from an MVA vaccine.</p> <h3>Results</h3><p>Four hundred twenty-five study participants had post-vaccination safety data analyzed, 382 received at least one MVA-containing vaccine and 43 received placebo; 717 routine ECGs and 930 cardiac troponin assays were performed. Forty-five MVA recipients (12%) had additional cardiac testing performed; 22 for cardiac symptoms, 19 for ECG/laboratory changes, and 4 for cardiac symptoms with an ECG/laboratory change. No participant had evidence of symptomatic or asymptomatic myo/pericarditis meeting the CDC-case definition and judged to be related to an MVA vaccine.</p> <h3>Conclusions</h3><p>Prospective surveillance of MVA recipients for myo/pericarditis did not detect cardiac adverse reactions in 382 study participants.</p> <h3>Trial Registration</h3><p>ClinicalTrials.gov <a href=\"http://clinicaltrials.gov/ct2/results?term=NCT00082446\">NCT00082446</a> <a href=\"http://clinicaltrials.gov/ct2/results?term=NCT003766090\">NCT003766090</a> <a href=\"http://clinicaltrials.gov/ct2/results?term=NCT00252148\">NCT00252148</a> <a href=\"http://clinicaltrials.gov/ct2/results?term=NCT00083603\">NCT00083603</a> <a href=\"http://clinicaltrials.gov/ct2/results?term=NCT00301184\">NCT00301184</a> <a href=\"http://clinicaltrials.gov/ct2/results?term=NCT00428337\">NCT00428337</a></p> </div>", "links"=>[], "tags"=>["prospective", "cardiac", "adverse", "events", "adults", "receiving", "modified", "vaccinia", "ankara", "systematic", "review"], "article_id"=>114413, "categories"=>["Cancer", "Immunology"], "users"=>["Marnie L. Elizaga", "Sandhya Vasan", "Mary A. Marovich", "Alicia H. Sato", "Dale N. Lawrence", "Bernard R. Chaitman", "Sharon E. Frey", "Michael C. Keefer"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0054407", "stats"=>{"downloads"=>9, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/Prospective_Surveillance_for_Cardiac_Adverse_Events_in_Healthy_Adults_Receiving_Modified_Vaccinia_Ankara_Vaccines_A_Systematic_Review__/114413", "title"=>"Prospective Surveillance for Cardiac Adverse Events in Healthy Adults Receiving Modified Vaccinia Ankara Vaccines: A Systematic Review", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-01-17 01:13:33"}
  • {"files"=>["https://ndownloader.figshare.com/files/505872"], "description"=>"a<p>p-values are calculated from Fisher’s exact test for association between variable and onset.</p>b<p>Left ventricular hypertrophy.</p>", "links"=>[], "tags"=>["onset", "ecg", "changes", "symptom-driven", "cardiac"], "article_id"=>176379, "categories"=>["Virology", "Infectious Diseases", "Immunology"], "users"=>["Marnie L. Elizaga", "Sandhya Vasan", "Mary A. Marovich", "Alicia H. Sato", "Dale N. Lawrence", "Bernard R. Chaitman", "Sharon E. Frey", "Michael C. Keefer"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0054407.t003", "stats"=>{"downloads"=>0, "page_views"=>0, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_New_onset_ECG_changes_from_routine_and_symptom_driven_cardiac_investigations_/176379", "title"=>"New onset ECG changes from routine and symptom-driven cardiac investigations.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-01-17 01:46:19"}
  • {"files"=>["https://ndownloader.figshare.com/files/505686"], "description"=>"<p>Flow diagram of participants screened, enrolled and followed with prospective cardiac safety assessments among the 6 trials included in this report. ‘MVA’ indicates MVA alone or an MVA-HIV recombinant candidate vaccine, whereas ‘Placebo’ was a buffered sterile saline solution.</p>", "links"=>[], "tags"=>["Virology", "immunology", "Infectious diseases"], "article_id"=>176200, "categories"=>["Virology", "Infectious Diseases", "Immunology"], "users"=>["Marnie L. Elizaga", "Sandhya Vasan", "Mary A. Marovich", "Alicia H. Sato", "Dale N. Lawrence", "Bernard R. Chaitman", "Sharon E. Frey", "Michael C. Keefer"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0054407.g002", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Participant_Flow_/176200", "title"=>"Participant Flow.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-01-17 01:43:20"}
  • {"files"=>["https://ndownloader.figshare.com/files/505900"], "description"=>"<p>Demographics of participants with cardiac safety assessments.</p>", "links"=>[], "tags"=>["cardiac"], "article_id"=>176417, "categories"=>["Virology", "Infectious Diseases", "Immunology"], "users"=>["Marnie L. Elizaga", "Sandhya Vasan", "Mary A. Marovich", "Alicia H. Sato", "Dale N. Lawrence", "Bernard R. Chaitman", "Sharon E. Frey", "Michael C. Keefer"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0054407.t001", "stats"=>{"downloads"=>0, "page_views"=>1, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Demographics_of_participants_with_cardiac_safety_assessments_/176417", "title"=>"Demographics of participants with cardiac safety assessments.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-01-17 01:46:57"}
  • {"files"=>["https://ndownloader.figshare.com/files/505590"], "description"=>"<p>Schema for each of the 6 clinical trials with prospective cardiac safety assessments included in this report, A) US Military HIV Research Program study [NCT00376090] <a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0054407#pone.0054407-Currier1\" target=\"_blank\">[30]</a>, B) National Institutes of Health Division of Microbiology and Infectious Disease/St. Louis University study [NCT00082446] <a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0054407#pone.0054407-Frey1\" target=\"_blank\">[11]</a>, C) Aaron Diamond AIDS Research Center/International AIDS Vaccine Initiative study [NCT00252148] <a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0054407#pone.0054407-Vasan1\" target=\"_blank\">[31]</a>, D) HIV Vaccine Trials Network 055 study [NCT00083603] <a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0054407#pone.0054407-Keefer1\" target=\"_blank\">[27]</a>, E) HIV Vaccine Trials Network 065 study [NCT00301184] <a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0054407#pone.0054407-Goepfert1\" target=\"_blank\">[28]</a>, and F) HIV Vaccine Trials Network 067 study [NCT00428337] <a href=\"http://www.plosone.org/article/info:doi/10.1371/journal.pone.0054407#pone.0054407-Gorse1\" target=\"_blank\">[29]</a>. ‘Arrows’ indicate time of vaccination; ‘X’ indicates time of routine ECGs; ‘N’ indicates total number of study participants included in this analysis; ‘A:P’ indicates ratio of participants who received active vaccination (A) to placebo (P).</p>", "links"=>[], "tags"=>["Virology", "immunology", "Infectious diseases"], "article_id"=>176101, "categories"=>["Virology", "Infectious Diseases", "Immunology"], "users"=>["Marnie L. Elizaga", "Sandhya Vasan", "Mary A. Marovich", "Alicia H. Sato", "Dale N. Lawrence", "Bernard R. Chaitman", "Sharon E. Frey", "Michael C. Keefer"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0054407.g001", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Overview_of_clinical_trial_designs_/176101", "title"=>"Overview of clinical trial designs.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2013-01-17 01:41:41"}
  • {"files"=>["https://ndownloader.figshare.com/files/505816"], "description"=>"a<p>total number of participants who received: MVA = 382; placebo = 43.</p>b<p>expressed in mean ± standard deviation; for participants who had multiple reports of a given symptom, the minimum number of days post-vaccination and maximum duration of symptoms were used.</p>c<p>palpitations and flu-like symptoms not collected for SLU-DMID study.</p><p>n/a = not applicable.</p>", "links"=>[], "tags"=>["self-reported", "symptoms", "suggestive", "visits", "weeks"], "article_id"=>176321, "categories"=>["Virology", "Infectious Diseases", "Immunology"], "users"=>["Marnie L. Elizaga", "Sandhya Vasan", "Mary A. Marovich", "Alicia H. Sato", "Dale N. Lawrence", "Bernard R. Chaitman", "Sharon E. Frey", "Michael C. Keefer"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0054407.t002", "stats"=>{"downloads"=>0, "page_views"=>6, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Cross_sectional_frequency_of_solicited_self_reported_symptoms_suggestive_of_myo_pericarditis_at_visits_2_weeks_post_vaccination_boost_/176321", "title"=>"Cross-sectional frequency of solicited, self-reported symptoms suggestive of myo/pericarditis at visits 2 weeks post-vaccination/boost.", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2013-01-17 01:45:21"}

PMC Usage Stats | Further Information

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  • {"unique-ip"=>"11", "full-text"=>"37", "pdf"=>"7", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"5", "supp-data"=>"1", "cited-by"=>"2", "year"=>"2016", "month"=>"1"}
  • {"unique-ip"=>"4", "full-text"=>"4", "pdf"=>"3", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"0", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"3"}
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  • {"unique-ip"=>"15", "full-text"=>"20", "pdf"=>"6", "abstract"=>"0", "scanned-summary"=>"0", "scanned-page-browse"=>"0", "figure"=>"2", "supp-data"=>"0", "cited-by"=>"0", "year"=>"2016", "month"=>"6"}
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Relative Metric

{"start_date"=>"2013-01-01T00:00:00Z", "end_date"=>"2013-12-31T00:00:00Z", "subject_areas"=>[{"subject_area"=>"/Biology and life sciences", "average_usage"=>[269, 466, 588, 697, 800, 896, 988, 1076, 1165, 1254, 1340, 1417]}, {"subject_area"=>"/Biology and life sciences/Immunology", "average_usage"=>[266, 466, 591, 701, 799, 887, 982, 1067, 1155, 1237, 1317, 1395, 1458]}, {"subject_area"=>"/Biology and life sciences/Microbiology", "average_usage"=>[293, 503, 638, 755, 861, 960, 1056, 1146, 1239, 1323, 1403, 1491, 1568]}, {"subject_area"=>"/Medicine and health sciences/Clinical medicine", "average_usage"=>[263, 451, 582, 699, 797, 889, 969, 1045, 1134, 1215, 1284, 1362, 1412]}, {"subject_area"=>"/Medicine and health sciences/Pharmacology", "average_usage"=>[265, 471, 604, 723, 827, 926, 1022, 1113, 1210, 1290, 1377, 1454, 1532]}]}
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