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Vaccine adverse events

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https://www.readbyqxmd.com/read/28226046/analysis-of-adverse-events-following-immunization-caused-by-immunization-errors
#1
Lúcia Helena Linheira Bisetto, Suely Itsuko Ciosak
Objective: to analyze adverse events following immunization (AEFI) caused by immunization error in the state of Paraná, Brazil, from 2003 to 2013. Method: this is a descriptive, documental, retrospective, and quantitative research using secondary data from the Adverse Event Following Immunization Information System and the Immunization Program Evaluation System. We included cases confirmed and/or associated with different types of vaccines. For the analysis, we collected frequencies and incidence rates, and used simple linear regression models with Student's t-test...
January 2017: Revista Brasileira de Enfermagem
https://www.readbyqxmd.com/read/28216244/safety-and-efficacy-of-pfspz-vaccine-against-plasmodium-falciparum-via-direct-venous-inoculation-in-healthy-malaria-exposed-adults-in-mali-a-randomised-double-blind-phase-1-trial
#2
Mahamadou S Sissoko, Sara A Healy, Abdoulaye Katile, Freda Omaswa, Irfan Zaidi, Erin E Gabriel, Bourama Kamate, Yacouba Samake, Merepen A Guindo, Amagana Dolo, Amadou Niangaly, Karamoko Niaré, Amatigue Zeguime, Kourane Sissoko, Hama Diallo, Ismaila Thera, Kelly Ding, Michael P Fay, Elise M O'Connell, Thomas B Nutman, Sharon Wong-Madden, Tooba Murshedkar, Adam J Ruben, Minglin Li, Yonas Abebe, Anita Manoj, Anusha Gunasekera, Sumana Chakravarty, B Kim Lee Sim, Peter F Billingsley, Eric R James, Michael Walther, Thomas L Richie, Stephen L Hoffman, Ogobara Doumbo, Patrick E Duffy
BACKGROUND: Plasmodium falciparum sporozite (PfSPZ) Vaccine is a metabolically active, non-replicating, whole malaria sporozoite vaccine that has been reported to be safe and protective against P falciparum controlled human malaria infection in malaria-naive individuals. We aimed to assess the safety and protective efficacy of PfSPZ Vaccine against naturally acquired P falciparum in malaria-experienced adults in Mali. METHODS: After an open-label dose-escalation study in a pilot safety cohort, we did a double-blind, randomised, placebo-controlled trial based in Donéguébougou and surrounding villages in Mali...
February 16, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28216183/safety-and-immunogenicity-of-the-novel-h4-ic31-tuberculosis-vaccine-candidate-in-bcg-vaccinated-adults-two-phase-i-dose-escalation-trials
#3
Maria Norrby, Timo Vesikari, Lars Lindqvist, Markus Maeurer, Raija Ahmed, Shahnaz Mahdavifar, Sean Bennett, J Bruce McClain, Barbara M Shepherd, Daner Li, David A Hokey, Ingrid Kromann, Søren T Hoff, Peter Andersen, Adriëtte W de Visser, Simone A Joosten, Tom H M Ottenhoff, Jan Andersson, Susanna Brighenti
BACKGROUND: Novel vaccine strategies are required to provide protective immunity in tuberculosis (TB) and prevent development of active disease. We investigated the safety and immunogenicity of a novel TB vaccine candidate, H4:IC31 (AERAS-404) that is composed of a fusion protein of M. tuberculosis antigens Ag85B and TB10.4 combined with an IC31® adjuvant. METHODS: BCG-vaccinated healthy subjects were immunized with various antigen (5, 15, 50, 150μg) and adjuvant (0, 100, 500nmol) doses of the H4:IC31 vaccine (n=106) or placebo (n=18) in two randomized, double-blind, placebo-controlled phase I studies conducted in a low TB endemic setting in Sweden and Finland...
February 16, 2017: Vaccine
https://www.readbyqxmd.com/read/28215654/dendritic-cell-vaccination-in-combination-with-docetaxel-for-patients-with-metastatic-castration-resistant-prostate-cancer-a-randomized-phase-ii-study
#4
Per Kongsted, Troels Holz Borch, Eva Ellebaek, Trine Zeeberg Iversen, Rikke Andersen, Özcan Met, Morten Hansen, Henriette Lindberg, Lisa Sengeløv, Inge Marie Svane
BACKGROUND AIMS: We investigated whether the addition of an autologous dendritic cell-based cancer vaccine (DCvac) induces an immune response in patients with metastatic castration-resistant prostate cancer treated with docetaxel. METHODS: Forty-three patients were randomized 1:1 to receive up to 10 cycles of docetaxel alone, 75 mg/m(2) every 3 weeks or in combination with DCvac. Monocytes were harvested following a leukapheresis procedure, matured ex vivo and subsequently transfected with messenger RNA encoding multiple tumor-associated antigens (TAAs)...
February 15, 2017: Cytotherapy
https://www.readbyqxmd.com/read/28205208/skin-to-skin-care-for-procedural-pain-in-neonates
#5
REVIEW
Celeste Johnston, Marsha Campbell-Yeo, Timothy Disher, Britney Benoit, Ananda Fernandes, David Streiner, Darlene Inglis, Rebekah Zee
BACKGROUND: Skin-to-skin care (SSC), often referred to as 'kangaroo care' (KC) due to its similarity with marsupial behaviour of ventral maternal-infant contact, is one non-pharmacological intervention for pain control in infants. OBJECTIVES: The primary objectives were to determine the effect of SSC alone on pain from medical or nursing procedures in neonates compared to no intervention, sucrose or other analgesics, or additions to simple SSC such as rocking; and to determine the effects of the amount of SSC (duration in minutes), method of administration (e...
February 16, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28202210/investigating-adverse-events-following-immunisation-with-pneumococcal-polysaccharide-vaccine-using-electronic-general-practice-data
#6
L Trinh, K Macartney, P McIntyre, C Chiu, A Dey, R Menzies
BACKGROUND: In early 2011, following an increased number of reports of severe vaccine-related injection site reactions, Australian authorities recommended against administering repeat doses of the 23-valent pneumococcal polysaccharide vaccine (23vPPV) in otherwise healthy adults. The aim of this study was to assess a source of electronic medical record data from primary care providers (General Practitioners, GPs), for validity and ability to retrospectively detect this adverse event signal...
February 12, 2017: Vaccine
https://www.readbyqxmd.com/read/28197393/preclinical-efficacy-and-safety-of-the-ty21a-vaccine-strain-for-intravesical-immunotherapy-of-non-muscle-invasive-bladder-cancer
#7
Sonia Domingos-Pereira, Valérie Cesson, Mathieu F Chevalier, Laurent Derré, Patrice Jichlinski, Denise Nardelli-Haefliger
Intravesical Bacillus-Calmette-Guérin (BCG) immunotherapy can reduce recurrence/progression of non-muscle-invasive bladder cancer (NMIBC), although significant adverse events and treatment failure argue for alternative options. Here, we examined whether another attenuated live vaccine, Vivotif/Ty21a, used since more than 30 y against typhoid fever, may be safely used intravesically to improve bladder-tumor treatment. Mice-bearing MB49 orthotopic bladder-tumors treated with intravesical Ty21a or BCG were compared for survival and bacteria recovery...
2017: Oncoimmunology
https://www.readbyqxmd.com/read/28192490/safety-of-measles-containing-vaccines-in-post-marketing-surveillance-in-anhui-china
#8
Fan-Ya Meng, Yong Sun, Yong-Gang Shen, Hai-Feng Pan, Ji-Hai Tang, Bin-Bing Wang, Chang-Hao Wu, Dong-Qing Ye
The safety of measles vaccination is of great interest and importance to public health practice and the general society. We have analyzed the adverse events following immunization (AEFIs) of currently used measles-containing vaccines (including live attenuated measles vaccine, live attenuated measles and rubella combined vaccine, live attenuated measles and mumps combined vaccine, live attenuated Measles, Mumps and Rubella Combined Vaccine) in Anhui Province, China. From 2009 to 2014, 9.9 million doses of measles-containing vaccines were administrated and 1893 AEFIs were found (191...
2017: PloS One
https://www.readbyqxmd.com/read/28188748/association-between-high-avidity-t-cell-receptors-induced-by-alpha-fetoprotein-derived-peptides-and-anti-tumor-effects-in-patients-with-hepatocellular-carcinoma
#9
Hidetoshi Nakagawa, Eishiro Mizukoshi, Eiji Kobayashi, Toshikatsu Tamai, Hiroshi Hamana, Tatsuhiko Ozawa, Hiroyuki Kishi, Masaaki Kitahara, Tatsuya Yamashita, Kuniaki Arai, Takeshi Terashima, Noriho Iida, Kazumi Fushimi, Atsushi Muraguchi, Shuichi Kaneko
BACKGROUND & AIMS: Levels of alpha fetoprotein (AFP) are measured for surveillance and diagnosis of hepatocellular carcinoma (HCC). We performed a phase 1 trial to evaluate the safety and efficacy of AFP-derived peptides as an anti-tumor vaccine for patients with advanced HCC, and characterized induction of AFP-specific T-cell receptors (TCRs). METHODS: We performed a prospective study, of 15 patients with HCC seen at Kanazawa University Hospital in Japan from March 2010 through March 2012...
February 7, 2017: Gastroenterology
https://www.readbyqxmd.com/read/28188612/hepatitis-b-immunoglobulin-during-pregnancy-for-prevention-of-mother-to-child-transmission-of-hepatitis-b-virus
#10
REVIEW
Ahizechukwu C Eke, George U Eleje, Uzoamaka A Eke, Yun Xia, Jiao Liu
BACKGROUND: Hepatitis is a viral infection of the liver. It is mainly transmitted between people through contact with infected blood, frequently from mother to baby in-utero. Hepatitis B poses significant risk to the fetus and up to 85% of infants infected by their mothers at birth develop chronic hepatitis B virus (HBV) infection. Hepatitis B immunoglobulin (HBIG) is a purified solution of human immunoglobulin that could be administered to the mother, newborn, or both. HBIG offers protection against HBV infection when administered to pregnant women who test positive for hepatitis B envelope antigen (HBeAg) or hepatitis B surface antigen (HBsAg), or both...
February 11, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28187952/immunogenicity-and-safety-of-an-as03-adjuvanted-h7n1-vaccine-in-healthy-adults-a-phase-i-ii-observer-blind-randomized-controlled-trial
#11
Anuradha Madan, Murdo Ferguson, Eric Sheldon, Nathan Segall, Laurence Chu, Azhar Toma, Paul Rheault, Damien Friel, Jyoti Soni, Ping Li, Bruce L Innis, Anne Schuind
BACKGROUND: H7 influenza strains have pandemic potential. AS03-adjuvanted H7N1 A/mallard/Netherlands/12/2000 split-virion vaccine formulations were evaluated as model H7-subtype vaccine and tested after H7N9 emerged in China, and caused severe human disease with high mortality. METHODS: In this phase I/II, observer-blind, randomized trial in US and Canada, 420 healthy adults (21-64years) were randomized to receive 1 of 4 H7N1 vaccine formulations (3.75 or 7.5μg hemagglutinin adjuvanted with either AS03A or AS03B), 15μg unadjuvanted H7N1 hemagglutinin, or saline placebo, given as 2-dose series...
February 7, 2017: Vaccine
https://www.readbyqxmd.com/read/28185740/vaccine-adverse-events-in-a-safety-net-healthcare-system-and-a-managed-care-organization
#12
Komal J Narwaney, Kristin Breslin, Colleen A Ross, Jo Ann Shoup, Kris F Wain, Eric S Weintraub, Michael M McNeil, Simon J Hambidge
BACKGROUND: The Institute of Medicine, in a 2013 report, recommended that the Vaccine Safety Datalink (VSD) expand collaborations to include more diversity in the study population. Kaiser Permanente Colorado (KPCO), an established VSD site, partnered with Denver Health (DH), an integrated safety net healthcare system, to demonstrate the feasibility of integrating DH data within the VSD. Prior to incorporating the data, we examined the identification of specific vaccine associated adverse events (VAEs) in these two distinct healthcare systems...
February 6, 2017: Vaccine
https://www.readbyqxmd.com/read/28178396/immunological-evaluation-of-peptide-vaccination-for-cancer-patients-with-the-hla-a11-or-a33-allele
#13
Shijoro Sakamoto, Satoko Matsueda, Shinzou Takamori, Uhi Toh, Masanori Noguchi, Shigeru Yutani, Akira Yamada, Shigeki Shichijo, Teppei Yamada, Shigetaka Suekane, Kouichirou Kawano, Masayasu Naitou, Tetsuro Sasada, Noboru Hattori, Nobuoki Kohno, Kyogo Itoh
The HLA-A11 or -A33 allele is found in approximately 18% or 10% of the Asian population, respectively, but each of which is a minor allele worldwide, and therefore no clinical trials were previously conducted. To develop a therapeutic peptide vaccine for each of them, we investigated immunological responses of advanced cancer patients with the HLA-A11(+) /A11(+) (n=18) or -A33(+) /A33(+) (n=13) allele to personalized peptide vaccine (PPV) regimens. The primary sites of HLA-A11+/A11+ or -A33+/A33+ patients were the colon (n=4 or 2), stomach (2 or 3), breast (3 or 2), lung and pancreas(2 or 2), and so on...
February 8, 2017: Cancer Science
https://www.readbyqxmd.com/read/28176175/safety-and-immunogenicity-of-neoadjuvant-treatment-using-wt1-immunotherapeutic-in-combination-with-standard-therapy-in-patients-with-wt1-positive-stage-ii-iii-breast-cancer-a-randomized-phase-i-study
#14
M Higgins, G Curigliano, V Dieras, S Kuemmel, G Kunz, P A Fasching, M Campone, T Bachelot, P Krivorotko, S Chan, A Ferro, L Schwartzberg, M Gillet, P M De Sousa Alves, V Wascotte, F F Lehmann, P Goss
PURPOSE: This Phase I, multicenter, randomized study (ClinicalTrials.gov NCT01220128) evaluated the safety and immunogenicity of recombinant Wilms' tumor 1 (WT1) protein combined with the immunostimulant AS15 (WT1-immunotherapeutic) as neoadjuvant therapy administered concurrently with standard treatments in WT1-positive breast cancer patients. METHODS: Patients were treated in 4 cohorts according to neoadjuvant treatment (A: post-menopausal, hormone receptor [HR]-positive patients receiving aromatase inhibitors; B: patients receiving chemotherapy; C: HER2-overexpressing patients on trastuzumab-chemotherapy combination; D: HR-positive/HER2-negative patients on chemotherapy)...
February 7, 2017: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/28174201/safety-of-second-dose-single-antigen-varicella-vaccine
#15
John R Su, Zanie Leroy, Paige W Lewis, Penina Haber, Mona Marin, Jessica Leung, Emily Jane Woo, Tom T Shimabukuro
BACKGROUND AND OBJECTIVE: In 2006, routine 2-dose varicella vaccination for children was recommended to improve control of varicella. We assessed the safety of second-dose varicella vaccination. METHODS: We identified second-dose single-antigen varicella vaccine reports in the Vaccine Adverse Event Reporting System during 2006 to 2014 among children aged 4 to 18 years. We analyzed reports by age group (4-6 and 7-18 years), sex, serious or nonserious status, most common adverse events (AEs), and whether other vaccines were administered concomitantly with varicella vaccine...
February 7, 2017: Pediatrics
https://www.readbyqxmd.com/read/28169076/metabolites-as-biomarkers-of-adverse-reactions-following-vaccination-a-pilot-study-using-nuclear-magnetic-resonance-metabolomics
#16
Bruce M McClenathan, Delisha A Stewart, Christina E Spooner, Wimal W Pathmasiri, Jason P Burgess, Susan L McRitchie, Y Sammy Choi, Susan C J Sumner
An Adverse Event Following Immunization (AEFI) is an adverse reaction to a vaccination that goes above and beyond the usual side effects associated with vaccinations. One serious AEFI related to the smallpox vaccine is myopericarditis. Metabolomics involves the study of the low molecular weight metabolite profile of cells, tissues, and biological fluids, and provides a functional readout of the phenotype. Metabolomics may help identify a particular metabolic signature in serum of subjects who are predisposed to developing AEFIs...
March 1, 2017: Vaccine
https://www.readbyqxmd.com/read/28168172/comparison-of-immunogenicity-and-safety-of-an-influenza-vaccine-administered-concomitantly-with-a-13-valent-pneumococcal-conjugate-vaccine-or-23-valent-polysaccharide-pneumococcal-vaccine-in-the-elderly
#17
Yu Bin Seo, Won Suk Choi, Jacob Lee, Joon Young Song, Hee Jin Cheong, Woo Joo Kim
PURPOSE: Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. MATERIALS AND METHODS: During the 2012-2013 influenza vaccination period, 224 healthy elderly volunteers aged 65 years and older randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio...
January 2017: Clinical and Experimental Vaccine Research
https://www.readbyqxmd.com/read/28168171/psychogenic-illness-following-vaccination-exploratory-study-of-mass-vaccination-against-pandemic-influenza-a-h1n1-in-2009-in-south-korea
#18
Tae Un Yang, Hee Jung Kim, Yeon Kyeong Lee, Young-Joon Park
PURPOSE: Adverse events during mass vaccination campaigns have had a profoundly negative impact on vaccine coverage rates. The objective of the study was to identify the characteristics of reported psychogenic illness cases following mass vaccination that needed further interventions of the national immunization program. MATERIALS AND METHODS: We collected documents that were submitted to the Korea Centers for Disease Control and Prevention for vaccine injury compensation, and analyzed cases of psychogenic illness following pandemic influenza A (H1N1) vaccination in 2009 which were confirmed by the Korean Advisory Committee on Vaccine Injury Compensation...
January 2017: Clinical and Experimental Vaccine Research
https://www.readbyqxmd.com/read/28166783/active-surveillance-study-of-adverse-events-following-immunisation-of-children-in-the-czech-republic
#19
Jana Danova, Aneta Kocourkova, Alexander M Celko
BACKGROUND: Despite the undisputed public health benefits of routine vaccination, adverse events following immunisation (AEFI) remain a concern. As most adverse events are mild, they may be under-reported; this may underlie the wide range of AEFI rates reported in the literature. We investigated the rates of AEFI related to routine vaccination of children 0-10 years old in the Czech Republic. METHODS: The study reviewed patients' records in a sample of 49 paediatric GP practices covering all 12 administrative regions of the Czech Republic between 2011 and 2013...
February 6, 2017: BMC Public Health
https://www.readbyqxmd.com/read/28162821/safety-of-live-vaccinations-on-immunosuppressive-therapy-in-patients-with-immune-mediated-inflammatory-diseases-solid-organ-transplantation-or-after-bone-marrow-transplantation-a-systematic-review-of-randomized-trials-observational-studies-and-case-reports
#20
REVIEW
Evelina Croce, Christoph Hatz, Emile F Jonker, L G Visser, Veronika K Jaeger, Silja Bühler
BACKGROUND: Live vaccines are generally contraindicated on immunosuppressive therapy due to safety concerns. However, data are limited to corroborate this practice. OBJECTIVES: To estimate the safety of live vaccinations in patients with immune-mediated inflammatory diseases (IMID) or solid organ transplantation (SOT) on immunosuppressive treatment and in patients after bone-marrow transplantation (BMT). DATA SOURCES: A search was conducted in electronic databases (Cochrane, Pubmed, Embase) and additional literature was identified by targeted searches...
February 2, 2017: Vaccine
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