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Vaccine adverse events

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https://www.readbyqxmd.com/read/28339668/immunogenicity-of-a-booster-dose-of-quadrivalent-meningococcal-conjugate-vaccine-in-previously-immunized-hiv-infected-children-and-youth
#1
Meredith G Warshaw, George K Siberry, Paige Williams, Michael D Decker, Patrick Jean-Philippe, Jorge Lujan-Zilbermann
Background.: The US Advisory Committee on Immunization Practices recommends a booster dose of quadrivalent meningococcal conjugate vaccine (MCV4) after initial immunization for patients at high risk for meningococcal infection. Methods.: The International Maternal Pediatric Adolescents AIDS Clinical Trials (IMPAACT) P1065 trial evaluated the use of MCV4 in human immunodeficiency virus (HIV)-infected children and youth. The final step of this trial was an open-label study of an MCV4 booster dose 3...
February 18, 2017: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/28339574/arm-paralysis-after-routine-childhood-vaccinations-application-of-advanced-molecular-methods-to-the-causality-assessment-of-an-adverse-event-after-immunization
#2
Jana Shaw, Neal A Halsey, Adriana Weinberg, D Scott Schmid, Kirsten St George, William C Weldon, Michael Jordan, Patrick W Bryant, Philip S LaRussa, Deborah Y Bradshaw, Theresa Harrington, Anne Gershon
Post-licensure surveillance for adverse events following immunizations (AEFI) can identify rare complications of vaccinations and rigorous vaccine adverse event causality assessments can help to identify possible causal relationships. We report the development of arm paralysis after varicella vaccination in a 1-year-old child. Paralysis was initially presumed to be due to vOka because of the temporal relationship between vaccination and onset of arm weakness; however, molecular studies identified wild-type varicella zoster virus VZV (WT-VZV) in the CSF, leading the authors to conclude that WT-VZV was the probable cause...
January 25, 2017: Journal of the Pediatric Infectious Diseases Society
https://www.readbyqxmd.com/read/28338507/ny-eso-1-protein-cancer-vaccine-with-poly-iclc-and-ok-432-rapid-and-strong-induction-of-ny-eso-1-specific-immune-responses-by-poly-iclc
#3
Tomohira Takeoka, Hirotsugu Nagase, Koji Kurose, Yoshihiro Ohue, Makoto Yamasaki, Shuji Takiguchi, Eiichi Sato, Midori Isobe, Takayuki Kanazawa, Mitsunobu Matsumoto, Kota Iwahori, Atsunari Kawashima, Akiko Morimoto-Okazawa, Hiroyoshi Nishikawa, Mikio Oka, Linda Pan, Ralph Venhaus, Eiichi Nakayama, Masaki Mori, Yuichiro Doki, Hisashi Wada
We conducted a clinical trial of a cancer vaccine using NY-ESO-1 protein with polyinosinic-polycytidylic acid-poly-L-lysine carboxymethylcellulose (poly-ICLC) and/or OK-432 against solid tumors. A total of 15 patients were sequentially enrolled in 4 cohorts. Patients in cohort 1 received NY-ESO-1 protein; cohort 2a received NY-ESO-1 protein+OK-432; cohort 2b received NY-ESO-1 protein+poly-ICLC; cohort 3 received NY-ESO-1 protein+OK-432+poly-ICLC with Montanide ISA-51. The endpoints of this trial were safety, NY-ESO-1 immune responses, and clinical response...
March 23, 2017: Journal of Immunotherapy
https://www.readbyqxmd.com/read/28329211/therapeutic-vaccine-for-genital-herpes-simplex-virus-2-infection-findings-from-a-randomized-trial
#4
David I Bernstein, Anna Wald, Terri Warren, Kenneth Fife, Stephen Tyring, Patricia Lee, Nick Van Wagoner, Amalia Magaret, Jessica B Flechtner, Sybil Tasker, Jason Chan, Amy Morris, Seth Hetherington
Background.: Genital herpes simplex virus type 2 (HSV-2) infection causes recurrent lesions and frequent viral shedding. GEN-003 is a candidate therapeutic vaccine containing HSV-2 gD2ΔTMR and ICP4.2, and Matrix-M2 adjuvant. Methods.: Persons with genital herpes were randomized into three dose cohorts to receive three intramuscular doses 21 days apart of 10 µg, 30 µg, or 100 µg of GEN-003, antigens without adjuvant, or placebo. Participants obtained genital swabs twice-daily for HSV-2 detection and monitored genital lesions for 28-day periods at baseline and intervals after the last dose...
January 30, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28328346/efficacy-of-a-low-cost-heat-stable-oral-rotavirus-vaccine-in-niger
#5
Sheila Isanaka, Ousmane Guindo, Celine Langendorf, Amadou Matar Seck, Brian D Plikaytis, Nathan Sayinzoga-Makombe, Monica M McNeal, Nicole Meyer, Eric Adehossi, Ali Djibo, Bruno Jochum, Rebecca F Grais
Background Each year, rotavirus gastroenteritis is responsible for about 37% of deaths from diarrhea among children younger than 5 years of age worldwide, with a disproportionate effect in sub-Saharan Africa. Methods We conducted a randomized, placebo-controlled trial in Niger to evaluate the efficacy of a live, oral bovine rotavirus pentavalent vaccine (BRV-PV, Serum Institute of India) to prevent severe rotavirus gastroenteritis. Healthy infants received three doses of the vaccine or placebo at 6, 10, and 14 weeks of age...
March 23, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28326907/skin-sensitizers-in-cosmetics-and-beyond-potential-multiple-mechanisms-of-action-and-importance-of-t-cell-assays-for-in-vitro-screening
#6
Stanislav Vukmanović, Nakissa Sadrieh
Allergic contact dermatitis (ACD) is a delayed-type hypersensitivity (DTH) reaction induced by repeated contact with sensitizers. The ability of a chemical to act as a sensitizer has most frequently been tested in animals. As the use of animals for these purposes is gradually and globally being phased out, there is a need for reliable in vitro surrogate assays. Currently proposed in vitro assays are designed to test four key events of the adverse outcome pathway (AOP) involving covalent modification of self-proteins by sensitizers (haptenation) and presentation of new antigens (hapten/carrier complexes) to the immune system...
March 22, 2017: Critical Reviews in Toxicology
https://www.readbyqxmd.com/read/28321817/adverse-events-in-cancer-immunotherapy
#7
Noha Abdel-Wahab, Anas Alshawa, Maria E Suarez-Almazor
Cancer immunotherapy has resulted in durable responses in patients with metastatic disease, unseen with traditional chemotherapy. Several therapies have been approved by the Food and Drug Administration for the treatment of various cancers, including: immune checkpoint inhibitors, cytokines - interleukin 2 (IL-2) and interferon alpha (IFN), and the cancer vaccine sipuleucel-T. These therapies upregulate the immune system to enhance antitumor responses. As a consequence, they can cause inflammatory and immune-related adverse events that can affect one or more organs, can be serious, and on occasion lifethreatening...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/28318767/immunogenicity-and-safety-of-concomitant-administration-of-meningococcal-serogroup-b-4cmenb-and-serogroup-c-menc-crm-vaccines-in-infants-a-phase-3b-randomized-controlled-trial
#8
Marco Aurelio P Safadi, Federico Martinon-Torres, Lily Yin Weckx, Edson Duarte Moreira, Eduardo Jorge da Fonseca Lima, Ilhem Mensi, Marco Calabresi, Daniela Toneatto
BACKGROUND: After implementation of routine infant MenC vaccination, MenB remains a serious cause of meningococcal disease, yet to be targeted by vaccination programs in several countries. This study (NCT01339923) investigated the immunogenicity and safety of MenC CRM-conjugated vaccine (MenC-CRM) concomitantly administered with MenB vaccine (4CMenB). METHODS: Infants (N=251) were randomised 1:1 to receive 4CMenB and MenC-CRM (Group 1) or MenC-CRM alone (Group 2) at 3 and 5months (M3, M5) and a booster at 12months of age (M12), and pneumococcal vaccine at M3, M5, M7, M12...
March 15, 2017: Vaccine
https://www.readbyqxmd.com/read/28317660/safety-tolerability-and-efficacy-of-intradermal-rabies-immunization-with-debioject%C3%A2
#9
Paul Vescovo, Nils Rettby, Nirinarilala Ramaniraka, Julie Liberman, Karen Hart, Astrid Cachemaille, Laurent-Dominique Piveteau, Reto Zanoni, Pierre-Alexandre Bart, Giuseppe Pantaleo
In a single-center study, 66 healthy volunteers aged between 18 and 50years were randomized to be immunized against rabies with three different injection routes: intradermal with DebioJect™ (IDJ), standard intradermal with classical needle (IDS), also called Mantoux method, and intramuscular with classical needle (IM). "Vaccin rabique Pasteur®" and saline solution (NaCl 0.9%) were administered at D0, D7 and D28. Antigen doses for both intradermal routes were 1/5 of the dose for IM. Tolerability, safety and induced immunogenicity of IDJ were compared to IDS and IM routes...
March 27, 2017: Vaccine
https://www.readbyqxmd.com/read/28304251/using-hematology-data-from-malaria-vaccine-research-trials-in-humans-and-rhesus-macaques-macaca-mulatta-to-guide-volume-limits-for-blood-withdrawal
#10
Sara R Hegge, Bradley W Hickey, Shannon M Mcgrath, V Ann Stewart
Guidelines on safe volume limits for blood collection from research participants in both humans and laboratory animals vary widely between institutions. The main adverse event that may be encountered in large blood volume withdrawal is iron-deficiency anemia. Monitoring various parameters in a standard blood panel may help to prevent this outcome. To this end, we analyzed the Hgb and MCV values from 43 humans and 46 macaques in malaria vaccine research trials. Although the percentage of blood volume removed was greater for macaques than humans, macaques demonstrated an overall increase of MCV over time, indicating the ability to respond appropriately to frequent volume withdrawals...
December 1, 2016: Comparative Medicine
https://www.readbyqxmd.com/read/28302411/immunogenicity-and-safety-of-a-quadrivalent-inactivated-influenza-vaccine-compared-with-two-trivalent-inactivated-influenza-vaccines-containing-alternate-b-strains-in-adults-a-phase-3-randomized-noninferiority-study
#11
John T Treanor, Frank R Albano, Daphne C Sawlwin, Alison Graves Jones, Jolanta Airey, Neil Formica, Vince Matassa, Jane Leong
BACKGROUND: Vaccination is the most effective means of influenza prevention. Efficacy of trivalent vaccines may be enhanced by including both B strain lineages. This phase 3, double-blind study assessed the immunogenicity and safety/tolerability of a quadrivalent inactivated influenza vaccine (IIV4) versus the United States (US)-licensed 2014-2015 trivalent inactivated influenza vaccine (IIV3-Yamagata [IIV3-YAM]; Afluria) and IIV3 containing the alternate Victoria B strain (IIV3-VIC) in adults ≥18years...
March 13, 2017: Vaccine
https://www.readbyqxmd.com/read/28302407/immunogenicity-and-safety-of-an-as03-adjuvanted-h7n1-vaccine-in-adults-65years-of-age-and-older-a-phase-ii-observer-blind-randomized-controlled-trial
#12
Anuradha Madan, Murdo Ferguson, Paul Rheault, David Seiden, Azhar Toma, Damien Friel, Jyoti Soni, Ping Li, Bruce L Innis, Anne Schuind
BACKGROUND: H7 influenza strains can cause severe and often fatal human infections, especially in the elderly. This phase II, observer-blind, randomized trial (www.ClinicalTrials.gov: NCT01949090) assessed the immunogenicity and safety of a novel AS03-adjuvanted H7N1 vaccine that may serve as a model H7-subtype vaccine. METHODS: 360 adults ≥65years of age in stable health received either 1 of 4 adjuvanted A/mallard/Netherlands/12/2000 split virion vaccine formulations (3...
March 13, 2017: Vaccine
https://www.readbyqxmd.com/read/28301266/immunogenicity-and-safety-of-a-trivalent-inactivated-influenza-vaccine-produced-in-shenzhen-china
#13
Zhaojun Mo, Yi Nong, Shuzhen Liu, Ming Shao, Xueyan Liao, Kerry Go, Nathalie Lavis
A split-virion trivalent inactivated influenza vaccine produced according to the Chinese pharmacopeia (Shz-IIV3) has been commercially available in China since 2014. Here, we describe the results of a phase IV open-label trial to describe the immunogenicity and safety of the 2014-2015 Northern Hemisphere formulation of Shz-IIV3 in individuals ≥ 6 months of age. Subjects 6-35 months of age received 2 half-doses of Shz-IIV3 (0.25 ml) 28 d apart, and subjects ≥ 3 y of age received a single full dose (0...
February 14, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28296286/nanomedicine-approaches-to-improve-cancer-immunotherapy
#14
REVIEW
Hui Qiu, Yuanzeng Min, Zach Rodgers, Longzhen Zhang, Andrew Z Wang
Significant advances have been made in the field of cancer immunotherapy by orchestrating the body's immune system to eradicate cancer cells. However, safety and efficacy concerns stemming from the systemic delivery of immunomodulatory compounds limits cancer immunotherapies expansion and application. In this context, nanotechnology presents a number of advantages, such as targeted delivery to immune cells, enhanced clinical outcomes, and reduced adverse events, which may aid in the delivery of cancer vaccines and immunomodulatory agents...
March 10, 2017: Wiley Interdisciplinary Reviews. Nanomedicine and Nanobiotechnology
https://www.readbyqxmd.com/read/28293864/using-probabilistic-record-linkage-of-structured-and-unstructured-data-to-identify-duplicate-cases-in-spontaneous-adverse-event-reporting-systems
#15
Kory Kreimeyer, David Menschik, Scott Winiecki, Wendy Paul, Faith Barash, Emily Jane Woo, Meghna Alimchandani, Deepa Arya, Craig Zinderman, Richard Forshee, Taxiarchis Botsis
INTRODUCTION: Duplicate case reports in spontaneous adverse event reporting systems pose a challenge for medical reviewers to efficiently perform individual and aggregate safety analyses. Duplicate cases can bias data mining by generating spurious signals of disproportional reporting of product-adverse event pairs. OBJECTIVE: We have developed a probabilistic record linkage algorithm for identifying duplicate cases in the US Vaccine Adverse Event Reporting System (VAERS) and the US Food and Drug Administration Adverse Event Reporting System (FAERS)...
March 14, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28285495/pharmacological-interventions-for-acute-hepatitis-c-infection-an-attempted-network-meta-analysis
#16
REVIEW
Maria Kalafateli, Elena Buzzetti, Douglas Thorburn, Brian R Davidson, Emmanuel Tsochatzis, Kurinchi Selvan Gurusamy
BACKGROUND: Hepatitis C virus (HCV) is a single-stranded RNA (ribonucleic acid) virus that has the potential to cause inflammation of the liver. The traditional definition of acute HCV infection is the first six months following infection with the virus. Another commonly used definition of acute HCV infection is the absence of HCV antibody and subsequent seroconversion (presence of HCV antibody in a person who was previously negative for HCV antibody). Approximately 40% to 95% of people with acute HCV infection develop chronic HCV infection, that is, have persistent HCV RNA in their blood...
March 13, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28278415/paediatric-active-enhanced-disease-surveillance-inaugural-annual-report-2014
#17
Yvonne A Zurynski, Jocelynne E McRae, Helen E Quinn, Nicholas J Wood, Kristine K Macartney
INTRODUCTION: The Paediatric Active Enhanced Disease Surveillance (PAEDS) network is a hospital-based active surveillance system employing prospective case ascertainment of selected uncommon vaccine preventable diseases and potential adverse events following immunisation (AEFI). PAEDS enhances other Australian surveillance systems by providing prospective detailed clinical and laboratory data for the same child. METHODS: Specialist surveillance nurses screen hospital admissions, emergency department records, laboratory and other data, to prospectively identify hospitalised children aged under 15 years in 5 paediatric tertiary referral hospitals in New South Wales, Victoria, South Australia, Western Australia and Queensland...
September 30, 2016: Communicable Diseases Intelligence Quarterly Report
https://www.readbyqxmd.com/read/28278414/surveillance-of-adverse-events-following-immunisation-in-australia-annual-report-2014
#18
Aditi Dey, Han Wang, Helen E Quinn, Richard Hill, Kristine K Macartney
This report summarises Australian passive surveillance data for adverse events following immunisation (AEFI) for 2014 reported to the Therapeutic Goods Administration for 2014 and describes reporting trends over the 15-year period 1 January 2000 to 31 December 2014. There were 3,087 AEFI records for vaccines administered in 2014; an annual AEFI reporting rate of 13.2 per 100,000 population. There was a decline of 5% in the overall AEFI reporting rate in 2014 compared with 2013. This decline in reported adverse events in 2014 compared with the previous year was mainly attributable to fewer reports following the human papillomavirus (HPV) vaccine as it was the 2nd year of the extension of the National HPV Vaccination Program to males...
September 30, 2016: Communicable Diseases Intelligence Quarterly Report
https://www.readbyqxmd.com/read/28277801/the-immunogenicity-and-safety-of-a-hib-menac-vaccine-a-non-inferiority-randomized-observer-blind-trial-in-infants-aged-3-5-months
#19
Yu-Xiao Wang, Hong Tao, Jian-Li Hu, Jing-Xin Li, Wei-Ming Dai, Jin-Fang Sun, Pei Liu, Jie Tang, Wen-Yu Liu, Feng-Cai Zhu
BACKGROUND: The objective of this study was to evaluate the immunogenicity and safety of the novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroup A and C-tetanus toxoid conjugate vaccine (Hib-MenAC). RESEARCH DESIGN AND METHODS: We conducted a non-inferiority, randomized, observer-blind, positive control clinical trial in 900 healthy infants aged between 3-5 months in Funing County, Jiangsu Province, China. Participants were randomly allocated, in a ratio of 2:1 (block=6), to receive experimental combined Hib-MenAC vaccines co-administrated with placebo or the co-administration of licensed Hib vaccine and MenAC vaccine, according to a three-dose immunization schedule...
March 9, 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/28275375/a-comparative-phase-i-study-of-combination-homologous-subtype-c-dna-mva-and-env-gp140-protein-adjuvant-hiv-vaccines-in-two-immunization-regimes
#20
Sarah Joseph, Killian Quinn, Aldona Greenwood, Alethea V Cope, Paul F McKay, Peter J Hayes, Jakub T Kopycinski, Jill Gilmour, Aleisha N Miller, Christof Geldmacher, Yuka Nadai, Mohamed I M Ahmed, David C Montefiori, Len Dally, George Bouliotis, David J M Lewis, Roger Tatoud, Ralf Wagner, Mariano Esteban, Robin J Shattock, Sheena McCormack, Jonathan Weber
There remains an urgent need for a prophylactic HIV vaccine. We compared combined MVA and adjuvanted gp140 to sequential MVA/gp140 after DNA priming. We expected Env-specific CD4+ T-cells after DNA and MVA priming, and Env-binding antibodies in 100% individuals after boosting with gp140 and that combined vaccines would not compromise safety and might augment immunogenicity. Forty volunteers were primed three times with DNA plasmids encoding (CN54) env and (ZM96) gag-pol-nef at 0, 4 and 8 weeks then boosted with MVA-C (CN54 env and gag-pol-nef) and glucopyranosyl lipid adjuvant-aqueous formulation (GLA-AF) adjuvanted CN54gp140...
2017: Frontiers in Immunology
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