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Vaccine safety

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https://www.readbyqxmd.com/read/28224099/using-quality-improvement-methods-to-increase-use-of-pain-prevention-strategies-for-childhood-vaccination
#1
Jennifer Verrill Schurman, Amanda D Deacy, Rebecca J Johnson, Jolynn Parker, Kristi Williams, Dustin Wallace, Mark Connelly, Lynn Anson, Kevin Mroczka
AIM: To increase evidence-based pain prevention strategy use during routine vaccinations in a pediatric primary care clinic using quality improvement methodology. METHODS: Specific intervention strategies (i.e., comfort positioning, nonnutritive sucking and sucrose analgesia, distraction) were identified, selected and introduced in three waves, using a Plan-Do-Study-Act framework. System-wide change was measured from baseline to post-intervention by: (1) percent of vaccination visits during which an evidence-based pain prevention strategy was reported as being used; and (2) caregiver satisfaction ratings following the visit...
February 8, 2017: World Journal of Clinical Pediatrics
https://www.readbyqxmd.com/read/28221166/prevalence-of-needlestick-injuries-attitude-changes-and-prevention-practices-over-12-years-in-an-urban-academic-hospital-surgery-department
#2
Jessica M Hasak, Christine B Novak, Jennifer Megan M Patterson, Susan E Mackinnon
OBJECTIVE: Needlestick injury prevalence, protection practices, and attitudes were assessed. Current medical students were compared with 2003 data to assess any changes that occurred with engineered safety feature implementation. BACKGROUND: Risk of occupational exposure to bloodborne pathogens is elevated in the operating room particularly with surgeons in training and nurses. METHODS: A cross-sectional survey was distributed to medical students (n = 358) and Department of Surgery staff (n = 247)...
February 17, 2017: Annals of Surgery
https://www.readbyqxmd.com/read/28218278/development-of-in-vitro-and-in-vivo-rabies-virus-neutralization-assays-based-on-a-high-titer-pseudovirus-system
#3
Jianhui Nie, Xiaohong Wu, Jian Ma, Shouchun Cao, Weijin Huang, Qiang Liu, Xuguang Li, Yuhua Li, Youchun Wang
Pseudoviruses are useful virological tools because of their safety and versatility; however the low titer of these viruses substantially limits their wider applications. We developed a highly efficient pseudovirus production system capable of yielding 100 times more rabies pseudovirus than the traditional method. Employing the high-titer pseudoviruses, we have developed robust in vitro and in vivo neutralization assays for the evaluation of rabies vaccine, which traditionally relies on live-virus based assays...
February 20, 2017: Scientific Reports
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
#4
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
#5
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/28214906/-evaluating-the-quality-of-care-in-nursing-homes-comparison-of-three-international-models
#6
Alessandro Rubino, Fabrizio Leigheb, Carmela Rinaldi, Angelo Di Dio, Sanita Knesse, Chiara Donnarumma, Massimiliano Panella
The aim of this observational descriptive study was to identify the main international models evaluating the quality of nursing homes for non self-sufficient elderly persons, and to apply them in the Italian health system. Firstly, a bibliographic search of institutional websites and Pubmed-Medline was performed to identify the main international models. Secondly, three variables were chosen to evaluate the level of implementability of the models: (1) frequency of use of quality indicators in the international models; (2) degree of constructability of the models in two Italian nursing homes; (3) perceived relevance of the indicators used by the chosen models, by nursing home workers...
November 2016: Igiene e Sanità Pubblica
https://www.readbyqxmd.com/read/28214045/factors-affecting-the-willingness-of-nursing-students-to-receive-annual-seasonal-influenza-vaccination-a-large-scale-cross-sectional-study
#7
Kin Cheung, Sin Man Simone Ho, Winsome Lam
Nursing students are at high risk of exposure to vaccine-preventable diseases such as seasonal influenza. However, due to the limited number of studies conducted in this area, the prevalence and factors affecting annual seasonal influenza vaccination (ASIV) uptake remain unclear. This was a large-scale cross-sectional survey study conducted among 902 nursing students in different years of study. The questionnaire was developed based on the Health Belief Model (HBM), and logistic regression was used to determine the predictors of ASIV uptake...
February 14, 2017: Vaccine
https://www.readbyqxmd.com/read/28213262/one-single-fast-and-robust-capillary-electrophoresis-method-for-the-direct-quantification-of-intact-adenovirus-particles-in-upstream-and-downstream-processing-samples
#8
Ewoud van Tricht, Lars Geurink, Harold Backus, Marta Germano, Govert W Somsen, Cari E Sänger-van de Griend
During development of adenovirus-based vaccines, samples have to be analyzed in order to either monitor the production process or control the quality and safety of the product. An important quality attribute is the total concentration of intact adenoviruses, which currently is determined by quantitative polymerase chain reaction (qPCR) or anion exchange-HPLC. Capillary Electrophoresis (CE) was evaluated as alternative to the current methods with the aim to have one single method that allows reliable and fast quantification of adenovirus particles throughout the full process...
May 1, 2017: Talanta
https://www.readbyqxmd.com/read/28212334/transfer-of-anti-rotavirus-antibodies-during-pregnancy-and-in-milk-following-maternal-vaccination-with-a-herpes-simplex-virus-type-1-amplicon-vector
#9
Anita F Meier, Mark Suter, Elisabeth M Schraner, Bruno M Humbel, Kurt Tobler, Mathias Ackermann, Andrea S Laimbacher
Rotaviruses (RVs) are important enteric pathogens of newborn humans and animals, causing diarrhea and in rare cases death, especially in very young individuals. Rotavirus vaccines presently used are modified live vaccines that lack complete biological safety. Previous work from our laboratory suggested that vaccines based on in situ produced, non-infectious rotavirus-like particles (RVLPs) are efficient while being entirely safe. However, using either vaccine, active mucosal immunization cannot induce protective immunity in newborns due to their immature immune system...
February 16, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28207817/comparative-analysis-of-the-immunogenicity-of-monovalent-and-multivalent-rotavirus-immunogens
#10
Kai Mi, Xia Ou, Lili Guo, Jing Ye, Jinyuan Wu, Shan Yi, Xianglian Niu, Xiaoqin Sun, Hongjun Li, Maosheng Sun
The strategies for developing rotavirus (RV) vaccines have always been controversial. At present, both the monovalent RV vaccine and the multivalent RV vaccine have displayed excellent safety and efficacy against RV infection and shown cross-reactive immunity, which laid the question whether the multivalent RV vaccine could be replaced by the monovalent RV vaccine. In this study, we focused on comparing the immunogenicity (serum neutralization activity and protection against homotypic and heterotypic RVs' challenge) of individual standard RV strains (monovalent RV immunogens) and different combinations of them (multivalent RV immunogens)...
2017: PloS One
https://www.readbyqxmd.com/read/28205285/natural-history-and-clinical-characteristics-of-inhibitors-in-previously-treated-haemophilia-a-patients-a-case-series
#11
A Iorio, A M Barbara, M Makris, K Fischer, G Castaman, C Catarino, E Gilman, K Kavakli, T Lambert, R Lassila, T Lissitchkov, E Mauser-Bunschoten, M E Mingot-Castellano, N Ozdemir, I Pabinger, R Parra, J Pasi, K Peerlinck, A Rauch, V Roussel-Robert, M Serban, A Tagliaferri, J Windyga, E Zanon
BACKGROUND: Development of inhibitors is the most serious complication in haemophilia A treatment. The assessment of risk for inhibitor formation in new or modified factor concentrates is traditionally performed in previously treated patients (PTPs). However, evidence on risk factors for and natural history of inhibitors has been generated mostly in previously untreated patients (PUPs). The purpose of this study was to examine cases of de novo inhibitors in PTPs reported in the scientific literature and to the EUropean HAemophilia Safety Surveillance (EUHASS) programme, and explore determinants and course of inhibitor development...
February 15, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28205208/skin-to-skin-care-for-procedural-pain-in-neonates
#12
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/28205150/the-potential-cost-effectiveness-of-different-dengue-vaccination-programmes-in-malaysia-a-value-based-pricing-assessment-using-dynamic-transmission-mathematical-modelling
#13
Asrul Akmal Shafie, Hui Yee Yeo, Laurent Coudeville, Lucas Steinberg, Balvinder Singh Gill, Rohani Jahis, Amar-Singh Hss
BACKGROUND: Dengue disease poses a great economic burden in Malaysia. METHODS: This study evaluated the cost effectiveness and impact of dengue vaccination in Malaysia from both provider and societal perspectives using a dynamic transmission mathematical model. The model incorporated sensitivity analyses, Malaysia-specific data, evidence from recent phase III studies and pooled efficacy and long-term safety data to refine the estimates from previous published studies...
February 15, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28202751/superiority-in-rhesus-macaques-of-targeting-hiv-1-env-gp140-to-cd40-versus-lox-1-in-combination-with-replication-competent-nyvac-kc-for-induction-of-env-specific-antibody-and-t-cell-responses
#14
Gerard Zurawski, Xiaoying Shen, Sandra Zurawski, Georgia D Tomaras, David C Montefiori, Mario Roederer, Guido Ferrari, Christine Lacabaratz, Peter Klucar, Zhiqing Wang, Kathryn E Foulds, Shing-Fen Kao, Xuesong Yu, Alicia Sato, Nicole L Yates, Celia LaBranche, Sherry Stanfield-Oakley, Karen Kibler, Bertram Jacobs, Andres Salazar, Steve Self, Jimmy Fulp, Raphael Gottardo, Lindsey Galmin, Deborah Weiss, Anthony Cristillo, Giuseppe Pantaleo, Yves Levy
We compared the HIV-1-specific immune responses generated by targeting HIV-1 envelope protein (Env gp140) to either CD40 or LOX-1, two endocytic receptors on dendritic cells (DCs), in Rhesus macaques primed with a poxvirus vector (NYVAC-KC) expressing Env gp140. The DC-targeting vaccines, humanized recombinant monoclonal antibodies fused to Env gp140, were administered as a boost with poly ICLC adjuvant either alone or co-administered with the NYVAC-KC vector. All the DC-targeting vaccine administrations with poly ICLC increased the low-level serum anti-Env IgG responses elicited by NYVAC-KC priming significantly more (up to P =0...
February 15, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28202210/investigating-adverse-events-following-immunisation-with-pneumococcal-polysaccharide-vaccine-using-electronic-general-practice-data
#15
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/28197701/-innovative-forms-of-specific-immunotherapy
#16
REVIEW
P Zieglmayer
The clinical efficacy of allergen-specific immunotherapy depends on tolerance induction. Treatment success is currently limited by treatment-related adverse reactions. Novel approaches mainly target improvement of tolerability in addition to optimized immunogenicity. For epicutaneous immunotherapy (EPIT), commercially available treatment extracts are applied to skin via a patch. The route exhibits excellent tolerability and good clinical efficacy. The first encouraging data on a peanut EPIT were published in 2016...
February 14, 2017: Der Hautarzt; Zeitschrift Für Dermatologie, Venerologie, und Verwandte Gebiete
https://www.readbyqxmd.com/read/28197393/preclinical-efficacy-and-safety-of-the-ty21a-vaccine-strain-for-intravesical-immunotherapy-of-non-muscle-invasive-bladder-cancer
#17
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/28196715/safety-of-the-oral-cholera-vaccine-in-pregnancy-retrospective-findings-from-a-subgroup-following-mass-vaccination-campaign-in-dhaka-bangladesh
#18
Ashraful Islam Khan, Mohammad Ali, Fahima Chowdhury, Amit Saha, Iqbal Ansary Khan, Arifuzzaman Khan, Afroza Akter, Muhammad Asaduzzaman, Md Taufiqul Islam, Alamgir Kabir, Young Ae You, Nirod Chandra Saha, Alejandro Cravioto, John D Clemens, Firdausi Qadri
BACKGROUND: Pregnant women are vulnerable to complications of cholera. Killed oral cholera vaccines (OCV) are not recommended for pregnant women though there is no evidence of harmful effects during pregnancy. We evaluated the effect of a killed OCV, Shanchol™, on pregnancy outcomes during an effectiveness trial of the vaccine in urban Bangladesh. METHODOLOGY: Individuals ⩾1year were invited to participate in the trial, conducted in 2011 in Dhaka, Bangladesh...
February 11, 2017: Vaccine
https://www.readbyqxmd.com/read/28193249/factors-associated-with-parental-reasons-for-no-intent-to-vaccinate-female-adolescents-with-human-papillomavirus-vaccine-national-immunization-survey-teen-2008-2012
#19
Vinay K Cheruvu, Madhav P Bhatta, Lauren N Drinkard
BACKGROUND: 1) To identify socio-demographic factors associated with parental "no-intent" for their 13-17 year old unvaccinated daughter to receive the human papillomavirus (HPV) vaccine series within the next twelve months, 2) to describe patterns in "no-intent" by socio-demographic factors, and 3) to identify socio-demographic factors associated with parental reasons for "no-intent". METHODS: Data from 2008-2012 National Immunization Survey - Teen (NIS - Teen) were examined in this study...
February 13, 2017: BMC Pediatrics
https://www.readbyqxmd.com/read/28192490/safety-of-measles-containing-vaccines-in-post-marketing-surveillance-in-anhui-china
#20
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
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