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Vaccine adverse events

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https://www.readbyqxmd.com/read/29784470/immunogenicity-and-safety-of-menacwy-tt-a-meningococcal-conjugate-vaccine-co-administered-with-routine-childhood-vaccine-in-healthy-infants-a-phase-iii-randomized-study
#1
Ghassan Dbaibo, Juan Carlos Tinoco Favila, Magali Traskine, Archana Jastorff, Marie Van der Wielen
BACKGROUND: Invasive meningococcal disease has a high burden in young children, particularly during infancy. We investigated the immunogenicity and safety of a quadrivalent meningococcal conjugated vaccine (MenACWY-TT) co-administered with routine vaccines in healthy infants. METHODS: In this phase IIIb study (NCT01340898) conducted in 2 centers in Lebanon and Mexico, 750 infants were randomized (2:1:1) to receive MenACWY-TT according to 3 schedules: 3+1 (at ages 2, 4, 6 and 15-18 months; group ACWY3+1); 1+1 (at 6 and 15-18 months; group ACWY1+1) or single-dose at 15-18 months (group ACWY1)...
May 18, 2018: Vaccine
https://www.readbyqxmd.com/read/29779922/safety-tolerability-acceptability-and-immunogenicity-of-an-influenza-vaccine-delivered-to-human-skin-by-a-novel-high-density-microprojection-array-patch-nanopatch%C3%A2
#2
Germain J P Fernando, Julian Hickling, Cesar M Jayashi Flores, Paul Griffin, Christopher D Anderson, S Rachel Skinner, Cristyn Davies, Katey Witham, Melinda Pryor, Jesse Bodle, Steve Rockman, Ian H Frazer, Angus H Forster
BACKGROUND: Injection using needle and syringe (N&S) is the most widely used method for vaccination, but requires trained healthcare workers. Fear of needles, risk of needle-stick injury, and the need to reconstitute lyophilised vaccines, are also drawbacks. The Nanopatch (NP) is a microarray skin patch comprised of a high-density array of microprojections dry-coated with vaccine that is being developed to address these shortcomings. Here we report a randomised, partly-blinded, placebo-controlled trial that represents the first use in humans of the NP to deliver a vaccine...
May 17, 2018: Vaccine
https://www.readbyqxmd.com/read/29778515/safety-and-immunogenicity-of-fractional-dose-intradermal-injection-of-two-quadrivalent-conjugated-meningococcal-vaccines
#3
Emile F F Jonker, Mariëtte B van Ravenhorst, Guy A M Berbers, Leo G Visser
BACKGROUND: Vaccination with conjugated meningococcal vaccines is the best way to prevent invasive meningococcal disease. Changes in serogroup epidemiology have led to the inclusion of quadrivalent vaccines in the national immunization programs of several countries, but vaccines are frequently in short supply. Intradermal administration has the potential to increase vaccine availability through dose reduction, without sacrificing efficacy. It has never before been investigated for glycoconjugate meningococcal vaccines...
May 16, 2018: Vaccine
https://www.readbyqxmd.com/read/29777868/comparative-efficacy-and-safety-of-different-antiviral-agents-for-cytomegalovirus-prophylaxis-in-allogeneic-hematopoietic-cell-transplantation-a-systematic-review-and-meta-analysis
#4
Nico Gagelmann, Per Ljungman, Jan Styczynski, Nicolaus Kröger
Over the past 25 years, several randomized controlled trials have investigated the efficacy of different antiviral agents for cytomegalovirus (CMV) prophylaxis in allogeneic hematopoietic-cell transplantation. We performed a systematic literature review, conventional meta-analysis and network meta-analysis using a random-effects model and risk ratios (RR) with corresponding 95% confidence intervals (CI) as effect estimates. Fifteen randomized controlled trials were identified, including seven different antiviral agents: acyclovir, ganciclovir, maribavir, brincidofovir, letermovir, valacyclovir, and vaccine...
May 16, 2018: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/29776750/safety-and-immunogenicity-of-a-vi-dt-typhoid-conjugate-vaccine-phase-i-trial-in-healthy-filipino-adults-and-children
#5
Maria Rosario Capeding, Samuel Teshome, Tarun Saluja, Khalid Ali Syed, Deok Ryun Kim, Ju Yeon Park, Jae Seung Yang, Yang Hee Kim, Jiwook Park, Sue-Kyoung Jo, Yun Chon, Sudeep Kothari, Seon-Young Yang, Dong Soo Ham, Ji Hwa Ryu, Hee-Seong Hwang, Ju-Hwan Mun, Julia Lynch, Jerome Kim, Hun Kim, Jean-Louis Excler, Sushant Sahastrabuddhe
BACKGROUND: Typhoid fever remains a major public health problem in low- and middle-income countries where children aged 2-14 years bear the greatest burden. Vi polysaccharide is poorly immunogenic in children <2 years of age, and protection in adults is modest. The limitations of Vi polysaccharide vaccines can be overcome by conjugation of the Vi to a carrier protein. A typhoid conjugate vaccine composed of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) has been developed...
May 15, 2018: Vaccine
https://www.readbyqxmd.com/read/29769450/heat-shock-protein-peptide-complex-96-vaccination-for-newly-diagnosed-glioblastoma-a-phase-i-single-arm-trial
#6
Nan Ji, Yang Zhang, Yunpeng Liu, Jian Xie, Yi Wang, Shuyu Hao, Zhixian Gao
BACKGROUND: Heat shock protein peptide complex-96 (HSPPC-96) triggers adaptive and innate antitumor immune responses. The safety and efficacy of HSPPC-96 vaccination was examined in patients with newly diagnosed glioblastoma multiforme (GBM). METHODS: In this open-label, single-arm, phase I study, adult patients were vaccinated with HSPPC-96 in combination with the standard treatment for newly diagnosed GBM after surgical resection. Primary endpoints were frequency of adverse events and progression-free survival (PFS) at 6 months...
May 17, 2018: JCI Insight
https://www.readbyqxmd.com/read/29769256/early-use-of-antibiotics-for-at-risk-children-with-influenza-archie-protocol-for-a-double-blind-randomised-placebo-controlled-trial
#7
Kay Wang, Tricia Carver, Sharon Tonner, Malcolm G Semple, Alastair D Hay, Michael Moore, Paul Little, Christopher Butler, Andrew Farmer, Rafael Perera, Ly-Mee Yu, Susan Mallett, Jane Wolstenholme, Anthony Harnden
INTRODUCTION: Influenza and influenza-like illness (ILI) create considerable burden on healthcare resources each winter. Children with pre-existing conditions such as asthma, diabetes mellitus and cerebral palsy are among those at greatest risk of clinical deterioration from influenza/ILI. The Antibiotics for at Risk CHildren with InfluEnza (ARCHIE) trial aims to determine whether early oral treatment with the antibiotic co-amoxiclav reduces the likelihood of reconsultation due to clinical deterioration in these 'at risk' children...
May 16, 2018: BMJ Open
https://www.readbyqxmd.com/read/29768667/analyzing-self-controlled-case-series-data-when-case-confirmation-rates-are-estimated-from-an-internal-validation-sample
#8
Stanley Xu, Christina L Clarke, Sophia R Newcomer, Matthew F Daley, Jason M Glanz
Vaccine safety studies are often electronic health record (EHR)-based observational studies. These studies often face significant methodological challenges, including confounding and misclassification of adverse event. Vaccine safety researchers use self-controlled case series (SCCS) study design to handle confounding effect and employ medical chart review to ascertain cases that are identified using EHR data. However, for common adverse events, limited resources often make it impossible to adjudicate all adverse events observed in electronic data...
May 16, 2018: Biometrical Journal. Biometrische Zeitschrift
https://www.readbyqxmd.com/read/29767739/efficacy-immunogenicity-and-safety-of-a-9-valent-human-papillomavirus-vaccine-subgroup-analysis-of-participants-from-asian-countries
#9
S M Garland, P Pitisuttithum, H Y S Ngan, C-H Cho, C-Y Lee, C-A Chen, Y C Yang, T-Y Chu, N-F Twu, R Samakoses, Y Takeuchi, T H Cheung, S C Kim, L-M Huang, B-G Kim, Y-T Kim, K-H Kim, Y-S Song, S Lalwani, J-H Kang, M Sakamoto, H-S Ryu, N Bhatla, H Yoshikawa, M C Ellison, S R Han, E Moeller, S Murata, M Ritter, M Sawata, C Shields, A Walia, G Perez, A Luxembourg
Background: A 9-valent human papillomavirus-6/11/16/18/31/33/45/52/58 (9vHPV) vaccine extends coverage to 5 next most common oncogenic types (31/33/45/52/58) in cervical cancer versus quadrivalent HPV (qHPV) vaccine. We describe efficacy, immunogenicity, and safety in Asian participants (India, Hong Kong, South Korea, Japan, Taiwan, and Thailand) from 2 international studies: a randomized, double-blinded, qHPV vaccine-controlled efficacy study (young women aged 16-26 years; NCT00543543; Study 001); and an immunogenicity study (girls and boys aged 9-15 years; NCT00943722; Study 002)...
May 15, 2018: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29757414/vaccination-coverage-in-systemic-lupus-erythematosus-a-cross-sectional-analysis-of-the-german-long-term-study-lula-cohort
#10
Gamal Chehab, Jutta G Richter, Ralph Brinks, Rebecca Fischer-Betz, Borgi Winkler-Rohlfing, Matthias Schneider
Objectives: Vaccinations are an important measure to prevent infections in immunocompromised patients. The knowledge of vaccination coverage and reasons for non-vaccination in patients with SLE is scarce. The aim of this study was to assess coverage rates of selected vaccinations in a representative sample of SLE patients and to identify predictors for non-vaccination. Methods: In 2013, information on selected vaccinations (coverage, application and reservations) and on demographics, clinical parameters and health beliefs was assessed by means of a self-reported questionnaire among a representative sample of SLE patients in Germany (LuLa cohort)...
May 10, 2018: Rheumatology
https://www.readbyqxmd.com/read/29752026/safety-of-a-heat-stable-rotavirus-vaccine-among-children-in-niger-data-from-a-phase-3-randomized-double-blind-placebo-controlled-trial
#11
Matthew E Coldiron, Ousmane Guindo, Rockyath Makarimi, Issaka Soumana, Amadou Matar Seck, Souna Garba, Emilie Macher, Sheila Isanaka, Rebecca F Grais
BACKGROUND: Rotavirus remains a major cause of diarrhea among children under 5 years of age. The efficacy of RotaSIIL, a pentavalent rotavirus vaccine, was shown in an event-driven trial in Niger. We describe the two-year safety follow-up of this trial. METHODS: Follow-up of safety outcomes began upon administration of the first dose of RotaSIIL or placebo. Adverse events were followed until 28 days after the third dose, and serious adverse events were followed until 2 years of age...
May 8, 2018: Vaccine
https://www.readbyqxmd.com/read/29751176/il-4-mediates-the-delayed-neurobehavioral-impairments-induced-by-neonatal-hepatitis-b-vaccination-that-involves-the-down-regulation-of-the-il-4-receptor-in-the-hippocampus
#12
Xiao Wang, Junhua Yang, Zhiwei Xing, Hongyang Zhang, Yaru Wen, Fangfang Qi, Zejie Zuo, Jie Xu, Zhibin Yao
We have previously verified that neonatal hepatitis B vaccination induced hippocampal neuroinflammation and behavior impairments in mice. However, the exact mechanism of these effects remain unclear. In this study, we observed that neonatal hepatitis B vaccination induced an anti-inflammatory cytokine response lasting for 4-5 weeks in both the serum and the hippocampus, primarily indicated by elevated IL-4 levels. Three weeks after the vaccination schedule, however, hepatitis B vaccine (HBV)-mice showed delayed hippocampal neuroinflammation...
May 8, 2018: Cytokine
https://www.readbyqxmd.com/read/29748940/surveillance-of-adverse-events-following-immunization-in-oman-2006-2015
#13
Prakash K Patel, Bader Al-Rawahi, Athari Al-Jawari, Idris Al-Abaidani, Seif Al-Abri
Background: In 1996, Oman launched its surveillance programme for adverse events following immunization (AEFI) to address vaccine safety concerns. In 2010, an analysis of surveillance activities for AEFI was done for 10 years (1996-2005). Objectives: The main objective of the study was to describe the trend of AEFI over the 10-year period, 2006-2015, and compare the findings with a previous report in Oman and reports from other countries. Methods: A descriptive record-based review of AEFI was carried out using the national AEFI surveillance database for the study period, 2006-2015...
May 3, 2018: Eastern Mediterranean Health Journal, la Revue de Santé de la Méditerranée Orientale
https://www.readbyqxmd.com/read/29745007/a-randomized-phase-2-study-of-asp0113-a-dna-based-vaccine-for-the-prevention-of-cmv-in-cmv-seronegative-kidney-transplant-recipients-receiving-a-kidney-from-a-cmv-seropositive-donor
#14
Flavio Vincenti, Klemens Budde, Pierre Merville, Fuad Shihab, V Ram Peddi, Malay Shah, Kate Wyburn, Elisabeth Cassuto-Viguier, Alexander Weidemann, Misun Lee, Teresa Flegel, Jay Erdman, Xuegong Wang, Christopher Lademacher
Cytomegalovirus (CMV) is a latent infection in most infected individuals, but can be pathogenic in immunocompromised kidney transplant recipients. ASP0113 is a DNA-based vaccine for the prevention of CMV-related mortality and end-organ disease in transplant recipients. The efficacy, safety, and immunogenicity of ASP0113 was assessed in a phase 2, double-blind, placebo-controlled study in CMV-seronegative kidney transplant recipients receiving a kidney from a CMV-seropositive donor. Transplant recipients were randomized (1:1) to receive five doses of ASP0113 (5 mg; n=75) or placebo (n=74) on Days 30/60/90/120/180 post transplant, and received prophylactic valganciclovir/ganciclovir 10-100 days post transplant...
May 9, 2018: American Journal of Transplantation
https://www.readbyqxmd.com/read/29741289/grommets-ventilation-tubes-for-recurrent-acute-otitis-media-in-children
#15
REVIEW
Roderick P Venekamp, Paul Mick, Anne Gm Schilder, Desmond A Nunez
BACKGROUND: Acute otitis media (AOM) is one of the most common childhood illnesses. While many children experience sporadic AOM episodes, an important group suffer from recurrent AOM (rAOM), defined as three or more episodes in six months, or four or more in one year. In this subset of children AOM poses a true burden through frequent episodes of ear pain, general illness, sleepless nights and time lost from nursery or school. Grommets, also called ventilation or tympanostomy tubes, can be offered for rAOM...
May 9, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29740819/prophylactic-vaccination-against-human-papillomaviruses-to-prevent-cervical-cancer-and-its-precursors
#16
REVIEW
Marc Arbyn, Lan Xu, Cindy Simoens, Pierre Pl Martin-Hirsch
BACKGROUND: Persistent infection with high-risk human papillomaviruses (hrHPV) types is causally linked with the development of cervical precancer and cancer. HPV types 16 and 18 cause approximately 70% of cervical cancers worldwide. OBJECTIVES: To evaluate the harms and protection of prophylactic human papillomaviruses (HPV) vaccines against cervical precancer and HPV16/18 infection in adolescent girls and women. SEARCH METHODS: We searched MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL) and Embase (June 2017) for reports on effects from trials...
May 9, 2018: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/29737499/vaccines-targeting-pcsk9-a-promising-alternative-to-passive-immunization-with-monoclonal-antibodies-in-the-management-of-hyperlipidaemia
#17
Stefan Weisshaar, Markus Zeitlinger
Hypercholesterolaemia is frequently observed in patients with cardiovascular diseases (CVD) and is associated with increased mortality. Statin treatment has been the standard of care for reducing low-density lipoprotein cholesterol (LDL-C) to improve cardiovascular outcomes. However, statins have limited effects in some patients and may be discontinued due to adverse effects resulting in LDL-C above target levels. The proprotein convertase subtilisin kexin type 9 (PCSK9) is a pivotal regulator in the LDL-C metabolism by degrading the LDL-C receptor on hepatocytes...
May 8, 2018: Drugs
https://www.readbyqxmd.com/read/29736961/unified-screening-for-potential-elevated-adverse-event-risk-and-other-associations
#18
A Lawrence Gould
Patients in large clinical trials and in studies employing large observational databases report many different adverse events, most of which will not have been anticipated at the outset. Conventional hypothesis testing of between group differences for each adverse event can be problematic: Lack of significance does not mean lack of risk, the tests usually are not adjusted for multiplicity, and the data determine which hypotheses are tested. This article describes a Bayesian screening approach suitable for clinical trials and large observational databases that do not test hypotheses, are self-adjusting for multiplicity, provide a direct assessment of the likelihood of no material drug-event association, and quantify the strength of the observed association...
May 7, 2018: Statistics in Medicine
https://www.readbyqxmd.com/read/29734337/highly-targeted-cholera-vaccination-campaigns-in-urban-setting-are-feasible-the-experience-in-kalemie-democratic-republic-of-congo
#19
Louis Albert Massing, Soumah Aboubakar, Alexandre Blake, Anne-Laure Page, Sandra Cohuet, Adalbert Ngandwe, Eric Mukomena Sompwe, Romain Ramazani, Marcela Allheimen, Philippe Levaillant, Pauline Lechevalier, Marie Kashimi, Axelle de la Motte, Arielle Calmejane, Malika Bouhenia, Ernest Dabire, Didier Bompangue, Benoit Kebela, Klaudia Porten, Francisco Luquero
INTRODUCTION: Oral cholera vaccines are primarily recommended by the World Health Organization for cholera control in endemic countries. However, the number of cholera vaccines currently produced is very limited and examples of OCV use in endemic countries, and especially in urban settings, are scarce. A vaccination campaign was organized by Médecins Sans Frontières and the Ministry of Health in a highly endemic area in the Democratic Republic of Congo. This study aims to describe the vaccine coverage achieved with this highly targeted vaccination campaign and the acceptability among the vaccinated communities...
May 7, 2018: PLoS Neglected Tropical Diseases
https://www.readbyqxmd.com/read/29721782/herpes-zoster-in-frail-elderly-patients-prevalence-impact-management-and-preventive-strategies
#20
REVIEW
Ermanno Zorzoli, Francesca Pica, Giulia Masetti, Elisabetta Franco, Antonio Volpi, Giovanni Gabutti
Population aging is a worldwide phenomenon with significant and manifold impacts on society. Advanced age correlates with the onset of frailty. In this vulnerable state, the immune response is weakened and a higher susceptibility to infectious diseases is observed. The present narrative review aims to cover the topic of herpes zoster (HZ) and its complications in frail populations. The lifetime risk of developing HZ is estimated at about 20-30%, and the risk increases with age. In older people, HZ can lead to the inability to recover the lifestyle, the interests, and the level of activity that existed before its development...
May 2, 2018: Aging Clinical and Experimental Research
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