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Vaccine safety

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https://www.readbyqxmd.com/read/28739116/pneumococcal-conjugate-vaccine-induced-igg-and-nasopharyngeal-carriage-of-pneumococci-hyporesponsiveness-and-immune-correlates-of-protection-for-carriage
#1
John Ojal, Laura L Hammitt, John Gaitho, J Anthony G Scott, David Goldblatt
BACKGROUND: Prior studies have demonstrated hyporesponsiveness to pneumococcal conjugate vaccines (PCVs) when administered in the presence of homologous carriage. This may be substantially more important in Africa where carriage prevalence is high. Deriving a correlate of protection (CoP) for carriage is important in guiding the future use of extended PCVs as population control of pneumococcal disease by vaccination is now focused principally on its indirect effect. We therefore explored the complex relationship between existing carriage and vaccine responsiveness, and between serum IgG levels and risk of acquisition...
June 19, 2017: Vaccine
https://www.readbyqxmd.com/read/28738137/public-health-and-economic-consequences-of-vaccine-hesitancy-for-measles-in-the-united-states
#2
Nathan C Lo, Peter J Hotez
Importance: Routine childhood vaccination is declining in some regions of the United States due to vaccine hesitancy, which risks the resurgence of many infectious diseases with public health and economic consequences. There are ongoing policy debates on the state and national level, including legislation around nonmedical (personal-belief) exemptions for childhood vaccination and possibly a special government commission on vaccine safety, which may affect vaccine coverage. Objective: To estimate the number of measles cases in US children and the associated economic costs under scenarios of different levels of vaccine hesitancy, using the case example of measles, mumps, and rubella (MMR) vaccination and measles...
July 24, 2017: JAMA Pediatrics
https://www.readbyqxmd.com/read/28736201/text-message-reminders-for-vaccination-of-adolescents-with-chronic-medical-conditions-a-randomized-clinical-trial
#3
Annika M Hofstetter, Angela Barrett, Stewin Camargo, Susan L Rosenthal, Melissa S Stockwell
BACKGROUND: Many adolescents with chronic medical conditions (CMCs) are at risk of vaccine-preventable infection, yet are frequently under-vaccinated. Text message reminders, particularly those with embedded educational information, have been shown to increase general pediatric vaccination. Their use has not been studied specifically among adolescents with CMCs. METHODS: Eligible parents of adolescents with CMCs receiving care at one of 4 academically-affiliated pediatric clinics and requiring human papillomavirus (first dose), influenza, and/or pneumococcal polysaccharide vaccines were randomized in 4 consecutive cohorts to receive text message vaccine reminders with or without embedded educational information ("educational" vs...
July 20, 2017: Vaccine
https://www.readbyqxmd.com/read/28736045/comparative-effectiveness-of-high-dose-versus-standard-dose-influenza-vaccination-on-numbers-of-us-nursing-home-residents-admitted-to-hospital-a-cluster-randomised-trial
#4
Stefan Gravenstein, H Edward Davidson, Monica Taljaard, Jessica Ogarek, Pedro Gozalo, Lisa Han, Vincent Mor
BACKGROUND: Immune responses to influenza vaccines decline with age, reducing clinical effectiveness. We compared the effect of the more immunogenic high-dose trivalent influenza vaccine with a standard-dose vaccine to identify the effect on reducing hospital admissions of nursing home residents in the USA. METHODS: We did a single-blind, pragmatic, comparative effectiveness, cluster-randomised trial with a 2 × 2 factorial design. Medicare-certified nursing homes in the USA located within 50 miles of a Centers for Disease Control and Prevention influenza reporting city were recruited, so long as the facilities were not located in a hospital, had more than 50 long-stay residents, had less than 20% of the population aged under 65 years, and were not already planning to administer the high-dose influenza vaccine to residents...
July 20, 2017: Lancet Respiratory Medicine
https://www.readbyqxmd.com/read/28735965/safety-profile-and-immunologic-responses-of-a-novel-vaccine-against-shigella-sonnei-administered-intramuscularly-intradermally-and-intranasally-results-from-two-parallel-randomized-phase-1-clinical-studies-in-healthy-adult-volunteers-in-europe
#5
Odile Launay, David J M Lewis, Alessandra Anemona, Pierre Loulergue, Jo Leahy, Antonella Silvia Sciré, Anaïs Maugard, Elisa Marchetti, Stefano Zancan, Zhiming Huo, Simona Rondini, Rachid Marhaba, Oretta Finco, Laura B Martin, Jochen Auerbach, Daniel Cohen, Allan Saul, Christiane Gerke, Audino Podda
BACKGROUND: Approximately 164,000 deaths yearly are due to shigellosis, primarily in developing countries. Thus, a safe and affordable Shigella vaccine is an important public health priority. The GSK Vaccines Institute for Global Health (GVGH) developed a candidate Shigella sonnei vaccine (1790GAHB) using the Generalized Modules for Membrane Antigens (GMMA) technology. The paper reports results of 1790GAHB Phase 1 studies in healthy European adults. METHODS: To evaluate the safety and immunogenicity profiles of 1790GAHB, we performed two parallel, phase 1, observer-blind, randomized, placebo-controlled, dose escalation studies in France ("study 1") and the United Kingdom ("study 2") between February 2014 and April 2015 (ClinicalTrials...
July 15, 2017: EBioMedicine
https://www.readbyqxmd.com/read/28733439/implementation-of-a-model-based-design-in-a-phase-1b-study-of-combined-targeted-agents
#6
Nolan A Wages, Craig A Portell, Michael E Williams, Mark R Conaway, Gina R Petroni
In recent years, investigators have recognized the rigidity of single agent, safety only, traditional designs, rendering them ineffective for conducting contemporary early-phase clinical trials, such as those involving combinations and /or biological agents.  Novel approaches are required to address these research questions, such as those posed in trials involving targeted therapies. We describe the implementation of a model-based design for identifying an optimal treatment combination, defined by low toxicity and high efficacy, in an early-phase trial evaluating a combination of two oral targeted inhibitors in relapsed / refractory mantle cell lymphoma...
July 21, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28733429/proteogenomic-analysis-and-discovery-of-immune-antigens-in-mycobacterium-vaccae
#7
Jianhua Zheng, Lihong Chen, Liguo Liu, Haifeng Li, Bo Liu, Dandan Zheng, Tao Liu, Jie Dong, Lilian Sun, Yafang Zhu, Jian Yang, Xiaobing Zhang, Qi Jin
Tuberculosis (TB) is one of the leading causes of death worldwide, especially in developing countries. Neonatal BCG vaccination occurs in various regions, but the level of protection varies in different populations. Recently, Mycobacterium vaccae is found to be an immunomodulating therapeutic agent that could confer a significant level of protection against TB. It is the only vaccine in a phase III trial from WHO to assess its efficacy and safety in preventing TB disease in people with latent TB infection. However, the mechanism of immunotherapy of M...
July 21, 2017: Molecular & Cellular Proteomics: MCP
https://www.readbyqxmd.com/read/28731912/assessing-infant-and-maternal-readiness-for-newborn-discharge
#8
Ling Jing, Casidhe-Nicole Bethancourt, Thomas McDonagh
PURPOSE OF REVIEW: The review highlights the shift from prescribed length of stay (LOS) to mother-infant dyad readiness as the basis for making discharge decisions for healthy term newborns. We describe the components of readiness that should be considered in making the decision, focusing on infant clinical readiness, and maternal and familial readiness. RECENT FINDINGS: Although the Newborns' and Mothers' Health Protection Act of 1996 aimed to protect infants and mothers by establishing a minimum LOS, the American Academy of Pediatrics 2015 policy on newborn discharge acknowledges the shift from LOS-based to readiness-based discharge decision-making...
July 20, 2017: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/28730853/dengue-in-the-elderly-a-review
#9
Ray Junhao Lin, Tau Hong Lee, Yee Sin Leo
Changing dengue epidemiological trends have resulted in a shift in the disease burden to the adult population. Older adults suffer from poorer outcomes as compared to their younger counterparts, making clinical management of this sub-population particularly challenging. Areas covered: We present a review of the current literature on the changing epidemiology of dengue in the elderly, the atypical features of the clinical disease in this population with emphasis on severe disease presentations and challenges in the current management strategies...
July 21, 2017: Expert Review of Anti-infective Therapy
https://www.readbyqxmd.com/read/28730271/serious-adverse-events-after-hpv-vaccination-a-critical-review-of-randomized-trials-and-post-marketing-case-series
#10
Manuel Martínez-Lavín, Luis Amezcua-Guerra
This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study...
July 20, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28729879/safety-and-immunogenicity-of-the-quadrivalent-human-papillomavirus-qhpv-vaccine-in-hiv-positive-spanish-men-who-have-sex-with-men-msm
#11
Carmen Hidalgo-Tenorio, Jessica Ramírez-Taboada, Concepción Gil-Anguita, Javier Esquivias, Mohamed Omar-Mohamed-Balgahata, Antonio SamPedro, Miguel Lopez-Ruz, Juan Pasquau
BACKGROUND: Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa. METHODS: This is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine...
2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/28729019/safety-reactogenicity-and-immunogenicity-of-two-investigational-pneumococcal-protein-based-vaccines-results-from-a-randomized-phase-ii-study-in-infants
#12
Roman Prymula, Leszek Szenborn, Sven-Arne Silfverdal, Jacek Wysocki, Piotr Albrecht, Magali Traskine, Asparuh Gardev, Yue Song, Dorota Borys
INTRODUCTION: Vaccination with formulations containing pneumococcal protein antigens such as pneumolysin toxoid (dPly) and histidine-triad protein D (PhtD) may extend serotype-related protection of pneumococcal conjugate vaccines (PCVs) against Streptococcus pneumoniae. METHODS: This phase II, multi-center, observer-blind trial conducted in Europe (NCT01204658) assessed 2 investigational vaccines containing 10 serotype-specific polysaccharide conjugates of PHiD-CV and either 10 or 30µg of dPly and PhtD each...
July 17, 2017: Vaccine
https://www.readbyqxmd.com/read/28728074/no-pain-no-gain-adjuvant-effects-of-alum-and-monophosphoryl-lipid-a-in-pertussis-and-hpv-vaccines
#13
REVIEW
Thomas C Mitchell, Carolyn R Casella
Development of non-infectious subunit vaccines is hampered by a slow pipeline of new adjuvants to replace or enhance alum in part because expectations of safety are high. Transient vaccine side effects are not clinical priorities because they cause no lasting harm and vaccine development has appropriately been focused on avoidance of serious adverse events. As a result, surprisingly little is known about the extent to which side effects caused by a vaccine's reactogencicity are predictive of successful immunization outcomes...
July 17, 2017: Current Opinion in Immunology
https://www.readbyqxmd.com/read/28727817/immunogenicity-of-a-novel-clade-b-hiv-1-vaccine-combination-results-of-phase-1-randomized-placebo-controlled-trial-of-an-hiv-1-gm-csf-expressing-dna-prime-with-a-modified-vaccinia-ankara-vaccine-boost-in-healthy-hiv-1-uninfected-adults
#14
Susan P Buchbinder, Nicole A Grunenberg, Brittany J Sanchez, Kelly E Seaton, Guido Ferrari, M Anthony Moody, Nicole Frahm, David C Montefiori, Christine M Hay, Paul A Goepfert, Lindsey R Baden, Harriet L Robinson, Xuesong Yu, Peter B Gilbert, M Juliana McElrath, Yunda Huang, Georgia D Tomaras
BACKGROUND: A phase 1 trial of a clade B HIV vaccine in HIV-uninfected adults evaluated the safety and immunogenicity of a DNA prime co-expressing GM-CSF (Dg) followed by different numbers and intervals of modified vaccinia Ankara Boosts (M). Both vaccines produce virus-like particles presenting membrane-bound Env. METHODS: Four US sites randomized 48 participants to receiving 1/10th the DNA dose as DgDgMMM given at 0, 2, 4, 6 and 8 months, or full dose DgDgM_M or DgDgMM_M regimens, given at 0, 2, 4, and 8 months, and 0, 2, 4, 6, and 10 months, respectively...
2017: PloS One
https://www.readbyqxmd.com/read/28724768/synthetic-tlr4-and-tlr7-ligands-work-additively-via-myd88-to-induce-protective-antiviral-immunity-in-mice
#15
Peter H Goff, Tomoko Hayashi, Wenqian He, Shiyin Yao, Howard B Cottam, Gene S Tan, Brian Crain, Florian Krammer, Karen Messer, Minya Pu, Dennis A Carson, Peter Palese, Maripat Corr
We have previously demonstrated that the combination of synthetic small molecule Toll-like receptor 4 (TLR4) and TLR7 ligands is a potent adjuvant for recombinant influenza virus hemagglutinin, inducing rapid and sustained immunity protective against influenza viruses in homologous, heterologous and heterosubtypic murine challenge models. Combining TLR4 and TLR7 ligands balances Th1/Th2-type immune responses for long-lived cellular and neutralizing humoral immunity against the viral hemagglutinin. Here, we demonstrate that the protective response induced in mice by this combined adjuvant is dependent upon TLR4 and TLR7 signaling via myeloid differentiation primary response gene 88 (MyD88), indicating that the adjuvants function in vivo via their known receptors with negligible off-target effects to induce protective immunity...
July 19, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28724343/vero-cell-technology-for-rapid-development-of-inactivated-whole-virus-vaccines-for-emerging-viral-diseases
#16
P Noel Barrett, Sara J Terpening, Doris Snow, Ronald R Cobb, Otfried Kistner
Rapid development and production of vaccines against emerging diseases requires well established, validated, robust technologies to allow industrial scale production and accelerated licensure of products. Areas covered: A versatile Vero cell platform has been developed and utilized to deliver a wide range of candidate and licensed vaccines against emerging viral diseases. This platform builds on the 35 years' experience and safety record with inactivated whole virus vaccines such as polio vaccine. The current platform has been optimized to include a novel double inactivation procedure in order to ensure a highly robust inactivation procedure for novel emerging viruses...
July 20, 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/28721859/immunogenicity-and-safety-of-the-inactivated-hepatitis-a-vaccine-in-children-with-juvenile-idiopathic-arthritis-on-methotrexate-treatment-a-matched-case-control-study
#17
Despoina N Maritsi, Susan E Coffin, Ioanna Argyri, George Vartzelis, Nick Spyridis, Maria N Tsolia
OBJECTIVES: To describe the immunogenicity and side effects of immunisation against hepatitis A virus (HAV) in JIA patients on methotrexate treatment, who have not been previously exposed to HAV. METHODS: Case-control study performed in JIA patients and healthy controls matched on age and gender. The subjects received two doses of inactivated anti-HAV vaccine (720 mIU/ml) intramuscularly at 0 and 6 months. Seroconversion, seroprotection rates and anti-HAV-IgG titres were measured at 1, 7 and 18 months...
July 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28720463/incidence-rates-of-guillain-barr%C3%A3-gbs-chronic-fatigue-systemic-exertion-intolerance-disease-cfs-seid-and-postural-orthostatic-tachycardia-syndrome-pots-prior-to-introduction-of-human-papilloma-virus-hpv-vaccination-among-adolescent-girls-in-finland-2002-2012
#18
J Skufca, J Ollgren, E Ruokokoski, O Lyytikäinen, H Nohynek
BACKGROUND: In Finland a vaccination programme against human papillomavirus (HPV) was introduced in November 2013 for girls aged 11-12 years with a catchup for girls 13-15 years. Allegations that HPV vaccine is causing Guillain Barré syndrome (GBS) and non-specific diagnostic entities, such as chronic fatigue syndrome/systemic exertion intolerance disease (CFS/SEID) and postural orthostatic tachycardia syndrome (POTS), continue to surface. We examined population register-based incidence rates of CFS/SEID, GBS and POTS to provide baseline data for future HPV vaccine safety evaluations...
June 2017: Papillomavirus Research
https://www.readbyqxmd.com/read/28720446/acceptability-of-multipurpose-human-papillomavirus-vaccines-among-providers-and-mothers-of-adolescent-girls-a-mixed-methods-study-in-five-countries
#19
Nadja A Vielot, Shoshana K Goldberg, Gregory Zimet, Sara B Smith, Mary Anne McDonald, Silvina Ramos, Karen Morgan, Chan Joo Kim, Karin L Richter, Merce Peris, Kevin J Whaley, Jennifer S Smith
INTRODUCTION: Multipurpose vaccines (MPVs) could be formulated to prevent multiple sexually transmitted infections simultaneously. Little is known about acceptability of MPVs among vaccine health care providers (HCPs) or mothers of adolescent girls. METHODS: 151 adolescent vaccine providers and 118 mothers of adolescent girls aged 9-14 were recruited from five geographically-diverse countries: Argentina, Malaysia, South Africa, South Korea, and Spain. We assessed providers' preferences for single-purpose human papillomavirus (HPV) vaccine versus MPVs (including HPV+herpes simplex virus (HSV)-2, HPV+HIV, or HPV+HSV-2+HIV) via quantitative surveys...
June 2017: Papillomavirus Research
https://www.readbyqxmd.com/read/28720281/evaluation-of-a-primary-course-of-h9n2-vaccine-with-or-without-as03-adjuvant-in-adults-a-phase-i-ii-randomized-trial
#20
Anuradha Madan, Harry Collins, Eric Sheldon, Louise Frenette, Laurence Chu, Damien Friel, Mamadou Drame, David W Vaughn, Bruce L Innis, Anne Schuind
BACKGROUND: Avian influenza A H9N2 strains have pandemic potential. METHODS: In this randomized, observer-blind study (ClinicalTrials.gov: NCT01659086), 420 healthy adults, 18-64years of age, received 1 of 10 H9N2 inactivated split-virus vaccination regimens (30 participants per group), or saline placebo (120 participants). H9N2 groups received 2 doses (days 0, 21) of 15µg hemagglutinin (HA) without adjuvant, or 1.9µgHA+AS03A, 1.9µgHA+AS03B, 3.75µgHA+AS03A, or 3...
July 15, 2017: Vaccine
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