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High dose influenza vaccine

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https://www.readbyqxmd.com/read/28431815/efficacy-and-safety-of-high-dose-influenza-vaccine-in-elderly-adults-a-systematic-review-and-meta-analysis
#1
REVIEW
Krista Wilkinson, Yichun Wei, Andrea Szwajcer, Rasheda Rabbani, Ryan Zarychanski, Ahmed M Abou-Setta, Salaheddin M Mahmud
INTRODUCTION: Older adults are prioritized for influenza vaccination but also have lowered antibody responses to the vaccine. Higher-doses of influenza antigen may increase immune response and thus be more effective. Our objectives were to compare the efficacy and safety of the high-dose influenza vaccine to the standard-dose influenza vaccine in the elderly (age>65). METHODS: Data sources: Randomized trials (RCTs) from Medline (Ovid), EMBASE (Ovid), Cochrane Library (Wiley), ClinicalTrials...
April 18, 2017: Vaccine
https://www.readbyqxmd.com/read/28413427/immunogenicity-and-safety-of-a-respiratory-syncytial-virus-fusion-protein-rsv-f-nanoparticle-vaccine-in-older-adults
#2
Louis Fries, Vivek Shinde, Jeffrey J Stoddard, D Nigel Thomas, Eloi Kpamegan, Hanxin Lu, Gale Smith, Somia P Hickman, Pedro Piedra, Gregory M Glenn
BACKGROUND: A preventative strategy for Respiratory Syncytial Virus (RSV) infection constitutes an under-recognized unmet medical need among older adults. Four formulations of a novel recombinant RSV F nanoparticle vaccine (60 or 90 μg RSV F protein, with or without aluminum phosphate adjuvant) administered concurrently with a licensed inactivated trivalent influenza vaccine (TIV) in older adult subjects were evaluated for safety and immunogenicity in this randomized, observer-blinded study...
2017: Immunity & Ageing: I & A
https://www.readbyqxmd.com/read/28378403/dose-sparing-and-lack-of-dose-response-relationship-with-an-influenza-vaccine-in-adult-and-elderly-patients-a-randomised-double-blind-clinical-trial
#3
Zoltan Vajo, Gergely Balaton, Peter Vajo, Laszlo Kalabay, Adam Erdman, Peter Torzsa
AIMS: The currently licensed seasonal trivalent influenza vaccines contain 15 micrograms of hemagglutinin per strain for adult, and up to 60 micrograms for elderly patients. However, due to recent shortages, dose sparing to increase production capacity would be highly desirable. In the present study, we attempted to find a dose-response relationship for immunogenicity and thus, the optimal dose for seasonal influenza vaccines in adult and elderly patients. METHODS: A total of 256 subjects, including adult (ages 18-60 years) and elderly (age over 60 years) were enrolled...
April 5, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28347293/comparison-of-a-novel-microcrystalline-tyrosine-adjuvant-with-aluminium-hydroxide-for-enhancing-vaccination-against-seasonal-influenza
#4
M D Heath, N J Swan, A C Marriott, N J Silman, B Hallis, C Prevosto, K E Gooch, M A Skinner
BACKGROUND: Vaccination against seasonal influenza strains is recommended for "high risk" patient groups such as infants, elderly and those with respiratory or circulatory diseases. However, efficacy of the trivalent influenza vaccine (TIV) is poor in many cases and in the event of an influenza pandemic, mono-valent vaccines have been rapidly developed and deployed. One of the main issues with use of vaccine in pandemic situations is the lack of a suitable quantity of vaccine early enough during the pandemic to exert a major influence on the transmission of virus and disease outcome...
March 27, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28343904/clinical-and-serologic-responses-after-a-two-dose-series-of-high-dose-influenza-vaccine-in-plasma-cell-disorders-a-prospective-single-arm-trial
#5
Andrew R Branagan, Eamon Duffy, Randy A Albrecht, Dennis L Cooper, Stuart Seropian, Terri L Parker, Geliang Gan, Fangyong Li, Daniel Zelterman, Chandra Sekhar Boddupalli, Lin Zhang, Rakesh Verma, Thomas M Ferencz, Madhav V Dhodapkar
BACKGROUND: Patients with multiple myeloma (MM) and other plasma cell disorders are highly susceptible to influenza infections, which are major causes of morbidity in this population, despite the routine administration of a seasonal influenza vaccination. Existing data are limited by small and retrospective studies, which suggest poor seroprotection rates of < 20% after standard influenza vaccination in patients with MM. PATIENTS AND METHODS: Patients with plasma cell dyscrasia (n = 51) were treated with a 2-dose series of high-dose inactivated trivalent influenza vaccine during the 2014 to 2015 influenza season...
March 7, 2017: Clinical Lymphoma, Myeloma & Leukemia
https://www.readbyqxmd.com/read/28342667/a-fast-and-efficient-purification-platform-for-cell-based-influenza-viruses-by-flow-through-chromatography
#6
Yu-Fen Tseng, Tsai-Chuan Weng, Chia-Chun Lai, Po-Ling Chen, Min-Shi Lee, Alan Yung-Chih Hu
Since newly emerging influenza viruses with pandemic potentials occurred in recent years, the demand for producing pandemic influenza vaccines for human use is high. For the development of a quick and efficient vaccine production, we proposed an efficient purification platform from the harvest to the purified bulk for the cell-based influenza vaccine production. This platform based on flow-through chromatography and filtration steps and the process only involves a few purification steps, including depth filtration, inactivation by formaldehyde, microfiltration, ultrafiltration, anion-exchange and ligand-core chromatography and sterile filtration...
March 22, 2017: Vaccine
https://www.readbyqxmd.com/read/28340322/immunogenicity-and-safety-of-primary-and-booster-vaccination-with-2-investigational-formulations-of-diphtheria-tetanus-and-haemophilus-influenzae-type-b-antigens-in-a-hexavalent-dtpa-hbv-ipv-hib-combination-vaccine-in-comparison-with-the-licensed-infanrix-hexa
#7
Timo Vesikari, Luis Rivera, Tiina Korhonen, Anitta Ahonen, Brigitte Cheuvart, Marjan Hezareh, Winnie Janssens, Narcisa Mesaros
Safety and immunogenicity of 2 investigational formulations of diphtheria, tetanus and Haemophilus influenzae type b antigens of the combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliomyelitis-Hib vaccine (DTPa-HBV-IPV/Hib) were evaluated in a Primary (NCT01248884) and a Booster vaccination (NCT01453998) study. In the Primary study, 721 healthy infants (randomized 1:1:1) received 3 doses of DTPa-HBV-IPV/Hib formulation A (DATAPa-HBV-IPV/Hib), or B (DBTBPa-HBV-IPV/Hib) or the licensed DTPa-HBV-IPV/Hib vaccine (Infanrix hexa, GSK; control group) at 2, 3, 4 months of age...
March 24, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28329311/comparative-effectiveness-of-high-dose-versus-standard-dose-influenza-vaccines-among-us-medicare-beneficiaries-in-preventing-postinfluenza-deaths-during-2012-2013-and-2013-2014
#8
David K Shay, Yoganand Chillarige, Jeffrey Kelman, Richard A Forshee, Ivo M Foppa, Michael Wernecke, Yun Lu, Jill M Ferdinands, Arjun Iyengar, Alicia M Fry, Chris Worrall, Hector S Izurieta
Background.: Recipients of high-dose vs standard-dose influenza vaccines have fewer influenza illnesses. We evaluated the comparative effectiveness of high-dose vaccine in preventing postinfluenza deaths during 2012-2013 and 2013-2014, when influenza viruses and vaccines were similar. Methods.: We identified Medicare beneficiaries aged ≥65 years who received high-dose or standard-dose vaccines in community-located pharmacies offering both vaccines. The primary outcome was death in the 30 days following an inpatient or emergency department encounter listing an influenza International of Classification of Diseases, Ninth Revision, Clinical Modification code...
February 15, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28303960/the-immune-correlates-of-protection-for-an-avian-influenza-h5n1-vaccine-in-the-ferret-model-using-oil-in-water-adjuvants
#9
Sook-San Wong, Susu Duan, Jennifer DeBeauchamp, Mark Zanin, Lisa Kercher, Stephanie Sonnberg, Thomas Fabrizio, Trushar Jeevan, Jeri-Carol Crumpton, Christine Oshansky, Yilun Sun, Li Tang, Paul Thomas, Richard Webby
Because of the pathogenicity and low incidence of avian influenza virus infections in humans, the immune correlates of protection for avian influenza vaccines cannot be determined from clinical studies. Here, we used the ferret model to address this for an avian influenza H5N1 vaccine. Using oil-in-water adjuvants, we generated groups of ferrets with undetectable (geometric mean titer [GMT] < 10), low (GMT = 28.3), or high (GMT > 761.1) hemagglutination-inhibition (HAI) titers to the A/Viet Nam/1203/2004 (H5N1) virus...
March 17, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28301266/immunogenicity-and-safety-of-a-trivalent-inactivated-influenza-vaccine-produced-in-shenzhen-china
#10
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/28279563/a-small-molecule-irf3-agonist-functions-as-an-influenza-vaccine-adjuvant-by-modulating-the-antiviral-immune-response
#11
Peter Probst, John B Grigg, Myra Wang, Ernesto Muñoz, Yueh-Ming Loo, Renee C Ireton, Michael Gale, Shawn P Iadonato, Kristin M Bedard
Vaccine adjuvants are essential to drive a protective immune response in cases where vaccine antigens are weakly immunogenic, where vaccine antigen is limited, or where an increase in potency is needed for a specific population, such as the elderly. To discover novel vaccine adjuvants, we used a high-throughput screen (HTS) designed to identify small-molecule agonists of the RIG-I-like receptor (RLR) pathway leading to interferon regulatory factor 3 (IRF3) activation. RLRs are a group of cytosolic pattern-recognition receptors that are essential for the recognition of viral nucleic acids during infection...
March 6, 2017: Vaccine
https://www.readbyqxmd.com/read/28279345/generation-of-a-live-attenuated-influenza-vaccine-that-elicits-broad-protection-in-mice-and-ferrets
#12
Lulan Wang, Su-Yang Liu, Hsiang-Wen Chen, Juan Xu, Maxime Chapon, Tao Zhang, Fan Zhou, Yao E Wang, Natalie Quanquin, Guiqin Wang, Xiaoli Tian, Zhanlong He, Longding Liu, Wenhai Yu, David Jesse Sanchez, Yuying Liang, Taijiao Jiang, Robert Modlin, Barry R Bloom, Qihan Li, Jane C Deng, Paul Zhou, F Xiao-Feng Qin, Genhong Cheng
New influenza vaccines that provide effective and broad protection are desperately needed. Live attenuated viruses are attractive vaccine candidates because they can elicit both humoral and cellular immune responses. However, recent formulations of live attenuated influenza vaccines (LAIVs) have not been protective. We combined high-coverage transposon mutagenesis of influenza virus with a rapid high-throughput screening for attenuation to generate W7-791, a live attenuated mutant virus strain. W7-791 produced only a transient asymptomatic infection in adult and neonatal mice even at doses 100-fold higher than the LD50 of the parent strain...
March 8, 2017: Cell Host & Microbe
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
#13
RANDOMIZED CONTROLLED TRIAL
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). 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...
May 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/28219461/evaluating-the-impact-of-pharmacies-on-pandemic-influenza-vaccine-administration
#14
Joy Schwerzmann, Samuel B Graitcer, Barbara Jester, David Krahl, Daniel Jernigan, Carolyn B Bridges, Joseph Miller
OBJECTIVES: The objective of this study was to quantify the potential retail pharmacy vaccine administration capacity and its possible impact on pandemic influenza vaccine uptake. METHODS: We developed a discrete event simulation model by use of ExtendSim software (Imagine That Inc, San Jose, CA) to forecast the potential effect of retail pharmacy vaccine administration on total weekly vaccine administration and the time needed to reach 80% vaccination coverage with a single dose of vaccine per person...
February 21, 2017: Disaster Medicine and Public Health Preparedness
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
#15
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/28159612/a-prime-boost-vaccination-with-ha-dna-and-pichia-produced-ha-protein-elicits-a-strong-humoral-response-in-chickens-against-h5n1
#16
Anna Stachyra, Maria Pietrzak, Agnieszka Macioła, Anna Protasiuk, Monika Olszewska, Krzysztof Śmietanka, Zenon Minta, Anna Góra-Sochacka, Edyta Kopera, Agnieszka Sirko
Highly pathogenic avian influenza viruses cause severe disease and huge economic losses in domestic poultry and might pose a serious threat to people because of the high mortality rates in case of an accidental transmission to humans. The main goal of this work was to evaluate the immune responses and hemagglutination inhibition potential elicited by a combined DNA/recombinant protein prime/boost vaccination compared to DNA/DNA and protein/protein regimens in chickens. A plasmid encoding hemagglutinin (HA) from the A/swan/Poland/305-135V08/2006 (H5N1) virus, or the recombinant HA protein produced in Pichia pastoris system, both induced H5 HA-specific humoral immune responses in chickens...
January 31, 2017: Virus Research
https://www.readbyqxmd.com/read/28109709/the-effect-of-gamma-irradiation-conditions-on-the-immunogenicity-of-whole-inactivated-influenza-a-virus-vaccine
#17
Shannon C David, Josyane Lau, Eve V Singleton, Rachelle Babb, Justin Davies, Timothy R Hirst, Shaun R McColl, James C Paton, Mohammed Alsharifi
Gamma-irradiation, particularly an irradiation dose of 50kGy, has been utilised widely to sterilise highly pathogenic agents such as Ebola, Marburg Virus, and Avian Influenza H5N1. We have reported previously that intranasal vaccination with a gamma-irradiated Influenza A virus vaccine (γ-Flu) results in cross-protective immunity. Considering the possible inclusion of highly pathogenic Influenza strains in future clinical development of γ-Flu, an irradiation dose of 50kGy may be used to enhance vaccine safety beyond the internationally accepted Sterility Assurance Level (SAL)...
January 18, 2017: Vaccine
https://www.readbyqxmd.com/read/28089151/influenza-vaccination-reduces-hemorrhagic-stroke-risk-in-patients-with-atrial-fibrillation-a-population-based-cohort-study
#18
Ju-Chi Liu, Ta-Jung Wang, Li-Chin Sung, Pai-Feng Kao, Tsung-Yeh Yang, Wen-Rui Hao, Chun-Chao Chen, Yi-Ping Hsu, Szu-Yuan Wu
PURPOSE: The risk of hemorrhagic stroke in patients with atrial fibrillation (AF) is low but the consequences of its occurrence are extremely severe. In this study, we investigated the association of influenza vaccination with the risk of hemorrhagic stroke to develop an efficient strategy for reducing this risk in patients with AF. METHODS: In this study, data were retrieved from the Taiwan National Health Insurance Research Database. The study cohort comprised all patients who received a diagnosis of AF (n=14,454) before January 1, 2005 (index date) and were followed until December 31, 2012...
December 21, 2016: International Journal of Cardiology
https://www.readbyqxmd.com/read/28063707/a-novel-vaccinological-evaluation-of-intranasal-vaccine-and-adjuvant-safety-for-preclinical-tests
#19
Eita Sasaki, Madoka Kuramitsu, Haruka Momose, Kouji Kobiyama, Taiki Aoshi, Hiroshi Yamada, Ken J Ishii, Takuo Mizukami, Isao Hamaguchi
Vaccines are administered to healthy humans, including infants, so the safety and efficacy must be very high. Therefore, evaluating vaccine safety in preclinical and clinical studies, according to World Health Organization guidelines, is crucial for vaccine development and clinical use. A change in the route of administration is considered to alter a vaccine's immunogenicity. Several adjuvants have also been developed and approved for use in vaccines. However, the addition of adjuvants to vaccines may cause unwanted immune responses, including facial nerve paralysis and narcolepsy...
February 1, 2017: Vaccine
https://www.readbyqxmd.com/read/28052136/intranasal-immunization-using-mannatide-as-a-novel-adjuvant-for-an-inactivated-influenza-vaccine-and-its-adjuvant-effect-compared-with-mf59
#20
Shu-Ting Ren, Xue-Mei Zhang, Peng-Fei Sun, Li-Juan Sun, Xue Guo, Tian Tian, Jian Zhang, Qi-Yuan Guo, Xue Li, Li-Jun Guo, Jin Che, Bing Wang, Hui Zhang
Intranasal vaccination is more potent than parenteral injection for the prevention of influenza. However, because the poor efficiency of antigen uptake across the nasal mucosa is a key issue, immunostimulatory adjuvants are essential for intranasal vaccines. The immunomodulator mannatide or polyactin (PA) has been used for the clinical treatment of impaired immunity in China, but its adjuvant effect on an inactivated trivalent influenza vaccine (ITIV) via intranasal vaccination is unclear. To explore the adjuvant effect of PA, an inactivated trivalent influenza virus with or without PA or MF59 was instilled intranasally once a week in BALB/c mice...
2017: PloS One
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