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Vaccine safety

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https://www.readbyqxmd.com/read/28324748/influenza-vaccination-in-adult-patients-with-solid-tumours-treated-with-chemotherapy
#1
REVIEW
Albert Vollaard, Imke Schreuder, Lizzy Slok-Raijmakers, Wim Opstelten, Guus Rimmelzwaan, Hans Gelderblom
Patients with solid tumours receiving chemotherapy are at risk for influenza complications. Yearly influenza vaccination is recommended to patients treated with chemotherapy. However, adherence to vaccination is low, most likely due to lack of data on efficacy, optimal timing and safety of vaccination. There is scarce evidence for the effectiveness of the influenza vaccine in adult patients with solid tumours and chemotherapy on reduction of pneumonia, decreased mortality and fewer interruptions of oncological treatment...
March 16, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28319456/reactogenicity-of-cervarix-and-gardasil-human-papillomavirus-hpv-vaccines-in-a-randomized-single-blind-trial-in-healthy-uk-adolescent-females
#2
Tao Haskins-Coulter, Jo Southern, Nick Andrews, Elizabeth Miller
One hundred and ninety eight females aged 12-15 y were enrolled in an observer-blinded randomized trial to assess the immunogenicity and reactogenicity of the tetravalent HPV vaccine Gardasil® (group 2), in comparison to the bivalent HPV vaccine, Cervarix® (group 1), which was routinely offered in the national vaccination schedule at the time. Participants were blinded to treatment group until all 3 vaccinations had been given, while laboratory staff were masked during testing. For the majority of local and general reactions, recipients of both vaccines reported comparable frequencies...
March 20, 2017: Human Vaccines & Immunotherapeutics
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
#3
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/28317872/preclinical-evaluation-of-the-efficacy-pharmacokinetics-and-immunogenicity-of-js-001-a-programmed-cell-death-protein-1-pd-1-monoclonal-antibody
#4
Jie Fu, Fang Wang, Li-Hou Dong, Jing Zhang, Cheng-Lian Deng, Xue-Li Wang, Xin-Yao Xie, Jing Zhang, Ruo-Xian Deng, Li-Bo Zhang, Hai Wu, Hui Feng, Bo Chen, Hai-Feng Song
JS-001 is the first monoclonal antibody (mAb) against programmed cell death protein-1 (PD-1) approved by the China Food and Drug Administration (CFDA) into the clinical trails. To date, however, no pre-clinical pharmacological and pharmacokinetic (PK) data are available. In this study, we investigated the efficacy of JS-001 and conducted a preclinical PK study, including the monitoring of anti-drug antibodies (ADAs). We found that JS-001 specifically bound to PD-1 antigen with an EC50 of 21 nmol/L, and competently blocked the binding of PD-1 antigen to PD-L1 and PD-L2 with IC50 of 3...
March 20, 2017: Acta Pharmacologica Sinica
https://www.readbyqxmd.com/read/28317660/safety-tolerability-and-efficacy-of-intradermal-rabies-immunization-with-debioject%C3%A2
#5
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/28315060/results-of-a-phase-ib-trial-of-combination-immunotherapy-with-a-cd8-%C3%A2-t-cell-eliciting-vaccine-and-trastuzumab-in-breast-cancer-patients
#6
G Travis Clifton, Jennifer K Litton, Karen Arrington, Sathibalan Ponniah, Nuhad K Ibrahim, Victor Gall, Gheath Alatrash, George E Peoples, Elizabeth A Mittendorf
BACKGROUND: CD8+ T cell-eliciting vaccines are being investigated in breast cancer patients. Preclinical data showed that trastuzumab increases the susceptibility of tumor cells to lysis by vaccine-generated CD8+ T cells, suggesting potential benefit of a combination immunotherapy strategy. The current trial was undertaken to demonstrate the safety of this approach. METHODS: This study was designed as a dose-escalation trial enrolling clinically disease-free, human leukocyte antigen A2+ or A3+ , human epidermal growth factor receptor 2 (HER2)-positive breast cancer patients...
March 17, 2017: Annals of Surgical Oncology
https://www.readbyqxmd.com/read/28314493/beyond-visas-and-vaccines-preparing-students-for-domestic-and-global-health-engagement
#7
EDITORIAL
Lisa V Adams, Anne N Sosin
At campuses across the United States, scores of students are embarking on global health experiences in low- and middle-income countries. The desire to improve the health of poor communities while preparing for future health careers is often the main driver. The spotlight on domestic health issues also has fueled a resurgence of interest in underserved communities in the United States. Regardless of the destination, rigorous preparation is needed to ensure that the students' presence benefits the communities they aim to serve...
November 2016: Annals of Global Health
https://www.readbyqxmd.com/read/28304231/f199e-substitution-reduced-toxicity-of-clostridium-perfringens-epsilon-toxin-by-depriving-the-receptor-binding-capability
#8
Jingjing Kang, Jie Gao, Wenwu Yao, Lin Kang, Shan Gao, Hao Yang, Bin Ji, Ping Li, Jing Liu, Jiahao Yao, Wenwen Xin, Baohua Zhao, Jinglin Wang
Epsilon toxin (ETX), a potent toxin, is produced by types B and D strains of Clostridium perfringens, which could cause severe diseases in humans and domestic animals. Mutant rETX(F199E) was previously demonstrated to be a good vaccine candidate. However, the mechanism concerned remains unknown. To clarify how F199E substitution reduced ETX toxicity, we performed a series of experiments. The results showed that the cell-binding and pore-forming ability of rETX(F199E) was almost abolished. We speculated that F199E substitution reduced toxicity by depriving the receptor binding capability of ETX, which contributed to the hypothesis that domain I of ETX is responsible for cell binding...
March 17, 2017: Human Vaccines & Immunotherapeutics
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
#9
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
#10
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/28301282/immunogenicity-and-safety-of-high-dose-hepatitis-b-vaccine-among-drug-users-a-randomized-open-labeled-blank-controlled-trial
#11
Yongliang Feng, Jing Shi, Linying Gao, Tian Yao, Dan Feng, Dan Luo, Zhansheng Li, Yawei Zhang, Fuzhen Wang, Fuqiang Cui, Li Li, Xiaofeng Liang, Suping Wang
Due to the low uptake, adherence, and completion of vaccination among drug users, and their compromised immune responses to hepatitis B vaccination, the current practice of hepatitis B vaccination may not provide optimal protection. The aim of this study was to evaluate the immunogenicity and safety of 60 µg and 20 µg hepatitis B vaccines among drug users. A randomized, open-labeled, blank-controlled trial was conducted among drug users at 2 drug rehabilitation centers in China. The eligible participants were drug users who were serologically negative for the hepatitis B surface antigen (HBsAg) and the hepatitis B surface antibody (anti-HBs)...
March 16, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28301266/immunogenicity-and-safety-of-a-trivalent-inactivated-influenza-vaccine-produced-in-shenzhen-china
#12
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/28298208/looking-back-to-move-forward-a-twenty-year-audit-of-herpes-zoster-in-asia-pacific
#13
REVIEW
Liang-Kung Chen, Hidenori Arai, Liang-Yu Chen, Ming-Yueh Chou, Samsuridjal Djauzi, Birong Dong, Taro Kojima, Ki Tae Kwon, Hoe Nam Leong, Edward M F Leung, Chih-Kuang Liang, Xiaohong Liu, Dilip Mathai, Jiun Yit Pan, Li-Ning Peng, Eduardo Rommel S Poblete, Philip J H Poi, Stewart Reid, Terapong Tantawichien, Chang Won Won
BACKGROUND: Herpes zoster (HZ) is a prevalent viral disease that inflicts substantial morbidity and associated healthcare and socioeconomic burdens. Current treatments are not fully effective, especially among the most vulnerable patients. Although widely recommended, vaccination against HZ is not routine; barriers in Asia-Pacific include long-standing neglect of adult immunisation and sparse local data. To address knowledge gaps, raise awareness, and disseminate best practice, we reviewed recent data and guidelines on HZ from the Asia-Pacific region...
March 15, 2017: BMC Infectious Diseases
https://www.readbyqxmd.com/read/28296763/evaluating-the-immunogenicity-and-safety-of-a-biondvax-developed-universal-influenza-vaccine-multimeric-001-either-as-a-standalone-vaccine-or-as-a-primer-to-h5n1-influenza-vaccine-phase-iib-study-protocol
#14
Eva van Doorn, Heng Liu, Tamar Ben-Yedidia, Shimon Hassin, Ildiko Visontai, Stephen Norley, Henderik W Frijlink, Eelko Hak
INTRODUCTION: Influenza is a major respiratory viral infection of humans with high mortality and morbidity rates and profound economic impact. Although influenza vaccines are generally updated yearly to match the viruses expected in the coming season, genetic mutation and reassortment can result in unexpected novel strains. Therefore, it is important to develop universal vaccines inducing protective immunity to such strains before they appear. This clinical trial is designed to evaluate the safety and immunogenicity of Multimeric-001 (M-001), which contains conserved epitopes of influenza A and B...
March 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28296286/nanomedicine-approaches-to-improve-cancer-immunotherapy
#15
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
#16
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/28293422/regional-disparities-in-immunization-services-in-ghana-through-a-bottleneck-analysis-approach-implications-for-sustaining-national-gains-in-immunization
#17
A E Yawson, G Bonsu, L K Senaya, A O Yawson, J B Eleeza, J K Awoonor-Williams, H K Banskota, E E A Agongo
BACKGROUND: Immunization is considered one of the most cost effective public health interventions for reducing child morbidity, mortality and disability. The aim of this work is to describe the application of the Bottleneck analysis (BNA) process to assess gaps in immunization services in Ghana and implications for sustaining the gains in Immunization coverage. METHODS: A national assessment was conducted in May 2015, through use of desk reviews, field visits and key informant interviews...
2017: Archives of Public Health, Archives Belges de Santé Publique
https://www.readbyqxmd.com/read/28290130/the-choosing-wisely-initiative-in-infectious-diseases
#18
REVIEW
Clara Lehmann, Reinhard Berner, Johannes R Bogner, Oliver A Cornely, Katja de With, Susanne Herold, Winfried V Kern, Sebastian Lemmen, Mathias W Pletz, Bernhard Ruf, Bernd Salzberger, Hans Jürgen Stellbrink, Norbert Suttorp, Andrew J Ullmann, Gerd Fätkenheuer, Norma Jung
OBJECTIVE: "Choosing Wisely" is a growing international campaign aiming at practice changes to improve patient health and safety by both, conduct of essential and avoidance of unnecessary diagnostic, preventive and therapeutic procedures. The goal is to create an easily recognizable and distributable list ("Choosing Wisely items") that addresses common over- and underuse in the management of infectious diseases. METHODS: The German Society of Infectious Diseases (DGI) participates in the campaign "Klug Entscheiden" by the German Society of Internal Medicine...
March 13, 2017: Infection
https://www.readbyqxmd.com/read/28289684/polyprenyl-immunostimulant-in-feline-rhinotracheitis-randomized-placebo-controlled-experimental-and-field-safety-studies
#19
Alfred M Legendre, Tanya Kuritz, Robert Eric Heidel, Vivian M Baylor
Feline rhinotracheitis is a ubiquitous disease caused by feline herpesvirus type 1 (FHV-1). The disease is easily transmissible and common in multi-cat environments where even vaccinated cats can develop clinical signs of respiratory or ocular disease or both when exposed to the virus. Prior to the work reported here, there was no licensed treatment for the disease on the market. We hypothesized that polyprenyl immunostimulant (PI), an immunomodulatory veterinary biologic, would be useful in treating feline rhinotracheitis by reducing the severity of respiratory or/and ocular disease...
2017: Frontiers in Veterinary Science
https://www.readbyqxmd.com/read/28288861/biotechnology-approaches-to-produce-potent-self-adjuvanting-antigen-adjuvant-fusion-protein-subunit-vaccines
#20
REVIEW
Peter Michael Moyle
Traditional vaccination approaches (e.g. live attenuated or killed microorganisms) are among the most effective means to prevent the spread of infectious diseases. These approaches, nevertheless, have failed to yield successful vaccines against many important pathogens. To overcome this problem, methods have been developed to identify microbial components, against which protective immune responses can be elicited. Subunit antigens identified by these approaches enable the production of defined vaccines, with improved safety profiles...
March 10, 2017: Biotechnology Advances
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