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formulation antibody

Rengaswamy Sankaranarayanan, Smita Joshi, Richard Muwonge, Pulikottil Okkuru Esmy, Partha Basu, Priya Prabhu, Neerja Bhatla, Bhagwan M Nene, Janmesh Shaw, Usha Rani Reddy Poli, Yogesh Verma, Eric Zomawia, Sharmila Pimple, Massimo Tommasino, Michael Pawlita, Tarik Gheit, Tim Waterboer, Peter Sehr, Madhavan Radhakrishna Pillai
BACKGROUND: Human papillomavirus (HPV) vaccination is a major strategy for preventing cervical and other ano-genital cancers. Worldwide HPV vaccination introduction and coverage will be facilitated if a single dose of vaccine is as effective as two or three doses or demonstrates significant protective effect compared to 'no vaccination'. METHODS: In a multi-centre cluster randomized trial of two vs three doses of quadrivalent HPV vaccination (GARDASIL©) in India, suspension of the vaccination due to events unrelated to the study led to per protocol and partial vaccination of unmarried 10-18 year old girls leading to four study groups, two by design and two by default...
March 15, 2018: Vaccine
Morteza Abkar, Mahdi Fasihi-Ramandi, Hamid Kooshki, Abbas Sahebghadam Lotfi
Brucella (B) species are brucellosis causative agents, a worldwide zoonotic illness causing Malta fever in humans and abortion in domestic animals. In this work, we evaluated the vaccine potential of Trimethyl chitosan (TMC) nanoparticles formulation of Urease (TMC/Urease) against brucellosis. TMC/Urease nanoparticles and urease without any adjuvant were separately administered both orally and intraperitoneally. Intraperitoneal (i.p.) administration of urease alone as well as oral administration of both TMC/Urease and urease alone, elicited low titers of specific immunoglobulin G (IgG), while i...
March 13, 2018: Immunology Letters
Gaetan Barbet, Leif E Sander, Matthew Geswell, Irina Leonardi, Andrea Cerutti, Iliyan Iliev, J Magarian Blander
Live vaccines historically afford superior protection, yet the cellular and molecular mechanisms mediating protective immunity remain unclear. Here we found that vaccination of mice with live, but not dead, Gram-negative bacteria heightened follicular T helper cell (Tfh) differentiation, germinal center formation, and protective antibody production through the signaling adaptor TRIF. Complementing the dead vaccine with an innate signature of bacterial viability, bacterial RNA, recapitulated these responses...
March 9, 2018: Immunity
Jitendrakumar Patel, Jitendra Amrutiya, Priyanka Bhatt, Ankit Javia, Mukul Jain, Ambikanandan Misra
Aim of this study was to develop anti EGFR antibody conjugated poly (lactide-co-glycolide) nanoparticles (NPs) to target epidermal growth factor receptor, highly expressed on non-small cell lung cancer cells to improve cytotoxicity and site specificity. Cetuximab was conjugated to Docetaxel loaded PLGA NPs by known EDC/NHS chemistry and characterized for size, zeta potential, conjugation efficiency and results were 128.4 ±3.6 nm, -31.0 ± 0.8 mV and 39.77 ± 3.4% respectively. In-vitro release study demonstrated sustained release of drug from NPs with 25% release at pH 5...
March 15, 2018: Journal of Microencapsulation
Maria Vono, Christiane Sigrid Eberhardt, Elodie Mohr, Floriane Auderset, Dennis Christensen, Mirco Schmolke, Rhea Coler, Andreas Meinke, Peter Andersen, Paul-Henri Lambert, Beatris Mastelic-Gavillet, Claire-Anne Siegrist
Neonates and infants are more vulnerable to infections and show reduced responses to vaccination. Consequently, repeated immunizations are required to induce protection and early life vaccines against major pathogens such as influenza are yet unavailable. Formulating antigens with potent adjuvants, including immunostimulators and delivery systems, is a demonstrated approach to enhance vaccine efficacy. Yet, adjuvants effective in adults may not meet the specific requirements for activating the early life immune system...
2018: Frontiers in Immunology
Jonas V Schaefer, Erik Sedlák, Florian Kast, Michal Nemergut, Andreas Plückthun
Biophysical properties of antibody-based biopharmaceuticals are a critical part of their release criteria. In this context, finding the appropriate formulation is equally important as optimizing their intrinsic biophysical properties through protein engineering, and both are mutually dependent. Most previous studies have empirically tested the impact of additives on measures of colloidal stability, while mechanistic aspects have usually been limited to only the thermodynamic stability of the protein. Here we emphasize the kinetic impact of additives on the irreversible denaturation steps of immunoglobulins G (IgG) and their antigen-binding fragments (Fabs), as these are the key committed steps preceding aggregation, and thus especially informative in elucidating the molecular parameters of activity loss...
March 14, 2018: MAbs
Hu He-Hua, Zhang Xia, Zhang Chun-Bin, Yao Yi-Bin, Cui Cai-Xia, Li Xia, Wen Xiao-Hong, Liu Jun, Xiao Chuan-Yun, Liu Xiong, Cao Chun-Li
OBJECTIVE: To investigate the changes of serum anti-schistosome antibody titers in schistosomiasis japonica patients after treatment, in order to provide the evidence for formulating the schistosomiasis surveillance program in marshland and lake regions. METHODS: Upon prospective cohort study, the stool examination positive schistosomiasis patients and blood examination positive suspected patients (the titer was more than 1:80, including 1:80) were selected as the research objects in Jiangling County in 2014, and they received the 2-day praziquantel therapy...
January 15, 2018: Zhongguo Xue Xi Chong Bing Fang Zhi za Zhi, Chinese Journal of Schistosomiasis Control
Yoosoo Yang, Yeonsun Hong, Eunji Cho, Gi Beom Kim, In-San Kim
Membrane proteins are of great research interest, particularly because they are rich in targets for therapeutic application. The suitability of various membrane proteins as targets for therapeutic formulations, such as drugs or antibodies, has been studied in preclinical and clinical studies. For therapeutic application, however, a protein must be expressed and purified in as close to its native conformation as possible. This has proven difficult for membrane proteins, as their native conformation requires the association with an appropriate cellular membrane...
2018: Journal of Extracellular Vesicles
Jenna Anderson, Thorunn A Olafsdottir, Sven Kratochvil, Paul F McKay, Malin Östensson, Josefine Persson, Robin J Shattock, Ali M Harandi
Systems biology approaches have recently provided new insights into the mechanisms of action of human vaccines and adjuvants. Here, we investigated early transcriptional signatures induced in whole blood of healthy subjects following vaccination with a recombinant HIV-1 envelope glycoprotein subunit CN54gp140 adjuvanted with the TLR4 agonist glucopyranosyl lipid adjuvant-aqueous formulation (GLA-AF) and correlated signatures to CN54gp140-specific serum antibody responses. Fourteen healthy volunteers aged 18-45 years were immunized intramuscularly three times at 1-month intervals and whole blood samples were collected at baseline, 6 h, and 1, 3, and 7 days post first immunization...
2018: Frontiers in Immunology
Andreas H Laustsen, José María Gutiérrez, Cecilie Knudsen, Kristoffer H Johansen, Erick Bermúdez Méndez, Felipe A Cerni, Jonas A Jürgensen, Mia Øhlenschlæger, Line Ledsgaard, Andrea Martos Esteban, Urska Pus, Mikael R Andersen, Bruno Lomonte, Mikael Engmark, Manuela B Pucca
Antibody technologies are being increasingly applied in the field of toxinology. Fuelled by the many advances in immunology, synthetic biology, and antibody research, different approaches and antibody formats are being investigated for the ability to neutralize animal toxins. These different molecular formats each have their own therapeutic characteristics. In this review, we provide an overview of the advances made in the development of toxin-targeting antibodies, and discuss the benefits and drawbacks of different antibody formats in relation to their ability to neutralize toxins, pharmacokinetic features, propensity to cause adverse reactions, formulation, and expression for research and development (R&D) purposes and large-scale manufacturing...
March 10, 2018: Toxicon: Official Journal of the International Society on Toxinology
Fatemeh Tabatabaie, Nasim Samarghandi, Somayeh Zarrati, Fatemeh Maleki, Mehdi Shafiee Ardestani, Taher Elmi, Sayed Hussain Mosawi
BACKGROUND: Leishmaniasis is a parasitic disease induced by a protozoan from the genus Leishmania . No effective vaccine has yet been developed against the disease. AIM: In this work, two nano-vaccines, TSA recombinant plasmid and dendrimer and poly (methyl methacrylate) (PMMA) nanoparticles (as adjuvants), were designed and tested for their immunogenicity in BALB/c mice. METHODS: After the plasmid construction and preparation of adjuvants, three intramuscular injections of the nano-vaccines (100 µg) and the recombinant TSA protein (20 µg) were subcutaneously performed...
February 15, 2018: Open Access Macedonian Journal of Medical Sciences
Jacqueline Horn, Julia Schanda, Wolfgang Friess
PURPOSE: Mannitol/sucrose formulations are employed to generate lyophilizates for biopharmaceuticals with an elegant cake appearance. The aim of this study was to dry protein/mannitol/sucrose formulations as fast as possible without loss of cake appearance and protein stability. Glycerol was included as potential additional protein stabilizer. Three proteins (lysozyme and two monoclonal antibodies) at low and high concentration were analyzed comparing fast with conservative freeze-drying...
March 6, 2018: European Journal of Pharmaceutics and Biopharmaceutics
Madelon Q Wentink, Henk M W Verheul, Arjan W Griffioen, Kenneth A Schafer, Susan McPherson, Richard J Early, Hans J van der Vliet, Tanja D de Gruijl
INTRODUCTION: Vascular endothelial growth factor (VEGF) is pivotal in tumor angiogenesis and therapies targeting the VEGF axis are widely used in the clinic for the treatment of cancer. We have developed a therapeutic vaccine targeting human (h)VEGF165 . hVEGF26-104 /RFASE is based on the truncated protein hVEGF26-104 as antigen formulated in an oil-in-water emulsion containing the sulpholipopolysaccharide RFASE as adjuvant. Here we describe the toxicity and immunogenicity of this therapeutic vaccine in cynomolgus monkeys...
March 5, 2018: Vaccine
Shima Gholizadeh, Emmy M Dolman, Rebecca Wieriks, Rolf W Sparidans, Wim E Hennink, Robbert J Kok
PURPOSE: Sepantronium bromide (YM155) is a hydrophilic quaternary compound that cannot be administered orally due to its low oral bioavailability; it is furthermore rapidly eliminated via the kidneys. The current study aims at improving the pharmacokinetic profile of YM155 by its formulation in immunoliposomes that can achieve its enhanced delivery into tumor tissue and facilitate uptake in neuroblastoma cancer cells. METHODS: PEGylated YM155 loaded liposomes composed of DPPC, cholesterol and DSPE-PEG2000 were prepared via passive film-hydration and extrusion method...
March 7, 2018: Pharmaceutical Research
Qi Gao, Nian-Zhang Zhang, Fu-Kai Zhang, Meng Wang, Ling-Ying Hu, Xing-Quan Zhu
BACKGROUND: Toxoplasma gondii is an obligate intracellular parasite that can infect almost all warm-blooded animals. T. gondii profilin (TgPF) plays a crucial role in parasite motility and host cell invasion, and has shown promise against toxoplasmosis. DNA vaccine was considered to elicit effective humoral and cell-mediated immunity against T. gondii infection. The objective of the present study was to evaluate the immunogenicity of TgPF in mice using a DNA vaccination strategy. METHODS: A DNA vaccine (pVAX-PF) encoding TgPF gene was constructed and then was intramuscularly injected into mice with and without a plasmid encoding IL-15 (pVAX-IL-15)...
March 7, 2018: BMC Infectious Diseases
Clemente Diaz, Leyi Lin, Luis J Martinez, Kenneth H Eckels, Maribel Campos, Richard G Jarman, Rafael De La Barrera, Edith Lepine, Jean-François Toussaint, Irma Febo, Bruce L Innis, Stephen J Thomas, Alexander C Schmidt
The safety and immunogenicity of four adjuvanted formulations of an investigational tetravalent dengue purified inactivated vaccine (DPIV) were evaluated in a predominantly dengue-primed population in Puerto Rico. In this placebo-controlled, randomized, observer-blind, phase I trial, 100 healthy adults were randomized 1:1:1:1:1 to receive DPIV at Day (D)0 and D28 (1 μg per dengue virus [DENV] type 1-4 adjuvanted with either alum, AS01E or AS03B , or 4 μg per DENV type adjuvanted with alum) or saline placebo...
March 5, 2018: American Journal of Tropical Medicine and Hygiene
John Syrios, Evelina Pappa, Nikolaos Volakakis, Anastasios Grivas, John Alafis, Sofia Manioudaki, Vasiliki Tzouda, Athanasios Korogiannos, Cleopatra Rapti, Nektarios Koufopoulos, Adamantia Nikolaidou, Eleftheria Kanavou, Athanasios Alexopoulos, Anna Koumarianou
Purpose: Trastuzumab, a humanized anti-human epidermal growth factor receptor 2 (anti-HER2) antibody delivered intravenously, has revolutionized the treatment of patients with breast cancer overexpressing HER2 protein. Recently, a newer subcutaneous formulation was shown to have comparable efficacy to the initial intravenous trastuzumab. In this study, we aimed to evaluate the impact of subcutaneous trastuzumab on the health-related quality of life (HRQoL) of patients diagnosed with early or metastatic HER2-overexpressing breast cancer...
2018: Breast Cancer: Basic and Clinical Research
Akira Endo, Keisuke Ejima, Hiroshi Nishiura
PURPOSE: To explore the heterogeneous transmission dynamics for influenza and identify the optimal serum antibody titer cutoff values for estimating its cumulative incidence. METHODS: We constructed a mathematical model describing serologically dependent disease transmission. The diagnostic performances of two serum antibody titer tests (single serum test and paired sera test) were evaluated, and cumulative disease incidence estimators were formulated. The model simulated the 2009 Japanese influenza A/H1N1 epidemic and investigated the optimal cutoff values and cumulative incidence estimates for this epidemic...
February 21, 2018: Annals of Epidemiology
G Yan-Li, X Yi-Qing, Z Yong-Gen, X U Da-Cheng, X U Wen-Wei, D Yang, S Ming-Xue
Objective To investigate the prevalence of Toxoplasma gondii infection and related knowledge and behavior among special population in Changzhou City, so as to provide the evidence for formulating effective measures of toxoplasmosis prevention. Methods The pregnant women and patients with neoplasia in Changzhou hospitals, and livestock and poultry breeding or processing workers were selected as the subjects of the study. Venous blood samples were collected from each participant for detecting IgG and IgM antibodies against T...
March 20, 2017: Zhongguo Xue Xi Chong Bing Fang Zhi za Zhi, Chinese Journal of Schistosomiasis Control
Ayaka Okamoto, Tomohiro Asai, Yusuke Hirai, Kosuke Shimizu, Hiroyuki Koide, Tetsuo Minamino, Naoto Oku
Triple-negative breast cancer is one of intractable cancers that are not sensitive to the treatment with existing molecular-targeted drugs. Recently, there has been much interest in RNA interference-mediated treatment of triple-negative breast cancer. In the present study, we have developed lipid nanoparticles encapsulating siRNA (LNP-siRNA) decorated with an Fab' antibody against heparin-binding EGF-like growth factor (αHB-EGF LNP-siRNA). αHB-EGF LNP-siRNA targeting polo-like kinase 1 (PLK1) was prepared and evaluated for its anticancer effect using MDA-MB-231 human triple-negative breast cancer cells overexpressing HB-EGF on their cell surface...
March 5, 2018: Molecular Pharmaceutics
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