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aluminium adjuvant

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
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
Zrinka Oreskovic, Hana Kudlackova, Josef Krejci, Katerina Nechvatalova, Martin Faldyna
The effects of intradermal application of antigen with or without different adjuvants and activation of immune response are presented in this study. Six groups of six piglets each were immunized with keyhole limpet haemocyanin (KLH) antigen in combination with aluminium hydroxide or oil-based adjuvants (complete and incomplete Freund's adjuvants, Montanide ISA 206 and Emulsigen). IgG1 and IgG2 levels in sera were measured by KLH-specific ELISA. Interestingly, oil-based adjuvants induced high primary IgG2 response, suggesting the Th1 lymphocyte polarization...
March 11, 2017: Research in Veterinary Science
Paul Blanc-Durand, Axel Van Der Gucht, Mehdi Aoun Sebaiti, Mukedaisi Abulizi, Francois-Jérome Authier, Emmanuel Itti
We address this letter in addition to our recent published study (1). The aim is to add some insight to the evolution of the brain abnormalities that are observed with macrophagic myofasciitis (MMF). MMF is a chronic disease whom evolution is slow and symptoms first may occurs from months to year after a vaccination containing aluminium hydroxid adjuvants (2). Nevertheless, its evolution is not fully understood or known. MMF associated cognitive dysfunction (MACD) is based on a tripod combining dysexecutive syndrom, visual memory impairment and interhemispheric disconnection...
March 16, 2017: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
Karin Weisser, Sabine Stübler, Walter Matheis, Wilhelm Huisinga
As a potentially toxic agent on nervous system and bone, the safety of aluminium exposure from adjuvants in vaccines and subcutaneous immune therapy (SCIT) products has to be continuously re-evaluated, especially regarding concomitant administrations. For this purpose, knowledge on absorption and disposition of aluminium in plasma and tissues is essential. Pharmacokinetic data after vaccination in humans, however, are not available, and for methodological and ethical reasons difficult to obtain. To overcome these limitations, we discuss the possibility of an in vitro-in silico approach combining a toxicokinetic model for aluminium disposition with biorelevant kinetic absorption parameters from adjuvants...
February 22, 2017: Regulatory Toxicology and Pharmacology: RTP
Joshua Tobias, Joanna Jasinska, Karin Baier, Michael Kundi, Nicholas Ede, Christoph Zielinski, Ursula Wiedermann
BACKGROUND: We previously identified three short single peptides (P4, P6 and P7) representing different B-cell epitopes on the extracellular domain of Her-2/neu for a vaccine that was tested in a phase-I clinical trial. Here we describe the improvement of the multi peptide vaccine by fusing the single peptides to a hybrid peptide P467. METHODS: After coupling to either virosomes or to diphtheria toxoid CRM197 (CRM), the hybrid peptide was tested in different concentrations in combination with either Montanide or Aluminium hydroxide (Alum) in preclinical studies...
February 9, 2017: BMC Cancer
Line M Lindgren, Pernille N Tingskov, Annette H Justesen, Bettina S Nedergaard, Klaus J Olsen, Lars V Andreasen, Ingrid Kromann, Charlotte Sørensen, Jes Dietrich, Birgit Thierry-Carstensen
BACKGROUND: There is a demand of affordable IPV in the World. Statens Serum Institut (SSI) has developed three reduced dose IPV formulations adsorbed to aluminium hydroxide; 1/3 IPV-Al, 1/5 IPV-Al and 1/10 IPV-Al SSI, and now report the results of the first investigations in humans. METHODS: 240 Danish adolescents, aged 10-15years, and childhood vaccinated with IPV were booster vaccinated with 1/3 IPV-Al, 1/5 IPV-Al, 1/10 IPV-Al or IPV Vaccine SSI. The booster effects (GMTRs) of the three IPV-Al SSI were compared to IPV Vaccine SSI, and evaluated for non-inferiority...
January 23, 2017: Vaccine
Qi Guo, Ze Liu, Jingxia Gao, Jian Zhou, Wenzhu Hu, Yina Cun, Weidong Li, Guoyang Liao
BACKGROUND: There are sporadic cases and local outbreaks of H5N1 avian influenza virus worldwide every year. The World Health Organization (WHO) has paid close attention to the avian influenza epidemic trend. Avian influenza vaccines (AIV) are considered to be useful when an epidemic occurs. However, the use of AIV for humans is not yet widespread. METHODS: This study assessed the immunogenicity and safety of pandemic influenza H5N1 vaccines with inactivated whole virus, split virus and subunit virus vaccines for healthy adults...
2016: Cellular Physiology and Biochemistry
Lata Jain, Mayank Rawat, Saravanan Ramakrishnan, Bablu Kumar
Brucellosis is an economically important zoonosis of worldwide significance. Earlier (Jain et al., 2015) we reported methodology for generation of phage lysate preparations against Brucella abortus S19 using brucellaphage 'ϕLd'. In this study, using a fixed dose (Two mouse PD100) of lysates, the prophylactic efficacies of both plain and alum gel adjuvanted lysates were evaluated in guinea pig by direct virulent challenge and passive mouse protection test (PMPT). Strong humoral and cell mediated immune responses in guinea pigs and protection comparable to S19 vaccine was observed with low dose (1...
January 2017: Biologicals: Journal of the International Association of Biological Standardization
Guillemette Crépeaux, Housam Eidi, Marie-Odile David, Yasmine Baba-Amer, Eleni Tzavara, Bruno Giros, François-Jérôme Authier, Christopher Exley, Christopher A Shaw, Josette Cadusseau, Romain K Gherardi
Aluminium (Al) oxyhydroxide (Alhydrogel(®)), the main adjuvant licensed for human and animal vaccines, consists of primary nanoparticles that spontaneously agglomerate. Concerns about its safety emerged following recognition of its unexpectedly long-lasting biopersistence within immune cells in some individuals, and reports of chronic fatigue syndrome, cognitive dysfunction, myalgia, dysautonomia and autoimmune/inflammatory features temporally linked to multiple Al-containing vaccine administrations. Mouse experiments have documented its capture and slow transportation by monocyte-lineage cells from the injected muscle to lymphoid organs and eventually the brain...
January 15, 2017: Toxicology
Ida Genta, Claudia Colonna, Bice Conti, Paolo Caliceti, Stefano Salmaso, Pietro Speziale, Giampiero Pietrocola, Enrica Chiesa, Tiziana Modena, Rossella Dorati
The aim of this work was the assessment of the "in vivo" immune response of a poly(lactide-co-glycolide)-based nanoparticulate adjuvant for a sub-unit vaccine, namely, a purified recombinant collagen-binding bacterial adhesion fragment (CNA19), against Staphylococcus aureus-mediated infections. "In vivo" immunogenicity studies were performed on mice: immunisation protocols encompassed subcutaneous and intranasal administration of CNA19 formulated as nanoparticles (NPs) and furthermore, CNA19-loaded NPs formulated in a set-up thermosetting chitosan-β-glycerolphosphate (chitosan-β-GP) solution for intranasal route in order to extend antigen exposure to nasal mucosa...
December 2016: Journal of Microencapsulation
Gro Tunheim, Marianne Arnemo, Lisbeth M Naess, Gunnstein Norheim, Luis Garcia, Daniel Cardoso, Aleida Mandiarote, Domingo Gonzalez, Kalpana Sinnadurai, Åse-Karine Fjeldheim, Karin Bolstad, Einar Rosenqvist
Meningococci (Neisseria meningiditis) of serogroups A and W have caused large epidemics of meningitis in sub-Saharan Africa for decades, and affordable and multivalent vaccines, effective in all age groups, are needed. A bivalent serogroup A and W (A + W) meningococcal vaccine candidate consisting of deoxycholate-extracted outer membrane vesicles (OMV) from representative African disease isolates was previously found to be highly immunogenic in outbred mice when formulated with the adjuvant aluminium hydroxide (AH)...
November 2016: APMIS: Acta Pathologica, Microbiologica, et Immunologica Scandinavica
Dennis Christensen
Novel vaccine strategies include the so-called subunit vaccines, which encompass only the part of the pathogen to which immune recognition results in protection. The high purity of these vaccines make adverse events less likely, but it also makes the vaccines less immunogenic and therefore potentially less effective. Vaccine adjuvants that increase and modulate the immunogenicity of the vaccine are therefore added to solve this problem. Besides aluminum salts, which have been used in vaccines for 90 years, a number of novel vaccine adjuvants have been included in licensed vaccines over the last 30 years...
October 2, 2016: Human Vaccines & Immunotherapeutics
Matthew Mold, Emma Shardlow, Christopher Exley
Aluminium adjuvants remain the most widely used and effective adjuvants in vaccination and immunotherapy. Herein, the particle size distribution (PSD) of aluminium oxyhydroxide and aluminium hydroxyphosphate adjuvants was elucidated in attempt to correlate these properties with the biological responses observed post vaccination. Heightened solubility and potentially the generation of Al(3+) in the lysosomal environment were positively correlated with an increase in cell mortality in vitro, potentially generating a greater inflammatory response at the site of simulated injection...
August 12, 2016: Scientific Reports
R Isbrucker, A Daas, L Wagner, A Costanzo
Current regulations for acellular pertussis (aP) vaccines require that they are tested for the presence of residual or reversion-derived pertussis toxin (PTx) activity using the mouse histamine sensitisation test (HIST). Although a CHO cell clustering assay can be used by manufacturers to verify if sufficient inactivation of the substance has occurred in-process, this assay cannot be used at present for the final product due to the presence of aluminium adjuvants which interfere with mammalian cell cultures...
2016: Pharmeuropa Bio & Scientific Notes
Can Çokçalışkan, Tunçer Türkoğlu, Beyhan Sareyyüpoğlu, Ergün Uzunlu, Ayca Babak, Banu B Özbilge, Veli Gülyaz
PURPOSE: One of the most important tools against foot-and-mouth disease, a highly contagious and variable viral disease of cloven-hoofed animals, is vaccination. However, the effectiveness of foot-and-mouth disease vaccines on slowing the spread of the disease is questionable. In contrast, high potency vaccines providing early protection may solve issues with the spread of the disease, escaping mutants, and persistency. To increase the potency of the vaccine, additives such as saponin and aluminium hydroxide are used...
July 2016: Clinical and Experimental Vaccine Research
Lidia Gómez-Gascón, Fernando Cardoso-Toset, Carmen Tarradas, Jaime Gómez-Laguna, Alfonso Maldonado, Jens Nielsen, Alfonso Olaya-Abril, Manuel J Rodríguez-Ortega, Inmaculada Luque
The efforts made to develop vaccines against Streptococcus suis have failed because of lack of common antigens cross-reactive against different serotypes of this species. The cell wall-anchored proteins can be good vaccine candidates due to their high expression and accessibility to antibodies, among these, a cell-wall protein, DNA-nuclease (SsnA), present in most of the S. suis serotypes and clinical isolates collected from infected pigs, was selected. An experimental challenge against S. suis serotype 2 in a pig model was used to validate the efficacy of recombinant SsnA combined with aluminium hydroxide plus Quil A as adjuvants, previously tested in mice by our research group with good results...
August 2016: Comparative Immunology, Microbiology and Infectious Diseases
Cosette M Wheeler, S Rachel Skinner, M Rowena Del Rosario-Raymundo, Suzanne M Garland, Archana Chatterjee, Eduardo Lazcano-Ponce, Jorge Salmerón, Shelly McNeil, Jack T Stapleton, Céline Bouchard, Mark G Martens, Deborah M Money, Swee Chong Quek, Barbara Romanowski, Carlos S Vallejos, Bram Ter Harmsel, Vera Prilepskaya, Kah Leng Fong, Henry Kitchener, Galina Minkina, Yong Kuei Timothy Lim, Tanya Stoney, Nahida Chakhtoura, Margaret E Cruickshank, Alevtina Savicheva, Daniel Pereira da Silva, Murdo Ferguson, Anco C Molijn, Wim G V Quint, Karin Hardt, Dominique Descamps, Pemmaraju V Suryakiran, Naveen Karkada, Brecht Geeraerts, Gary Dubin, Frank Struyf
BACKGROUND: Although the risk of human papillomavirus (HPV) infection is greatest in young women, women older than 25 years remain at risk. We present data from the VIVIANE study of the HPV 16/18 AS04-adjuvanted vaccine in adult women after 7 years of follow-up. METHODS: In this phase 3, double-blind, randomised controlled trial, healthy women older than 25 years were enrolled (age stratified: 26-35 years, 36-45 years, and ≥46 years). Up to 15% in each age stratum had a history of HPV infection or disease...
October 2016: Lancet Infectious Diseases
Francisco Fontenla, Verónica Blanco-Abad, Belén G Pardo, Iria Folgueira, Manuel Noia, Antonio Gómez-Tato, Paulino Martínez, José M Leiro, Jesús Lamas
We used a microarray approach to examine changes in gene expression in turbot peritoneal cells after injection of the fish with vaccines containing the ciliate parasite Philasterides dicentrarchi as antigen and one of the following adjuvants: chitosan-PVMMA microspheres, Freund́s complete adjuvant, aluminium hydroxide gel or Matrix-Q (Isconova, Sweden). We identified 374 genes that were differentially expressed in all groups of fish. Forty-two genes related to tight junctions and focal adhesions and/or actin cytoskeleton were differentially expressed in free peritoneal cells...
July 2016: Molecular Immunology
Michael Schwameis, Bernhard Roppenser, Christa Firbas, Corina S Gruener, Nina Model, Norbert Stich, Andreas Roetzer, Nina Buchtele, Bernd Jilma, Martha M Eibl
BACKGROUND: Staphylococcal toxic shock syndrome is a superantigen-driven potentially life-threatening disease affecting mainly young and otherwise healthy individuals. Currently, no specific treatment or preventive measure is available. We aimed to assess the safety, tolerability, and immunogenicity of a recombinant detoxified toxic shock syndrome toxin-1 variant (rTSST-1v) vaccine in adult volunteers. METHODS: In this randomised, double-blind, adjuvant-controlled, dose-escalation first-in-human trial, healthy adults aged 18-64 years were enrolled from the Medical University of Vienna, Austria...
September 2016: Lancet Infectious Diseases
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