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aluminum vaccine

Kelly M Rausch, Daming Zhu
The quantification of antigens adsorbed to aluminum-based adjuvants (alum) typically involves a method that first extracts antigen from the alum followed by the quantification of the antigen available in the extract. Extraction procedures often result in less than 100 % desorption of the antigen from the alum adjuvant and may alter the conformation of the antigen, reducing the accuracy of the subsequent method used for quantification. There is no generic method available for directly assessing the protein content when formulated on alum...
2017: Methods in Molecular Biology
Sachin G Thakkar, Zhengrong Cui
Many human vaccines contain certain insoluble aluminum salts such as aluminum oxyhydroxide and aluminum hydroxyphosphate as vaccine adjuvants to boost the immunogenicity of the vaccines. Aluminum salts have been used as vaccine adjuvants for decades and have an established, favorable safety profile. However, preparing aluminum salts and aluminum salt-adjuvanted vaccines in a consistent manner remains challenging. This chapter discusses methods to prepare aluminum salts and aluminum salt-adjuvanted vaccines, factors to consider during preparation, and methods to characterize the vaccines after preparation...
2017: Methods in Molecular Biology
John D Campbell
The development of aluminum salts (alum) as vaccine adjuvants was an empirical process with little understanding of the mechanism of action and, with decades of use, it has become clear that there is a need for alternatives where alum-based adjuvants are suboptimal. Oligonucleotides containing unmethylated CpG sequences represent one alternative as they are potent stimulators of the vertebrate innate immune system through activation of Toll-like receptor-9. This chapter outlines the methods used by Dynavax Technologies to progress a CpG-containing oligonucleotide sequence termed 1018 through preclinical and clinical testing as an adjuvant for immunization against hepatitis B virus (HBV)...
2017: Methods in Molecular Biology
Yue-Qi Wang, Qing-Ze Fan, Yan Liu, Hua Yue, Xiao-Wei Ma, Jie Wu, Guang-Hui Ma, Zhi-Guo Su
In this study, we developed the quaternized chitosan microgels without chemical crosslinking as an adjuvant of H5N1 split vaccine. The microgels with pH-sensitivity, positive surface charge and good biocompatibility, have been demonstrated in favor of enhancing both humoral and cellular immune response. However, the detailed mechanism of the chitosan-based microgels to enhance antigen specific immune responses remains unclear. Therefore, we prepared the quaternized chitosan microgels with well defined quaternization degrees (QDs, 20-80%) and particle sizes (800nm-5μm) by the premix membrane emulsification technique, and investigated the effect of quaternization degree (QD) and size on the adjuvanticity of microgels...
September 30, 2016: International Journal of Pharmaceutics
Jean-Daniel Masson, Michel Thibaudon, Laurent Bélec, Guillemette Crépeaux
Calcium phosphate was used as an adjuvant in France in diphtheria, tetanus, pertussis and poliomyelitis vaccines. It was later completely substituted by alum salts in the late 80's, but it still remains as an approved adjuvant for the World Health Organization for human vaccination. Area covered: Thus, calcium phosphate is now considered as one of the substances that could replace alum salts in vaccines. The aim of this paper is to draw a review of existing data on calcium phosphate as an adjuvant in order to bring out the strengths and weaknesses for its use on a large scale...
October 3, 2016: Expert Review of Vaccines
Christine T Lauren, Donald V Belsito, Kimberly D Morel, Philip LaRussa
Routine childhood immunizations have resulted in great reductions in vaccine-preventable infectious diseases. Vaccine-related adverse events, albeit rare, can be of significant consequence. Although anaphylaxis, or type I hypersensitivity, is recognized as a potential reaction after vaccination, delayed type hypersensitivity or type IV reactions are less so. We present a case of persistent subcutaneous nodules and sterile abscesses in the setting of delayed type hypersensitivity to aluminum, confirmed by patch testing and recurrence on re-exposure...
September 27, 2016: Pediatrics
Yunier Rodríguez-Álvarez, Yanelys Morera-Díaz, Haydee Gerónimo-Pérez, Jorge Castro-Velazco, Rafael Martínez-Castillo, Pedro Puente-Pérez, Vladimir Besada-Pérez, Eugenio Hardy-Rando, Araceli Chico-Capote, Klaudia Martínez-Cordovez, Alicia Santos-Savio
BACKGROUND: Interleukin-15 is an immunostimulatory cytokine overexpressed in several autoimmune and inflammatory diseases such as Rheumatoid Arthritis, psoriasis and ulcerative colitis; thus, inhibition of IL-15-induced signaling could be clinically beneficial in these disorders. Our approach to neutralize IL-15 consisted in active immunization with structurally modified human IL-15 (mhIL-15) with the aim to induce neutralizing antibodies against native IL-15. In the present study, we characterized the antibody response in Macaca fascicularis, non-human primates that were immunized with a vaccine candidate containing mhIL-15 in Aluminum hydroxide (Alum), Montanide and Incomplete Freund's Adjuvant...
September 26, 2016: BMC Immunology
Petra Zieglmayer, Margarete Focke-Tejkl, René Schmutz, Patrick Lemell, René Zieglmayer, Milena Weber, Renata Kiss, Katharina Blatt, Peter Valent, Frank Stolz, Hans Huber, Angela Neubauer, Anette Knoll, Friedrich Horak, Rainer Henning, Rudolf Valenta
BACKGROUND: We have developed a recombinant B cell epitope-based vaccine (BM32) for allergen-specific immunotherapy (AIT) of grass pollen allergy. The vaccine contains recombinant fusion proteins consisting of allergen-derived peptides and the hepatitis B surface protein domain preS as immunological carrier. METHODS: We conducted a randomized, double-blind, placebo-controlled AIT study to determine safety, clinical efficacy and immunological mechanism of three subcutaneous injections of three BM32 doses adsorbed to aluminum hydroxide versus aluminum hydroxide (placebo) applied monthly to grass pollen allergic patients (n=70)...
September 2016: EBioMedicine
Yousef Amini, Bagher Moradi, Mahdi Fasihi-Ramandi
Many materials such as aluminum hydroxide have been tried as adjuvants to compensate low inherent immunogenicity of subunit vaccines. The aim of this study was to evaluate the specific immune response following the administration of aluminum hydroxide nanoparticles with EsxV antigen. The physiochemical properties of the nanoparticle were characterized in vitro. After subcutaneous immunization, cytokine secretion patterns including IFN-gama,IL-4, and TGF-beta levels were measured by indirect enzyme linked immunosorbent assay (ELISA)...
September 20, 2016: Artificial Cells, Nanomedicine, and Biotechnology
Nathalie Garçon, Alberta Di Pasquale
Adjuvants are substances added to vaccines to improve their immunogenicity. Used for more than 80 years, aluminum, the first adjuvant in human vaccines, proved insufficient to develop vaccines that could protect against new challenging pathogens such as HIV and malaria. New adjuvants and new combinations of adjuvants (Adjuvant Systems) have opened the door to the delivery of improved and new vaccines against re-emerging and difficult pathogens. Adjuvant Systems concept started through serendipity. The access to new developments in technology, microbiology and immunology have been instrumental for the dicephering of what they do and how they do it...
September 16, 2016: Human Vaccines & Immunotherapeutics
Trong Lan Phan, Vinh Thang Ho, Minh Huong Vu, Tuyet Nga Nguyen, Huu Thai Duong, Renee Holt, Rahnuma Wahid, John Donnelly, Jorge Flores
We tested an inactivated egg-grown whole virus influenza A/H5N1 vaccine candidate developed by the Institute of Vaccines and Medical Biologicals (IVAC), a state-run vaccine manufacturer in Vietnam, in a Phase 1, placebo controlled, double blinded, randomized trial. The vaccine was adjuvanted with aluminum hydroxide. The trial enrolled 75 subjects who were randomized to receive two injections of one of the following: low-dose of vaccine (7.5 mcg HA), high-dose of vaccine (15 mcg HA), or placebo. The vaccine candidate was well tolerated with minimal local reactogenicity consisting of mild, short-lived injection site pain and/or tenderness...
October 26, 2016: Vaccine
Mark S Riddle, Robert W Kaminski, Claudio Di Paolo, Chad K Porter, Ramiro L Gutierrez, Kristen A Clarkson, Hailey E Weerts, Christopher Duplessis, Amy Castellano, Cristina Alaimo, Kristopher Paolino, Robert Gormley, Veronica Gambillara Fonck
BACKGROUND: Several candidate vaccines against Shigellae are in development, but the lack of a clear correlate of protection and challenges with the induction of adequate immune responses among the youngest age-groups in the developing world has hampered Shigella vaccine development over the past several decades. The bio-conjugation technology, exploited here for the S. flexneri 2a candidate vaccine, offers a novel and potentially a cost effective way to develop and produce vaccines against a major pathogen of global health importance...
August 31, 2016: Clinical and Vaccine Immunology: CVI
C R Cabauatan, R Campana, K Niespodziana, C Reinisch, U Lundberg, A Meinke, R Henning, A Neubauer, R Valenta
Epicutaneous allergen-specific immunotherapy (EPIT) is proposed as an alternative route for allergen-specific immunotherapy (AIT). The induction of allergen-specific blocking IgG antibodies represents an important mechanism underlying AIT, but has not been investigated for EPIT. Here, we compared the induction of allergen-specific blocking IgG in outbred guinea pigs which had been immunized with recombinant birch pollen allergen Bet v 1 using patch delivery system (PDS) with or without heat-labile toxin (LT) from Escherichia coli or subcutaneously with Aluminum hydroxide (Alum)-adsorbed rBet v 1...
August 29, 2016: Allergy
Jennifer Palomo, Beatris Mastelic-Gavillet, Estelle Woldt, Sabina Troccaz, Emiliana Rodriguez, Gaby Palmer, Claire-Anne Siegrist, Cem Gabay
Human and mouse neonates exhibit limited vaccine responses characterized by predominant Th2 and limited Th1 responses. Because IL-36 exerts a synergic adjuvant effect with IL-12, enhancing Th1 polarization in adult (AD) mice, we administered IL-36β to neonatal (1-wk old) and AD control mice at the time of immunization with tetanus toxoid adsorbed to aluminum hydroxide (TT/Alum). Unexpectedly, the combination of IL-36β with TT/Alum, which was well tolerated in AD mice, proved toxic and even lethal in neonates...
September 15, 2016: Journal of Immunology: Official Journal of the American Association of Immunologists
Moushira M Mostafa, Medhat A Al-Ghobashy, Faten A Fathalla, Maissa Y Salem
A sandwich-type ELISA was optimized and validated to determine the in-vitro relative potency of the four-component prophylactic Human papillomavirus (HPV) vaccine. The vaccine contains the non-infectious virus like particles (VLP) corresponding to HPV Types 6, 11, 16 and 18. A modification of the desorption step required to release the VLPs from the aluminum adjuvant was carried out. Samples were incubated with citrate buffer for two hours at 37 °C instead of overnight incubation at room temperature. Assay validation was then carried out according to ICH guidelines...
August 11, 2016: Biologicals: Journal of the International Association of Biological Standardization
Patrick L Ahl, Christopher Mensch, Binghua Hu, Heidi Pixley, Lan Zhang, Lance Dieter, Ryann Russell, William J Smith, Craig Przysiecki, Mike Kosinski, Jeffrey T Blue
Vaccine drug product thermal stability often depends on formulation input factors and how they interact. Scientific understanding and professional experience typically allows vaccine formulators to accurately predict the thermal stability output based on formulation input factors such as pH, ionic strength, and excipients. Thermal stability predictions, however, are not enough for regulators. Stability claims must be supported by experimental data. The Quality by Design approach of Design of Experiment (DoE) is well suited to describe formulation outputs such as thermal stability in terms of formulation input factors...
October 2016: Journal of Pharmaceutical Sciences
Sodiomon B Sirima, Benjamin Mordmüller, Paul Milligan, Ulysse Ateba Ngoa, Fred Kironde, Frank Atuguba, Alfred B Tiono, Saadou Issifou, Mark Kaddumukasa, Oscar Bangre, Clare Flach, Michael Christiansen, Peter Bang, Roma Chilengi, Søren Jepsen, Peter G Kremsner, Michael Theisen
BACKGROUND: GMZ2 is a recombinant protein malaria vaccine, comprising two blood-stage antigens of Plasmodium falciparum, glutamate-rich protein and merozoite surface protein 3. We assessed efficacy of GMZ2 in children in Burkina Faso, Gabon, Ghana and Uganda. METHODS: Children 12-60months old were randomized to receive three injections of either 100μg GMZ2 adjuvanted with aluminum hydroxide or a control vaccine (rabies) four weeks apart and were followed up for six months to measure the incidence of malaria defined as fever or history of fever and a parasite density ⩾5000/μL...
August 31, 2016: Vaccine
Shaye Kivity, Maria-Teresa Arango, Nicolás Molano-González, Miri Blank, Yehuda Shoenfeld
Human papillomavirus vaccine (HPVv) is used worldwide for prevention of infection. However several reports link this vaccine, with immune-mediated reactions, especially with neurological manifestations. Our previous results showed that HPVv-Gardasil and aluminum-immunized mice developed behavioral impairments. Studies have shown a positive effect of phospholipid supplementation on depression and cognitive functions in mice. Therefore, our goal was to evaluate the effect of a dietary supplement on vaccine-induced depression...
July 27, 2016: Immunologic Research
T R Pavan, J Di Domenico, K S Kirsten, C O Nied, R Frandoloso, L C Kreutz
Adjuvants are essential to boost the immune response to inoculated antigen and play a central role in vaccine development. In this study, we investigated the efficacy of several adjuvants in the production of anti-bovine serum albumin (BSA) antibodies in silver catfish. Two hundred and seventy juvenile silver catfish (60-80 g) of both sexes were intraperitoneally vaccinated with BSA (200 µg/fish) alone or mixed to the following adjuvants: Freund's complete adjuvant (FCA), Freund's incomplete adjuvant (FIA), aluminum hydroxide (AlOH), Montanide, four types of cytosine-phosphate-guanine (CpG) oligodeoxynucleotides (ODNs) and three concentrations of β-glucan, and the immune enhancing property was evaluated by measuring anti-BSA antibodies in blood samples at biweekly intervals...
July 25, 2016: Brazilian Journal of Medical and Biological Research, Revista Brasileira de Pesquisas Médicas e Biológicas
Nelli K Akhmatova, Ekaterina A Kurbatova, Elvin A Akhmatov, Nadezhda B Egorova, Denis Yu Logunov, Marina L Gening, Elena V Sukhova, Dmitry V Yashunsky, Yury E Tsvetkov, Nikolay E Nifantiev
We report the effect of a bovine serum albumin (BSA) conjugate of a synthetic hexasaccharide (HS) related to the fragment of the capsular polysaccharide (PS) of Streptococcus pneumoniae type 14 on the stimulation of innate immune system and the subsequent development of a PS-specific antibody response. Glycoconjugate (GC) in the presence (GC + AL) or absence of aluminum hydroxide was administered to mice twice. GC increased the number of TLR2-expressing cells and induced the maturation of dendritic cells (CD11c(+), CD80(+) and, MHCII(+)), which secreted IL-1β, IL-6, and TNFα into the culture medium...
2016: Frontiers in Immunology
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