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https://www.readbyqxmd.com/read/28730271/serious-adverse-events-after-hpv-vaccination-a-critical-review-of-randomized-trials-and-post-marketing-case-series
#1
Manuel Martínez-Lavín, Luis Amezcua-Guerra
This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study...
July 20, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28725106/development-of-porcine-circovirus-2-pcv2-open-reading-frame-2-dna-vaccine-with-different-adjuvants-and-comparison-with-commercial-pcv2-subunit-vaccine-in-an-experimental-challenge
#2
Changhoon Park, Jiwoon Jeong, Kyuhyung Choi, Su-Jin Park, Ikjae Kang, Chanhee Chae
The objective of this study was to compare the protection against challenge with porcine circovirus 2 (PCV2) induced by an experimental vaccine based on open reading frame (ORF) 2 of PCV2 DNA plus an adjuvant (aluminum hydroxide, cobalt oxide, or liposome) and a commercial PCV2 subunit vaccine. A total of 35 colostrum-fed, cross-bred, conventional piglets were randomly divided into 7 groups. The commercial vaccine was more efficacious against PCV2 challenge than the 4 experimental vaccines according to immunologic, virologic, and pathological outcomes...
July 2017: Canadian Journal of Veterinary Research, Revue Canadienne de Recherche Vétérinaire
https://www.readbyqxmd.com/read/28719287/phase-1-randomized-study-of-a-tetravalent-dengue-purified-inactivated-vaccine-in-healthy-adults-in-the-united-states
#3
Alexander C Schmidt, Leyi Lin, Luis J Martinez, Richard C Ruck, Kenneth H Eckels, Alix Collard, Rafael De La Barrera, Kristopher M Paolino, Jean-François Toussaint, Edith Lepine, Bruce L Innis, Richard G Jarman, Stephen J Thomas
AbstractThe safety and immunogenicity of four formulations of an investigational tetravalent dengue purified inactivated vaccine (DPIV), formulated at 1 or 4 μg with aluminum hydroxide (alum) or at 1 μg with an adjuvant system (AS01E or AS03B), were evaluated in a first-time-in-human, placebo-controlled, randomized, observer-blind, phase 1 trial in the continental United States. Two doses of vaccine or placebo were administered intramuscularly 4 weeks apart to 100 healthy adults 18-39 years of age, randomized 1:1:1:1:1 to receive one of four DPIV formulations or saline placebo...
June 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28712326/calcium-phosphate-nanoparticles-as-a-new-generation-vaccine-adjuvant
#4
Yahua Lin, Xin Wang, Xiaofen Huang, Jun Zhang, Ningshao Xia, Qinjian Zhao
Adjuvants are essential components in vaccine formulations to induce robust immunity against pathogens. The most widely used adjuvants in human vaccines are aluminum salts, that can effectively elicit a T helper type-2 (Th2)-biased humoral immune response for producing a high antibody titer but with a limited cellular immune response. Biocompatible calcium phosphate nanoparticles (CaP-NPs) with tunable characteristics have potentials to function as adjuvants for inducing more balanced T helper type-1 (Th1) and Th2 immune responses...
July 17, 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/28710002/diphtheria-toxoid-and-n-trimethyl-chitosan-layer-by-layer-coated-ph-sensitive-microneedles-induce-potent-immune-responses-upon-dermal-vaccination-in-mice
#5
Pim Schipper, Koen van der Maaden, Vincent Groeneveld, Mitchel Ruigrok, Stefan Romeijn, Sven Uleman, Cees Oomens, Gideon Kersten, Wim Jiskoot, Joke Bouwstra
Dermal immunization using antigen-coated microneedle arrays is a promising vaccination strategy. However, reduction of microneedle sharpness and the available surface area for antigen coating is a limiting factor. To overcome these obstacles, a layer-by-layer coating approach can be applied onto pH-sensitive microneedles. Following this approach, pH-sensitive microneedle arrays (positively charged at coating pH5.8 and nearly uncharged at pH7.4) were alternatingly coated with negatively charged diphtheria toxoid (DT) and N-trimethyl chitosan (TMC), a cationic adjuvant...
July 11, 2017: Journal of Controlled Release: Official Journal of the Controlled Release Society
https://www.readbyqxmd.com/read/28697661/safety-of-a-proteoliposome-from-neisseria-meningitides-as-adjuvant-for-a-house-dust-mite-allergy-vaccine
#6
Wendy Ramírez, Virgilio Bourg, Damaris Torralba, Elisa Facenda, Beatriz Tamargo, Bárbara O González, Gustavo Sierra, Oliver Pérez, Yordanis Perez-Llano, Alexis Labrada
The proteoliposome (PL) of Neisseria meningitidis serogroup B has been reported as a safe and potent vaccine adjuvant, inducing a TH1-skewed response. The present study describes a pre-clinical safety evaluation of an allergy therapeutic vaccine candidate based on purified allergens from Dermatophagoides siboney house dust mite and PL as adjuvant, both components adsorbed onto aluminum hydroxide gel. Two separate studies of acute toxicity evaluation were performed in mice and rabbits, and two repeat-dose studies were conducted in non-sensitized and allergen-sensitized Balb/c mice, respectively...
December 2017: Journal of Immunotoxicology
https://www.readbyqxmd.com/read/28687406/comparative-efficacy-and-toxicity-of-two-vaccine-candidates-against-sporothrix-schenckii-using-either-montanide%C3%A2-pet-gel-a-or-aluminum-hydroxide-adjuvants-in-mice
#7
Deivys Leandro Portuondo, Alexander Batista-Duharte, Lucas Souza Ferreira, Cleverton Roberto de Andrade, Camila Quinello, Damiana Téllez-Martínez, Maria Luiza de Aguiar Loesch, Iracilda Zeppone Carlos
Sporotrichosis is an important zoonosis in Brazil and the most frequent subcutaneous mycosis in Latin America, caused by different Sporothrix species. Currently, there is no effective vaccine available to prevent this disease. In this study, the efficacy and toxicity of the adjuvant Montanide™ Pet Gel A (PGA) formulated with S. schenckii cell wall proteins (ssCWP) was evaluated and compared with that of aluminum hydroxide (AH). Balb/c mice received two subcutaneous doses (1st and 14th days) of either the unadjuvanted or adjuvanted vaccine candidates...
July 4, 2017: Vaccine
https://www.readbyqxmd.com/read/28675247/protection-by-humoral-elements-independent-of-virus-neutralization-activity-against-an-influenza-virus-challenge
#8
Julia Sarkadi, David Kuti, Mate Jankovics, Eva Pallinger, Kinga Fodor, Zoltan Kis, Eva Gonczol, Ildiko Visontai, Istvan Jankovics
To investigate the protective efficacy of a seasonal trivalent inactivated whole virion influenza vaccine (TIV) adjuvanted with aluminum phosphate (Fluval AB, referred to here as TIV+Al), we immunized mice with the TIV+Al, and as controls, with TIV, TIV+Al combined with Freund adjuvant (TIV+Al+F), inactivated A/PR/8/34(H1N1) (PR8) strain or PBS, and challenged them with a lethal dose of a mouse-adapted PR8 virus. Serum pools from immunized mice were passively transferred to recipient mice that were then challenged similarly...
July 4, 2017: New Microbiologica
https://www.readbyqxmd.com/read/28668573/safety-and-immunogenicity-of-an-inactivated-cell-culture-derived-h7n9-influenza-vaccine-in-healthy-adults-a-phase-i-ii-prospective-randomized-open-label-trial
#9
Un-In Wu, Szu-Min Hsieh, Wen-Sen Lee, Ning-Chi Wang, Hsiang-Chi Kung, Tsong-Yih Ou, Fu-Lun Chen, Te-Yu Lin, Yee-Chun Chen, Shan-Chwen Chang
BACKGROUND: We conducted a phase I/II clinical trial to evaluate the safety and immunogenicity of a Madin-Darby canine kidney (MDCK) cell-grown inactivated H7N9 influenza vaccine for pandemic preparedness purposes. METHODS: Between April 7, 2015 and May 27, 2016, healthy adults aged 20-60years were enrolled sequentially in phase I (n=40) and phase II (n=160) from three hospitals in Taiwan and randomized to receive 2 doses of whole-virus H7N9 vaccine (15 or 30μg hemagglutinin antigen (HA) with or without an aluminum hydroxide adjuvant) at 21-day intervals...
June 28, 2017: Vaccine
https://www.readbyqxmd.com/read/28645718/optimizing-adjuvants-for-intradermal-delivery-of-menc-glycoconjugate-vaccine
#10
Agnese Donadei, Cristiana Balocchi, Maria R Romano, Luigi Panza, Roberto Adamo, Francesco Berti, Derek T O'Hagan, Simona Gallorini, Barbara C Baudner
Intradermal vaccine delivery is a promising alternative to the conventional intramuscular route. The skin layer is immunologically supported by a densely network of antigen presenting cells, while the skeletal muscle is loaded with a relatively sparse population of APCs. Nevertheless, the vaccine to be suitable for intradermal delivery needs a new formulation to facilitate either smaller injection volumes or the introduction into new delivery devises as micro-needles. This study presents a proof of concept for intradermal delivery of the MenC-CRM197 glycoconjugate vaccine using a mouse model...
July 13, 2017: Vaccine
https://www.readbyqxmd.com/read/28633319/immunotherapy-targeting-adenosine-synthase-a-decreases-severity-of-staphylococcus-aureus-infection-in-mouse-model
#11
Bao-Zhong Zhang, JianPiao Cai, Bin Yu, Lifeng Xiong, Qiubin Lin, Xiao-Yan Yang, Chen Xu, SongYue Zheng, Richard Yi-Tsun Kao, Konghung Sze, Kwok-Yung Yuen, Jian-Dong Huang
Staphylococcus aureus (S. aureus) is a severe pathogen found in the community and in hospitals. Most notably, Methicillin-resistant S. aureus (MRSA) is resistant to almost all antibiotics, which is a growing public health concern. The emergence of drug-resistant strains has prompted the search for alternative treatments such as immunotherapeutic approaches. Previous research showed that S. aureus exploit the immunomodulatory attributes of adenosine to escape host immunity. In this study, we investigated adenosine synthase A (AdsA), a S...
June 13, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28626461/neoglycoconjugate-of-tetrasaccharide-representing-one-repeating-unit-of-the-streptococcus-pneumoniae-type-14-capsular-polysaccharide-induces-the-production-of-opsonizing-igg1-antibodies-and-possesses-the-highest-protective-activity-as-compared-to-hexa-and-octasaccharide
#12
Ekaterina A Kurbatova, Nelli K Akhmatova, Elina A Akhmatova, Nadezhda B Egorova, Natalya E Yastrebova, Elena V Sukhova, Dmitriy V Yashunsky, Yury E Tsvetkov, Marina L Gening, Nikolay E Nifantiev
Identifying protective synthetic oligosaccharide (OS) epitopes of Streptococcus pneumoniae capsular polysaccharides (CPs) is an indispensable step in the development of third-generation carbohydrate pneumococcal vaccines. Synthetic tetra-, hexa-, and octasaccharide structurally related to CP of S. pneumoniae type 14 were coupled to bovine serum albumin (BSA), adjuvanted with aluminum hydroxide, and tested for their immunogenicity in mice upon intraperitoneal prime-boost immunizations. Injections of the conjugates induced production of opsonizing anti-OS IgG1 antibodies (Abs)...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28624420/biophysical-characterization-and-thermal-stability-of-pneumococcal-histidine-triad-protein-d-phtd-in-the-presence-of-zinc-and-manganese
#13
Salvador F Ausar, Kavisha Jayasundara, Lamees Akawi, Cristopher Roque, Anthony Sheung, Jian Hu, Marina Kirkitadze, Nausheen Rahman
The Pneumococcal Histidine Triad Protein D (PhtD) is believed to play a central role in pneumococcal metal ion homeostasis and has been proposed as a promising vaccine candidate against pneumococcal disease. To investigate for potential stabilizers, a panel of physiologically relevant metals was screened using the thermal shift assay and it was found that only Zn(2+) and Mn(2+) were able to increase PhtD melting temperature. Differential Scanning Calorimetry (DSC) analysis revealed a sequential unfolding of PhtD and the presence of at least 3 independent folding domains that can be stabilized by Zn(2+) and Mn(2+)...
June 14, 2017: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28621928/aluminum-oxy-hydroxide-nanosticks-synthesized-in-bicontinuous-reverse-microemulsion-have-potent-vaccine-adjuvant-activity
#14
Xu Li, Stephanie Hufnagel, Haiyue Xu, Solange A Valdes, Sachin G Thakkar, Zhengrong Cui, Hugo Celio
Insoluble aluminum salts such as aluminum (oxy)hydroxide are commonly used as vaccine adjuvants. Recently, there is evidence suggesting that the adjuvant activity of aluminum salt-based materials is tightly related to their physicochemical properties, including nanometer-scale size, shape with long aspect ratio, and low degree of crystallinity. Herein, for the first time, the bicontinuous reverse microemulsion (RM) technique was utilized to synthesize stick-like monodisperse aluminum (oxy)hydroxide nanoparticles with a long aspect ratio of ∼10, length of ∼80 nm, and low degree of crystallinity (denoted as Al-nanosticks)...
July 12, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28599844/somatoform-and-neurocognitive-syndromes-after-hpv-immunization-are-not-associated-to-cell-mediated-hypersensitivity-to-aluminum
#15
Dimitri Poddighe, Maria Vadalà, Carmen Laurino, Beniaminoi Palmieri
Vaccines against human papilloma virus (HPV) have been demonstrated to be very effective to prevent infection-related neoplasms. However, several reports describing heterogeneous post-vaccination phenomena have been published in last few years. The spectrum of these disorders includes both immune-mediated neurological diseases and neuropsychiatric functional disorders. Some researchers speculated about a genetic predisposition, but others hypothesized a role of adjuvants, including some metals and, particularly, aluminum...
June 6, 2017: Toxicology in Vitro: An International Journal Published in Association with BIBRA
https://www.readbyqxmd.com/read/28596090/liposomes-containing-monophosphoryl-lipid-a-and-qs-21-serve-as-an-effective-adjuvant-for-soluble-circumsporozoite-protein-malaria-vaccine-fmp013
#16
Christopher J Genito, Zoltan Beck, Timothy W Phares, Fanta Kalle, Keith J Limbach, Maureen E Stefaniak, Noelle B Patterson, Elke S Bergmann-Leitner, Norman C Waters, Gary R Matyas, Carl R Alving, Sheetij Dutta
Malaria caused by Plasmodium falciparum continues to threaten millions of people living in the tropical parts of the world. A vaccine that confers sterile and life-long protection remains elusive despite more than 30years of effort and resources invested in solving this problem. Antibodies to a malaria vaccine candidate circumsporozoite protein (CSP) can block invasion and can protect humans against malaria. We have manufactured the Falciparum Malaria Protein-013 (FMP013) vaccine based on the nearly full-length P...
June 5, 2017: Vaccine
https://www.readbyqxmd.com/read/28592561/vaccine-priming-is-restricted-to-draining-lymph-nodes-and-controlled-by-adjuvant-mediated-antigen-uptake
#17
Frank Liang, Gustaf Lindgren, Kerrie J Sandgren, Elizabeth A Thompson, Joseph R Francica, Anja Seubert, Ennio De Gregorio, Susan Barnett, Derek T O'Hagan, Nancy J Sullivan, Richard A Koup, Robert A Seder, Karin Loré
The innate immune mechanisms by which adjuvants enhance the potency and protection of vaccine-induced adaptive immunity are largely unknown. We introduce a model to delineate the steps of how adjuvant-driven innate immune activation leads to priming of vaccine responses using rhesus macaques. Fluorescently labeled HIV-1 envelope glycoprotein (Env) was administered together with the conventional aluminum salt (alum) adjuvant. This was compared to Env given with alum with preabsorbed Toll-like receptor 7 (TLR7) ligand (alum-TLR7) or the emulsion MF59 because they show superiority over alum for qualitatively and quantitatively improved vaccine responses...
June 7, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/28590715/enhanced-immune-adjuvant-activity-of-aluminum-oxyhydroxide-nanorods-through-cationic-surface-functionalization
#18
Bingbing Sun, Zhaoxia Ji, Yu-Pei Liao, Chong Hyun Chang, Xiang Wang, Justine Ku, Changying Xue, Vahid Mirshafiee, Tian Xia
Aluminum-salt-based vaccine adjuvants are prevailingly used in FDA-approved vaccines for the prevention of infectious diseases for over eighty years. Despite their safe applications, the mechanisms regarding how the material characteristics affect the interactions at nano-bio interface and immunogenicity remain unclear. Recently, studies have indicated that the activation of NLRP3 inflammasome plays a critical role in inducing adjuvant effects that are controlled by the inherent shape and hydroxyl contents of aluminum oxyhydroxide (AlOOH) nanoparticles; however, the detailed relationship between surface properties and adjuvant effects for these materials remains unknown...
June 23, 2017: ACS Applied Materials & Interfaces
https://www.readbyqxmd.com/read/28585001/testing-antifungal-vaccines-in-an-animal-model-of-invasive-candidiasis-and-in-human-mucosal-candidiasis
#19
Esther Segal
The following article will concentrate on the NDV-3 anti-Candida and Staphylococcus vaccine. The vaccine is composed of the N-terminal portion of the Candida albicans agglutinin-like sequence 3 protein (Als3p) and aluminum hydroxide as adjuvant. The vaccine conferred protection to mice against experimental vaginal, oral, and intravenous challenge with C. albicans. Due to the sequence and structural homology of the Als3p with Staphylococcus aureus surface proteins, the vaccine also protected against experimental skin and IV infection with S...
2017: Methods in Molecular Biology
https://www.readbyqxmd.com/read/28579233/a-phase-2-randomized-observer-blind-placebo-controlled-dose-ranging-trial-of-aluminum-adjuvanted-respiratory-syncytial-virus-f-particle-vaccine-formulations-in-healthy-women-of-childbearing-age
#20
Allison August, Gregory M Glenn, Eloi Kpamegan, Somia P Hickman, Dewal Jani, Hanxin Lu, D Nigel Thomas, Judy Wen, Pedro A Piedra, Louis F Fries
OBJECTIVE: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in infants. We are developing an RSV fusion (F) protein nanoparticle vaccine for immunization of third trimester pregnant women to passively protect infants through transfer of RSV-specific maternal antibodies. The present trial was performed to assess the immunogenicity and safety of several formulations of RSV F vaccine in 1-dose or 2-dose schedules. METHODS: Placebo, or vaccine with 60μg or 120μg RSV F protein and 0...
June 27, 2017: Vaccine
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