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Vaccine safety

Julie Mouchet, Bernard Bégaud
INTRODUCTION: Hepatitis B (HB) vaccination programs were set up worldwide in the early 1990s. Despite their major focus on reducing the burden of HB infection, they have seldom achieved the targeted population coverage in most countries, including the USA, with around 24.5% of adults being vaccinated against HB. Among proposed reasons for this is the persisting doubt about a possible link between HB vaccination and the occurrence of cases of multiple sclerosis (MS). OBJECTIVE: Our objective was to evaluate a potential safety signal between MS and HB vaccination...
March 20, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Indranil Sarkar, Ravendra Garg, Sylvia van Drunen Littel-van den Hurk
Respiratory syncytial virus (RSV) causes acute respiratory tract infections in infants, the elderly and immunocompromised individuals. No licensed vaccine is available against RSV. We previously reported that intranasal immunization of rodents and lambs with a RSV vaccine candidate (ΔF/TriAdj) induces protective immunity with a good safety profile. ΔF/TriAdj promoted innate immune responses in respiratory mucosal tissues in vivo, by local chemokine and cytokine production, as well as infiltration and activation of immune cells including macrophages...
March 17, 2018: Vaccine
Susan J Ermlich, Charles P Andrews, Steven Folkerth, Richard Rupp, David Greenberg, Richard D McFetridge, Jonathan Hartzel, Rocio D Marchese, Jon E Stek, Chitrananda Abeygunawardana, Luwy K Musey
BACKGROUND: Pneumococcal disease remains a public health priority in adults. Safety and immunogenicity of 15-valent pneumococcal conjugate vaccine (PCV15) containing 13 serotypes included in 13-valent pneumococcal conjugate vaccine (PCV13) plus 2 additional serotypes (22F and 33F) was evaluated in adults ≥50 years old (NCT01513551). METHODS: 691 adults received one dose of PCV15, PCV13, or 23-valent pneumococcal polysaccharide vaccine (PPV23) and were followed 14 days for safety...
March 17, 2018: Vaccine
Grace VanHoy, Michelle Carman, Greg Habing, Jeffrey Lakritz, C Austin Hinds, Andrew Niehaus, Ray M Kaplan, Antoinette E Marsh
Haemonchosis in camelids remains a challenging disease to treat, and prevention has become increasingly problematic due to widespread anthelmintic resistance. Barbervax® is an adjuvanted vaccine containing natural H-11, H-gal-GP antigens obtained from Haemonchus contortus adults via a proprietary process and solubilized in Quil A. This vaccine is approved for use in Australia, after demonstrating its safety and efficacy in sheep and goats. There are no published studies evaluating Barbervax in other ruminants/pseudoruminants such as camelids which can be parasitized with H...
March 15, 2018: Veterinary Parasitology
J M Carrascosa, E Del-Alcazar
Biologic drugs have revolutionized the treatment of moderate to severe psoriasis in recent years because of their high efficacy and low risk of toxicity. However, even within the group of biologic therapies, there are differences related to the different mechanisms of action. Areas covered: We review the main adverse events associated with the biologic agents currently available for the treatment of psoriasis and the new inhibitors targeting the p19 subunit of interleukin (IL) 23 and the IL-17A receptor. This review covers injection site reactions, infections, cardiovascular events, demyelinating disorders, tumours, class effects secondary adverse events, immunogenicity, safety in pregnancy and vaccines efficacy...
March 20, 2018: Expert Review of Clinical Immunology
Martin Mielke
Clinically relevant infections are the primary indication for the use of antimicrobial agents in human medicine. Consequently, the prevention of infections is the fundament of all measures to rationally reduce the use of antibiotics. A prevented infection must not be treated. For the prevention of several community-acquired infections, vaccines are available. In addition, several infections may be prevented on the basis of knowledge and responsible behavior. However, the prevention of nosocomial infections depends mainly on the responsibility of third parties in the context of medical procedures...
March 19, 2018: Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz
Jacob D Estes, Scott W Wong, Jason M Brenchley
Humans have a close phylogenetic relationship with nonhuman primates (NHPs) and share many physiological parallels, such as highly similar immune systems, with them. Importantly, NHPs can be infected with many human or related simian viruses. In many cases, viruses replicate in the same cell types as in humans, and infections are often associated with the same pathologies. In addition, many reagents that are used to study the human immune response cross-react with NHP molecules. As such, NHPs are often used as models to study viral vaccine efficacy and antiviral therapeutic safety and efficacy and to understand aspects of viral pathogenesis...
March 19, 2018: Nature Reviews. Immunology
Hiroyuki Kishino, Kenichi Takahashi, Miyuki Sawata, Yoshiyuki Tanaka
Hepatitis B vaccines are highly effective in preventing hepatitis B virus infection and have been included in the national immunization program of Japan since 2016. Heptavax®-II is one of two hepatitis B vaccine products licensed in Japan, and its manufacturing process is being modified to reduce variability of manufacturing and optimize immunogenicity. In this study (NCT01463683), the immunogenicity and safety of a modified-process hepatitis B vaccine (mpHBV) were compared to those of the licensed Heptavax®-II...
March 19, 2018: Human Vaccines & Immunotherapeutics
Soedjatmiko Soedjatmiko, Bernie Endyarni Medise, Hartono Gunardi, Rini Sekartini, Hindra Irawan Satari, Sri Rezeki Hadinegoro, Novilia Sjafri Bachtiar, Rini Mulia Sari
INTRODUCTION: High rate of influenza infection in children made influenza vaccination strongly recommended for all person aged >6 months in Indonesia. Bio Farma Trivalent Influenza HA (Flubio®) vaccine has been used in adolescents and adults, resulted in increased seroconversion, seroprotection rates and geometric mean titer (GMT). However, no data is available regarding its efficacy and safety in children. This study aimed to assess the immunogenicity and safety of Flubio® vaccine in infants and children...
March 15, 2018: Vaccine
Yolanda Revilla, Daniel Pérez-Núñez, Juergen A Richt
African swine fever (ASF) is an acute and often fatal disease affecting domestic pigs and wild boar, with severe economic consequences for affected countries. ASF is endemic in sub-Saharan Africa and the island of Sardinia, Italy. Since 2007, the virus emerged in the republic of Georgia, and since then spread throughout the Caucasus region and Russia. Outbreaks have also been reported in Belarus, Ukraine, Lithuania, Latvia, Estonia, Romania, Moldova, Czech Republic, and Poland, threatening neighboring West European countries...
2018: Advances in Virus Research
Chengchao Ding, Junfei Ma, Qingli Dong, Qing Liu
Live bacteria, including attenuated bacteria and probiotics, can be engineered to deliver target antigen to excite the host immune system. The preponderance of these live bacterial vaccine vectors is that they can stimulate durable humoral and cellular immunity. Moreover, delivery strategies of heterologous antigen in live bacterial promote the applications of new vaccine development. Genetic technologies are evolving, which potentiate the developing of heterologous antigen delivery systems, including bacterial surface display system, bacterial secretion system and balanced lethal vector system...
March 14, 2018: Immunology Letters
J Hansen, L Zhang, A Eaton, R Baxter, C A Robertson, M D Decker, D P Greenberg, E Bassily, N P Klein
BACKGROUND: Menactra® vaccine (MenACWY-D) was licensed in the United States in 2005 for persons 11-55 years of age, in 2007 for children 2-10 years of age, and in 2011 for infants/toddlers 9-23 months of age. We conducted two studies at Kaiser Permanente Northern California (KPNC), an integrated health care organization, to assess the safety of MenACWY-D in 2-10-year-olds and 9-23-month-olds receiving the vaccine during routine clinical care. METHODS: We conducted observational, retrospective studies of MenACWY-D in 2-10-year-olds (October 2007-October 2010) and in 9-23-month-olds (June 2011-June 2014)...
March 14, 2018: Vaccine
Lejla Čalkić, Muhamed Skomorac, Salih Tandir, Suad Sivić, Lejla Bajramović Omeragić
Aim To investigate epidemiological characteristics of the measles epidemic (risk factors and reasons for its emergence) in order to establish better control and prevention of future epidemics as well as to determine an influence of poor collective immunization of children against measles on appearance of epidemic disease. Methods An open retrospective epidemiological study of measles infection was conducted during the epidemic in Zenica-Doboj Canton (ZDC) in the period 2014-2015. Disease reports, Disease Reporting Forms for measles and rubella cases and the Bulletin of the Institute for Health and Food Safety Zenica were used for data collection...
February 1, 2018: Medicinski Glasnik
Tomas Jelinek, Michael A Cromer, Jakob P Cramer, Deborah J Mills, Kenneth Lessans, Anthony W Gherardin, Elizabeth D Barnett, Stefan H F Hagmann, Helena H Askling, Sigrid Kiermayr, Vera Kadlecek, Susanne Eder-Lingelbach, Christian Taucher, Katrin L Dubischar
BACKGROUND: Young travelers to South-East Asia may be at risk for Japanese encephalitis (JE). METHODS: IXIARO® (0.25 ml or 0.5 ml, depending on age) were administrated to 100 travelers aged ≥ 2 months to < 18 years. Solicited AEs were collected for 7 days after each injection, unsolicited adverse events (AEs) for a total of 7 months. JE neutralizing antibodies were assessed in 64 subjects. RESULTS: The most common solicited local AEs were redness (3/12 subjects), induration and tenderness (both 1/12) with 0...
March 13, 2018: Travel Medicine and Infectious Disease
Cynthia Chapel, Nathalie Rocher-Hélion, Nathalie Mantel, Sandy Imbert, Eric Deshaies, Véronique Barban, Alain Sabouraud, Jean-Philippe Barbe, Laurent Mallet
Absence of 'live' residual poliovirus in Inactivated Poliovirus Vaccine (IPV) is routinely checked using Primary Monkey Kidney Cells (PMKC). However, the increasing demand for IPV and the ethical, technical and safety issues associated with the use of non-human primates in research and quality control, has made the replacement of primary cells with an established cell line a priority, in line with the principles of the 3Rs (Replacement, Reduction and Refinement in animal testing). As an alternative to PMKC, we evaluated the L20B cell line; a mouse cell-line genetically engineered to express human poliovirus receptor, CD155...
March 13, 2018: Journal of Virological Methods
Kimberly R Kalli, Matthew S Block, Pashtoon M Kasi, Courtney L Erskine, Timothy J Hobday, Allan Dietz, Douglas Padley, Michael P Gustafson, Barath Shreeder, Danell Puglisi-Knutson, Daniel W Visscher, Toni Kay Mangskau, Glynn Wilson, Keith L Knutson
PURPOSE: Folate receptor alpha (FR) is overexpressed in several cancers. Endogenous immunity to the FR has been demonstrated in patients and suggests the feasibility of targeting FR with vaccine or other immune therapies. CD4 helper T cells are central to the development of coordinated immunity and prior work shows their importance in protecting against relapse. Our previous identification of degenerate HLA-class II epitopes from human FR led to the development of a broad coverage epitope pool potentially useful in augmenting antigen-specific immune responses in most patients...
March 15, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Winnie Wing Yan Yuen, Albert Lee, Paul K S Chan, Lynn Tran, Erica Sayko
The present study is aimed at assessing the feasibility of delivering the HPV (human papillomavirus) vaccine to girls through a school-based program in Hong Kong, as well as to examine the facilitators and barriers associated with their participation. We approached 1,229 eligible girls aged 9 to 14 at eight schools in Hong Kong to join the program and then delivered the bivalent HPV vaccine at 0 and 6 months over the course of one school year. The students and their parents completed separate questionnaires to indicate their decision on whether or not to participate, and to assess their knowledge of cervical cancer and the HPV vaccine...
2018: PloS One
Raches Ella, Radhika Bobba, Sanjay Muralidhar, Sudhir Babji, Krishna Mohan Vadrevu, Maharaj Kishan Bhan
BACKGROUND: The World Health Organization recommends that rotavirus vaccines should be included in all national immunization programs. Some currently licensed oral rotavirus vaccines contain a buffering agent (either as part of a ready-to-use liquid formulation or added during reconstitution) to reduce possible degradation of the vaccine virus in the infant gut, which poses several programmatic challenges (the large dose volume or the reconstitution requirement) during vaccine administration...
March 15, 2018: Human Vaccines & Immunotherapeutics
James C Barton, Jackson Clayborn Barton, Luigi F Bertoli
BACKGROUND: We sought to learn more about the utility and safety of implanted ports for monthly immunoglobulin G infusions in adults with primary immune deficiency. METHODS: We reviewed charts of adults who were referred to a single practice during the interval 2006-2016 for evaluation and management of frequent or severe upper and lower respiratory tract and other infections, subnormal total immunoglobulin G or immunoglobulin G subclasses, and suboptimal responses to polyvalent pneumococcal polysaccharide vaccinations; were diagnosed to have primary immune deficiency; and were advised to undergo immunoglobulin G therapy...
March 1, 2018: Journal of Vascular Access
Hiroshi Maeda, Mahin Khatami
For over six decades reductionist approaches to cancer chemotherapies including recent immunotherapy for solid tumors produced outcome failure-rates of 90% (±5) according to governmental agencies and industry. Despite tremendous public and private funding and initial enthusiasm about missile-therapy for site-specific cancers, molecular targeting drugs for specific enzymes such as kinases or inhibitors of growth factor receptors, the outcomes are very bleak and disappointing. Major scientific reasons for repeated failures of such therapeutic approaches are attributed to reductionist approaches to research and infinite numbers of genetic mutations in chaotic molecular environment of solid tumors that are bases of drug development...
March 1, 2018: Clinical and Translational Medicine
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