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Vaccine safety

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https://www.readbyqxmd.com/read/29785403/immunotherapy-for-hepatocellular-carcinoma-current-advances-and-future-expectations
#1
REVIEW
Yingjun Xie, Yien Xiang, Jiyao Sheng, Dan Zhang, Xiaoxiao Yao, Yongsheng Yang, Xuewen Zhang
Primary liver cancer is a common kind of digestive cancers with high malignancy, causing 745,500 deaths each year. Hepatocellular carcinoma is the major pathological type of primary liver cancer. Traditional treatment methods for patients with hepatocellular carcinoma have shown poor efficacy in killing residual cancer cells for a long time. In recent years, tumor immunotherapy has emerged as a promising method owing to its safety and efficacy with respect to delaying the progression of advanced tumors and protecting postoperative patients against tumor relapse and metastasis...
2018: Journal of Immunology Research
https://www.readbyqxmd.com/read/29785233/therapeutic-outcome-of-intralesional-immunotherapy-in-cutaneous-warts-using-the-mumps-measles-and-rubella-vaccine-a-randomized-placebo-controlled-trial
#2
Guneet Awal, Simplepreet Kaur
Background: Various treatment modalities have been described in the literature for treating warts, but none thus far have demonstrated optimal results. Recently, the mumps, measles, and rubella (MMR) antigen has gained popularity because of its proven efficacy in the treatment of warts. Aim: The goal was to evaluate the efficacy and safety of intralesional MMR antigen in the treatment of cutaneous warts. Methods: Patients were divided into an MMR (study) group and a normal saline (control) group. Injections were administered into the single largest wart on each patient every two weeks...
May 2018: Journal of Clinical and Aesthetic Dermatology
https://www.readbyqxmd.com/read/29784470/immunogenicity-and-safety-of-menacwy-tt-a-meningococcal-conjugate-vaccine-co-administered-with-routine-childhood-vaccine-in-healthy-infants-a-phase-iii-randomized-study
#3
Ghassan Dbaibo, Juan Carlos Tinoco Favila, Magali Traskine, Archana Jastorff, Marie Van der Wielen
BACKGROUND: Invasive meningococcal disease has a high burden in young children, particularly during infancy. We investigated the immunogenicity and safety of a quadrivalent meningococcal conjugated vaccine (MenACWY-TT) co-administered with routine vaccines in healthy infants. METHODS: In this phase IIIb study (NCT01340898) conducted in 2 centers in Lebanon and Mexico, 750 infants were randomized (2:1:1) to receive MenACWY-TT according to 3 schedules: 3+1 (at ages 2, 4, 6 and 15-18 months; group ACWY3+1); 1+1 (at 6 and 15-18 months; group ACWY1+1) or single-dose at 15-18 months (group ACWY1)...
May 18, 2018: Vaccine
https://www.readbyqxmd.com/read/29784457/the-dynamic-role-of-dengue-cross-reactive-immunity-changing-the-approach-to-defining-vaccine-safety-and-efficacy
#4
REVIEW
Kathryn B Anderson, Timothy P Endy, Stephen J Thomas
Dengue virus infections cause a substantial public health burden in tropical and subtropical regions. A single dengue vaccine has been approved by regulatory authorities in 19 countries, but concerns regarding vaccine safety in people who are dengue naive at the time of immunisation has introduced uncertainty into the vaccine's future. As other dengue vaccines complete or enter large-scale efficacy trials, we argue that foundational work by Sabin, historic epidemiological observations of dengue outbreaks, and prospective cohort studies in Asia and the Americas indicate that modifications must be made to the methods of assessing dengue vaccines...
May 18, 2018: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29782508/parent-and-caregiver-perceptions-about-the-safety-and-effectiveness-of-foreign-and-domestic-vaccines-in-shanghai-china
#5
Zhuoying Huang, Xiaodong Sun, Abram L Wagner, Jia Ren, Matthew L Boulton, Lisa A Prosser, Brian J Zikmund-Fisher
BACKGROUND: Chinese parents have access to domestic and foreign vaccines for their children. Their vaccine preferences are unclear, especially given recent pharmaceutical quality scandals and widely held beliefs deriving from Traditional Chinese Medicine (TCM). This study characterized parental beliefs about the safety and effectiveness of Chinese and foreign vaccines. METHODS: In May 2014, caregivers of young children at public immunization clinics in Shanghai, China, responded to a survey on vaccine perceptions...
2018: PloS One
https://www.readbyqxmd.com/read/29781359/rhabdoviruses-as-vaccine-platforms-for-infectious-disease-and-cancer
#6
Franz Zemp, Jahanara Rajwani, Douglas J Mahoney
The family Rhabdoviridae (RV) comprises a large, genetically diverse collection of single-stranded, negative sense RNA viruses from the order Mononegavirales. Several RV members are being developed as live-attenuated vaccine vectors for the prevention or treatment of infectious disease and cancer. These include the prototype recombinant Vesicular Stomatitis Virus (rVSV) and the more recently developed recombinant Maraba Virus, both species within the genus Vesiculoviridae. A relatively strong safety profile in humans, robust immunogenicity and genetic malleability are key features that make the RV family attractive vaccine platforms...
May 21, 2018: Biotechnology & Genetic Engineering Reviews
https://www.readbyqxmd.com/read/29780848/controlled-human-hookworm-infection-accelerating-human-hookworm-vaccine-development
#7
David Diemert, Doreen Campbell, Jill Brelsford, Caitlyn Leasure, Guangzhao Li, Jin Peng, Maria Zumer, Naji Younes, Maria Elena Bottazzi, Rojelio Mejia, David I Pritchard, John M Hawdon, Jeffrey M Bethony
Background: Controlled human hookworm infection (CHHI) is a central component of a proposed hookworm vaccination-challenge model (HVCM) to test the efficacy of candidate vaccines. Critical to CHHI is the manufacture of Necator americanus infective larvae ( Na L3) according to current Good Manufacturing Practice (cGMP) and the determination of an inoculum of Na L3 that is safe and reliably induces patent infection. Methods: cGMP-grade Na L3 were produced for a phase 1 trial in 20 healthy, hookworm-naïve adults in the United States, who received either 25 or 50 Na L3...
May 2018: Open Forum Infectious Diseases
https://www.readbyqxmd.com/read/29779922/safety-tolerability-acceptability-and-immunogenicity-of-an-influenza-vaccine-delivered-to-human-skin-by-a-novel-high-density-microprojection-array-patch-nanopatch%C3%A2
#8
Germain J P Fernando, Julian Hickling, Cesar M Jayashi Flores, Paul Griffin, Christopher D Anderson, S Rachel Skinner, Cristyn Davies, Katey Witham, Melinda Pryor, Jesse Bodle, Steve Rockman, Ian H Frazer, Angus H Forster
BACKGROUND: Injection using needle and syringe (N&S) is the most widely used method for vaccination, but requires trained healthcare workers. Fear of needles, risk of needle-stick injury, and the need to reconstitute lyophilised vaccines, are also drawbacks. The Nanopatch (NP) is a microarray skin patch comprised of a high-density array of microprojections dry-coated with vaccine that is being developed to address these shortcomings. Here we report a randomised, partly-blinded, placebo-controlled trial that represents the first use in humans of the NP to deliver a vaccine...
May 17, 2018: Vaccine
https://www.readbyqxmd.com/read/29778515/safety-and-immunogenicity-of-fractional-dose-intradermal-injection-of-two-quadrivalent-conjugated-meningococcal-vaccines
#9
Emile F F Jonker, Mariëtte B van Ravenhorst, Guy A M Berbers, Leo G Visser
BACKGROUND: Vaccination with conjugated meningococcal vaccines is the best way to prevent invasive meningococcal disease. Changes in serogroup epidemiology have led to the inclusion of quadrivalent vaccines in the national immunization programs of several countries, but vaccines are frequently in short supply. Intradermal administration has the potential to increase vaccine availability through dose reduction, without sacrificing efficacy. It has never before been investigated for glycoconjugate meningococcal vaccines...
May 16, 2018: Vaccine
https://www.readbyqxmd.com/read/29777868/comparative-efficacy-and-safety-of-different-antiviral-agents-for-cytomegalovirus-prophylaxis-in-allogeneic-hematopoietic-cell-transplantation-a-systematic-review-and-meta-analysis
#10
Nico Gagelmann, Per Ljungman, Jan Styczynski, Nicolaus Kröger
Over the past 25 years, several randomized controlled trials have investigated the efficacy of different antiviral agents for cytomegalovirus (CMV) prophylaxis in allogeneic hematopoietic-cell transplantation. We performed a systematic literature review, conventional meta-analysis and network meta-analysis using a random-effects model and risk ratios (RR) with corresponding 95% confidence intervals (CI) as effect estimates. Fifteen randomized controlled trials were identified, including seven different antiviral agents: acyclovir, ganciclovir, maribavir, brincidofovir, letermovir, valacyclovir, and vaccine...
May 16, 2018: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/29776750/safety-and-immunogenicity-of-a-vi-dt-typhoid-conjugate-vaccine-phase-i-trial-in-healthy-filipino-adults-and-children
#11
Maria Rosario Capeding, Samuel Teshome, Tarun Saluja, Khalid Ali Syed, Deok Ryun Kim, Ju Yeon Park, Jae Seung Yang, Yang Hee Kim, Jiwook Park, Sue-Kyoung Jo, Yun Chon, Sudeep Kothari, Seon-Young Yang, Dong Soo Ham, Ji Hwa Ryu, Hee-Seong Hwang, Ju-Hwan Mun, Julia Lynch, Jerome Kim, Hun Kim, Jean-Louis Excler, Sushant Sahastrabuddhe
BACKGROUND: Typhoid fever remains a major public health problem in low- and middle-income countries where children aged 2-14 years bear the greatest burden. Vi polysaccharide is poorly immunogenic in children <2 years of age, and protection in adults is modest. The limitations of Vi polysaccharide vaccines can be overcome by conjugation of the Vi to a carrier protein. A typhoid conjugate vaccine composed of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) has been developed...
May 15, 2018: Vaccine
https://www.readbyqxmd.com/read/29773196/reconsideration-of-the-immunotherapeutic-pediatric-safe-dose-levels-of-aluminum
#12
James Lyons-Weiler, Robert Ricketson
FDA regulations require safety testing of constituent ingredients in drugs (21 CFR 610.15). With the exception of extraneous proteins, no component safety testing is required for vaccines or vaccine schedules. The dosing of aluminum in vaccines is based on the production of antibody titers, not safety science. Here we estimate a Pediatric Dose Limit that considers body weight. We identify several serious historical missteps in past analyses of provisional safe levels of aluminum in vaccines, and provide updates relevant to infant aluminum exposure in the pediatric schedule considering pediatric body weight...
July 2018: Journal of Trace Elements in Medicine and Biology
https://www.readbyqxmd.com/read/29773050/the-importance-of-complying-with-vaccination-protocols-in-developed-countries-anti-vax-hysteria-and-the-spread-of-severe-preventable-diseases
#13
Franco Pandolfi, Laura Franza, Laura Todi, Valentina Carusi, Michele Centrone, Alessandro Bonomo, Estelle E Newton, Domenico Schiavino, Eleonora Nucera
BACKGROUND: Vaccines are very effective medical tools for disease prevention and life span increase. Controversies have raised concern about their safety, from autism to polio vaccine contamination with simian virus 40 (SV-40). Hysteria surrounding vaccine-associated risks has resulted in a declining number of vaccinations in developed countries. Outbreaks of vaccine-preventable diseases (e.g. measles) have occurred in Europe and North America, causing also some causalities. OBJECTIVES: In this review, data on safety and efficacy of vaccines are discussed, showing that the benefits of vaccines far outweigh the risks and that it is important to comply with vaccination protocols, to avoid spreading of severe, preventable diseases...
May 17, 2018: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/29771596/safety-tolerability-and-immunogenicity-of-the-expec4v-jnj-63871860-vaccine-for-prevention-of-invasive-extraintestinal-pathogenic-escherichia-coli-disease-a-phase-1-randomized-double-blind-placebo-controlled-study-in-healthy-japanese-participants
#14
Megumi Inoue, Tetsuro Ogawa, Hiroshi Tamura, Yosuke Hagiwara, Yuki Saito, Darren Abbanat, Germie van den Dobbelsteen, Peter Hermans, Stefan Thoelen, Jan Poolman, Patricia Ibarra de Palacios
This Phase 1, randomized, double-blind, placebo-controlled study was conducted to evaluate the safety, tolerability and immunogenicity of different doses of ExPEC4V conjugate vaccine (4-16µg Polysaccharide [PS]/serotype) in healthy Japanese participants, stratified into younger (≥20 to <50 years) or older age groups (≥50 years). Within each age group, participants were randomized to a single vaccination with 1 of 3 dose levels of ExPEC4V (4, 8 and 16 µg PS/serotype) or placebo. Safety and tolerability were the primary objectives; immunogenicity was secondary...
May 17, 2018: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29770084/canada-s-pandemic-vaccine-strategy
#15
B Henry, S Gadient
The Public Health Agency of Canada has a mandate to prepare and respond to public health events, including influenza pandemics. Pandemic preparedness requires a multifaceted approach with collaboration from all levels of government. The Canadian Pandemic Influenza Preparedness: Planning Guidance for the Health Sector (CPIP) is a guidance document that outlines key health sector preparedness activities designed to ensure Canada is ready to respond to the next influenza pandemic. This article, the first in a series, outlines Canada's pandemic influenza vaccine strategy as described in the CPIP annex on vaccines...
July 6, 2017: Canada Communicable Disease Report, Relevé des Maladies Transmissibles Au Canada
https://www.readbyqxmd.com/read/29770080/public-health-surveillance-for-the-toronto-2015-pan-parapan-american-games
#16
E Chan, K Hohenadel, B Lee, M Helferty, J R Harris, L Macdonald, T Badiani
Background: Public health surveillance for previous Olympic and Paralympic Games have been described in the literature, but surveillance for regional, multisport events on a smaller scale have rarely been explored. Objective: To describe the public health surveillance planning, implementation, results, and lessons learned from the 2015 Pan/Parapan American Games in Toronto, Ontario, Canada. Intervention: Public health surveillance planning for the Games began two years in advance and involved local, provincial and federal partners, primarily focusing on infectious disease...
July 6, 2017: Canada Communicable Disease Report, Relevé des Maladies Transmissibles Au Canada
https://www.readbyqxmd.com/read/29770079/summary-of-the-naci-update-on-the-recommended-use-of-human-papillomavirus-hpv-vaccine-nine-valent-hpv-vaccine-two-dose-immunization-schedule-and-the-use-of-hpv-vaccines-in-immunocompromised-populations
#17
S L Deeks, M C Tunis, S Ismail
Background: Human papillomavirus (HPV) infections are the most common sexually transmitted infections. In the absence of vaccination, it is estimated that 75% of sexually active Canadians will have an HPV infection at some point in their lives. HPV vaccine programs were first recommended by Canada's National Advisory Committee on Immunization (NACI) in 2007. In addition to the existing HPV vaccine options in Canada, NACI recently recommended the use of a newly authorized nine-valent HPV (HPV9) vaccine according to a 3-dose immunization schedule for the prevention of HPV types 6-, 11-, 16-, 18-, 31-, 33-, 45-, 52- and 58-related cancers and anogenital warts in females aged 9 to 45 years and males aged 9 to 26 years...
June 1, 2017: Canada Communicable Disease Report, Relevé des Maladies Transmissibles Au Canada
https://www.readbyqxmd.com/read/29769450/heat-shock-protein-peptide-complex-96-vaccination-for-newly-diagnosed-glioblastoma-a-phase-i-single-arm-trial
#18
Nan Ji, Yang Zhang, Yunpeng Liu, Jian Xie, Yi Wang, Shuyu Hao, Zhixian Gao
BACKGROUND: Heat shock protein peptide complex-96 (HSPPC-96) triggers adaptive and innate antitumor immune responses. The safety and efficacy of HSPPC-96 vaccination was examined in patients with newly diagnosed glioblastoma multiforme (GBM). METHODS: In this open-label, single-arm, phase I study, adult patients were vaccinated with HSPPC-96 in combination with the standard treatment for newly diagnosed GBM after surgical resection. Primary endpoints were frequency of adverse events and progression-free survival (PFS) at 6 months...
May 17, 2018: JCI Insight
https://www.readbyqxmd.com/read/29769376/-lactobacillus-mucosal-vaccine-vectors-immune-responses-against-bacterial-and-viral-antigens
#19
REVIEW
Jonathan S LeCureux, Gregg A Dean
Lactic acid bacteria (LAB) have been utilized since the 1990s for therapeutic heterologous gene expression. The ability of LAB to elicit an immune response against expressed foreign antigens has led to their exploration as potential mucosal vaccine candidates. LAB vaccine vectors offer many attractive advantages: simple, noninvasive administration (usually oral or intranasal), the acceptance and stability of genetic modifications, relatively low cost, and the highest level of safety possible. Experimentation using LAB of the genus Lactobacillus has become popular in recent years due to their ability to elicit strong systemic and mucosal immune responses...
June 27, 2018: MSphere
https://www.readbyqxmd.com/read/29769344/efficient-delivery-of-hcmv-t-cell-antigens-by-attenuated-sendai-virus-vectors
#20
Richard Kiener, Markus Fleischmann, Marian Alexander Wiegand, Niels A W Lemmermann, Christiane Schwegler, Christine Kaufmann, Angelique Renzaho, Simone Thomas, Eva Felder, Hans Helmut Niller, Benedikt Asbach, Ralf Wagner
Human Cytomegalovirus (HCMV) represents a major cause of clinical complications during pregnancy as well as immunosuppression and the licensing of a protective HCMV vaccine remains an unmet global need. Herein, we designed and validated novel Sendai virus (SeV) vectors delivering T cell immunogens IE-1 and pp65. To enhance vector safety, we used a replication-deficient strain (rdSeV) that infects target cells in a non-productive manner while retaining viral gene expression. In this study, we explored the impact that transduction with rdSeV has on human dendritic cells (DCs) by comparing it to the parental, replication-competent Sendai virus strain (rcSeV) as well as the poxvirus strain Modified Vaccinia Ankara (MVA)...
May 16, 2018: Journal of Virology
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