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Vaccine safety

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https://www.readbyqxmd.com/read/28540936/antigen-presenting-cell-targeted-lentiviral-vectors-do-not-support-the-development-of-productive-t-cell-effector-responses-implications-for-in-vivo-targeted-vaccine-delivery
#1
C Goyvaerts, Y De Vlaeminck, D Escors, S Lienenklaus, M Keyaerts, G Raes, K Breckpot
Targeting transgene expression specifically to antigen-presenting cells (APCs) has been put forward as a promising strategy to direct the immune system towards immunity. We developed the nanobody-display technology to restrict the tropism of lentiviral vectors (LVs) to APCs. However, we observed that immunization with APC-targeted LVs (DC2.1-LVs) did not evoke strong antigen-specific T-cell immunity when compared to immunization with broad tropism LVs (VSV.G-LVs). In this study, we report that VSV.G-LVs are more immunogenic than DC2...
May 25, 2017: Gene Therapy
https://www.readbyqxmd.com/read/28539888/safety-and-immunogenicity-of-a-human-epidermal-growth-factor-receptor-1-her1-based-vaccine-in-prostate-castration-resistant-carcinoma-patients-a-dose-escalation-phase-i-study-trial
#2
Iraida Caballero, Lazaro E Aira, Anabel Lavastida, Xitlally Popa, Javier Rivero, Joaquín González, Mónica Mesa, Narjara González, Kelly Coba, Patricia Lorenzo-Luaces, Barbara Wilkinson, Yuliannis Santiesteban, Yanela Santiesteban, Mayelin Troche, Eduardo Suarez, Tania Crombet, Belinda Sánchez, Angel Casacó, Amparo Macías, Zaima Mazorra
Metastatic castration-resistant prostate cancer (CRPC) remains incurable due to the lack of effective therapies. Activation of the human epidermal growth factor receptor 1 (HER1) in prostate cancer contributes to metastatic progression as well as to disease relapse. Here, we determined the toxicity and immunogenicity of a HER1-based cancer vaccine in CRPC patients included in a phase I clinical trial. CRPC patients (n = 24) were intramuscularly vaccinated with HER1 vaccine consisting of the extracellular domain of HER1 molecule (ECD) and very small size proteoliposome from Neisseria meningitidis (VSSP) and Montanide ISA-51 VG as adjuvants...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28539852/abnormal-brain-connectivity-spectrum-disorders-following-thimerosal-administration-a-prospective-longitudinal-case-control-assessment-of-medical-records-in-the-vaccine-safety-datalink
#3
David A Geier, Janet K Kern, Kristin G Homme, Mark R Geier
BACKGROUND: Autism spectrum disorder (ASD), tic disorder (TD), and hyperkinetic syndrome of childhood (attention deficit disorder [ADD]/attention deficit hyperactivity disorder [ADHD]) are disorders recently defined as abnormal connectivity spectrum disorders (ACSDs) because they show a similar pattern of abnormal brain connectivity. This study examines whether these disorders are associated with exposure to thimerosal, a mercury (Hg)-based preservative. METHODS: A hypothesis testing case-control study evaluated the Vaccine Safety Datalink for the potential dose-dependent odds ratios (ORs) for diagnoses of ASD, TD, and ADD/ADHD compared to controls, following exposure to Hg from thimerosal-containing Haemophilus influenzae type b vaccines administrated within the first 15 months of life...
January 2017: Dose-response: a Publication of International Hormesis Society
https://www.readbyqxmd.com/read/28538691/the-potential-cost-effectiveness-of-pre-exposure-prophylaxis-combined-with-hiv-vaccines-in-the-united-states
#4
Blythe J S Adamson, Josh J Carlson, James G Kublin, Louis P Garrison
This economic evaluation aims to support policy-making on the combined use of pre-exposure prophylaxis (PrEP) with HIV vaccines in development by evaluating the potential cost-effectiveness of implementation that would support the design of clinical trials for the assessment of combined product safety and efficacy. The target study population is a cohort of men who have sex with men (MSM) in the United States. Policy strategies considered include standard HIV prevention, daily oral PrEP, HIV vaccine, and their combination...
May 24, 2017: Vaccines
https://www.readbyqxmd.com/read/28538494/committee-opinion-no-704-summary-human-papillomavirus-vaccination
#5
(no author information available yet)
Human papillomavirus (HPV) is associated with anogenital cancer (including cervical, vaginal, vulvar, penile, and anal), oropharyngeal cancer, and genital warts. The HPV vaccination significantly reduces the incidence of anogenital cancer and genital warts. Despite the benefits of HPV vaccines, only 41.9% of girls in the recommended age group, and only 28.1% of males in the recommended age group have received all recom-mended doses. Compared with many other countries, HPV vaccination rates in the United States are unacceptably low...
June 2017: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/28536329/-multilateral-strategies-utilizing-exosomes-for-cancer-therapy
#6
Nao Nishida-Aoki, Takahiro Ochiya
Exosomes are nano-sized extracellular vesicles which transfer their components such as RNA, DNA, and proteins from one cell to another cell. The components are released to the cytoplasm of the recipient cells, having an effect on the cells. Cancerderived exosomes promote cancer progression, invasion, gain of drug resistance, and metastasis. Recently, according to their characteristics, it is expected to apply exosomes to cancer therapies, such as utilizing exosomes as drug delivery systems(DDS) for anticancer drugs and as cancer vaccines to enhance immunity to cancer cells...
May 2017: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/28536030/lot-to-lot-consistency-safety-and-immunogenicity-of-3-lots-of-haemophilus-influenzae-type-b-conjugate-vaccine-results-from-a-phase-iii-randomized-multicenter-study-in-infants
#7
Nicola P Klein, Remon Abu-Elyazeed, Matthew Cornish, Michael L Leonardi, Leonard B Weiner, Peter E Silas, Stanley E Grogg, Meera Varman, Robert W Frenck, Brigitte Cheuvart, Yaela Baine, Jacqueline M Miller, Maarten Leyssen, Narcisa Mesaros, Sumita Roy-Ghanta
BACKGROUND: Vaccination against Haemophilus influenzae type b (Hib) is included in routine pediatric immunization schedule in the United States. Previous vaccine shortages have created the need for additional options for Hib vaccination. METHODS: This phase III, randomized, multi-centered study (NCT01000974) evaluated the safety and immunogenicity of a monovalent tetanus toxoid-conjugate Hib vaccine (Hib-TT) compared to a monovalent (Hib-TT control) and a combination Hib-TT vaccine...
May 20, 2017: Vaccine
https://www.readbyqxmd.com/read/28536029/specific-humoral-and-cellular-immune-responses-in-cancer-patients-undergoing-chronic-immunization-with-a-vegf-based-therapeutic-vaccine
#8
Yanelys Morera, Javier Sánchez, Mónica Bequet-Romero, Katty-Hind Selman-Housein, Ana de la Torre, Francisco Hernández-Bernal, Yenima Martín, Acralys Garabito, Jesús Piñero, Cimara Bermúdez, Josué de la Torre, Marta Ayala, Jorge V Gavilondo
CIGB-247 is a cancer therapeutic vaccine, based on recombinant modified human vascular endothelial growth factor (VEGF) as antigen, in combination with the adjuvant VSSP, a bacterially-derived adjuvant. The vaccine have demonstrated efficacy in several murine malignancy models. These studies supported the rationale for a phase I clinical trial where safety, tolerance, and immunogenicity of CIGB-247 was studied in patients with advanced solid tumors at three antigen dose level. Surviving individuals of this clinical trial were eligible to receive off-trial voluntary re-immunizations...
May 20, 2017: Vaccine
https://www.readbyqxmd.com/read/28536027/live-attenuated-tetravalent-g1-g4-bovine-human-reassortant-rotavirus-vaccine-brv-tv-randomized-controlled-phase-iii-study-in-indian-infants
#9
Tarun Saluja, Sonali Palkar, Puneet Misra, Madhu Gupta, Potula Venugopal, Ashwani Kumar Sood, Ravi Mandyam Dhati, Avinash Shetty, Sangappa Malappa Dhaded, Sharad Agarkhedkar, Amlan Choudhury, Ramesh Kumar, Sundaram Balasubramanian, Sudhir Babji, Lopa Adhikary, Martin Dupuy, Sangeet Mohan Chadha, Forum Desai, Darshna Kukian, Badri Narayan Patnaik, Mandeep Singh Dhingra
BACKGROUND: Rotavirus remains the leading cause of diarrhoea among children <5years. We assessed immunogenic non-inferiority of a tetravalent bovine-human reassortant rotavirus vaccine (BRV-TV) over the licensed human-bovine pentavalent rotavirus vaccine RV5. METHODS: Phase III single-blind study (parents blinded) in healthy infants randomized (1:1) to receive three doses of BRV-TV or RV5 at 6-8, 10-12, and 14-16weeks of age. All concomitantly received a licensed diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b conjugate vaccine (DTwP-HepB-Hib) and oral polio vaccine (OPV)...
May 20, 2017: Vaccine
https://www.readbyqxmd.com/read/28533093/safety-and-immunogenicity-of-a-live-attenuated-influenza-h5-candidate-vaccine-strain-a-17-turkey-turkey-05-133-h5n2-and-its-priming-effects-for-potential-pre-pandemic-use-a-randomised-double-blind-placebo-controlled-trial
#10
Punnee Pitisuttithum, Kobporn Boonnak, Supat Chamnanchanunt, Pilaipan Puthavathana, Viravarn Luvira, Hatairat Lerdsamran, Jaranit Kaewkungwal, Saranath Lawpoolsri, Vipa Thanachartwet, Udomsak Silachamroon, Wanibtisam Masamae, Alexandra Schuetz, Ponthip Wirachwong, Sit Thirapakpoomanunt, Larisa Rudenko, Erin Sparrow, Martin Friede, Marie-Paule Kieny
BACKGROUND: The emergence of highly pathogenic avian influenza H5N1 viruses has raised concerns about their pandemic potential. Vaccination is the most effective way of preventing influenza. In this study, we investigated the safety and immunogenicity of an avian H5N2 live attenuated influenza vaccine (LAIV H5N2) in healthy Thai adults and its priming immune responses with an H5N1 inactivated vaccine boost. METHODS: This study was done at the Vaccine Trial Centre at Mahidol University, Bangkok, Thailand and was divided into two parts...
May 19, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28533054/reduced-schedules-of-4cmenb-vaccine-in-infants-and-catch-up-series-in-children-immunogenicity-and-safety-results-from-a-randomised-open-label-phase-3b-trial
#11
Federico Martinón-Torres, Marco Aurelio P Safadi, Alfonso Carmona Martinez, Pilar Infante Marquez, Juan Carlos Tejedor Torres, Lily Yin Weckx, Edson Duarte Moreira, Ilhem Mensi, Marco Calabresi, Daniela Toneatto
BACKGROUND: This study evaluated the immunogenicity and safety of a licensed meningococcal serogroup B vaccine (4CMenB) administered alone according to reduced schedules in infants or catch-up series in children. METHODS: In this open-label, multicentre, phase 3b study (NCT01339923), infants randomised 1:1:1 received 4CMenB: 2+1 doses at 3½-5-11months or 6-8-11months of age, 3+1 doses at ages 2½-3½-5-11months. Children aged 2-10years received 2 catch-up doses administered 2months apart...
May 19, 2017: Vaccine
https://www.readbyqxmd.com/read/28532790/a-safe-and-molecular-tagged-brucella-canis-ghosts-confers-protection-against-virulent-challenge-in-mice
#12
Jing Qian, Zhaoyang Bu, Xulong Lang, Guangmou Yan, Yanling Yang, Xiuran Wang, Xinglong Wang
Canine brucellosis, caused by Brucella canis, is a persistent infectious reproductive disease in dogs. The absence of effective treatment to the intracellular pathogen and the irreversible consequence of infection makes the need of a specific vaccine urgent. Bacterial ghosts (BGs) are the empty envelopes of bacteria with no genome content inside, which emerge as a proper vaccine candidate due to its intact outer antigen. It is generally derived from a genetically engineered strain, through the expression of Bacteriophage phiX174 lysis E gene upon induction...
May 2017: Veterinary Microbiology
https://www.readbyqxmd.com/read/28531130/comparative-safety-and-efficacy-profile-of-a-novel-oil-in-water-vaccine-adjuvant-comprising-vitamins-a-and-e-and-a-catechin-in-protective-anti-influenza-immunity
#13
Sapna Patel, Yasser Faraj, Debra K Duso, William W Reiley, Erik A Karlsson, Stacey Schultz-Cherry, Michael Vajdy
Non-replicating vaccines, such as those based on recombinant proteins, require adjuvants and delivery systems, which have thus far depended on mimicking pathogen danger signals and strong pro-inflammatory responses. In search of a safer and more efficacious alternative, we tested whether vaccinations with influenza recombinant hemagglutinin (HA) mixed with a novel vegetable oil in water emulsion adjuvant (Natural Immune-enhancing Delivery System, NIDS), based on the immune-enhancing synergy of vitamins A and E and a catechin, could protect against intra-nasal challenge with live influenza virus...
May 21, 2017: Nutrients
https://www.readbyqxmd.com/read/28530308/-influenza-vaccination-among-healthcare-workers-the-data-and-the-duty
#14
Sonia Habib, Shmuel Rishpon, Itamar Grotto, Arnon Afek
Seasonal influenza is a significant disease affecting public health due to substantial morbidity and mortality and a high economic burden. in view of its high propensity for genetic mutations, the virus can easily evade preexisting immunity acquired from prior exposure to it, thereby causing severe seasonal epidemics. Influenza vaccination has been shown to be safe and effective. In many countries, including Israel, it is recommended to all members of the population aged 6 months and older, especially those with a higher risk of developing severe complications...
January 2017: Harefuah
https://www.readbyqxmd.com/read/28529001/a-single-intranasal-administration-of-virus-like-particle-vaccine-induces-an-efficient-protection-for-mice-against-human-respiratory-syncytial-virus
#15
Yue-Ying Jiao, Yuan-Hui Fu, Yi-Fei Yan, Ying Hua, Yao Ma, Xiu-Juan Zhang, Jing-Dong Song, Xiang-Lei Peng, Jiaqiang Huang, Tao Hong, Jin-Sheng He
Human respiratory syncytial virus (RSV) is an important pediatric pathogen causing acute viral respiratory disease in infants and young children. However, no licensed vaccines are currently available. Virus-like particles (VLPs) may bring new hope to producing RSV VLP vaccine with high immunogenicity and safety. Here, we constructed the recombinants of matrix protein (M) and fusion glycoprotein (F) of RSV, respectively into a replication-deficient first-generation adenoviral vector (FGAd), which were used to co-infect Vero cells to assemble RSV VLPs successfully...
May 18, 2017: Antiviral Research
https://www.readbyqxmd.com/read/28528764/dengue-vaccine-safety-signal-immune-enhancement-waning-immunity-or-chance-occurrence
#16
Bradford D Gessner, Neal Halsey
A new dengue vaccine was associated with increased risk of hospitalized virologically-confirmed disease during year 3 of follow-up among children age 2-5years. Among hypotheses to explain this finding, we could not distinguish definitively between antibody dependent enhancement, waning immunity, or chance occurrence. However, any theory must account for the following: (a) the signal occurred mainly because of decreased dengue among controls rather than increased dengue among vaccinees; (b) among 48 data points, a statistically significant increase in hospitalization among vaccinated children occurred for only one age group, during one year, and in one region; (c) cumulative risk was similar for vaccinated vs...
May 18, 2017: Vaccine
https://www.readbyqxmd.com/read/28528762/safety-and-immunogenicity-of-a-prototype-anti-chlamydia-pecorum-recombinant-protein-vaccine-in-lambs-and-pregnant-ewes
#17
Marion Desclozeaux, Martina Jelocnik, Katrina Whitting, Siamak Saifzadeh, Sankhya Bommana, Andrew Potter, Volker Gerdts, Peter Timms, Adam Polkinghorne
Arthritis and kerato-conjunctivitis caused by Chlamydia pecorum in lambs are difficult to diagnose and treat. We tested the ability of a prototype C. pecorum vaccine (SC-vaccine), comprised of C. pecorum major outer membrane protein (MOMP-G) and polymorphic membrane protein G (PmpG), to trigger a Chlamydia-specific humoral and cell-mediated immune response in lambs and pregnant ewes. Vaccinations with the SC-vaccine (one and two injections) were very well tolerated by all ewes and lambs. Although the overall immune responses of ewes to SC-vaccination was poor, their lambs showed stronger antigen-specific immune response than lambs from control vaccine ewes...
May 18, 2017: Vaccine
https://www.readbyqxmd.com/read/28528017/-identification-of-sentinel-events-in-primary-care
#18
G Olivera Cañadas, A Cañada Dorado, M Drake Canela, B Fernández-Martínez, G Ordóñez León, M Cimas Ballesteros
OBJECTIVE: To identify and describe a list of sentinel events (SEs) for Primary Care (PC). METHODODOLOGY: A structured experts' consensus was obtained by using two online questionnaires. The participants were selected because of their expertise in PC and patient safety. The first questionnaire assessed the suitability of the hospital SEs established in the National Quality Forum 2006 for use in PC via responses of "yes", "no", or "yes but with modification". In the latter case, a re-wording of the SE was requested...
May 17, 2017: Revista de Calidad Asistencial: Organo de la Sociedad Española de Calidad Asistencial
https://www.readbyqxmd.com/read/28525963/the-use-of-transgenic-parasites-in-malaria-vaccine-research
#19
Ahmad Syibli Othman, Catherin Marin-Mogollon, Ahmed M Salman, Blandine M Franke-Fayard, Chris J Janse, Shahid M Khan
Transgenic malaria parasites expressing foreign genes, for example fluorescent and luminescent proteins, are used extensively to interrogate parasite biology and host-parasite interactions associated with malaria pathology. Increasingly transgenic parasites are also exploited to advance malaria vaccine development. Areas Covered: We review how transgenic malaria parasites are used, in vitro and in vivo, to determine protective efficacy of different antigens and vaccination strategies and to determine immunological correlates of protection...
May 19, 2017: Expert Review of Vaccines
https://www.readbyqxmd.com/read/28522338/year-round-influenza-immunisation-during-pregnancy-in-nepal-a-phase-4-randomised-placebo-controlled-trial
#20
Mark C Steinhoff, Joanne Katz, Janet A Englund, Subarna K Khatry, Laxman Shrestha, Jane Kuypers, Laveta Stewart, Luke C Mullany, Helen Y Chu, Steven C LeClerq, Naoko Kozuki, Monica McNeal, Adriana M Reedy, James M Tielsch
BACKGROUND: Influenza immunisation during pregnancy is recommended but not widely implemented in some low-income regions. We assessed the safety and efficacy in mothers and infants of year-round maternal influenza immunisation in Nepal, where influenza viruses circulate throughout the year. METHODS: In this phase 4, randomised, placebo-controlled trial, we enrolled two consecutive sequential annual cohorts of pregnant women from the Sarlahi district in southern Nepal...
May 15, 2017: Lancet Infectious Diseases
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