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Vaccine adverse events

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https://www.readbyqxmd.com/read/28933663/type-iii-hypersensitivity-reactions-to-a-b-cell-epitope-antigen-are-abrogated-using-a-depot-forming-vaccine-platform
#1
Lisa D MacDonald, Alecia MacKay, Valarmathy Kaliaperumal, Genevieve Weir, Andrea Penwell, Rajkannan Rajagopalan, Joanne Langley, Scott Halperin, Marc Mansour, Marianne M Stanford
Peptide antigens are combined with an adjuvant in order to increase immunogenicity in vivo. The immunogenicity and safety of a RSV vaccine formulated in a novel oil-based platform, DepoVax™ (DPX), was compared to an alum formulation. A peptide B cell epitope derived from RSV small hydrophobic ectodomain (SHe) served as the antigen. Both vaccines induced SHe-specific antibodies after immunization of mice. A single dose of the DPX-based formulation resulted in anti-SHe titres for up to 20 weeks. Boosting with Alum-SHe, but not with DPX-SHe, led to unexpected clinical signs such as decreased activity, cyanosis and drop in body temperature in mice but not in rabbits...
September 21, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28933626/immunogenicity-and-safety-of-the-2015-southern-hemisphere-formulation-of-a-split-virion-inactivated-quadrivalent-vaccine
#2
Cecilia Montalban, May Book Montellano, Jaime Santos, Nathalie Lavis
An inactivated split-virion quadrivalent influenza vaccine (IIV4; Fluzone® Quadrivalent; Sanofi Pasteur) has been available in the US since 2013 and in the Southern Hemisphere since 2015. Here, we describe the results of an open-label, post-licensure trial (WHO Universal Trial Number, U1111-1143-9256) to confirm the immunogenicity and safety of the Southern Hemisphere 2015 formulation of IIV4. Adults 18-60 years of age and > 60 years of age (n = 60 per age group) received a single 0.5-mL intramuscular injection of IIV4...
September 21, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28933625/immunogenicity-and-safety-of-a-split-virion-quadrivalent-influenza-vaccine-in-adults-18-60%C3%A2-years-of-age-in-the-republic-of-korea
#3
Won Suk Choi, Ji Yun Noh, Jacob Lee, Jun Yong Choi, Jin-Soo Lee, Moo Soo Kim, Hee Soo Kim, Joon Bang, Nathalie Lavis, Woo Joo Kim
VaxigripTetra® (Sanofi Pasteur, Lyon, France) is a quadrivalent split-virion inactivated influenza vaccine (IIV4) containing two B-lineage strains approved in the European Union and Taiwan in 2016 for individuals ≥ 3 years of age. Here, we describe an observer-blind, randomized, controlled, multicenter trial study evaluating the immunogenicity and safety of the Northern Hemisphere 2015-2016 formulations of IIV4 and the licensed split-virion trivalent inactivated influenza vaccine (IIV3) in the Republic of Korea (ClinicalTrials...
September 21, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28930165/timeliness-of-childhood-primary-immunization-and-risk-factors-related-with-delays-evidence-from-the-2014-zhejiang-provincial-vaccination-coverage-survey
#4
Yu Hu, Qian Li, Yaping Chen
Background: this study aimed to assess both immunization coverage and timeliness, as well as reasons for non-vaccination, and identity the risk factors of delayed immunization, for the vaccines scheduled during the first year of life, in Zhejiang province, east China. Methods: A cluster survey among children aged 24-35 months was conducted. Demographic information and socio-economic characteristics of the selected child, the mother, and the household were collected. Immunization data were transcribed from immunization cards...
September 20, 2017: International Journal of Environmental Research and Public Health
https://www.readbyqxmd.com/read/28926579/cervical-screening-with-primary-hpv-testing-or-cytology-in-a-population-of-women-in-which-those-aged-33-years-or-younger-had-previously-been-offered-hpv-vaccination-results-of-the-compass-pilot-randomised-trial
#5
Karen Canfell, Michael Caruana, Val Gebski, Jessica Darlington-Brown, Stella Heley, Julia Brotherton, Dorota Gertig, Chloe J Jennett, Annabelle Farnsworth, Jeffrey Tan, C David Wrede, Philip E Castle, Marion Saville
BACKGROUND: Using primary human papillomavirus (HPV) testing for cervical screening increases detection of high-grade cervical intraepithelial neoplastic lesions and invasive cancer (cervical intraepithelial neoplasia grade 2+ [CIN2+]) compared to cytology, but no evaluation has been conducted in a population previously offered HPV vaccination. We aimed to assess colposcopy referral and CIN2+ detection rates for HPV-screened versus cytology-screened women in Australia's HPV-vaccinated population (by 2014, resident women ≤33 years had been age-eligible for HPV vaccination, with 3-dose uptake across age cohorts being about 50%-77%)...
September 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28925801/mf59-adjuvanted-influenza-vaccine-fluad%C3%A2-elicits-higher-immune-responses-than-a-non-adjuvanted-influenza-vaccine-fluzone%C3%A2-a-randomized-multicenter-phase-iii-pediatric-trial-in-mexico
#6
Aurelio Cruz-Valdez, Gabriel Valdez-Zapata, Sanjay S Patel, Flavia V Castelli, Marcia G Garcia, Wim T Jansen, Ashwani Kumar Arora, Esther Heijnen
The poor immune response elicited by trivalent influenza vaccines (TIVs) in children can be enhanced by the addition of adjuvants. This observer-blind, randomized Phase III trial assessed the immunogenicity and safety of the MF59-adjuvanted trivalent influenza vaccine FLUAD® (aTIV) and a non-adjuvanted TIV, in healthy children (aged 6 to <72 months) from 3 centers in Mexico, during the 2014-2015 season. The primary objectives were to assess the non-inferiority of aTIV to TIV, measured by geometric mean titers (GMTs), and the safety of aTIV and TIV...
September 19, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28916690/suspect-drug-interaction-in-gimmers
#7
(no author information available yet)
Suspect serious adverse event associated with vaccination in gimmersMultiple congenital defects in a stillborn calfSuspected alpha mannosidosis in a bovine fetusClostridial myocarditis in a two-week-old lambOtitis media in pigs These are among matters discussed in the disease surveillance report for May 2017 from SAC Consulting: Veterinary Services (SAC C VS).
September 16, 2017: Veterinary Record
https://www.readbyqxmd.com/read/28915908/advances-in-paediatrics-in-2016-current-practices-and-challenges-in-allergy-autoimmune-diseases-cardiology-endocrinology-gastroenterology-infectious-diseases-neonatology-nephrology-neurology-nutrition-pulmonology
#8
REVIEW
Carlo Caffarelli, Francesca Santamaria, Dora Di Mauro, Carla Mastrorilli, Silvia Montella, Sergio Bernasconi
This review reports main progresses in various pediatric issues published in Italian Journal of Pediatrics and in international journals in 2016. New insights in clinical features or complications of several disorders may be useful for our better understanding. They comprise severe asthma, changing features of lupus erythematosus from birth to adolescence, celiac disease, functional gastrointestinal disorders, Moebius syndrome, recurrent pneumonia. Risk factors for congenital heart defects, Kawasaki disease have been widely investigated...
September 16, 2017: Italian Journal of Pediatrics
https://www.readbyqxmd.com/read/28910563/safety-and-immunogenicity-of-the-killed-bivalent-o1-and-o139-whole-cell-cholera-vaccine-in-the-philippines
#9
Maria Rosario Z Capeding, Maria Liza Antoinette M Gonzales, Mandeep Singh Dhingra, Naveena Aloysia D'cor, Venkat Jayanth Midde, Badri Narayan Patnaik, Yaël Thollot, Eric Desauziers
The killed bivalent (O1 and O139) whole cell oral cholera vaccine (OCV) (Shanchol™) was first licensed in India in 2009 and World Health Organization pre-qualified in 2011. We assessed the safety and immunogenicity of this OCV in the Philippines. This was a phase IV, single-arm, descriptive, open-label study. We recruited 336 participants from two centers: 112 participants in each age group (1-4, 5-14 and ≥15 years). Participants received two OCV doses 14 days apart. Safety was monitored throughout the trial...
September 14, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28898532/immunological-efficacy-of-herbal-medicines-in-prostate-cancer-patients-treated-by-personalized-peptide-vaccine
#10
Noriko Koga, Fukuko Moriya, Kayoko Waki, Akira Yamada, Kyogo Itoh, Masanori Noguchi
This randomized phase II study investigated the immunological efficacy of herbal medicines (HMs) using Hochu-ekki-to and Keishi-bukuryo-gan in combination with personalized peptide vaccination (PPV) for castration-resistant prostate cancer (CRPC). Seventy patients with CRPC were assigned to two arms; PPV plus HMs or PPV alone. Two to four peptides were chosen from 31 peptides derived from cancer antigens for the eight-time subcutaneous injection of PPV according to the patient's human leukocyte antigen type and levels of antigen-specific immunoglobulin G (IgG) titer before PPV treatment...
September 12, 2017: Cancer Science
https://www.readbyqxmd.com/read/28893478/pain-caused-by-measles-mumps-and-rubella-vaccines-a-systematic-literature-review
#11
REVIEW
Corinne Willame, Ouzama Henry, Lan Lin, Volker Vetter, Laurence Baril, Nicolas Praet
PURPOSE: The risk of post-vaccination adverse events (AEs) is a primary public health concern. Among the AEs, pain is a significant source of anxiety for both children and their parents. This review describes and assesses the intensity of pain experienced by children post-vaccination with widely used Measles-Mumps-Rubella (MMR) vaccines. METHODS: A systematic literature search was conducted in Pubmed, Embase and Cochrane to identify publications describing immediate pain at injection site (primary objective) or pain within days (secondary objective) after 2 specific MMR vaccines...
September 8, 2017: Vaccine
https://www.readbyqxmd.com/read/28893477/live-attenuated-tetravalent-dengue-vaccines-the-needs-and-challenges-of-post-licensure-evaluation-of-vaccine-safety-and-effectiveness
#12
REVIEW
Ole Wichmann, Kirsten Vannice, Edwin J Asturias, Expedito José de Albuquerque Luna, Ira Longini, Anna Lena Lopez, Peter G Smith, Hasitha Tissera, In-Kyu Yoon, Joachim Hombach
Since December 2015, the first dengue vaccine has been licensed in several Asian and Latin American countries for protection against disease from all four dengue virus serotypes. While the vaccine demonstrated an overall good safety and efficacy profile in clinical trials, some key research questions remain which make risk-benefit-assessment for some populations difficult. As for any new vaccine, several questions, such as very rare adverse events following immunization, duration of vaccine-induced protection and effectiveness when used in public health programs, will be addressed by post-licensure studies and by data from national surveillance systems after the vaccine has been introduced...
September 8, 2017: Vaccine
https://www.readbyqxmd.com/read/28893272/killed-whole-hiv-vaccine-employing-a-well-established-strategy-for-antiviral-vaccines
#13
REVIEW
C Yong Kang, Yong Gao
The development of an efficient prophylactic HIV vaccine has been one of the major challenges in infectious disease research during the last three decades. Here, we present a mini review on strategies employed for the development of HIV vaccines with an emphasis on a well-established vaccine technology, the killed whole-virus vaccine approach. Recently, we reported an evaluation of the safety and the immunogenicity of a genetically modified and killed whole-HIV-1 vaccine designated as SAV001 [1]. HIV-1 Clade B NL4-3 was genetically modified by deleting the nef and vpu genes and substituting the coding sequence of the Env signal peptide with that of honeybee melittin to produce an avirulent and replication efficient HIV-1...
September 12, 2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/28886946/postmarketing-safety-surveillance-of-trivalent-recombinant-influenza-vaccine-reports-to-the-vaccine-adverse-event-reporting-system
#14
Emily Jane Woo, Pedro L Moro, Maria Cano, Christopher Jankosky
On January 16, 2013, the Food and Drug Administration approved recombinant hemagglutinin influenza vaccine (RIV3) (Spodoptera frugiperda cell line; Flublok), which is the first completely egg-free flu vaccine licensed in the United States. To improve our understanding of the safety profile of this vaccine, we reviewed and summarized reports to the Vaccine Adverse Event Reporting System (VAERS) following RIV3. Through June 30, 2016, VAERS received 88 reports. Allergic reactions, including anaphylaxis, were the most common type of adverse event...
September 5, 2017: Vaccine
https://www.readbyqxmd.com/read/28886907/final-efficacy-immunogenicity-and-safety-analyses-of-a-nine-valent-human-papillomavirus-vaccine-in-women-aged-16-26-years-a-randomised-double-blind-trial
#15
Warner K Huh, Elmar A Joura, Anna R Giuliano, Ole-Erik Iversen, Rosires Pereira de Andrade, Kevin A Ault, Deborah Bartholomew, Ramon M Cestero, Edison N Fedrizzi, Angelica L Hirschberg, Marie-Hélène Mayrand, Angela Maria Ruiz-Sternberg, Jack T Stapleton, Dorothy J Wiley, Alex Ferenczy, Robert Kurman, Brigitte M Ronnett, Mark H Stoler, Jack Cuzick, Suzanne M Garland, Susanne K Kjaer, Oliver M Bautista, Richard Haupt, Erin Moeller, Michael Ritter, Christine C Roberts, Christine Shields, Alain Luxembourg
BACKGROUND: Primary analyses of a study in young women aged 16-26 years showed efficacy of the nine-valent human papillomavirus (9vHPV; HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58) vaccine against infections and disease related to HPV 31, 33, 45, 52, and 58, and non-inferior HPV 6, 11, 16, and 18 antibody responses when compared with quadrivalent HPV (qHPV; HPV 6, 11, 16, and 18) vaccine. We aimed to report efficacy of the 9vHPV vaccine for up to 6 years following first administration and antibody responses over 5 years...
September 5, 2017: Lancet
https://www.readbyqxmd.com/read/28881846/safety-and-efficacy-of-p62-dna-vaccine-elenagen-in-a-first-in-human-trial-in-patients-with-advanced-solid-tumors
#16
Dmitry M Ponomarenko, Irina D Klimova, Yulia A Chapygina, Viktoria V Dvornichenko, Natalia V Zhukova, Rashida V Orlova, Georgy M Manikhas, Alexandr V Zyryanov, Lilya A Burkhanova, Irina I Badrtdinova, Basile N Oshchepkov, Elena V Filippova, Sergei V Orlov, Sergei I Kolesnikov, Albert A Sufianov, Svetlana R Baum, Olga Y Zaitzeva, Andrey B Komissarov, Mikhail P Grudinin, Oleg I Kiselev, Anatoly F Tsyb, Franco Venanzi, Vita Shcherbinina, Andrey Chursov, Vladimir L Gabai, Alexander M Shneider
Elenagen is a plasmid encoding p62/SQSTM1, the first DNA vaccine possessing two mutually complementing mechanisms of action: it elicits immune response against p62 and mitigates systemic chronic inflammation. Previously, Elenagen demonstrated anti-tumor efficacy and safety in rodent tumor models and spontaneous tumors in dogs. This multicenter I/IIa trial evaluated safety and clinical activity of Elenagen in patients with advanced solid tumors. Fifteen patients were treated with escalating doses of Elenagen (1- 5 mg per doses, 5 times weekly) and additional 12 patients received 1 mg dose...
August 8, 2017: Oncotarget
https://www.readbyqxmd.com/read/28881165/safety-and-immunogenicity-of-a-13-valent-pneumococcal-conjugate-vaccine-in-adults-50%C3%A2-to-65%C3%A2-years-of-age-in-india-an-open-label-trial
#17
Bhagirath B Solanki, Christine Juergens, Manojkumar B Chopada, Pravin Supe, Vani Sundaraiyer, Natacha Le Dren-Narayanin, Mark W Cutler, William C Gruber, Daniel A Scott, Beate Schmoele-Thoma
Streptococcus pneumoniae infection is a major global public health concern in older adults, especially as life expectancy continues to increase in most countries, including India. Recently, a 13-valent pneumococcal conjugate vaccine (PCV13) with the ability to enhance immunity (immunologic memory) on natural exposure or revaccination has been shown to protect against community-acquired pneumonia and invasive pneumococcal disease in adults 65 years of age and older. An unconjugated 23-valent pneumococcal polysaccharide vaccine has been available for decades; however, data on protection against pneumonia are inconsistent...
September 7, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28880972/effect-of-modified-vaccinia-ankara-5t4-and-low-dose-cyclophosphamide-on-antitumor-immunity-in-metastatic-colorectal-cancer-a-randomized-clinical-trial
#18
Martin Scurr, Tom Pembroke, Anja Bloom, David Roberts, Amanda Thomson, Kathryn Smart, Hayley Bridgeman, Richard Adams, Alison Brewster, Robert Jones, Sarah Gwynne, Daniel Blount, Richard Harrop, Melissa Wright, Robert Hills, Awen Gallimore, Andrew Godkin
Importance: The success of immunotherapy with checkpoint inhibitors is not replicated in most cases of colorectal cancer; therefore, different strategies are urgently required. The oncofetal antigen 5T4 is expressed in more than 90% of cases of metastatic colorectal cancer (mCRC). Preliminary data using modified vaccinia Ankara-5T4 (MVA-5T4) in mCRC demonstrated that it safely induced serologic and T-cell responses. Objective: To determine whether antitumor immunity in mCRC could be increased using MVA-5T4, metronomic low-dose cyclophosphamide, or a combination of both treatments...
September 7, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28874323/the-effect-of-probiotics-and-zinc-supplementation-on-the-immune-response-to-oral-rotavirus-vaccine-a-randomized-factorial-design-placebo-controlled-study-among-indian-infants
#19
Robin P Lazarus, Jacob John, E Shanmugasundaram, Anand K Rajan, S Thiagarajan, Sidhartha Giri, Sudhir Babji, Rajiv Sarkar, P Saravankumar Kaliappan, Srinivasan Venugopal, Ira Praharaj, Uma Raman, Meghana Paranjpe, Nicholas C Grassly, Edward P K Parker, Umesh D Parashar, Jacqueline E Tate, Jessica A Fleming, A Duncan Steele, Jayaprakash Muliyil, Asha M Abraham, Gagandeep Kang
BACKGROUND: Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function. METHODS: Infants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (10(10)Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix®, GlaxoSmithKline Biologicals) given at 6 and 10weeks of age...
September 2, 2017: Vaccine
https://www.readbyqxmd.com/read/28870657/use-of-biologic-therapy-by-pregnant-women-with-inflammatory-bowel-disease-does-not-affect-infant-response-to-vaccines
#20
Dawn B Beaulieu, Ashwin N Ananthakrishnan, Christopher Martin, Russell D Cohen, Sunanda V Kane, Uma Mahadevan
BACKGROUND & AIMS: In women with inflammatory bowel diseases (IBD), exposure to immunomodulator or biologic therapy has not been associated with adverse events during pregnancy or outcomes of newborns. We investigated whether exposure of patients to these agents during pregnancy affects serologic responses to vaccines in newborns. METHODS: We collected data from the Pregnancy in IBD and Neonatal Outcomes registry, which records outcomes of pregnant women with diagnosis of IBD receiving care at multiple centers in the United States, from 2007 - 2016...
September 1, 2017: Clinical Gastroenterology and Hepatology
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