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Vaccine adverse events

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https://www.readbyqxmd.com/read/28430750/elevated-immune-response-among-children-4-years-of-age-with-pronounced-local-adverse-events-after-the-fifth-dtap-vaccination
#1
Saskia van der Lee, Jeanet M Kemmeren, Lia G H de Rond, Kemal Öztürk, Anneke Westerhof, Hester E de Melker, Elisabeth A M Sanders, Guy A M Berbers, Nicoline A T van der Maas, Hans C Rümke, Anne-Marie Buisman
BACKGROUND: In the Netherlands, acellular pertussis vaccines replaced the more reactogenic whole-cell pertussis vaccines. This replacement in the primary immunization schedule of infants coincided with a significant increase in pronounced local adverse events (AEs) in 4 years old children shortly after the administration of a fifth diphtheria, tetanus, acellular pertussis and inactivated polio (DTaP-IPV) vaccine. The objective of this study was to investigate possible differences in vaccine antigen-specific immune responses between children with and without a pronounced local AE after the fifth DTaP-IPV vaccination...
April 19, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28429115/comparison-of-the-tolerability-of-newly-introduced-childhood-vaccines-in-the-netherlands
#2
Jeanet M Kemmeren, Nicoline At van der Maas, Hester E de Melker
In 2011, the 7-valent conjugated pneumococcal vaccine (PCV7) was replaced by the 10-valent vaccine (PCV10) and universal hepatitis B vaccination has been introduced in the Netherlands. A questionnaire study was conducted to assess the tolerability of DTaP-IPV-Hib + PCV7 (PCV7-cohort), DTaP-IPV-Hib + PCV10 (PCV10-cohort), and DTaP-IPV-Hib-HepB + PCV10 (HepB-cohort). Parents were asked to report in questionnaires local reactions and systemic adverse events (AEs) before and after vaccination of their infant at 2, 3, 4, and 11 months of age...
April 20, 2017: European Journal of Pediatrics
https://www.readbyqxmd.com/read/28427844/cost-effectiveness-of-influenza-vaccination-in-patients-with-acute-coronary-syndrome-in-korea
#3
Jinuk Suh, Boyeon Kim, Yunseok Yang, Dong-Churl Suh, Eunyoung Kim
BACKGROUND: Influenza can cause cardiovascular abnormalities by inappropriately activating the coagulation cascade. Therefore, influenza vaccination is important because it decreases the risk of hospitalization for and mortality associated with heart disease. In particular, it reduces the occurrence of major adverse cardiovascular events (MACEs) in acute coronary syndrome (ACS) patients. Our study aimed to estimate the disease burden of MACEs and its related direct and indirect costs in ACS patients...
April 17, 2017: Vaccine
https://www.readbyqxmd.com/read/28424287/protective-efficacy-of-formaldehyde-inactivated-whole-virus-vaccine-and-antivirals-in-a-murine-model-of-coxsackievirus-a10-infection
#4
Zhenjie Zhang, Zhaopeng Dong, Juan Li, Michael J Carr, Dongming Zhuang, Jianxing Wang, Yawei Zhang, Shujun Ding, Yigang Tong, Dong Li, Weifeng Shi
Coxsackievirus A10 (CVA10) is one of the major pathogens associated with hand, foot and mouth disease (HFMD). CVA10 infection can cause herpangina and viral pneumonia, which can be complicated by severe neurological sequelae. Morbidity and mortality of CVA10-associated HFMD has been increasing in recent years, particularly in the pan-Pacific region. There are limited studies however on the pathogenesis and immunology of CVA10-associated HFMD infections, and few antiviral drugs or vaccines have been reported...
April 19, 2017: Journal of Virology
https://www.readbyqxmd.com/read/28419095/effectiveness-of-a-live-oral-human-rotavirus-vaccine-after-programmatic-introduction-in-bangladesh-a-cluster-randomized-trial
#5
K Zaman, David A Sack, Kathleen M Neuzil, Mohammad Yunus, Lawrence H Moulton, Jonathan D Sugimoto, Jessica A Fleming, Ilias Hossain, Shams El Arifeen, Tasnim Azim, Mustafizur Rahman, Kristen D C Lewis, Andrea J Feller, Firdausi Qadri, M Elizabeth Halloran, Alejandro Cravioto, John C Victor
BACKGROUND: Rotavirus vaccines are now globally recommended by the World Health Organization (WHO), but in early 2009 WHO's Strategic Advisory Group of Experts on Immunization reviewed available data and concluded that there was no evidence for the efficacy or effectiveness of a two-dose schedule of the human rotavirus vaccine (HRV; Rotarix) given early at 6 and 10 wk of age. Additionally, the effectiveness of programmatic rotavirus vaccination, including possible indirect effects, has not been assessed in low-resource populations in Asia...
April 2017: PLoS Medicine
https://www.readbyqxmd.com/read/28416261/feasibility-study-of-personalized-peptide-vaccination-for-advanced-small-cell-lung-cancer
#6
Shinjiro Sakamoto, Teppei Yamada, Yasuhiro Terazaki, Koichi Yoshiyama, Shunichi Sugawara, Shinzo Takamori, Satoko Matsueda, Shigeki Shichijo, Akira Yamada, Masanori Noguchi, Kyogo Itoh, Noboru Hattori, Nobuoki Kohno, Tetsuro Sasada
INTRODUCTION: The prognosis of patients with small cell lung cancer (SCLC) remains very poor. Therefore, the development of new therapeutic approaches, including immunotherapies, is desirable. PATIENTS AND METHODS: We conducted a phase II study of personalized peptide vaccination (PPV), in which a maximum of 4 human leukocyte antigen-matched peptides were selected from 31 pooled peptides according to the pre-existing peptide-specific IgG responses before vaccination...
March 24, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28413427/immunogenicity-and-safety-of-a-respiratory-syncytial-virus-fusion-protein-rsv-f-nanoparticle-vaccine-in-older-adults
#7
Louis Fries, Vivek Shinde, Jeffrey J Stoddard, D Nigel Thomas, Eloi Kpamegan, Hanxin Lu, Gale Smith, Somia P Hickman, Pedro Piedra, Gregory M Glenn
BACKGROUND: A preventative strategy for Respiratory Syncytial Virus (RSV) infection constitutes an under-recognized unmet medical need among older adults. Four formulations of a novel recombinant RSV F nanoparticle vaccine (60 or 90 μg RSV F protein, with or without aluminum phosphate adjuvant) administered concurrently with a licensed inactivated trivalent influenza vaccine (TIV) in older adult subjects were evaluated for safety and immunogenicity in this randomized, observer-blinded study...
2017: Immunity & Ageing: I & A
https://www.readbyqxmd.com/read/28410812/cd4-t-cells-support-establishment-of-rsv-specific-igg-and-iga-antibody-secreting-cells-in-the-upper-and-lower-murine-respiratory-tract-following-rsv-infection
#8
Robert E Sealy, Sherri L Surman, Julia L Hurwitz
The RSV vaccine field suffered a major set-back when children were vaccinated with a formalin-inactivated RSV vaccine (FI-RSV). Unexpectedly, the vaccinated children fared worse than unvaccinated children when they were naturally infected with RSV. Mouse models were then developed that implicated the CD4(+) T helper cell population as a contributor to adverse events. Today, the T cell is viewed with much caution in the RSV field, and its induction by vaccination is sometimes discouraged. Here we re-emphasize the beneficial role of the CD4(+) T cell...
April 11, 2017: Vaccine
https://www.readbyqxmd.com/read/28408120/quantifying-population-preferences-around-vaccination-against-severe-but-rare-diseases-a-conjoint-analysis-among-french-university-students-2016
#9
Joy Seanehia, Carole Treibich, Christine Holmberg, Jacqueline Müller-Nordhorn, Valerie Casin, Jocelyn Raude, Judith E Mueller
BACKGROUND: Several concepts are available to explain vaccine decision making by individual and inter-individual factors, including risk perception, social conformism and altruism. However, only a few studies have quantified the weight of these determinants in vaccine acceptance. Using a conjoint analysis tool, we aimed at eliciting preferences in a student population regarding vaccination against a rare, severe and rapidly evolving hypothetical disease, similar to meningococcal serogroup C meningitis or measles...
April 10, 2017: Vaccine
https://www.readbyqxmd.com/read/28406752/comparison-of-the-immunogenicity-and-safety-of-the-purified-chick-embryo-cell-rabies-vaccine-manufactured-in-india-and-germany-a-randomised-single-blind-multicentre-phase-iv-clinical-study
#10
Gadey Sampath, Angelika Banzhoff, Alaka Deshpande, Claudius Malerczyk, Ashwani Kumar Arora, Hoshang Vakil, Scott Preiss
This phase IV, single blind study assessed the immunogenicity and safety of India-manufactured purified chick embryo cell rabies vaccine (PCECV), compared to a German-manufactured batch obtained by the same production process. A total of 340 participants enrolled at 2 study sites in India were randomised (1:1:1:1) in 4 groups to receive a 5-dose Essen regimen with either 1 of the 3 Indian batches (PCECV-I) or the German batch (PCECV-G), administered on Days (D) 0, 3, 7, 14 and 30. The lot-to-lot consistency of PCECV-I batches in terms of induced immune response at D14 was demonstrated...
April 13, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28406746/immunogenicity-and-safety-of-a-cell-culture-derived-inactivated-quadrivalent-influenza-vaccine-nbp607-qiv-a-randomized-double-blind-multi-center-phase-iii-clinical-trial-in-adults-and-elderly-subjects
#11
Won Suk Choi, Ji Yun Noh, Joon Young Song, Hee Jin Cheong, Seong-Heon Wie, Jin Soo Lee, Jacob Lee, Shin-Woo Kim, Hye Won Jeong, Sook-In Jung, Yeon-Sook Kim, Heung Jeong Woo, Kyung Ho Kim, Hun Kim, Woo Joo Kim
BACKGROUND: The influenza B virus has two lineages; Yamagata and Victoria. The two lineages are antigenically distinct and it is difficult to expect cross-protection between the lineages. Actually, the mismatch between circulating influenza B viruses and vaccine strains has been occurred frequently. The cell-culture system for the production of influenza vaccine can contribute to improve vaccine strain selection and expand vaccine supplies. We investigated the immunogenicity and safety of cell culture-derived quadrivalent inactivated influenza vaccine (NBP607-QIV) in adults and elderly subjects...
April 13, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28404357/the-safety-and-immunogenicity-of-quadrivalent-hpv-qhpv-vaccine-in-systemic-lupus-erythematosus
#12
J Patricia Dhar, Lynnette Essenmacher, Renee Dhar, Ardella Magee, Joel Ager, Robert J Sokol
OBJECTIVE: This study evaluated the safety and immunogenicity of qHPV vaccine in SLE. METHODS: Subjects: 34 women ages 19-50years (yrs.) with mild to moderate SLE & minimally active or inactive SLE received qHPV vaccine at the standard dosing schedule. EXCLUSION CRITERIA: active SLE disease (SELENA-SLEDAI>2), history of severe SLE disease, deep venous thrombosis, on >400mg/day of hydroxychloroquine, on >15mg/day of prednisone, or active infections...
April 9, 2017: Vaccine
https://www.readbyqxmd.com/read/28403055/immunogenicity-and-safety-of-10-valent-pneumococcal-nontypeable-haemophilus-influenzae-protein-d-conjugate-vaccine-phid-cv-administered-to-children-with-sickle-cell-disease-between-8-weeks-and-2-years-of-age-a-phase-iii-open-controlled-study
#13
Sodiomon B Sirima, Alfred Tiono, Zakaria Gansané, Mohamadou Siribié, Angèle Zongo, Alphonse Ouédraogo, Nancy François, Ana Strezova, Kurt Dobbelaere, Dorota Borys
BACKGROUND: Immunogenicity, safety and reactogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) were evaluated in children with sickle cell disease (SCD), who are at increased risk for infections. METHODS: In this phase III, open-label, single-center, controlled study in Burkina Faso (NCT01175083), children with SCD (S) or without SCD (NS) were assigned to 6 groups (N = 300): children 8-11 weeks of age (<6 months; <6S and <6NS groups) received 3 primary doses and a booster dose of PHiD-CV coadministered with routine childhood vaccines; children 7-11 months of age (7-11S and 7-11NS groups) received 2 primary doses and a booster dose of PHiD-CV; children 12-23 months of age (12-23S and 12-23NS groups) received 2 catch-up doses of PHiD-CV...
May 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28398711/major-birth-defects-after-vaccination-reported-to-the-vaccine-adverse-event-reporting-system-vaers-1990-to-2014
#14
Pedro L Moro, Janet Cragan, Paige Lewis, Lakshmi Sukumaran
BACKGROUND: Major birth defects are important infant outcomes that have not been well studied in the postmarketing surveillance of vaccines given to pregnant women. We assessed the presence of major birth defects following vaccination in the Vaccine Adverse Event Reporting System (VAERS), a national spontaneous reporting system used to monitor the safety of vaccines in the United States. METHODS: We searched VAERS for reports of major birth defects during January 1, 1990, through December 31, 2014...
April 11, 2017: Birth Defects Res
https://www.readbyqxmd.com/read/28394705/establishment-of-a-cohort-for-deep-phenotyping-of-the-immune-response-to-influenza-vaccination-among-elderly-individuals-recruited-from-the-general-population
#15
Manas K Akmatov, Peggy Riese, Marcus May, Leonhard Jentsch, Malik W Ahmed, Damaris Werner, Anja Rösel, Megan Tyler, Kevin Pessler, Jana Prokein, Inga Bernemann, Norman Klopp, Blair Prochnow, Stephanie Trittel, Aravind Tallam, Thomas Illig, Christoph Schindler, Carlos A Guzmán, Frank Pessler
Elderly individuals have the highest burden of disease from influenza infection but also the lowest immune response to influenza vaccination. A better understanding of the host response to influenza vaccination in the elderly is therefore urgently needed. We conducted a biphasic prospective, population-based study from Dec. 2014 to May 2015 (pilot study) and Sept. 2015 to May 2016 (main study). Individuals 65-80 y of age were randomly selected from the residents' registration office in Hannover, Germany, for the pilot (n = 34) and main study (n = 200)...
April 10, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28391357/phase-i-iia-clinical-trial-of-a-novel-htert-peptide-vaccine-in-men-with-metastatic-hormone-naive-prostate-cancer
#16
Wolfgang Lilleby, Gustav Gaudernack, Paal F Brunsvig, Ljiljana Vlatkovic, Melanie Schulz, Kate Mills, Knut Håkon Hole, Else Marit Inderberg
In newly diagnosed metastatic hormone-naive prostate cancer (mPC), telomerase-based immunotherapy with the novel hTERT peptide vaccine UV1 can induce immune responses with potential clinical benefit. This phase I dose escalation study of UV1 evaluated safety, immune response, effects on prostate-specific antigen (PSA) levels, and preliminary clinical outcome. Twenty-two patients with newly diagnosed metastatic hormone-naïve PC (mPC) were enrolled; all had started androgen deprivation therapy and had no visceral metastases...
April 8, 2017: Cancer Immunology, Immunotherapy: CII
https://www.readbyqxmd.com/read/28390934/immunogenicity-and-safety-of-a-quadrivalent-inactivated-influenza-virus-vaccine-compared-with-a-comparator-quadrivalent-inactivated-influenza-vaccine-in-a-pediatric-population-a-phase-3-randomized-noninferiority-study
#17
Jolanta Airey, Frank R Albano, Daphne C Sawlwin, Alison Graves Jones, Neil Formica, Vince Matassa, Jane Leong
BACKGROUND: Seqirus 2010 Southern Hemisphere split-virion trivalent inactivated influenza vaccine (IIV3) was associated with increased febrile reactions in children. Studies in vitro concluded that increasing concentrations of splitting agent decreased residual lipids and attenuated proinflammatory cytokine signals associated with fever. We assessed immunogenicity and safety of a quadrivalent inactivated influenza vaccine (IIV4; produced using higher concentration of splitting agent) versus a United States-licensed comparator IIV4 in healthy children aged 5-17years...
April 5, 2017: Vaccine
https://www.readbyqxmd.com/read/28390584/live-attenuated-influenza-vaccine-use-and-safety-in-children-and-adults-with-asthma
#18
Jonathan Duffy, Melissa Lewis, Theresa Harrington, Roger Baxter, Edward A Belongia, Lisa A Jackson, Steven J Jacobsen, Grace M Lee, Allison L Naleway, James Nordin, Matthew F Daley
BACKGROUND: Live attenuated influenza vaccine (LAIV) might increase the risk of wheezing in persons with asthma or children younger than 5 years with a history of recurrent wheezing. OBJECTIVE: To describe the use and assess the safety of LAIV in persons with asthma in the Vaccine Safety Datalink population. METHODS: We identified persons with asthma using diagnosis codes and medication records in 7 health care organizations over 3 influenza seasons (2008-2009 through 2010-2011) and determined their influenza vaccination rates...
April 2017: Annals of Allergy, Asthma & Immunology
https://www.readbyqxmd.com/read/28390326/active-safety-monitoring-of-measles-mumps-rubella-vaccine-in-the-national-immunisation-programme-of-sri-lanka
#19
K Sanchayan, R Fernandopulle, A Amarasinghe, S N Thiyahiny, S Sri Ranganathan
Objectives: This study was designed to report incidence and characteristics of selected adverse events following immunisation which have consistent causal association (AEFIc) with Measles-Mumps-Rubella (MMR) vaccination given at the age of one year in the National Immunisation Programme of Sri Lanka. Methods: The data presented here were obtained from a cohort event monitoring study. It was carried out in the Jaffna Regional Directorate of Health Services area from November 2012 to December 2014...
March 31, 2017: Ceylon Medical Journal
https://www.readbyqxmd.com/read/28388548/safety-and-efficacy-of-p62-dna-vaccine-elenagen-in-a-first-in-human-trial-in-patients-with-advanced-solid-tumors
#20
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...
March 25, 2017: Oncotarget
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