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Vaccine adverse events

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https://www.readbyqxmd.com/read/29158855/clinical-evaluation-of-terap-c-vaccine-in-combined-treatment-with-interferon-and-ribavirin-in-patients-with-hepatitis-c
#1
Dorta Guridi Zaily, Castellanos Fernandez Marlen, Dueñas-Carrera Santiago, Martínez Donato Gillian, Valenzuela Silva Carmen, Cinza Estevez Zurina, Arús Soler Enrique R, Alvarez-Lajonchere Liz, González Fabián Lisset, Lazo Del Vallín Sacha, Ferrer Bataille Elena
Background: An estimated 170 million individuals worldwide are infected with the hepatitis C virus (HCV). Although treatment options using a combination of pegylated interferon and ribavirin (P-IFN/RBV) are available, sustained clearance of the virus is only achieved in approximately 40% of individuals infected with HCV genotype 1. Recent advances in the treatment of HCV using directly acting antiviral agents have been achieved; however, treatment can be very expensive and is associated with substantial side effects...
2017: Current Therapeutic Research, Clinical and Experimental
https://www.readbyqxmd.com/read/29158617/pertussis-outbreak-in-polish-shooters-with-adverse-event-analysis
#2
Monika Skrzypiec-Spring, Jarosław Krzywański, Monika Karlikowska-Skwarnik, Andrzej Pokrywka, Hubert Krysztofiak, Aneta Nitsch-Osuch, Ernest Kuchar
In addition to different injuries, infections are the most common reason for giving up training altogether or reducing its volume and intensity, as well as a lack of opportunities to participate in sports competitions. Nowadays, a slow but constant re-emergence of pertussis, especially among teenagers and young adults, including athletes, can be observed. This paper describes an outbreak of pertussis among professional Polish shooters, focusing on the transmission of Bordetella pertussis infection between members of the national team, its influence on performance capacity and adverse event analysis...
September 2017: Biology of Sport
https://www.readbyqxmd.com/read/29148124/the-safety-of-live-attenuated-influenza-vaccine-in-children-and-adolescents-2-through-17%C3%A2-years-of-age-a-vaccine-safety-datalink-study
#3
Matthew F Daley, Christina L Clarke, Jason M Glanz, Stanley Xu, Simon J Hambidge, James G Donahue, James D Nordin, Nicola P Klein, Steven J Jacobsen, Allison L Naleway, Michael L Jackson, Grace Lee, Jonathan Duffy, Eric Weintraub
PURPOSE: To evaluate the safety of live attenuated influenza vaccine (LAIV) in children 2 through 17 years of age. METHODS: The study was conducted in 6 large integrated health care organizations participating in the Vaccine Safety Datalink (VSD). Trivalent LAIV safety was assessed in children who received LAIV between September 1, 2003 and March 31, 2013. Eighteen pre-specified adverse event groups were studied, including allergic, autoimmune, neurologic, respiratory, and infectious conditions...
November 17, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29145470/active-immunization-in-patients-transplanted-for-hepatitis-b-virus-related-liver-diseases-a-prospective-study
#4
Anli Yang, Zhiyong Guo, Qingqi Ren, Linwei Wu, Yi Ma, Anbin Hu, Dongping Wang, Haidan Ye, Xiaofeng Zhu, Weiqiang Ju, Xiaoshun He
INTRODUCTION: Prophylactic administration of hepatitis B immunoglobulin (HBIG) and nucleos(t)ide analogues (NAs) is the standard treatment for controlling hepatitis B virus (HBV) recurrence after liver transplantation (LT). Since lifelong use of HBIG is expensive and inconvenient and the antibodies level in anti-hepatitis B surface (HBs) is not sustainable and stable, an alternative strategy is to produce anti-HBs antibodies by active immunization. Our present study aimed to prospectively investigate the efficacy and safety of procedural HBV vaccination in transplanted patients...
2017: PloS One
https://www.readbyqxmd.com/read/29140444/safety-and-immunogenicity-of-different-formulations-of-norovirus-vaccine-candidate-in-healthy-adults-a-randomized-controlled-double-blind-clinical-trial
#5
G Leroux-Roels, J P Cramer, P M Mendelman, J Sherwood, R Clemens, A Aerssens, I De Coster, A Borkowski, F Baehner, P Van Damme
Background: We investigated safety and immunogenicity of 1-2 doses of different bivalent virus-like particle (VLP) norovirus vaccine candidate (NoV) formulations in healthy 18-64-year-olds. Methods: On Days 1 and 28 participants (n=420) randomized to 14 equal groups received intramuscular control vaccine (hepatitis A) or one of 11 NoV formulations contained varying dosages of GI.1 and GII.4c genotype VLP antigens with Al(OH)3, and 0μg, 15μg or 50μg MPL. Immunogenicity was assessed on Days 1, 28, 56, 208 and 393...
November 13, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/29136037/safety-pharmacokinetics-and-immunological-activities-of-multiple-intravenous-or-subcutaneous-doses-of-an-anti-hiv-monoclonal-antibody-vrc01-administered-to-hiv-uninfected-adults-results-of-a-phase-1-randomized-trial
#6
Kenneth H Mayer, Kelly E Seaton, Yunda Huang, Nicole Grunenberg, Abby Isaacs, Mary Allen, Julie E Ledgerwood, Ian Frank, Magdalena E Sobieszczyk, Lindsey R Baden, Benigno Rodriguez, Hong Van Tieu, Georgia D Tomaras, Aaron Deal, Derrick Goodman, Robert T Bailer, Guido Ferrari, Ryan Jensen, John Hural, Barney S Graham, John R Mascola, Lawrence Corey, David C Montefiori
BACKGROUND: VRC01 is an HIV-1 CD4 binding site broadly neutralizing antibody (bnAb) that is active against a broad range of HIV-1 primary isolates in vitro and protects against simian-human immunodeficiency virus (SHIV) when delivered parenterally to nonhuman primates. It has been shown to be safe and well tolerated after short-term administration in humans; however, its clinical and functional activity after longer-term administration has not been previously assessed. METHODS AND FINDINGS: HIV Vaccine Trials Network (HVTN) 104 was designed to evaluate the safety and tolerability of multiple doses of VRC01 administered either subcutaneously or by intravenous (IV) infusion and to assess the pharmacokinetics and in vitro immunologic activity of the different dosing regimens...
November 2017: PLoS Medicine
https://www.readbyqxmd.com/read/29132988/safety-and-immunogenicity-of-a-novel-multiple-antigen-pneumococcal-vaccine-in-adults-a-phase-1-randomised-clinical-trial
#7
Claire Entwisle, Sue Hill, Yin Pang, Michael Joachim, Ann McIlgorm, Camilo Colaco, David Goldblatt, Polly De Gorguette D'Argoeuves, Chris Bailey
BACKGROUND: Pneumococcal vaccines, combining multiple protein antigens, provide an alternative approach to currently marketed vaccines and may provide broader protection against pneumococcal disease. This trial evaluated the safety and immunogenicity of a novel vaccine candidate PnuBioVax in healthy young adults. METHODS: In a Phase 1 double-blind study, 36 subjects (18-40 years) were randomised to receive 3 doses of PnuBioVax, 28 days apart, at one of three dose levels (50, 200, 500 µg) or placebo...
November 10, 2017: Vaccine
https://www.readbyqxmd.com/read/29129247/association-between-influenza-vaccination-and-reduced-risks-of-major-adverse-cardiovascular-events-in-elderly-patients
#8
Ming-Hsien Chiang, Hau-Hsin Wu, Chia-Jen Shih, Yung-Tai Chen, Shu-Chen Kuo, Te-Li Chen
BACKGROUND: This study was conducted to determine the protective effect of influenza vaccine against primary major adverse cardiovascular events (MACEs) in elderly patients, especially those with influenza-like illness (ILI). METHODS: This retrospective, population-based case-control study of an elderly population (age≥65 years) was conducted using Taiwan's National Health Insurance Research Database (2000-2013). One control was selected for each MACE case (n=80,363 each), matched according to age, year of study entry, and predisposing factors for MACEs...
November 2017: American Heart Journal
https://www.readbyqxmd.com/read/29128382/bad-news-the-influence-of-news-coverage-and-google-searches-on-gardasil-adverse-event-reporting
#9
Kate Faasse, Jarry T Porsius, Jonathan Faasse, Leslie R Martin
BACKGROUND: Human papilloma virus vaccines are a safe and effective tool for reducing HPV infections that can cause cervical cancer. However, uptake of these vaccines has been suboptimal, with many people holding negative beliefs and misconceptions. Such beliefs have been linked with the experience of unpleasant side effects following medical treatment, and media coverage may heighten such concerns. METHODS: The present study sought to assess the influence of news coverage (number of news articles per month) on adverse event reporting in response to Gardasil vaccination in New Zealand over a 7...
November 8, 2017: Vaccine
https://www.readbyqxmd.com/read/29128379/active-sms-based-influenza-vaccine-safety-surveillance-in-australian-children
#10
Alexis Pillsbury, Helen Quinn, Patrick Cashman, Alan Leeb, Kristine Macartney
INTRODUCTION: Australia's novel, active surveillance system, AusVaxSafety, monitors the post-market safety of vaccines in near real time. We analysed cumulative surveillance data for children aged 6 months to 4 years who received seasonal influenza vaccine in 2015 and/or 2016 to determine: adverse event following immunisation (AEFI) rates by vaccine brand, age and concomitant vaccine administration. METHODS: Parent/carer reports of AEFI occurring within 3 days of their child receiving an influenza vaccine in sentinel immunisation clinics were solicited by Short Message Service (SMS) and/or email-based survey...
November 8, 2017: Vaccine
https://www.readbyqxmd.com/read/29126292/safety-and-immunogenicity-of-inactivated-varicella-zoster-virus-vaccine-in-adults-with-autoimmune-disease-a-phase-2-randomized-double-blind-placebo-controlled-clinical-trial
#11
Michael Eberhardson, Stephen Hall, Kim A Papp, Tina M Sterling, Jon E Stek, Lei Pang, Yanli Zhao, Janie Parrino, Zoran Popmihajlov
Background: Immunogenicity and safety of inactivated zoster vaccine (ZVIN) were evaluated in adults with autoimmune disease. Methods: Adults with autoimmune disease treated with immunosuppressive therapy (biologic or nonbiologic) were randomized to receive 4 doses of ZVIN, ZVIN containing a higher quantity of antigen, or placebo. To measure varicella-zoster virus (VZV)-specific immune responses using glycoprotein enzyme-linked immunosorbent assay (gpELISA) and interferon-gamma enzyme-linked immunospot (IFN-γ ELISPOT), blood samples were collected at baseline, post-doses 2, 3, and 4...
October 1, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/29122463/immunogenicity-and-safety-of-one-versus-two-doses-of-tetravalent-dengue-vaccine-in-healthy-children-aged-2-17-years-in-asia-and-latin-america-18-month-interim-data-from-a-phase-2-randomised-placebo-controlled-study
#12
Xavier Sáez-Llorens, Vianney Tricou, Delia Yu, Luis Rivera, José Jimeno, Ana Cecilia Villarreal, Epiphany Dato, Sonia Mazara, Maria Vargas, Manja Brose, Martina Rauscher, Suely Tuboi, Astrid Borkowski, Derek Wallace
BACKGROUND: Development of vaccines that are effective against all four dengue virus serotypes (DENV-1-4) in all age groups is important. Here, we present 18-month interim data from an ongoing study undertaken to assess the immunogenicity and safety of Takeda's tetravalent dengue vaccine (TDV) candidate over 48 months in children living in dengue-endemic countries. METHODS: We undertook a phase 2, multicentre, randomised, double-blind, placebo-controlled study at three sites in the Dominican Republic, Panama, and the Philippines...
November 6, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29116880/safety-and-immunogenicity-of-clostridium-difficile-toxoid-vaccine-in-japanese-adults
#13
Osamu Matsuoka, Dhaval M Patel, Shin Sasaki, Hayato Oka, Toru Sasaki, Patricia J Pietrobon, Thelma Laot, Alain Bouckenooghe, Josemund Menezes, Guy de Bruyn
This was a randomized, placebo-controlled, Phase I/II study conducted in a Japanese cohort to assess the safety and immunogenicity of Clostridium difficile vaccine (the same formulation as that used in the ongoing global Phase III study). Healthy Japanese adults aged 40-75 years were randomized to receive either C. difficile vaccine (N = 67) or placebo (N = 34) by intramuscular injection on Days 0, 7, and 30. Serum IgG specific for toxins A and B was measured by enzyme-linked immunosorbent assay (ELISA) and in vitro functional activity by toxin neutralizing assay (TNA)...
November 8, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29116597/response-to-tetanus-and-pneumococcal-vaccination-following-administration-of-ixekizumab-in-healthy-participants
#14
Elisa V Gomez, Jessie L Bishop, Kimberley Jackson, Talia M Muram, Diane Phillips
BACKGROUND: Ixekizumab (IXE) is an interleukin (IL)-17A antagonist approved for the treatment of adults with moderate-to-severe psoriasis. OBJECTIVE: The objective of this study was to determine if the immune response to tetanus and pneumococcal vaccines in healthy subjects administered IXE was noninferior to control. METHODS: In a randomized, open-label, parallel-group study, adult subjects received vaccinations alone (N = 42, control) or in combination with 160 mg IXE subcutaneously 2 weeks prior to vaccination and 80 mg IXE on the day of vaccination (N = 41, IXE)...
November 7, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/29110942/adjuvant-therapy-for-locally-advanced-renal-cell-carcinoma-a-meta-analysis-and-systematic-review
#15
Yangyang Bai, Songchao Li, Zhankui Jia, Yinghui Ding, Chaohui Gu, Jinjian Yang
OBJECTIVES: Many adjuvant therapies have been widely used in an attempt to reduce the local recurrence or distant metastasis of locally advanced renal cell carcinoma (RCC) after surgical resection. However, the benefits of adjuvant therapy remain controversial. Thus, we performed this study to analyze the role and safety of adjuvant therapy in renal cancer setting. METHODS AND METHODS: We comprehensively searched PubMed, EMBASE, Web of Science, and the Cochrane Library for published randomized controlled trials comparing adjuvant therapy (chemotherapy, vaccine therapy, immune therapy, and targeted therapy) versus no active treatment after surgery among patients with locoregional RCC...
October 27, 2017: Urologic Oncology
https://www.readbyqxmd.com/read/29104170/general-practitioners-perceptions-of-vaccination-controversies-a-french-nationwide-cross-sectional-study
#16
Marion le Marechal, Lisa Fressard, Nelly Agrinier, Pierre Verger, Céline Pulcini
OBJECTIVES: - We aimed to study general practitioners (GPs) perceptions of vaccines that have been the object of controversies in France. METHODS: - A cross-sectional survey in 2014 asked a representative national sample of GPs, randomly selected from the exhaustive database of health professionals in France, about their perceptions of the likelihood of serious adverse events potentially associated with six different vaccines: for two of them the association was based on some scientific evidence, whereas for the other four this is not the case...
November 2, 2017: Clinical Microbiology and Infection
https://www.readbyqxmd.com/read/29100708/safety-and-immune-response-after-two-dose-meningococcal-c-conjugate-immunization-in-hiv-infected-children-and-adolescents-in-rio-de-janeiro-brazil
#17
Ana Cristina C Frota, Bianca Ferreira, Lee H Harrison, Gisele S Pereira, Wania Pereira-Manfro, Elizabeth S Machado, Ricardo Hugo de Oliveira, Thalita F Abreu, Lucimar G Milagres, Cristina B Hofer
We aimed to evaluate immunogenicity and adverse events (AEs) after a booster dose of Meningococcal C conjugated (MCC) vaccine in HIV-infected children and adolescents, who had a previous low seroconversion rate after priming with MCC, at a reference HIV-care center in Rio de Janeiro. METHODS: 2-18 years old HIV-infected subjects with CD4+ T-lymphocyte cell (CD4) ≥15%, without active infection or antibiotic use, were enrolled to receive 2 doses of conjugated meningococcal C oligosaccharide-CRM197 12-18 months apart...
October 31, 2017: Vaccine
https://www.readbyqxmd.com/read/29096936/nanogel-based-nasal-vaccines-for-infectious-and-lifestyle-related-diseases
#18
REVIEW
Tatsuhiko Azegami, Yoshikazu Yuki, Rika Nakahashi, Hiroshi Itoh, Hiroshi Kiyono
Because the mucosa is the major entry route for most pathogens, the development of mucosal vaccines is a rational approach for protecting against these undesired agents. Mucosal administration of vaccine antigen is useful for non-infectious chronic diseases as well, because of its advantages over injection routes, including comparable efficacy in the induction of systemic immune responses, less pain, and no risk of adverse events at the injection site. However, because it is difficult to effectively induce and regulate antigen-specific mucosal and systemic immune responses when antigen alone is mucosally administered, an appropriate form of mucosal delivery vehicle must be used...
October 30, 2017: Molecular Immunology
https://www.readbyqxmd.com/read/29082646/safety-and-efficacy-of-telbivudine-for-chronic-hepatitis-b-during-the-entire-pregnancy-long-term-follow-up
#19
J Shang, Q Wen, C C Wang, K Liu, L Bai, H Tang
The management of hepatitis B virus (HBV) infection in pregnancy is a unique issue. Telbivudine (LdT) is recommended to block HBV mother-to-child transmission (MTCT) in the third trimester. However, the safety of LdT treatment during the entire pregnancy for the long-term growth of infants is unclear. The aim of this study was to evaluate the efficacy and long-term safety of LdT for the entire pregnancy period. This retrospective cohort study included 40 pregnant women and 43 children from 2011 to 2017. The antiviral effects and maternal abnormalities were evaluated...
November 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/29081368/immunogenicity-and-safety-of-a-single-dose-of-a-live-attenuated-japanese-encephalitis-chimeric-virus-vaccine-in-vietnam-a-single-arm-single-center-study
#20
Vu Dinh Thiem, Nguyen Dang Quang, Tran Thi Ai Huong, Valérie Bosch-Castells, Céline Zocchetti, Guy Houillon
OBJECTIVE: To describe the immunogenicity and safety of the Japanese encephalitis chimeric virus vaccine (JE-CV) in children and adults in Vietnam. METHODS: In this prospective, open-label, single-center, single-arm study, 250 healthy participants aged 9 months to 60 years received a single dose of JE-CV (IMOJEV(®)). JE neutralizing antibody titers were assessed at baseline and 28days after vaccination using the 50% plaque reduction neutralization test (PRNT50)...
October 25, 2017: International Journal of Infectious Diseases: IJID
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