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Vaccine adverse events

Corinna La Rosa, Jeff Longmate, Joy Martinez, Qiao Zhou, Teodora I Kaltcheva, Weimin Tsai, Jennifer Drake, Mary Carroll, Felix Wussow, Flavia Chiuppesi, Nicola Hardwick, Sanjeet Dadwal, Ibrahim Aldoss, Ryotaro Nakamura, John A Zaia, Don J Diamond
Attenuated poxvirus Modified vaccinia Ankara (MVA) is a useful viral-based vaccine for clinical investigation, because of its excellent safety profile and property of inducing potent immune responses against recombinant (r) antigens. We developed Triplex by constructing an rMVA encoding three immunodominant CMV antigens which stimulates a host anti-viral response: UL83 (pp65), UL123 (IE1-exon4), and UL122 (IE2-exon5). We completed the first clinical evaluation of the Triplex vaccine in 24 healthy adults, with or without immunity to CMV and vaccinia virus (previous DryVax smallpox vaccination)...
October 19, 2016: Blood
Wataru Obara, Takashi Karashima, Kazuyoshi Takeda, Renpei Kato, Yoichiro Kato, Mitsugu Kanehira, Ryo Takata, Keiji Inoue, Toyomasa Katagiri, Taro Shuin, Yusuke Nakamura, Tomoaki Fujioka
PURPOSE: Through genome-wide expression profile analysis, hypoxia-inducible protein 2 (HIG2) has previously been identified as an oncoprotein involved in development/progression of renal cell carcinoma (RCC). We subsequently identified a highly immunogenic HLA-A*0201/0206-restricted epitope peptide (HIG2-9-4) corresponding to a part of HIG2 and applied it as a therapeutic vaccine. We conducted a phase I clinical trial using the HIG2-9-4 peptide for patients with advanced RCC. MATERIALS AND METHODS: Nine patients having HLA-A*0201 or HLA-A*0206 with metastatic or unresectable RCC after failure of the cytokine and/or tyrosine kinase inhibitor therapies were enrolled in this study...
October 18, 2016: Cancer Immunology, Immunotherapy: CII
Tatsuhiko Azegami, Yoshikazu Yuki, Kaori Hayashi, Mari Nakamura, Akihito Hishikawa, Hiroshi Kiyono, Hiroshi Itoh
OBJECTIVE: Previous studies have shown that injectable vaccines against renin-angiotensin system may be effective for the treatment of hypertension, but these injectable vaccines often cause local skin reactions and soreness at the injection site. The aim of this study was to develop a new non-injectable vaccine against angiotensin II type 1 receptor (AT1R) and examine its effect on blood pressure. DESIGN AND METHOD: The peptide, seven-amino-acid sequence from second extracellular loop of rat AT1R was synthesized and then conjugated with pneumococcal surface protein A (PspA) as a carrier protein for the nasal vaccination...
September 2016: Journal of Hypertension
Fengcai Zhu, Henri Deckx, Raphaele Roten, Bart Michiels, Michal Sarnecki
AIM: Compare efficacy, immunogenicity and safety of Hepavax-Gene TF (thimerosal free) vaccine with comparator in Chinese neonates. METHODS: Double-blind, randomized, parallel-group, stratified study was conducted at multiple sites in China in healthy neonates, consisting of three doses of Hepavax-Gene TF or Engerix-B vaccines administered at birth, one and six months of age, with a six month follow-up after vaccination. Based on hepatitis B virus (HBV) infection status of mothers, infants were assigned to one of two study strata for mothers positive for HBV infection (Stratum 1), with or without active replicating virus (Substrata 1a, 1b) and for HBV negative mothers (Stratum 2)...
October 6, 2016: Pediatric Infectious Disease Journal
Lotte Møller Smedegaard, Anja Poulsen, Ines Ackerl Kristensen, Susanne Rosthøj, Kjeld Schmiegelow, Ulrikka Nygaard
BACKGROUND: Varicella-zoster virus (VZV) can be fatal or cause severe complications in children with acute lymphoblastic leukemia (ALL). This analysis set out to investigate the morbidity and mortality of VZV vaccination without interruption of maintenance therapy in children with ALL. METHODS: Files of 73 seronegative children with ALL were examined for data regarding VZV vaccination and infection, and long-term seroconversion was measured. Criteria before VZV vaccination were (1) seronegative, (2) in complete remission, (3) age ≥ 1...
November 2016: Pediatric Infectious Disease Journal
Jiangan Xie, Christopher Codd, Kevin Mo, Yongqun He
M. bovis strain Bacillus Calmette-Guérin (BCG) has been the only licensed live attenuated vaccine against tuberculosis (TB) for nearly one century and has also been approved as a therapeutic vaccine for bladder cancer treatment since 1990. During its long time usage, different adverse events (AEs) have been reported. However, the AEs associated with the BCG preventive TB vaccine and therapeutic cancer vaccine have not been systematically compared. In this study, we systematically collected various BCG AE data mined from the US VAERS database and PubMed literature reports, identified statistically significant BCG-associated AEs, and ontologically classified and compared these AEs related to these two types of BCG vaccine...
2016: PloS One
Kawsar R Talaat, Ruth D Ellis, Janet Hurd, Autumn Hentrich, Erin Gabriel, Noreen A Hynes, Kelly M Rausch, Daming Zhu, Olga Muratova, Raul Herrera, Charles Anderson, David Jones, Joan Aebig, Sarah Brockley, Nicholas J MacDonald, Xiaowei Wang, Michael P Fay, Sara A Healy, Anna P Durbin, David L Narum, Yimin Wu, Patrick E Duffy
Transmission-blocking vaccines (TBVs) that target sexual stage parasite development could be an integral part of measures for malaria elimination. Pfs25 is a leading TBV candidate, and previous studies conducted in animals demonstrated an improvement of its functional immunogenicity after conjugation to EPA, a recombinant, detoxified ExoProtein A from Pseudomonas aeruginosa. In this report, we describe results of an open-label, dose-escalating Phase 1 trial to assess the safety and immunogenicity of Pfs25-EPA conjugates formulated with Alhydrogel®...
2016: PloS One
Nobuyoshi Ozawa, Kiyoshi Ito, Toru Tase, Hirohito Metoki, Nobuo Yaegashi
Prevention of cervical cancer has been unsuccessful in Japan because of low rates of cancer screening and vaccination. The Vaccine Adverse Review Committee of the Japanese Government investigated 2,475 adverse events and reported 617 (6.9/100,000) severe cases and 176 (2.0/100,000) cases with chronic pain. The proactive recommendation for human papillomavirus (HPV) vaccination has been suspended since June 2013. In this study, we examined vaccination rate and incidence of abnormal cervical cytology in women aged 20 to 24 years attending cancer screening in Miyagi...
2016: Tohoku Journal of Experimental Medicine
W Abdullah Brooks, K Zaman, Kristen D C Lewis, Justin R Ortiz, Doli Goswami, Jodi Feser, Amina Tahia Sharmeen, Kamrun Nahar, Mustafizur Rahman, Mohammed Ziaur Rahman, Burc Barin, Muhammad Yunus, Alicia M Fry, Joseph Bresee, Tasnim Azim, Kathleen M Neuzil
BACKGROUND: The rates of influenza illness and associated complications are high among children in Bangladesh. We assessed the clinical efficacy and safety of a Russian-backbone live attenuated influenza vaccine (LAIV) at two field sites in Bangladesh. METHODS: Between Feb 27 and April 9, 2013, children aged 2-4 years in urban Kamalapur and rural Matlab, Bangladesh, were randomly assigned in a 2:1 ratio, according to a computer-generated schedule, to receive one intranasal dose of LAIV or placebo...
October 13, 2016: Lancet Global Health
John C Victor, Kristen D C Lewis, Aldiouma Diallo, Mbayame N Niang, Bou Diarra, Ndongo Dia, Justin R Ortiz, Marc-Alain Widdowson, Jodi Feser, Rebecca Hoagland, Shannon L Emery, Kathryn E Lafond, Kathleen M Neuzil
BACKGROUND: Live attenuated influenza vaccines have been shown to significantly reduce influenza in diverse populations of children, but no efficacy studies have been done in resource-poor tropical settings. In Senegal, we assessed the efficacy and safety of a live attenuated influenza vaccine based on Russian-derived master donor viruses and licensed as a single dose. METHODS: In this double-blind, placebo-controlled, parallel group, single-centre trial done near Niakhar, Senegal, generally healthy children aged 2-5 years were randomly allocated (2:1) to receive a single intranasal dose of masked trivalent live attenuated influenza vaccine or placebo...
October 13, 2016: Lancet Global Health
Helen S Marshall, Peter C Richmond, Johannes Beeslaar, Qin Jiang, Kathrin U Jansen, Maria Garcés-Sánchez, Federico Martinón-Torres, Leszek Szenborn, Jacek Wysocki, Joseph Eiden, Shannon L Harris, Thomas R Jones, Su-San Lee, John L Perez
BACKGROUND: Bivalent rLP2086 is a recombinant factor H binding protein-based vaccine approved in the USA for prevention of meningococcal serogroup B disease in 10-25-year-olds. We aimed to assess the persistence of bactericidal antibodies up to 4 years after a three-dose schedule of bivalent rLP2086. METHODS: We did this randomised, single-blind, placebo-controlled, phase 2 trial at 25 sites in Australia, Poland, and Spain. In stage 1 of the study (February, 2009-May, 2010), healthy adolescents (aged 11-18 years) were randomly assigned, via an interactive voice and web-response system with computer-generated sequential random numbers, to receive either ascending doses of vaccine (60 μg, 120 μg, and 200 μg) or placebo at months 0, 2, and 6...
October 10, 2016: Lancet Infectious Diseases
Lindert Benedictus, Charlotte R Bell
Bovine neonatal pancytopenia (BNP) is a hemorrhagic disease that emerged in calves across Europe in 2007. Its occurrence is attributed to immunization of the calf's mother with a vaccine produced using an allogeneic cell line. Vaccine-induced alloantibodies specific for major-histocompatibility class I antigens are transferred from the mother to the calf via colostrum, leading to profound depletion of peripheral blood and bone marrow cells that is often fatal. Areas covered: Pubmed and Web of Science were used to search for literature relevant to BNP and the use of allogeneic vaccine cell lines...
October 17, 2016: Expert Review of Vaccines
Ellen P Carlin, Nichole Giller, Rebecca Katz
OBJECTIVE: To quantify the population at risk of serious adverse reactions to replicating smallpox vaccine. DESIGN AND SAMPLE: Conditions known or suspected to carry risk were identified via Centers for Disease Control and Prevention planning documents, other federal publications, and peer-reviewed literature. Conditions identified were categorized as historically recognized risks or more recently recognized immunocompromised states that may pose risk. Major historical risk factors were as follows: eczema/atopic dermatitis, pregnancy, HIV, and primary immunodeficiency...
October 13, 2016: Public Health Nursing
Alexander Batista-Duharte, Gisela Jorge Murillo, Ulpiano Marqués Pérez, Enieyis Naranjo Tur, Deivys Fuentes Portuondo, Bruno Téllez Martínez, Damiana Téllez-Martínez, Juan E Betancourt, Oliver Pérez
Local reactions are the most frequent adverse event associated with vaccines. Adjuvants are major constituents of many vaccines and they are frequently involved in these reactions, associated with their irritating effect and the stimulation of local inflammation. The hen's egg test on chorioallantoic membrane (HET-CAM) is an alternative toxicological method widely used to determine ocular irritation potential, but very few studies have demonstrated the utility of this method for assessing the irritant properties of vaccine adjuvants...
October 12, 2016: International Journal of Toxicology
K Sanchayan, R Fernandopulle, A Amarasinghe, S N Thiyahiny, S Sri Ranganathan
OBJECTIVES: This study was designed to describe the safety profile of the single dose live attenuated Japanese encephalitis vaccine (LJEV) SA-14-14-2 given at the age of 9 months in the National Immunisation programme of Sri Lanka. METHODS: cohort event monitoring (CEM) was conducted in the Jaffna district during November 2012 to January 2015. A representative sample of 3041 infants who received the LJEV at the age of 9 months was followed up actively over telephone interviews on days 1, 3, 14, 30 and 45 for adverse events (AE)...
2016: Ceylon Medical Journal
Brian I Rini, Arnulf Stenzl, Romauld Zdrojowy, Mikhail Kogan, Mikhail Shkolnik, Stephane Oudard, Steffen Weikert, Sergio Bracarda, Simon J Crabb, Jens Bedke, Joerg Ludwig, Dominik Maurer, Regina Mendrzyk, Claudia Wagner, Andrea Mahr, Jens Fritsche, Toni Weinschenk, Steffen Walter, Alexandra Kirner, Harpreet Singh-Jasuja, Carsten Reinhardt, Tim Eisen
BACKGROUND: In a phase 2 study in patients with metastatic renal cell carcinoma, overall survival was associated with T-cell responses against IMA901, a vaccine consisting of ten tumour-associated peptides. In this phase 3 trial, we aimed to determine the clinical effect of adding IMA901 to sunitinib, the standard first-line treatment in metastatic renal cell carcinoma with postulated favourable immunomodulatory effects. METHODS: The IMPRINT study is an open-label, randomised, controlled, phase 3 trial done at 124 clinical sites in 11 countries...
October 3, 2016: Lancet Oncology
Songtao Xu, Mukai Chen, Huanying Zheng, Haiyan Wang, Meng Chen, Jianhui Zhou, Wang Shuang, Pengbo Yu, Chaofeng Ma, Jilan He, Daxing Feng, Zhu Zhen, Zhang Yan, Mao Naiying, Aili Cui, Qiuhua Wu, Mengyuan Qi, Chongshan Li, Xiaoguang Xu, Wenbo Xu
BACKGROUND: In 2010, a universal nomenclature for varicella-zoster virus (VZV) clades was established, which is very useful in the monitoring of viral evolution, recombination, spread and genetic diversity. Currently, information about VZV clades has been disclosed worldwide, however, there are limited data regarding the characterization of circulating VZV clades in China, even where varicella remains widely epidemic. METHODS: From 2008 to 2012, clinical samples with varicella or zoster were collected in General Hospital in eight provinces and analyzed by PCR, restriction endonuclease digestion and sequencing...
October 7, 2016: BMC Infectious Diseases
Jennifer C Nelson, Robert Wellman, Onchee Yu, Andrea J Cook, Judith C Maro, Rita Ouellet-Hellstrom, Denise Boudreau, James S Floyd, Susan R Heckbert, Simone Pinheiro, Marsha Reichman, Azadeh Shoaibi
INTRODUCTION: The large-scale assembly of electronic health care data combined with the use of sequential monitoring has made proactive postmarket drug- and vaccine-safety surveillance possible. Although sequential designs have been used extensively in randomized trials, less attention has been given to methods for applying them in observational electronic health care database settings. EXISTING METHODS: We review current sequential-surveillance planning methods from randomized trials, and the Vaccine Safety Datalink (VSD) and Mini-Sentinel Pilot projects-two national observational electronic health care database safety monitoring programs...
2016: EGEMS
Wilbur H Chen, Marcela F Pasetti, Rajan P Adhikari, Holly Baughman, Robin Douglas, Jill El-Khorazaty, Nancy Greenberg, Frederick W Holtsberg, Grant C Liao, Mardi K Reymann, Xiaolin Wang, Kelly L Warfield, M Javad Aman
: Staphylococcus aureus produces several enterotoxins and superantigens, exposure to which can elicit profound toxic shock. A recombinant staphylococcal enterotoxin B (rSEB), containing 3 distinct mutations in the MHCII binding site, was combined with Alhydrogel as a potential parenteral vaccine named STEBVax.Consenting healthy adult volunteers, age 23-38 years, participated in a first-in-human open label dose-escalation study of parenteral doses of STEBVax ranging from 0.01 μg up to 20 μg...
October 5, 2016: Clinical and Vaccine Immunology: CVI
Jolanta Florczak-Wyspiańska, Ewa Nawotczyńska, Wojciech Kozubski
Yellow fever (YF) is a mosquito-borne viral hemorrhagic fever, which is a serious and potentially fatal disease with no specific antiviral treatment that can be effectively prevented by an attenuated vaccine (YEL). Despite the long history of safe and efficacious YF vaccination, sporadic case reports of serious adverse events (SAEs) have been reported, including yellow fever vaccine-associated neurotropic disease (YEL-AND). YEL-AND usually appears within one month of YF vaccination, manifesting as meningoencephalitis, Guillain-Barré syndrome (GBS) or acute disseminated encephalomyelitis (ADEM)...
September 22, 2016: Neurologia i Neurochirurgia Polska
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