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Vaccine safety

Małgorzata Stępień, Katarzyna Piwowarow, Mirosław P Czarkowski
OBJECTIVE: The aim of the study was to assess the epidemiological situation of hepatitis B in Poland in 2014 in comparison with the previous years. MATERIAL AND METHODS: The evaluation of the epidemiological situation was carried out on a basis of analysis of data from case-based reports on acute hepatitis B registered by sanitary and epidemiological stations, aggregate data derived from annual bulletins “Infectious diseases and poisonings in Poland”, data from annual bulletin “Vaccinations in Poland” and data on locally registered HBsAg carriers...
2016: Przegla̧d Epidemiologiczny
Marek L Kowalski, Ignacio Ansotegui, Werner Aberer, Mona Al-Ahmad, Mubeccel Akdis, Barbara K Ballmer-Weber, Kirsten Beyer, Miguel Blanca, Simon Brown, Chaweewan Bunnag, Arnaldo Capriles Hulett, Mariana Castells, Hiok Hee Chng, Frederic De Blay, Motohiro Ebisawa, Stanley Fineman, David B K Golden, Tari Haahtela, Michael Kaliner, Connie Katelaris, Bee Wah Lee, Joanna Makowska, Ulrich Muller, Joaquim Mullol, John Oppenheimer, Hae-Sim Park, James Parkerson, Giovanni Passalacqua, Ruby Pawankar, Harald Renz, Franziska Rueff, Mario Sanchez-Borges, Joaquin Sastre, Glenis Scadding, Scott Sicherer, Pongsakorn Tantilipikorn, James Tracy, Vera van Kempen, Barbara Bohle, G Walter Canonica, Luis Caraballo, Maximiliano Gomez, Komei Ito, Erika Jensen-Jarolim, Mark Larche, Giovanni Melioli, Lars K Poulsen, Rudolf Valenta, Torsten Zuberbier
One of the major concerns in the practice of allergy is related to the safety of procedures for the diagnosis and treatment of allergic disease. Management (diagnosis and treatment) of hypersensitivity disorders involves often intentional exposure to potentially allergenic substances (during skin testing), deliberate induction in the office of allergic symptoms to offending compounds (provocation tests) or intentional application of potentially dangerous substances (allergy vaccine) to sensitized patients. These situations may be associated with a significant risk of unwanted, excessive or even dangerous reactions, which in many instances cannot be completely avoided...
2016: World Allergy Organization Journal
Alain Luxembourg, Susanne K Kjaer, Mari Nygard, Misoo C Ellison, Thomas Group, J Brooke Marshall, David Radley, Alfred Saah
The 9-valent human papillomavirus (HPV) (9vHPV) vaccine targets four HPV types (6/11/16/18) also covered by the quadrivalent HPV (qHPV) vaccine and five additional types (31/33/45/52/58). Vaccine efficacy to prevent HPV infection and disease was established in a Phase III clinical study in women 16-26years of age. A long-term follow-up (LTFU) study has been initiated as an extension of the Phase III clinical study to assess effectiveness of the 9vHPV vaccine up to at least 14years after the start of vaccination...
October 21, 2016: Contemporary Clinical Trials
Dong Hoon Suh, Miseon Kim, Hak Jae Kim, Kyung Hun Lee, Jae Weon Kim
In 2015, fourteen topics were selected as major research advances in gynecologic oncology. For ovarian cancer, high-level evidence for annual screening with multimodal strategy which could reduce ovarian cancer deaths was reported. The best preventive strategies with current status of evidence level were also summarized. Final report of chemotherapy or upfront surgery (CHORUS) trial of neoadjuvant chemotherapy in advanced stage ovarian cancer and individualized therapy based on gene characteristics followed...
November 2016: Journal of Gynecologic Oncology
Pushpa Ranjan Wijesinghe, M R Nihal Abeysinghe, Sutee Yoksan, Yafu Yao, Benli Zhou, Lei Zhang, Jessica A Fleming, Anthony A Marfin, John C Victor
BACKGROUND: The performance of live attenuated Japanese Encephalitis SA 14-14-2 vaccine (CD-JEV) among children previously given inactivated mouse brain-derived JE vaccine (IMBV) is unknown. We evaluated the safety and immunogenicity of CD-JEV administered to 2- and 5-year-old children in Sri Lanka. METHODS: In this open-label, single arm trial in the Colombo District of Sri Lanka, generally healthy children 2 and 5years of age who had previously received two and three doses of IMBV, respectively, were administered one dose of CD-JEV subcutaneously...
October 20, 2016: Vaccine
M Topuridze, D Baliashvili, T Komakhidze, M Shishniashvili, N Grdzelidze, M Butsashvili
Rotavirus (RV) is the most common cause of severe gastroenteritis in infants and young children worldwide. RV causes approximately half a million deaths each year among children aged <5 years. According to WHO estimates for 2008, there were approximately 10 to 50 deaths annually in young children due to rotavirus diarrhea in Georgia. The purpose of this study was to assess the knowledge, attitudes, and practices related to rotavirus diarrhea and the rotavirus vaccine among health care workers (HCWs). The National Center for Disease Control and Public Health (NCDC) conducted a cross-sectional survey of HCWs involved in the expanded program of immunization (EPI)...
September 2016: Georgian Medical News
Anthony L Cunningham, Nathalie Garçon, Oberdan Leo, Leonard R Friedland, Richard Strugnell, Béatrice Laupèze, Mark Doherty, Peter Stern
In the 21st century, an array of microbiological and molecular allow antigens for new vaccines to be specifically identified, designed, produced and delivered with the aim of optimising the induction of a protective immune response against a well-defined immunogen. New knowledge about the functioning of the immune system and host pathogen interactions has stimulated the rational design of vaccines. The design toolbox includes vaccines made from whole pathogens, protein subunits, polysaccharides, pathogen-like particles, use of viral/bacterial vectors, plus adjuvants and conjugation technology to increase and broaden the immune response...
October 18, 2016: Vaccine
Huilin Ou, Wei Yao, Nanping Wu, Frederick X C Wang, Tianhao Weng, Chengcong Han, Xiangyun Lu, Dongshan Yu, Haibo Wu, Linfang Cheng, Honglin Chen, Hangping Yao, Lanjuan Li
Developing a safe and effective H7N9 influenza vaccine was initiated in early spring 2013, following human infections with a novel avian influenza A (H7N9) virus. In this study, a candidate H7N9 vaccine seed strain is produced using reverse genetics, with HA and NA derived from a human H7N9 virus and the remaining genes from the PR8 backbone virus which grows well in eggs. We verified that the virulence and transmissibility of the recombinant H7N9 vaccine seed strain were decreased as compared to wild-type H7N9 virus, to levels comparable with PR8...
October 19, 2016: Oncotarget
Yanping Li, Rong Cheng Li, Qiang Ye, Changgui Li, You Ping Liu, Xiao Ma, Yanan Li, Hong Zhao, Xiaoling Chen, Deepak Assudani, Naveen Karkada, Htay Htay Han, Olivier Van Der Meeren, Narcisa Mesaros
We conducted three phase III, randomized, open-label, clinical trials assessing the safety, reactogenicity (all studies), immunogenicity (Primary vaccination study) and persistence of immune responses (Booster study) to the combined diphtheria, tetanus, pertussis, poliomyelitis, and Haemophilus influenzae type b vaccine (DTPa-IPV/Hib) in Chinese infants and toddlers. In the Pilot study (NCT00964028), 50 infants (randomized 1:1) received three doses of DTPa-IPV/Hib at 2-3-4 (Group A) or 3-4-5 months of age (Group B)...
October 21, 2016: Human Vaccines & Immunotherapeutics
Yuxiao Wang, Jingxin Li, Yuemei Hu, Qi Liang, Mingwei Wei, Fengcai Zhu
Ebola virus disease (EVD) has become a great threat to humans across the world in recent years. The 2014 Ebola epidemic in West Africa caused numerous deaths and attracted worldwide attentions. Since no specific drugs and treatments against EVD was available, vaccination was considered as the most promising and effective method of controlling this epidemic. So far, 7 vaccine candidates had been developed and evaluated through clinical trials. Among them, the recombinant vesicular stomatitis virus-based vaccine (rVSV-EBOV) is the most promising candidate, which demonstrated a significant protection against EVD in phase III clinical trial...
October 20, 2016: Human Vaccines & Immunotherapeutics
Uhi Toh, Shuko Saku, Mina Okabe, Nobutaka Iwakuma, Yuko Kimitsuki, Momoko Akashi, Etsuyo Ogo, Akira Yamada, Shigeki Shichijo, Kyogo Itoh, Yoshito Akagi
Our previous phase II clinical trial showed that therapeutically selected personalized peptide vaccines(PPVs)were effective at boosting anticancer immunity; the immune response after PPV was associated with a clinical outcome as a prognostic factor for metastatic breast cancer(mBC). We conducted an early phase II study to evaluate the safety and efficacy of a new regimen using multiple peptide vaccines(KRM-19)for patients with metastatictriple -negative breast cancer. KRM-19 consisted of 19 mixed peptides chosen from the previously reported 31 PPVs according to their anti-tumor immunologiceffec ts and safety profiles for patients with mBC...
October 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
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
Michael A Stevenson
Vaccines were once produced almost exclusively by state-supported entities. While they remain essential tools for public health protection, the majority of the world's governments have allowed industry to assume responsibility for this function. This is significant because while the international harmonisation of quality assurance standards have effectively increased vaccine safety, they have also reduced the number of developing country vaccine producers, and Northern multinational pharmaceutical companies have shown little interest in offering the range of low-priced products needed in low and middle-income-country contexts...
October 19, 2016: Global Public Health
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
Troels Holz Borch, Lotte Engell-Noerregaard, Trine Zeeberg Iversen, Eva Ellebaek, Özcan Met, Morten Hansen, Mads Hald Andersen, Per Thor Straten, Inge Marie Svane
INTRODUCTION: Vaccination with dendritic cells (DCs) has generally not fulfilled its promise in cancer immunotherapy due to ineffective translation of immune responses into clinical responses. A proposed reason for this is intrinsic immune regulatory mechanisms, such as regulatory T cells (Tregs). A metronomic regimen of cyclophosphamide (mCy) has been shown to selectively deplete Tregs. To test this in a clinical setting, we conducted a phase I trial to evaluate the feasibility and safety of vaccination with DCs transfected with mRNA in combination with mCy in patients with metastatic malignant melanoma (MM)...
2016: Oncoimmunology
Young Hee Joung, Se Hee Park, Ki-Beom Moon, Jae-Heung Jeon, Hye-Sun Cho, Hyun-Soon Kim
Disease prevention through vaccination is considered to be the greatest contribution to public health over the past century. Every year more than 100 million children are vaccinated with the standard World Health Organization (WHO)-recommended vaccines including hepatitis B (HepB). HepB is the most serious type of liver infection caused by the hepatitis B virus (HBV), however, it can be prevented by currently available recombinant vaccine, which has an excellent record of safety and effectiveness. To date, recombinant vaccines are produced in many systems of bacteria, yeast, insect, and mammalian and plant cells...
October 13, 2016: International Journal of Molecular Sciences
Alice Gutjahr, Capucine Phelip, Anne-Line Coolen, Claire Monge, Anne-Sophie Boisgard, Stéphane Paul, Bernard Verrier
Vaccines have successfully eradicated a large number of diseases. However, some infectious diseases (such as HIV, Chlamydia trachomatis or Bacillus anthracis) keep spreading since there is no vaccine to prevent them. One way to overcome this issue is the development of new adjuvant formulations which are able to induce the appropriate immune response without sacrificing safety. Lymph nodes are the site of lymphocyte priming by antigen-presenting cells and subsequent adaptive immune response, and are a promising target for vaccine formulations...
October 12, 2016: Vaccines
Timo Vesikari, Sven Arne Silfverdal, Emilia Jordanov, Emmanuel Feroldi
OBJECTIVE: To assess the immunogenicity and safety of a fully liquid, ready-to-use hexavalent DTaP-IPV-HB-PRP-T vaccine when administered in a 2+1 schedule at 3, 5, 11-12 months of age. METHODS: Phase III, randomized, active-controlled, observer-blind, multi-center study. Infants were randomized to receive DTaP-IPV-HB-PRP-T (N=275) or a licensed control hexavalent vaccine (DTaP-IPV-HB//PRP~T: N=275), both given in co-administration with Prevenar 13™ (PCV13). Serum was analyzed for immune responses to all vaccine antigens...
October 6, 2016: Pediatric Infectious Disease Journal
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
Jessica Martin, Mark Wilcox
PURPOSE OF REVIEW: Clostridium difficile infection has attained high prominence given its prevalence and impacts on patients and healthcare institutions. Multiple new approaches to the prevention and treatment of C. difficile infection (CDI) are undergoing clinical trials. RECENT FINDINGS: Bezlotoxumab is a monoclonal antibody against toxin B that has successfully completed phase III studies, demonstrating a significant reduction in recurrent CDI when given with standard of care antibiotics...
October 7, 2016: Current Opinion in Infectious Diseases
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