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Vaccine adverse events

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https://www.readbyqxmd.com/read/28630358/assessing-the-safety-and-immunogenicity-of-recombinant-vesicular-stomatitis-virus-ebola-vaccine-in-healthy-adults-a-randomized-clinical-trial
#1
May S ElSherif, Catherine Brown, Donna MacKinnon-Cameron, Li Li, Trina Racine, Judie Alimonti, Thomas L Rudge, Carol Sabourin, Peter Silvera, Jay W Hooper, Steven A Kwilas, Nicole Kilgore, Christopher Badorrek, W Jay Ramsey, D Gray Heppner, Tracy Kemp, Thomas P Monath, Teresa Nowak, Shelly A McNeil, Joanne M Langley, Scott A Halperin
BACKGROUND: The 2013-2016 Ebola virus outbreak in West Africa was the most widespread in history. In response, alive attenuated recombinant vesicular stomatitis virus (rVSV) vaccine expressing Zaire Ebolavirus glycoprotein (rVSVΔG-ZEBOV-GP) was evaluated in humans. METHODS: In a phase 1, randomized, dose-ranging, observer-blind, placebo-controlled trial, healthy adults aged 18-65 years were randomized into 4 groups of 10 to receive one of 3 vaccine doses or placebo...
June 19, 2017: CMAJ: Canadian Medical Association Journal, Journal de L'Association Medicale Canadienne
https://www.readbyqxmd.com/read/28629665/efficacy-and-safety-of-tofacitinib-monotherapy-tofacitinib-with-methotrexate-and-adalimumab-with-methotrexate-in-patients-with-rheumatoid-arthritis-oral-strategy-a-phase-3b-4-double-blind-head-to-head-randomised-controlled-trial
#2
Roy Fleischmann, Eduardo Mysler, Stephen Hall, Alan J Kivitz, Robert J Moots, Zhen Luo, Ryan DeMasi, Koshika Soma, Richard Zhang, Liza Takiya, Svitlana Tatulych, Christopher Mojcik, Sriram Krishnaswami, Sujatha Menon, Josef S Smolen
BACKGROUND: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis. The Oral Rheumatoid Arthritis triaL (ORAL) Strategy aimed to assess the comparative efficacy of tofacitinib monotherapy, tofacitinib plus methotrexate, and adalimumab plus methotrexate for the treatment of rheumatoid arthritis in patients with a previous inadequate response to methotrexate. METHODS: ORAL Strategy was a 1 year, double-blind, phase 3b/4, head-to-head, non-inferiority, randomised controlled trial in patients aged 18 years or older with active rheumatoid arthritis despite methotrexate therapy...
June 15, 2017: Lancet
https://www.readbyqxmd.com/read/28626902/haemophilus-influenzae-oral-vaccination-for-preventing-acute-exacerbations-of-chronic-bronchitis-and-chronic-obstructive-pulmonary-disease
#3
REVIEW
Edward Teo, Kathleen Lockhart, Sai Navya Purchuri, Jennifer Pushparajah, Allan W Cripps, Mieke L van Driel
BACKGROUND: Chronic bronchitis and chronic obstructive pulmonary disease (COPD) are serious conditions in which patients are predisposed to viral and bacterial infections resulting in potentially fatal acute exacerbations. Chronic obstructive pulmonary disease is defined as a lung disease characterised by obstruction to lung airflow that interferes with normal breathing. Antibiotic therapy has not been particularly useful in eradicating bacteria such as non-typeable Haemophilus influenzae (NTHi) because they are naturally occurring flora of the upper respiratory tract in many people...
June 19, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28625884/lack-of-evidence-for-post-vaccine-onset-of-autoimmune-lymphoproliferative-disorders-during-a-nine-month-follow-up-in-multiply-vaccinated-italian-military
#4
Claudia Ferlito, Vincenzo Barnaba, Sergio Abrignani, Mauro Bombaci, Alessandro Sette, John Sidney, Roberto Biselli, Enrico Tomao, Maria Sofia Cattaruzza, Valentina Germano, Michela Ileen Biondo, Gerardo Salerno, Patrizia Lulli, Sara Caporuscio, Andrea Picchianti Diamanti, Mirella Falco, Valentina Biselli, Patrizia Cardelli, Alberto Autore, Elena Lucertini, Donato Pompeo De Cesare, Mario Stefano Peragallo, Florigio Lista, Carmela Martire, Simonetta Salemi, Roberto Nisini, Raffaele D'Amelio
Anecdotal case reports, amplified by mass media and internet-based opinion groups, have recently indicated vaccinations as possibly responsible for autoimmunity/lymphoproliferation development. Multiply vaccinated Italian military personnel (group 1, operating in Italy, group 2, operating in Lebanon) were followed-up for nine months to monitor possible post-vaccine autoimmunity/lymphoproliferation onset. No serious adverse event was noticed in both groups. Multivariate analysis of intergroup differences only showed a significant association between lymphocyte increase and tetanus/diphtheria vaccine administration...
June 15, 2017: Clinical Immunology: the Official Journal of the Clinical Immunology Society
https://www.readbyqxmd.com/read/28622427/feasibility-study-of-personalized-peptide-vaccination-for-hepatocellular-carcinoma-patients-refractory-to-loco-regional-therapies
#5
Shigeru Yutani, Takahisa Shirahama, Daisuke Muroya, Satoko Matsueda, Rin Yamaguchi, Michi Morita, Shigeki Shichijo, Akira Yamada, Tetsuro Sasada, Kyogo Itoh
Overall survival (OS) of patients with hepatocellular carcinoma (HCC) refractory to loco-regional therapy is dismal even by treatment with sorafenib, a multi-kinase inhibitor. To develop a more efficacious treatment modality, we conducted a feasibility study of personalized peptide vaccination (PPV) for HCC, in which the peptides were selected from 31 peptide candidates based on the pre-existing immunity. Twenty-six HCC patients refractory to loco-regional therapies (Cohort 1) and 30 patients refractory to both loco-regional and systemic therapies (Cohort 2) were entered to the study...
June 16, 2017: Cancer Science
https://www.readbyqxmd.com/read/28620382/phase-ii-study-of-adjuvant-immunotherapy-with-the-csf-470-vaccine-plus-bacillus-calmette-guerin-plus-recombinant-human-granulocyte-macrophage-colony-stimulating-factor-vs-medium-dose-interferon-alpha-2b-in-stages-iib-iic-and-iii-cutaneous-melanoma-patients
#6
José Mordoh, María Betina Pampena, Mariana Aris, Paula Alejandra Blanco, Mónica Lombardo, Erika María von Euw, Soledad Mac Keon, Michelle Yépez Crow, Alicia Inés Bravo, Juan Manuel O'Connor, Ana Gabriela Orlando, Franco Ramello, Estrella Mariel Levy, María Marcela Barrio
The irradiated, allogeneic, cellular CSF-470 vaccine plus Bacillus Calmette-Guerin (BCG) and recombinant human granulocyte macrophage-colony stimulating factor (rhGM-CSF) is being tested against medium-dose IFN-α2b in stages IIB-III cutaneous melanoma (CM) patients (pts) after surgery in an open, randomized, Phase II/III study. We present the results of the Phase II part of the ongoing CASVAC-0401 study (ClinicalTrials.gov: NCT01729663). Thirty-one pts were randomized to the CSF-470 vaccine (n = 20) or to the IFN-α2b arm (n = 11)...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28610824/safety-and-perception-what-are-the-greatest-enemies-of-hpv-vaccination-programmes
#7
Paolo Bonanni, Beatrice Zanella, Francesca Santomauro, Chiara Lorini, Angela Bechini, Sara Boccalini
Vaccines stimulate a person's immune system to produce an adequate reaction against a specific infectious agent; i.e. the person is protected from that disease without having to get it first. As vaccines are administrated to healthy subjects, they are held to the highest standards of safety. Regarding human papillomavirus (HPV) vaccines, at present three prophylactic vaccines are licensed (bivalent HPV 16/18, quadrivalent HPV 6/11/16/18 and the nonovalent HPV 6/11/16/18/31/33/45/52/58 vaccine). Pre- and post-licensure studies (i...
June 10, 2017: Vaccine
https://www.readbyqxmd.com/read/28606591/safety-and-immunogenicity-of-the-rvsv%C3%A2-g-zebov-gp-ebola-virus-vaccine-candidate-in-healthy-adults-a-phase-1b-randomised-multicentre-double-blind-placebo-controlled-dose-response-study
#8
D Gray Heppner, Tracy L Kemp, Brian K Martin, William J Ramsey, Richard Nichols, Emily J Dasen, Charles J Link, Rituparna Das, Zhi Jin Xu, Eric A Sheldon, Teresa A Nowak, Thomas P Monath
BACKGROUND: The 2014 Zaire Ebola virus outbreak highlighted the need for a safe, effective vaccine with a rapid onset of protection. We report the safety and immunogenicity of the recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSV∆G-ZEBOV-GP) across a 6 log10 dose range in two sequential cohorts. METHODS: In this phase 1b double-blind, placebo-controlled, dose-response study we enrolled and randomly assigned healthy adults (aged 18-61 years) at eight study sites in the USA to receive a single injection of vaccine or placebo, administered by intramuscular injection...
June 9, 2017: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/28603462/immune-response-to-seasonal-influenza-vaccine-in-patients-with-relapsing-remitting-multiple-sclerosis-receiving-long-term-daclizumab-beta-a-prospective-open-label-single-arm-study
#9
Lahar Mehta, Kimberly Umans, Gulden Ozen, Randy R Robinson, Jacob Elkins
BACKGROUND: For patients with relapsing-remitting multiple sclerosis (RRMS) undergoing continuous immunomodulatory therapy, understanding whether vaccinations can be performed safely and effectively is important. We tested the immune response to inactivated seasonal influenza vaccine during long-term daclizumab beta treatment. METHODS: In this prospective, open-label, single-arm extension SELECTED study, an optional vaccine substudy was performed on patients with RRMS who had already received daclizumab beta for 1 to 2 years in previous studies...
May 2017: International Journal of MS Care
https://www.readbyqxmd.com/read/28585776/comparison-of-adverse-events-following-pentavalent-and-diphtheria-tetanus-pertussis-vaccines-among-nigerian-children
#10
Ayebo Evawere Sadoh, Damian Uchechukwu Nwaneri, Bamidele Charity Ogboghodo, Wilson Ehidiamen Sadoh
INTRODUCTION: Adverse events following immunization (AEFI) may follow the use of any vaccine. There is thus a need for documentation of the types and prevalence of AEFIs for each vaccine and early identification of new events or those occurring at rates higher than expected. When one vaccine replaces another, it is important to document the safety of the new vaccine as well as compare to that of the old. In this study, we aimed to document the AEFIs following the use of pentavalent vaccine recently introduced into the National Programme on Immunization and compare with those of diphtheria-tetanus-pertussis (DTwP) vaccine which it replaced...
June 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28582563/participant-centred-active-surveillance-of-adverse-events-following-immunisation-a-narrative-review
#11
Patrick Cashman, Kristine Macartney, Gulam Khandaker, Catherine King, Michael Gold, David N Durrheim
The importance of active, participant-centred monitoring of adverse events following immunisation (AEFI) is increasingly recognised as a valuable adjunct to traditional passive AEFI surveillance. The databases OVID Medline and OVID Embase were searched to identify all published articles referring to AEFI. Only studies which sought participant response after vaccination were included. A total of 6060 articles published since the year 2000 were identified. After the application of screening inclusion and exclusion criteria, 25 articles describing 23 post-marketing AEFI systems were identified...
May 1, 2017: International Health
https://www.readbyqxmd.com/read/28581273/clinical-features-of-post-vaccination-guillain-barr%C3%A3-syndrome-gbs-in-korea
#12
Yong Shik Park, Keon Joo Lee, Seung Woo Kim, Kyung Min Kim, Bum Chun Suh
Guillain-Barré syndrome (GBS) is the most common immune-mediated polyradiculoneuropathy and it is also the most commonly reported severe adverse event following immunization in adults. To evaluate the results of clinical and laboratory features of GBS after vaccination in Korea, we analyzed the claims-based data from 2002 to 2014 using materials collected for the Advisory Committee Vaccination Injury Compensation (ACVIC) meeting including, clinical features, nerve conduction studies (NCSs), cerebrospinal fluid (CSF) profiles, treatment, and outcomes...
July 2017: Journal of Korean Medical Science
https://www.readbyqxmd.com/read/28579471/first-case-of-vaccine-strain-varicella-infection-as-manifestation-of-hiv-in-healthcare-worker-a-case-report-and-review-of-the-literature
#13
REVIEW
Bhagyashri D Navalkele, Oryan Henig, Marilynn Fairfax, Elaine Flanagan, Mark Upfal, Jim Russell, Sorabh Dhar, Keith Kaye, Teena Chopra
Live-attenuated varicella vaccination is safe in non-immunocompromised population and associated with rare non-serious adverse events. A healthcare worker (HCW) developed varicella infection and exposure investigation led to immunization against varicella in an exposed non-immune HCW. Subsequently, vaccine-strain induced disseminated varicella and progressive outer retinal necrosis in the exposed HCW resulted in identification of undiagnosed HIV infection. Here, we review serious adverse events from varicella vaccination and advice extreme caution prior to live vaccination of healthcare workers...
June 1, 2017: Journal of Hospital Infection
https://www.readbyqxmd.com/read/28579233/a-phase-2-randomized-observer-blind-placebo-controlled-dose-ranging-trial-of-aluminum-adjuvanted-respiratory-syncytial-virus-f-particle-vaccine-formulations-in-healthy-women-of-childbearing-age
#14
Allison August, Gregory M Glenn, Eloi Kpamegan, Somia P Hickman, Dewal Jani, Hanxin Lu, D Nigel Thomas, Judy Wen, Pedro A Piedra, Louis F Fries
OBJECTIVE: Respiratory syncytial virus (RSV) causes significant morbidity and mortality in infants. We are developing an RSV fusion (F) protein nanoparticle vaccine for immunization of third trimester pregnant women to passively protect infants through transfer of RSV-specific maternal antibodies. The present trial was performed to assess the immunogenicity and safety of several formulations of RSV F vaccine in 1-dose or 2-dose schedules. METHODS: Placebo, or vaccine with 60μg or 120μg RSV F protein and 0...
June 1, 2017: Vaccine
https://www.readbyqxmd.com/read/28575074/lessons-learnt-from-human-papillomavirus-hpv-vaccination-in-45-low-and-middle-income-countries
#15
Katherine E Gallagher, Natasha Howard, Severin Kabakama, Sandra Mounier-Jack, Ulla K Griffiths, Marta Feletto, Helen E D Burchett, D Scott LaMontagne, Deborah Watson-Jones
OBJECTIVE: To synthesise lessons learnt and determinants of success from human papillomavirus (HPV) vaccine demonstration projects and national programmes in low- and middle-income countries (LAMICs). METHODS: Interviews were conducted with 56 key informants. A systematic literature review identified 2936 abstracts from five databases; after screening 61 full texts were included. Unpublished literature, including evaluation reports, was solicited from country representatives; 188 documents were received...
2017: PloS One
https://www.readbyqxmd.com/read/28573876/a-safety-assessment-of-biological-therapies-targeting-the-il-23-il-17-axis-in-inflammatory-bowel-diseases
#16
Bram Verstockt, Barbara Deleenheer, Gert Van Assche, Séverine Vermeire, Marc Ferrante
Many different compounds targeting the interleukin 23/17 axis have been developed and successfully studied in several autoimmune diseases, including inflammatory bowel diseases. Nevertheless, interfering with key immunological pathways raises potential safety concerns. This review focuses on the safety profile of these novel biological therapies. Areas covered: A literature search until March 2017 was performed to collect safety data on different compounds targeting this pathway, with emphasis on ustekinumab and secukinumab...
June 9, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28560356/rotavac-%C3%A2-does-not-interfere-with-the-immune-response-to-childhood-vaccines-in-indian-infants-a-randomized-placebo-controlled-trial
#17
Temsunaro Rongsen Chandola, Sunita Taneja, Nidhi Goyal, Kalpana Antony, Kiran Bhatia, Deepak More, Nita Bhandari, Iksung Cho, Krishna Mohan, Sai Prasad, Gvja Harshavardhan, Tataji Surender Rao, Sudhanshu Vrati, Maharaj Kishan Bhan
A phase III randomized double-blind placebo-controlled trial was conducted in the urban neighborhoods of Delhi to assess whether Oral Rotavirus Vaccine ROTAVAC(®) interferes with the immune response to childhood vaccines when coadministered. Infants aged 6 weeks were randomized to receive three doses of either ROTAVAC(®) or placebo along with childhood vaccines: Oral Polio Vaccine and vaccines against Diphtheria, Pertussis, Tetanus, Hepatitis B and Haemophilus influenza type b given as Pentavalent at 6, 10, 14 weeks of age...
May 2017: Heliyon
https://www.readbyqxmd.com/read/28558983/enhancing-global-vaccine-pharmacovigilance-proof-of-concept-study-on-aseptic-meningitis-and-immune-thrombocytopenic-purpura-following-measles-mumps-containing-vaccination
#18
Silvia Perez-Vilar, Daniel Weibel, Miriam Sturkenboom, Steven Black, Christine Maure, Jose Luis Castro, Pamela Bravo-Alcántara, Caitlin N Dodd, Silvana A Romio, Maria de Ridder, Swabra Nakato, Helvert Felipe Molina-León, Varalakshmi Elango, Patrick L F Zuber
New vaccines designed to prevent diseases endemic in low and middle-income countries (LMICs) are now being introduced without prior record of utilization in countries with robust pharmacovigilance systems. To address this deficit, our objective was to demonstrate feasibility of an international hospital-based network for the assessment of potential epidemiological associations between serious and rare adverse events and vaccines in any setting. This was done through a proof-of-concept evaluation of the risk of immune thrombocytopenic purpura (ITP) and aseptic meningitis (AM) following administration of the first dose of measles-mumps-containing vaccines using the self-controlled risk interval method in the primary analysis...
May 27, 2017: Vaccine
https://www.readbyqxmd.com/read/28552510/post-marketing-safety-surveillance-for-inactivated-and-live-attenuated-japanese-encephalitis-vaccines-in-china-2008-2013
#19
Wendi Wu, Dawei Liu, Keli Li, J Pekka Nuorti, Hanna M Nohynek, Disha Xu, Jiakai Ye, Jingshan Zheng, Huaqing Wang
INTRODUCTION: Two types of Japanese encephalitis (JE) vaccines, inactivated JE vaccine (JE-I) and live-attenuated JE vaccine (JE-L), are available and used in China. In particular, one JE-L, produced by a domestic manufacturer in China, was prequalified by WHO in 2013. We assessed the safety of JE vaccines in China during 2008-2013 using the Chinese National Adverse Events Following Immunization Information System (CNAEFIS) data. METHODS: We retrieved AEFI reporting data about JE vaccines from CNAEFIS, 2008-2013, examined demographic characteristics of AEFI cases, and used administrative data on vaccine doses as denominator to calculate and compare crude reporting rates...
June 22, 2017: Vaccine
https://www.readbyqxmd.com/read/28552101/allergic-adverse-events-following-2015-seasonal-influenza-vaccine-victoria-australia
#20
Hazel J Clothier, Nigel Crawford, Melissa A Russell, Jim P Buttery
Australia was alerted to a possible increase in allergy-related adverse events following immunisation (AEFI) with 2015 seasonal trivalent influenza vaccines (TIV) by the Victorian state vaccine safety service, SAEFVIC. We describe SAEFVIC's initial investigation and upon conclusion of the 2015 influenza vaccination programme, to define the signal event and implications for vaccine programmes. Allergy-related AEFI were defined as anaphylaxis, angioedema, urticaria or generalised allergic reaction. Investigations compared 2015 TIV AEFI reports to previous years as proportions and reporting risk (RR) per 100,000, stratified by influenza vaccine brand...
May 18, 2017: Euro Surveillance: Bulletin Européen sur les Maladies Transmissibles, European Communicable Disease Bulletin
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