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Vaccine adverse events

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https://www.readbyqxmd.com/read/28730271/serious-adverse-events-after-hpv-vaccination-a-critical-review-of-randomized-trials-and-post-marketing-case-series
#1
Manuel Martínez-Lavín, Luis Amezcua-Guerra
This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study...
July 20, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28729879/safety-and-immunogenicity-of-the-quadrivalent-human-papillomavirus-qhpv-vaccine-in-hiv-positive-spanish-men-who-have-sex-with-men-msm
#2
Carmen Hidalgo-Tenorio, Jessica Ramírez-Taboada, Concepción Gil-Anguita, Javier Esquivias, Mohamed Omar-Mohamed-Balgahata, Antonio SamPedro, Miguel Lopez-Ruz, Juan Pasquau
BACKGROUND: Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa. METHODS: This is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine...
2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/28729019/safety-reactogenicity-and-immunogenicity-of-two-investigational-pneumococcal-protein-based-vaccines-results-from-a-randomized-phase-ii-study-in-infants
#3
Roman Prymula, Leszek Szenborn, Sven-Arne Silfverdal, Jacek Wysocki, Piotr Albrecht, Magali Traskine, Asparuh Gardev, Yue Song, Dorota Borys
INTRODUCTION: Vaccination with formulations containing pneumococcal protein antigens such as pneumolysin toxoid (dPly) and histidine-triad protein D (PhtD) may extend serotype-related protection of pneumococcal conjugate vaccines (PCVs) against Streptococcus pneumoniae. METHODS: This phase II, multi-center, observer-blind trial conducted in Europe (NCT01204658) assessed 2 investigational vaccines containing 10 serotype-specific polysaccharide conjugates of PHiD-CV and either 10 or 30µg of dPly and PhtD each...
July 17, 2017: Vaccine
https://www.readbyqxmd.com/read/28728074/no-pain-no-gain-adjuvant-effects-of-alum-and-monophosphoryl-lipid-a-in-pertussis-and-hpv-vaccines
#4
REVIEW
Thomas C Mitchell, Carolyn R Casella
Development of non-infectious subunit vaccines is hampered by a slow pipeline of new adjuvants to replace or enhance alum in part because expectations of safety are high. Transient vaccine side effects are not clinical priorities because they cause no lasting harm and vaccine development has appropriately been focused on avoidance of serious adverse events. As a result, surprisingly little is known about the extent to which side effects caused by a vaccine's reactogencicity are predictive of successful immunization outcomes...
July 17, 2017: Current Opinion in Immunology
https://www.readbyqxmd.com/read/28721859/immunogenicity-and-safety-of-the-inactivated-hepatitis-a-vaccine-in-children-with-juvenile-idiopathic-arthritis-on-methotrexate-treatment-a-matched-case-control-study
#5
Despoina N Maritsi, Susan E Coffin, Ioanna Argyri, George Vartzelis, Nick Spyridis, Maria N Tsolia
OBJECTIVES: To describe the immunogenicity and side effects of immunisation against hepatitis A virus (HAV) in JIA patients on methotrexate treatment, who have not been previously exposed to HAV. METHODS: Case-control study performed in JIA patients and healthy controls matched on age and gender. The subjects received two doses of inactivated anti-HAV vaccine (720 mIU/ml) intramuscularly at 0 and 6 months. Seroconversion, seroprotection rates and anti-HAV-IgG titres were measured at 1, 7 and 18 months...
July 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28720281/evaluation-of-a-primary-course-of-h9n2-vaccine-with-or-without-as03-adjuvant-in-adults-a-phase-i-ii-randomized-trial
#6
Anuradha Madan, Harry Collins, Eric Sheldon, Louise Frenette, Laurence Chu, Damien Friel, Mamadou Drame, David W Vaughn, Bruce L Innis, Anne Schuind
BACKGROUND: Avian influenza A H9N2 strains have pandemic potential. METHODS: In this randomized, observer-blind study (ClinicalTrials.gov: NCT01659086), 420 healthy adults, 18-64years of age, received 1 of 10 H9N2 inactivated split-virus vaccination regimens (30 participants per group), or saline placebo (120 participants). H9N2 groups received 2 doses (days 0, 21) of 15µg hemagglutinin (HA) without adjuvant, or 1.9µgHA+AS03A, 1.9µgHA+AS03B, 3.75µgHA+AS03A, or 3...
July 15, 2017: Vaccine
https://www.readbyqxmd.com/read/28720147/safety-and-immunogenicity-of-the-quadrivalent-human-papillomavirus-qhpv-vaccine-in-hiv-positive-spanish-men-who-have-sex-with-men-msm
#7
Carmen Hidalgo-Tenorio, Jessica Ramírez-Taboada, Concepción Gil-Anguita, Javier Esquivias, Mohamed Omar-Mohamed-Balgahata, Antonio SamPedro, Miguel Lopez-Ruz, Juan Pasquau
BACKGROUND: Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa. METHODS: This is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine...
July 18, 2017: AIDS Research and Therapy
https://www.readbyqxmd.com/read/28719496/safety-and-immunogenicity-of-13-valent-pneumococcal-conjugate-vaccine-in-children-aged-6-to-17-years-in-india-an-open-label-trial
#8
Sharad Agarkhedkar, Christine Juergens, Krishnamurthy Balasundaram, Shalaka Agarkhedkar, Vani Sundaraiyer, Natacha Le Dren-Narayanin, Mark W Cutler, William C Gruber, Daniel A Scott, Beate Schmoele-Thoma
In an open-label study in India, 200 healthy participants aged 6-17 years received 13-valent pneumococcal conjugate vaccine (PCV13). PCV13 elicited robust functional antibody immune responses. No adverse events were reported by caregivers at the 1-month follow-up visit. The immunogenicity results together with the known favorable risk-benefit profile of PCV13 support extension of the indication to this age group in India.ClinicalTrials.gov: NCT02034877.
July 15, 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28719287/phase-1-randomized-study-of-a-tetravalent-dengue-purified-inactivated-vaccine-in-healthy-adults-in-the-united-states
#9
Alexander C Schmidt, Leyi Lin, Luis J Martinez, Richard C Ruck, Kenneth H Eckels, Alix Collard, Rafael De La Barrera, Kristopher M Paolino, Jean-François Toussaint, Edith Lepine, Bruce L Innis, Richard G Jarman, Stephen J Thomas
AbstractThe safety and immunogenicity of four formulations of an investigational tetravalent dengue purified inactivated vaccine (DPIV), formulated at 1 or 4 μg with aluminum hydroxide (alum) or at 1 μg with an adjuvant system (AS01E or AS03B), were evaluated in a first-time-in-human, placebo-controlled, randomized, observer-blind, phase 1 trial in the continental United States. Two doses of vaccine or placebo were administered intramuscularly 4 weeks apart to 100 healthy adults 18-39 years of age, randomized 1:1:1:1:1 to receive one of four DPIV formulations or saline placebo...
June 2017: American Journal of Tropical Medicine and Hygiene
https://www.readbyqxmd.com/read/28718586/-adverse-events-of-biologic-therapies
#10
Gregory Fleury, Cem Gabay
Biological therapies have revolutionized the management and the outcome of patients with inflammatory rheumatic diseases. The prescription and the number of patients under biotherapies have greatly increased. Unfortunately, these treatments are occasionally accompanied by side effects usually reversible upon treatment discontinuation. Some are preventable or can be reduced, including through the screening and prevention (tuberculosis screening, vaccination…). It is important to be aware of these different side effects to adapt the prescription of biologics according to the patient's profile (history of infection, malignancy, heart failure…)...
March 8, 2017: Revue Médicale Suisse
https://www.readbyqxmd.com/read/28709556/intussusception-among-children-less-than-2years-of-age-findings-from-pre-vaccine-introduction-surveillance-in-pakistan
#11
Mohammad Tahir Yousafzai, Rozina Thobani, Saqib Hamid Qazi, Nasir Saddal, Catherine Yen, Negar Aliabadi, Syed Asad Ali
BACKGROUND: Rotavirus vaccination introduction in routine immunization is under consideration in Pakistan. Data on the baseline epidemiology of intussusception will inform surveillance strategies for intussusception after rotavirus vaccine introduction in Pakistan. We describe the epidemiology of intussusception-associated hospitalizations among children <2years of age in Karachi, Pakistan. METHODS: We conducted a retrospective chart review for July 01, 2012 through June 30, 2015 at the National Institute of Child Health (NICH) and Aga Khan University Hospital (AKUH) Karachi...
July 11, 2017: Vaccine
https://www.readbyqxmd.com/read/28704349/announcement-implementation-of-the-vaccine-adverse-event-reporting-system-2-0-reporting-form
#12
(no author information available yet)
The Vaccine Adverse Event Reporting System (VAERS), co-managed by CDC and the Food and Drug Administration (FDA), is the national postmarketing safety monitoring system that accepts reports about adverse events that occur after administration of U.S.-licensed vaccines (1,2). On June 30, 2017, CDC and FDA implemented a revised reporting form and a new process for submitting reports to VAERS. Persons reporting adverse events are now able to use the VAERS 2.0 online reporting tool to submit reports directly online; alternatively, they may download and complete the writable and savable VAERS 2...
July 14, 2017: MMWR. Morbidity and Mortality Weekly Report
https://www.readbyqxmd.com/read/28701892/a-pilot-study-of-post-operative-adjuvant-vaccine-for-advanced-gastric-cancer
#13
Yoshiyuki Fujiwara, Keijiro Sugimura, Hiroshi Miyata, Takeshi Omori, Hiroyuki Nakano, Chie Mochizuki, Katsuji Shimizu, Hiroaki Saito, Keigo Ashida, Soichiro Honjyo, Yusuke Nakamura, Masahiko Yano
BACKGROUND: Previously, we had performed a clinical study using human leukocyte antigen (HLA)-A24-binding peptide vaccines containing a combination of novel cancer-testis antigens and anti-angiogenic peptides derived from DEPDC1, URLC10, FOXM1, KIF20A and VEGFR1 for advanced gastric cancer (AGC) patients who were refractory to chemotherapy. We applied the cocktail vaccine to the combination therapy with S-1 for patients with AGC as a post-operative adjuvant therapy and performed this clinical pilot study...
June 2017: Yonago Acta Medica
https://www.readbyqxmd.com/read/28700282/a-randomized-open-label-clinical-trial-to-evaluate-immunogenicity-and-safety-of-an-indigenously-developed-dtwp-hib-tetravalent-combination-vaccine-easyfour%C3%A2-tt-with-quadrovax%C3%A2-in-indian-infants
#14
Lalitendu Mohanty, Sunil Sharma, Beauty Behera, Sachin Panwar, Charu Paliwal, Anit Singh, Anu Gupta, Deepak Chandra Chilkoti
An open-label, randomized, multi-centre trial was conducted to compare the immunogenicity and safety of an indigenously developed tetravalent DTwP-Hib vaccine, Easyfour®-TT with a commercially available vaccine, Quadrovax®. A total of 244 infants in good health, aged 6-10 weeks, were randomised in a 1:1 allocation to receive three doses of the test or comparator vaccine. Immunogenicity of the vaccines was determined by measuring the baseline and post-vaccination antibody response against the vaccine antigens; safety was evaluated in terms of local and systemic reactions (solicited and unsolicited) reported during the trial...
July 12, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28700265/safety-and-immunogenicity-of-a-quadrivalent-influenza-vaccine-in-adults-65%C3%A2-years-of-age-and-older
#15
David P Greenberg, Corwin A Robertson, H Keipp Talbot, Michael D Decker
Frequent mismatches between the predominant circulating B strain lineage and the B strain lineage in trivalent influenza vaccines have resulted in missed opportunities to prevent influenza illness. Quadrivalent influenza vaccines containing B strains from each of the two lineages have been developed for improved prevention of influenza B infections. Here, we describe the results of a phase III, randomized, double-blind, active-controlled, multicenter trial examining the safety and immunogenicity of a split-virion inactivated quadrivalent influenza vaccine (IIV4) in 675 adults ≥ 65 years of age (NCT01218646)...
July 12, 2017: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/28699543/a-signal-detection-method-for-temporal-variation-of-adverse-effect-with-vaccine-adverse-event-reporting-system-data
#16
Yi Cai, Jingcheng Du, Jing Huang, Susan S Ellenberg, Sean Hennessy, Cui Tao, Yong Chen
BACKGROUND: To identify safety signals by manual review of individual report in large surveillance databases is time consuming; such an approach is very unlikely to reveal complex relationships between medications and adverse events. Since the late 1990s, efforts have been made to develop data mining tools to systematically and automatically search for safety signals in surveillance databases. Influenza vaccines present special challenges to safety surveillance because the vaccine changes every year in response to the influenza strains predicted to be prevalent that year...
July 5, 2017: BMC Medical Informatics and Decision Making
https://www.readbyqxmd.com/read/28696530/immunogenicity-and-safety-of-single-dose-13-valent-pneumococcal-conjugate-vaccine-in-pediatric-and-adolescent-oncology-patients
#17
Te-Yu Hung, Rishi S Kotecha, Christopher C Blyth, Sarah K Steed, Ruth B Thornton, Anne L Ryan, Catherine H Cole, Peter C Richmond
BACKGROUND: Children receiving immunosuppressive treatment for cancer are at high risk for invasive pneumococcal disease. The 13-valent pneumococcal conjugate vaccine (PCV13) can prevent pneumococcal disease in healthy children; however, there is an absence of literature regarding the benefit of PCV13 in immunocompromised children with cancer. METHODS: A prospective, open-label cohort study recruited children between ages 1 and 18 years who were receiving active immunosuppressive therapy (AIT) or were within 12 months after completing immunosuppressive therapy (CIT)...
July 11, 2017: Cancer
https://www.readbyqxmd.com/read/28694146/can-causality-assessment-fulfill-the-new-european-definition-of-adverse-drug-reaction-a-review-of-methods-used-in-spontaneous-reporting
#18
REVIEW
Annamaria Mascolo, Cristina Scavone, Maurizio Sessa, Gabriella di Mauro, Daniela Cimmaruta, Valentina Orlando, Francesco Rossi, Liberata Sportiello, Annalisa Capuano
Causality assessment is a fundamental biomedical technique for the signal detection performed by Pharmacovigilance centers in a Spontaneous reporting system. Moreover, it is a crucial and important practice for detecting preventable adverse drug reactions. Among different methods for causality assessment, algorithms (such as the Naranjo, or Begaud Methods) seem for their operational procedure and easier applicability one of the most commonly used methods. With the upcoming of the new European Pharmacovigilance legislation including in the definition of the adverse event also effects resulting from abuse, misuse and medication error, all well-known preventable causes of ADRs, there was an emerging need to evaluate whether algorithms could fulfill this new definition...
July 8, 2017: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/28690279/towards-a-preventive-strategy-for-neosporosis-challenges-and-future-perspectives-for-vaccine-development-against-infection-with-neospora-caninum
#19
Yoshifumi Nishikawa
Neosporosis is caused by the intracellular protozoan parasite Neospora caninum. This major disease-causing pathogen is responsible for inducing abortion in cattle, and these adverse events occur sporadically all over the world, including Japan. Currently, there are no vaccines on the market against infection with N. caninum. Because live and attenuated vaccines against N. caninum have had safety and effectiveness issues, development of a next-generation vaccine is urgently required. To develop a vaccine against neosporosis, my laboratory has been focused on the following: 1) understanding the host immune responses against Neospora infection, 2) identifying vaccine antigens and 3) developing an effective antigen-delivery system...
July 7, 2017: Journal of Veterinary Medical Science
https://www.readbyqxmd.com/read/28689455/human-papillomavirus-vaccine-and-postural-orthostatic-tachycardia-syndrome-a-review-of-current-literature
#20
Breann N Butts, Philip R Fischer, Kenneth J Mack
The human papillomavirus (HPV) vaccine is efficacious in preventing complications of human papillomavirus infection including cervical cancer. However, there have been case reports of adverse events occurring after vaccination, one being postural orthostatic tachycardia syndrome (POTS). This article reviews published data and other available information regarding the relationship between the human papillomavirus vaccine and POTS. Background information is provided regarding the human papillomavirus vaccine and the proposed post-vaccination adverse event POTS...
January 1, 2017: Journal of Child Neurology
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