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Vaccine adverse events

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https://www.readbyqxmd.com/read/29337134/acetylcholine-receptor-antibody-titers-and-clinical-course-after-influenza-vaccination-in-patients-with-myasthenia-gravis-a-double-blind-randomized-controlled-trial-propatient-trial
#1
Björn Tackenberg, Maximilian Schneider, Franz Blaes, Christian Eienbröker, Carmen Schade-Brittinger, Anne Wellek, Marcus Deschauer, Markus Eickmann, Hans-Dieter Klenk, Hans-Helge Müller, Norbert Sommer
BACKGROUND: It is a continuous matter of discussion whether immune activation by vaccination in general and Influenza vaccination in particular increases the risk for clinical deterioration of autoimmune diseases. This prospective study investigated the serological and clinical course of autoimmune Myasthenia gravis (MG) after a seasonal influenza vaccination. METHODS: This randomized, placebo-controlled, double-blind study enrolled MG patients with antibodies against acetylcholine-receptors (AChR-ab)...
January 10, 2018: EBioMedicine
https://www.readbyqxmd.com/read/29335073/-enhance-research-prevention-and-control-of-pertussis-for-protecting-public-confidence-in-vaccination-focus-on-the-adverse-events-of-vaccine-with-insufficient-potency-and-its-long-term-impacts
#2
Kai-Hu Yao, Ju Jia
On November 3, 2017, the China Food and Drug Administration reported that the potency indexes of two batches of diphtheria-pertussis-tetanus vaccines produced by two companies did not reach the requirements. Insufficient potency could affect the protection effect of these vaccines immunization. Currently, pertussis cases have already showed an increasing trend in China and could last for several years. Such an increase could be linked to these adverse events of vaccine with insufficient potency, which could become an evidence to challenge or deny the effectiveness of vaccination, and brings a persistent inhibition of the public's acceptance for vaccination...
January 2018: Zhongguo Dang Dai Er Ke za Zhi, Chinese Journal of Contemporary Pediatrics
https://www.readbyqxmd.com/read/29334707/-comparing-the-immunogenicity-and-safety-of-sequential-inoculation-of-sipv-followed-by-bopv-%C3%A2-%C3%A2-in-different-dosage-forms
#3
H Ye, T Huang, Z F Ying, G L Li, Y C Che, Z M Zhao, J F Wang, X L Yang, L Shi, R J Jiang, X C Liu, Z J Mo, C G Li, J S Yang
Objective: To compare the safety and immunogenicity of two different sequential schedules of inactivated poliomyelitis vaccine made from Sabin strain (sIPV) followed by typeⅠ+Ⅲ bivalent oral poliovirus vaccine (bOPV) in Drug Candy (DC) form or liquid dosage form). Methods: This randomized, blinded, single center, parallel-group controlled trial was done from September 2015 to June 2016 in Liuzhou, Guangxi province. Healthy infants aged ≥2 months were eligible for enrollment and divided into 1sIPV+2bOPV or 2sIPV+1bOPV sequential schedules...
January 6, 2018: Zhonghua Yu Fang Yi Xue za Zhi [Chinese Journal of Preventive Medicine]
https://www.readbyqxmd.com/read/29333501/feasibility-of-conducting-intradermal-vaccination-campaign-with-inactivated-poliovirus-vaccine-using-tropis-intradermal-needle-free-injection-system-karachi-pakistan
#4
Mohammad Tahir Yousafzai, Ali Faisal Saleem, Ondrej Mach, Attaullah Baig, Roland W Sutter, Anita K M Zaidi
Background: Administration of intradermal fractional dose of inactivated poliovirus vaccine (fIPV) has proven to be safe and immunogenic; however, its intradermal application using needle and syringe is technically difficult and requires trained personnel. Methods: We assessed feasibility of conducting an intradermal fIPV campaign in polio high risk neighborhood of Karachi using Tropis needle-free injector. During the one-day fIPV campaign, we measured average "application time" to administer fIPV with Tropis, collected ergonomic information and measured vaccine wastage...
August 2017: Heliyon
https://www.readbyqxmd.com/read/29330232/interventions-must-be-realistic-to-be-useful-and-completed-in-family-medicine
#5
EDITORIAL
Marjorie A Bowman, Dean A Seehusen, Anne Victoria Neale
Being realistic while helping our patients is this issue's theme. Given the volume of tasks required in family medicine, recommendations for improvements in direct care or care measurement cannot just be evidence-based but must also be realistic. On the list of realistic: ordering antipsychotics for symptoms of dementia in the elderly, despite recommendations to not do so; ordering antidepressants without fear that the patient could develop hypertension; mental health care providers in primary care offices; forced choice for opioid management; plus agenda setting for visit efficiency...
January 2018: Journal of the American Board of Family Medicine: JABFM
https://www.readbyqxmd.com/read/29329957/safety-and-tolerability-of-a-novel-polyclonal-human-anti-mers-coronavirus-antibody-produced-from-transchromosomic-cattle-a-phase-1-randomised-double-blind-single-dose-escalation-study
#6
John H Beigel, Jocelyn Voell, Parag Kumar, Kanakatte Raviprakash, Hua Wu, Jin-An Jiao, Eddie Sullivan, Thomas Luke, Richard T Davey
BACKGROUND: Middle East respiratory syndrome (MERS) is a severe respiratory illness with an overall mortality of 35%. There is no licensed or proven treatment. Passive immunotherapy approaches are being developed to prevent and treat several human medical conditions where alternative therapeutic options are absent. We report the safety of a fully human polyclonal IgG antibody (SAB-301) produced from the hyperimmune plasma of transchromosomic cattle immunised with a MERS coronavirus vaccine...
January 9, 2018: Lancet Infectious Diseases
https://www.readbyqxmd.com/read/29322496/wt1-peptide-based-immunotherapy-for-advanced-thymic-epithelial-malignancies
#7
Yusuke Oji, Masayoshi Inoue, Yoshito Takeda, Naoki Hosen, Yasushi Shintani, Manabu Kawakami, Takuya Harada, Yui Murakami, Miki Iwai, Mari Fukuda, Sumiyuki Nishida, Jun Nakata, Yoshiki Nakae, Satoshi Takashima, Toshiaki Shirakata, Hiroko Nakajima, Kana Hasegawa, Hiroshi Kida, Takashi Kijima, Soyoko Morimoto, Fumihiro Fujiki, Akihiro Tsuboi, Eiichi Morii, Satoshi Morita, Junichi Sakamoto, Atsushi Kumanogoh, Yoshihiro Oka, Meinoshin Okumura, Haruo Sugiyama
Thymic epithelial tumors are rare malignancies, and no optimal therapeutic regimen has been defined for patients with advanced disease. Patients with advanced thymic epithelial tumors, which were resistant or intolerable to prior therapies, were eligible for this study. Patients received 9 mer-WT1-derived peptide emulsified with Montanide ISA51 adjuvant via intradermal administration once a week as a monotherapy. After the 3 month-protocol treatment, the treatment was continued mostly at intervals of 2 to 4 weeks until disease progression or intolerable adverse events occurred...
January 11, 2018: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/29321075/a-phase-i-open-label-trial-on-the-safety-and-immunogenicity-of-the-adjuvanted-tuberculosis-subunit-vaccine-h1-ic31%C3%A2-in-people-living-in-a-tb-endemic-area
#8
Jemal Hussein, Martha Zewdie, Lawrence Yamuah, Ahmed Bedru, Markos Abebe, Alemnew F Dagnew, Menberework Chanyalew, Asfawesen G Yohannes, Jemal Ahmed, Howard Engers, T Mark Doherty, Peter Bang, Ingrid Kromann, Søren T Hoff, Abraham Aseffa
BACKGROUND: H1/IC31® is a tuberculosis (TB) subunit vaccine candidate consisting of the fusion protein of Ag85B and ESAT-6 (H1) formulated with the IC31® adjuvant. Previous trials have reported on the H1/IC31® vaccine in M. tuberculosis (Mtb)-naïve, BCG-vaccinated and previously Mtb-infected individuals. In this trial, conducted between December 2008 and April 2010, the safety and immunogenicity of H1/IC31® was assessed in participants living in Ethiopia - a highly TB-endemic area...
January 10, 2018: Trials
https://www.readbyqxmd.com/read/29317560/a-new-combined%C3%A2-vaccine%C3%A2-against-measles-mumps-rubella-and-varicella-in-india
#9
Nitin Shah, Raunak Parikh, Giacomo Casabona, Shafi Kolhapure
A quadrivalent MMRV (measles-mumps-rubella-varicella) combination vaccine has recently been launched in India. This vaccine is highly immunogenic, with seroconversion rates against all antigens reaching 96.6-100% at 42 to 56 days after the second vaccine dose in unvaccinated children or in those previously vaccinated with MMR+/-V. Two doses efficacy, against all varicella is 94.1% and effectiveness reaches 91%. The most frequent solicited local adverse event after MMRV vaccine is redness, and fever is the most common solicited general symptom...
December 15, 2017: Indian Pediatrics
https://www.readbyqxmd.com/read/29317118/safety-and-immunogenicity-of-single-dose-live-oral-cholera-vaccine-strain-cvd-103-hgr-in-healthy-adults-age-18-45
#10
James M McCarty, Michael D Lock, Kristin M Hunt, Jakub K Simon, Marc Gurwith
The attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR, re-developed as PXVX0200, elicits a rapid serum vibriocidal antibody (SVA) response and protects against cholera diarrhea in volunteer challenge studies. We performed a phase 3, placebo controlled, double blind, multi-center study to further assess the safety, immunogenicity, and lot-to-lot consistency of PXVX0200. Adult volunteers 18-45 years of age were randomized 8:1 to receive a single dose of 1 × 109 CFU of PXVX0200 from three production lots or saline placebo...
January 6, 2018: Vaccine
https://www.readbyqxmd.com/read/29302556/process-evaluation-of-child-health-services-at-outreach-sites-during-health-and-nutrition-day-mamta-day-in-urban-slums-of-western-india
#11
Kedar Mehta, Chandresh Pandya, Paragkumar Chavda, Dipak Solanki
Introduction: Health indicators of rural and urban India show a wide variation. Rural areas have received large focus in child health services, but on the flip side, urban areas have been the last to receive such attention. Materials and Methods: A cross-sectional study was conducted to include one randomly selected outreach session from all the 19 urban primary health centers of Vadodara city from April 2013 to May 2014. Nineteen session sites were observed for the process evaluation of three components of child health care, namely, "planning of Health and Nutrition Day," "availability of vaccines/logistics," and "direct observation of actual immunization process" at the site using a structured checklist...
April 2017: Journal of Family Medicine and Primary Care
https://www.readbyqxmd.com/read/29301826/p53-reactive-t-cells-are-associated-with-clinical-benefit-in-patients-with-platinum-resistant-epithelial-ovarian-cancer-after-treatment-with-a-p53-vaccine-and-gemcitabine-chemotherapy
#12
Nicola R Hardwick, Paul Frankel, Christopher Ruel, Julie Kilpatrick, Weimin Tsai, Ferdynand Kos, Teodora I Kaltcheva, Lucille Leong, Robert Morgan, Vincent Chung, Raechelle Tinsley, Melissa Eng, Sharon P Wilczynski, Joshua D I Ellenhorn, Don J Diamond, Mihaela Cristea
PURPOSE: To conduct a Phase I trial of a Modified Vaccinia Ankara vaccine delivering wild type human p53 (p53MVA) in combination with gemcitabine chemotherapy in patients with platinum-resistant ovarian cancer. EXPERIMENTAL DESIGN: Patients received gemcitabine on days 1 and 8 and p53MVA vaccine on day 15, during the first 3 cycles of chemotherapy. Toxicity was classified using the NCI Common Toxicity Criteria and clinical response assessed by CT scan. Peripheral blood samples were collected for immunophenotyping and monitoring of anti-p53 immune responses...
January 4, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29297746/influenza-vaccines-evaluation-of-the-safety-profile
#13
Claudia Maria Trombetta, Elena Gianchecchi, Emanuele Montomoli
The safety of vaccines is a critical factor in maintaining public trust in national vaccination programs. Vaccines are recommended for children, adults and elderly subjects and have to meet higher safety standards, since they are administered to healthy subjects, mainly healthy children. Although vaccines are strictly monitored before authorization, the possibility of adverse events and/or rare adverse events cannot be totally eliminated. Two main types of influenza vaccines are currently available: parenteral inactivated influenza vaccines and intranasal live attenuated vaccines...
January 3, 2018: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29289382/head-to-head-immunogenicity-comparison-of-edmonston-zagreb-vs-aik-c-measles-vaccine-strains-in-infants-aged-8-12-months-a-randomized-clinical-trial
#14
Shahrokh Izadi, Seyed Mohsen Zahraei, Masoud Salehi, Mahdi Mohammadi, Seyed Mehdi Tabatabaei, Talat Mokhtari-Azad
BACKGROUND: A non-inferiority multi-centre parallel randomized double-blind trial was implemented in Zahedan district, Sistan-va-Baluchestan province, Iran, to compare the performance of the two measles vaccines which are in use in the National Immunization Programme of Iran and are of two different measles virus vaccine strains: Edmonston-Zagreb (EZ) strain vs. AIK-C strain. The main outcome measure was appearance of anti-measles antibody in sera. METHODS: 200 infants, 8-12 months old, whose parents consented for their children to be included in the study, were randomized in permutation blocks of size 4-8 in four Urban Health Clinics...
December 27, 2017: Vaccine
https://www.readbyqxmd.com/read/29282694/immune-checkpoint-blockade-in-breast-cancer-therapy
#15
Xia Bu, Yihui Yao, Xiaoyu Li
Cancer immunotherapy is emerging as the most promising novel strategy for cancer treatment. Cancer immunotherapy is broadly categorized into three forms: immune checkpoint modulation, adoptive cell transfer, and cancer vaccine. Immune checkpoint blockade is demonstrated as the most clinically effective treatment with low immune-related adverse events (irAE). Blockade of PD-1/PD-L1 and CTLA-4 has achieved remarkable success in treating various types of tumors, which sparks great interests in this therapeutic strategy and expands the role of immune checkpoint blockade in treating tumors including breast cancer...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29282691/progress-in-vaccine-therapies-for-breast-cancer
#16
Xiaoyu Li, Xia Bu
Therapeutic cancer vaccines aim to treat pre-existing cancer by boosting the patient's own immune system, which is an attractive strategy for cancer treatment. The cancer vaccines have mainly been designed to elicit antitumor T-cell immune responses that recognize and eradicate cancer. The advantages of cancer immunotherapy with cancer vaccines include a) high specificity of tumor antigen, b) minimal vaccine-related adverse events, and c) long-lasting immunity boosted by cancer vaccine which is important to control tumor relapse...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29280070/safety-of-human-papillomavirus-vaccines-an-updated-review
#17
REVIEW
Anastasia Phillips, Cyra Patel, Alexis Pillsbury, Julia Brotherton, Kristine Macartney
Human papillomavirus (HPV) vaccines are now included in immunisation programmes in 71 countries. Unfortunately, uptake has been impacted in some countries by reduced confidence in the safety of the HPV vaccine. In 2013, we published an extensive review demonstrating a reassuring safety profile for bivalent (2vHPV) and quadrivalent (4vHPV) vaccines. A nonavalent (9vHPV) vaccine is now available and HPV immunisation programmes have been extended to males in 11 countries. The aim of this updated narrative review was to examine the evidence on HPV vaccine safety, focusing on the 9vHPV vaccine, special populations and adverse events of special interest (AESI)...
December 26, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29277353/immunologic-non-inferiority-and-safety-of-the-investigational-pneumococcal-non-typeable-haemophilus-influenzae-protein-d-conjugate-vaccine-phid-cv-4-dose-vial-presentation-compared-to-the-licensed-phid-cv-1-dose-vial-presentation-in-infants-a-phase-iii-randomized
#18
Khalequ Zaman, Sheikh Farzana Zaman, Farzana Zaman, Asma Aziz, Sayeed-Bin Faisal, Magali Traskine, Md Ahsan Habib, Javier Ruiz-Guiñazú, Dorota Borys
BACKGROUND: To support vaccination programs in developing countries, a 4-dose vial presentation of pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was developed. This study assessed immunologic non-inferiority and safety of the investigational PHiD-CV 4-dose versus licensed 1-dose vial presentation in infants. METHODS: In this phase III, mono-center, observer-blind study in Bangladesh, 6-10-week-old infants were randomized 1:1 to receive PHiD-CV primary vaccination (at ages 6, 10, 18 weeks) and a booster dose (at age 9 months) with a 4-dose vial (with preservative, 4DV group) or 1-dose vial (preservative-free, 1DV group)...
December 22, 2017: Vaccine
https://www.readbyqxmd.com/read/29248264/safety-of-vaccines-that-have-been-kept-outside-of-recommended-temperatures-reports-to-the-vaccine-adverse-event-reporting-system-vaers-2008-2012
#19
Beth F Hibbs, Elaine Miller, Jing Shi, Kamesha Smith, Paige Lewis, Tom T Shimabukuro
BACKGROUND: Vaccines should be stored and handled according to manufacturer specifications. Inadequate cold chain management can affect potency; but, limited data exist on adverse events (AE) following administration of vaccines kept outside of recommended temperatures. OBJECTIVE: To describe reports to the Vaccine Adverse Event Reporting System (VAERS) involving vaccines inappropriately stored outside of recommended temperatures and/or exposed to temperatures outside of manufacturer specifications for inappropriate amounts of time...
December 13, 2017: Vaccine
https://www.readbyqxmd.com/read/29247502/immunotherapy-excluding-checkpoint-inhibitors-for-stage-i-to-iii-non-small-cell-lung-cancer-treated-with-surgery-or-radiotherapy-with-curative-intent
#20
REVIEW
Jianwei Zhu, Rui Li, Eva Tiselius, Raheleh Roudi, Olivia Teghararian, Chen Suo, Huan Song
BACKGROUND: Non-small cell lung cancer (NSCLC) is the most common lung cancer, accounting for approximately 80% to 85% of all cases. For patients with localised NSCLC (stages I to III), it has been speculated that immunotherapy may be helpful for reducing postoperative recurrence rates, or improving the clinical outcomes of current treatment for unresectable tumours. While several new agents have now entered phase III clinical trials, we felt a systematic review was needed to address the question of the effectiveness and safety of immunotherapy in patients with stages I to III NSCLC...
December 16, 2017: Cochrane Database of Systematic Reviews
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