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https://www.readbyqxmd.com/read/30431383/safety-and-immunogenicity-of-vaqta%C3%A2-in-children-12-to-23-months-of-age-with-and-without-administration-of-other-us-pediatric-vaccines
#1
Maria Petrecz, Camilo J Acosta, Stephanie O Klopfer, Barbara J Kuter, Michelle G Goveia, Jon E Stek, Florian P Schödel, Andrew W Lee
Safety and immunogenicity data from 5 clinical trials conducted in the US in children 12-to-23 months old where HAVi was administered alone or concomitantly with other pediatric vaccines (M-M-R®II, Varivax®, TRIPEDIA®, Prevnar®, ProQuad®, PedvaxHIB®, and INFANRIX®) were combined. Among 4,374 participants receiving ≥ 1 dose of HAVi, 4,222 (97%) had safety follow-up and the proportions reporting adverse events (AE) were comparable when administered alone (69.4%) or concomitantly with other pediatric vaccines (71...
November 15, 2018: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/30319951/from-glivec-%C3%A2-to-prevnar-13-%C3%A2-how-strong-is-the-indian-drug-patenting-system
#2
Gerard Marshall Raj
No abstract text is available yet for this article.
October 2018: Perspectives in Clinical Research
https://www.readbyqxmd.com/read/30166816/a-simple-approach-to-pneumococcal-vaccination-in-adults
#3
REVIEW
Calvin Green, Christine Ann Moore, Akhilesh Mahajan, Kailash Bajaj
Streptococcus pneumoniae is a bacterium responsible for a spectrum of diseases including lobar pneumonia, meningitis, otitis media, and sinusitis. Invasive pneumococcal disease is responsible for significant morbidity and mortality across the world. Concerted efforts led to the development of two vaccinations, Pneumova × 23 and Prevnar 13, for the prevention of pneumococcal disease. The Advisory Committee on Immunization Practices of the US Centers for Disease Control and Prevention provides vaccination schedules for predisposed adults, but the proposed schedules remain a challenge to health-care providers...
July 2018: Journal of Global Infectious Diseases
https://www.readbyqxmd.com/read/30089644/evaluation-of-a-validated-luminex-based-multiplex-immunoassay-for-measuring-immunoglobulin-g-antibodies-in-serum-to-pneumococcal-capsular-polysaccharides
#4
COMPARATIVE STUDY
Charles Y Tan, Fred W Immermann, Shite Sebastian, Michael W Pride, Danka Pavliakova, Kelly A Belanger, Wendy Watson, Daniel A Scott, Mohinder Sidhu, Kathrin U Jansen, Peter C Giardina
This article describes the results of a study designed to bridge the World Health Organization (WHO) pneumococcal enzyme-linked immunosorbent assay (ELISA) platform to the validated Luminex-based 13-plex direct immunoassay (dLIA) platform developed by Pfizer, Inc. Both assay platforms quantify serotype-specific serum IgG antibodies (in micrograms per milliliter) against an international reference standard serum. The primary goal of this study was to determine if the dLIA is a suitable replacement for the ELISA to support clinical vaccine studies that include the evaluation of immune responses to serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F...
August 8, 2018: MSphere
https://www.readbyqxmd.com/read/29993327/reports-of-lower-respiratory-tract-infection-following-dose-1-of-rotateq-and-rotarix-vaccines-to-the-vaccine-adverse-event-reporting-system-vaers-2008-2016
#5
Penina Haber, Muhammad Amin, Carmen Ng, Eric Weintraub, Michael M McNeil
A 2018 manufacturer post-licensure safety study identified a possible association between Rotarix (RV1) rotavirus vaccine and lower respiratory tract infections (LRTI) in infants within 0-6 days following receipt of RV1 dose 1. We reviewed reports to the Vaccine Adverse Event Reporting System (VAERS) of LRTI occurring 0-6 days and 0-29 days post vaccination following RotaTeq (RV5) or Rotarix (RV1) vaccinations in conjunction with either Prevnar (PCV7) or Prevnar 13 (PCV13), in infants aged 6 to 15 weeks...
July 11, 2018: Human Vaccines & Immunotherapeutics
https://www.readbyqxmd.com/read/29062961/novel-polysaccharide-protein-conjugates-provide-an-immunogenic-13-valent-pneumococcal-conjugate-vaccine-for-s-pneumoniae
#6
Allison E B Turner, Jonas E Gerson, Helen Y So, Daniel J Krasznai, Adrienne J St Hilaire, Donald F Gerson
Pneumonia remains the single leading cause of childhood death worldwide. Despite the commercial availability of multiple pneumococcal conjugate vaccines (PCVs), high dosage cost and supply shortages prevent PCV delivery to much of the developing world. The current work presents high-yield pneumococcal conjugates that are immunogenic in animals and suitable for use in human vaccine development. The 13-valent pneumococcal conjugate vaccine (PCV-13) investigated in this research incorporated serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F...
March 2017: Synthetic and Systems Biotechnology
https://www.readbyqxmd.com/read/29032897/prevnar-13-vaccine-failure-in-a-mouse-model-for-vitamin-a-deficiency
#7
Rhiannon R Penkert, Amy Iverson, Jason W Rosch, Julia L Hurwitz
Streptococcus pneumoniae (pneumococcus) is responsible for serious pediatric respiratory infections, and kills close to one million children under the age of five each year. Unfortunately, the Prevnar-13 vaccine (PCV-13) that is used to protect children from the serious consequences of pneumococcus infections is not always successful. Given that vitamin A deficiency (VAD) is known to affect children in both developed and developing countries, we asked if VAD could be responsible, at least in part, for PCV-13 vaccine failures...
November 1, 2017: Vaccine
https://www.readbyqxmd.com/read/28774562/defective-anti-polysaccharide-igg-vaccine-responses-in-iga-deficient-mice
#8
Yoichi Furuya, Girish S Kirimanjeswara, Sean Roberts, Rachael Racine, Jennifer Wilson-Welder, Alan M Sanfilippo, Sharon L Salmon, Dennis W Metzger
We report that IgA-/- mice exhibit specific defects in IgG antibody responses to various polysaccharide vaccines (Francisella tularensis LPS and Pneumovax), but not protein vaccines such as Fluzone. This defect further included responses to polysaccharide-protein conjugate vaccines (Prevnar and Haemophilus influenzae type b-tetanus toxoid vaccine). In agreement with these findings, IgA-/- mice were protected from pathogen challenge with protein- but not polysaccharide-based vaccines. Interestingly, after immunization with live bacteria, IgA+/+ and IgA-/- mice were both resistant to lethal challenge and their IgG anti-polysaccharide antibody responses were comparable...
September 5, 2017: Vaccine
https://www.readbyqxmd.com/read/28721392/the-response-to-typhi-vi-vaccination-is-compromised-in-individuals-with-primary-immunodeficiency
#9
Jeevani Kumarage, Suranjith L Seneviratne, Vijitha Senaratne, Amitha Fernando, Kirthi Gunasekera, Bandu Gunasena, Padmalal Gurugama, Sudath Peiris, Antony R Parker, Stephen Harding, Nilhan Rajiva de Silva
Measurement of an individuals ability to respond to polysaccharide antigens is a crucial test to determine adaptive immunity. Currently the response to Pneumovax(®) is utilized but with the success of Prevnar(®), measurement of the response to Pneumovax may be challenging. The aim of the study was to assess the response to Typhi Vi vaccination in both children and adult control groups and patients with primary immunodeficiency (PID). In the control groups, >95% of the individuals had pre Typhi Vi vaccination concentrations <100 U/mL and there was significant increase in concentration post Typhi Vi vaccination (p<0...
June 2017: Heliyon
https://www.readbyqxmd.com/read/28545925/peritoneal-b-1b-and-b-2-b-cells-confer-long-term-protection-from-pneumococcal-serotype-3-infection-after-vaccination-with-prevnar-13-and-are-defective-in-sickle-cell-disease-mice
#10
Christina Cotte, Steven M Szczepanek
Long-term immunity after inoculation with the pneumococcal conjugate vaccine (Prevnar-13) is impaired in sickle cell disease (SCD) mice. We sought to determine which B-cell subsets are defective in SCD mice after vaccination with Prevnar-13, yet confer long-term immunity in wild-type (WT) mice. We vaccinated WT and SCD mice three times at three week intervals with Prevnar-13. Fourteen weeks later, 5∗104 cells of isolated peritoneal B-1a, B-1b, and B-2 cells were harvested and intraperitoneally transferred to Rag -/- recipients...
June 16, 2017: Vaccine
https://www.readbyqxmd.com/read/28467237/effect-of-the-13-valent-pneumococcal-conjugate-vaccine-on-nasopharyngeal-carriage-by-respiratory-pathogens-among-greenlandic-children
#11
Johan Emdal Navne, Anders Koch, Hans-Christian Slotved, Mikael Andersson, Mads Melbye, Karin Ladefoged, Malene Børresen
BACKGROUND: In 2010, Greenland introduced the 13-valent pneumococcal conjugate vaccine (Prevnar 13®- PCV-13) in the childhood immunisation program. The authors aimed to evaluate the impact of PCV-13 on nasopharyngeal carriage of bacteria frequently associated with respiratory infections in children. METHOD: In 2013 a cross-sectional population-based study of nasopharyngeal carriage was conducted among Greenlandic children aged 0-6 years and results were compared with an equivalent study from 2011...
2017: International Journal of Circumpolar Health
https://www.readbyqxmd.com/read/28441266/safety-of-the-inactivated-japanese-encephalitis-virus-vaccine-ixiaro-in-children-an-open-label-randomized-active-controlled-phase-3-study
#12
RANDOMIZED CONTROLLED TRIAL
Katrin L Dubischar, Vera Kadlecek, Benjamin Sablan, Charissa Fay Borja-Tabora, Salvacion Gatchalian, Susanne Eder-Lingelbach, Zsuzsanna Mueller, Kerstin Westritschnig
BACKGROUND: Japanese encephalitis remains a serious health concern in Asian countries and has sporadically affected pediatric travelers. In the present study, we monitored the safety profile of the Japanese encephalitis virus vaccine IXIARO (Valneva Austria GmbH, Vienna, Austria) in a pediatric population. METHODS: We randomized 1869 children between 2 months and 17 years of age in an age-stratified manner to vaccination with IXIARO or one of the control vaccines, Prevnar (formerly Wyeth Pharmaceuticals Inc...
September 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/28275739/rapid-kinetics-of-serum-iga-after-vaccination-with-prevnar%C3%A2-13-followed-by-pneumovax%C3%A2-23
#13
Rebecca R Crowther, Christine M Collins, Cheryl Conley, Osvaldo J Lopez
Streptococcus pneumoniae is a causative agent of community-acquired pneumonias. The recommendations of the 2012 Advisory Committee on Immunization Practices include vaccination with Prevnar®13 (protein-polysaccharide conjugate vaccine; PCV), followed by Pneumovax®23 (polysaccharide-based vaccine; PSV) in adults 65+ or the immunocompromised. In this experiment, a group of 4 healthy volunteers were vaccinated with PCV followed by PSV 60 days later. ELISAs were optimized to study kinetics of IgA, IgM, total IgG and its four subclasses against 14 polysaccharides of the pneumococcal capsule...
February 2017: Heliyon
https://www.readbyqxmd.com/read/28069362/ex-vivo-antigen-pulsed-pbmcs-generate-potent-and-long-lasting-immunity-to-infection-when-administered-as-a-vaccine
#14
Sudeep Kumar, Raju Sunagar, Giang Pham, Edmund J Gosselin, David Nalin
Numerous studies have demonstrated that administration of antigen (Ag)-pulsed dendritic cells (DCs) is an effective strategy for enhancing immunity to tumors and infectious disease organisms. However, the generation and/or isolation of DCs can require substantial time and expense. Therefore, using inactivated F. tularensis (iFt) Ag as a model immunogen, we first sought to determine if DCs could be replaced with peripheral blood mononuclear cells (PBMCs) during the ex-vivo pulse phase and still provide protection against Ft infection...
February 15, 2017: Vaccine
https://www.readbyqxmd.com/read/27846058/lot-to-lot-consistency-safety-tolerability-and-immunogenicity-of-an-investigational-hexavalent-vaccine-in-us-infants
#15
RANDOMIZED CONTROLLED TRIAL
Stanley L Block, Nicola P Klein, Kwabena Sarpong, Stephen Russell, John Fling, Maria Petrecz, Sheryl Flores, Jin Xu, Guanghan Liu, Jon E Stek, Ginamarie Foglia, Andrew W Lee
BACKGROUND: This multicenter phase III study (NCT01340937) evaluated the consistency of immune responses to 3 separate lots of diphtheria-tetanus toxoids-acellular pertussis 5, inactivated poliovirus vaccine, Haemophilus influenzae type b, and hepatitis B (DTaP5-IPV-Hib-HepB), an investigational hexavalent vaccine (HV). METHODS: Healthy infants were randomized (2:2:2:1) to receive HV or Pentacel (Control). Groups 1, 2 and 3 received HV at 2, 4 and 6 months, and Control at 15 months...
February 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/27846055/a-phase-iii-randomized-double-blind-clinical-trial-of-an-investigational-hexavalent-vaccine-given-at-two-three-four-and-twelve-months
#16
RANDOMIZED CONTROLLED TRIAL
Timo Vesikari, Thomas Becker, Andre F Vertruyen, Katleen Poschet, Sheryl A Flores, Marco F Pagnoni, Jin Xu, G Frank Liu, Jon E Stek, Florence Boisnard, Stéphane Thomas, Eddy Ziani, Andrew W Lee
BACKGROUND: Combination vaccines simplify vaccination visits and improve coverage and timeliness. Diphtheria-tetanus toxoids-acellular pertussis 5, hepatitis B, inactivated poliovirus vaccine and Haemophilus influenzae type b (DTaP5-HB-IPV-Hib) is a new investigational, fully liquid, combination vaccine containing a 5-antigen pertussis component and is designed to protect against 6 infectious diseases. METHODS: In this multicenter, double-blind, comparator-controlled, phase III study (NCT01341639) conducted in Finland, Germany and Belgium, healthy infants were randomized 1:1 to receive 1 of 2 immunization regimens...
February 2017: Pediatric Infectious Disease Journal
https://www.readbyqxmd.com/read/27818299/a-semi-synthetic-oligosaccharide-conjugate-vaccine-candidate-confers-protection-against-streptococcus-pneumoniae-serotype-3-infection
#17
Sharavathi Guddehalli Parameswarappa, Katrin Reppe, Andreas Geissner, Petra Ménová, Subramanian Govindan, Adam D J Calow, Annette Wahlbrink, Markus W Weishaupt, Bopanna Ponnappa Monnanda, Roland Lawrence Bell, Liise-Anne Pirofski, Norbert Suttorp, Leif Erik Sander, Martin Witzenrath, Claney Lebev Pereira, Chakkumkal Anish, Peter H Seeberger
The identification of immunogenic glycotopes that render glycoconjugate vaccines protective is key to improving vaccine efficacy. Synthetic oligosaccharides are an attractive alternative to the heterogeneous preparations of purified polysaccharides that most marketed glycoconjugate vaccines are based on. To investigate the potency of semi-synthetic glycoconjugates, we chose the least-efficient serotype in the current pneumococcal conjugate vaccine Prevnar 13, Streptococcus pneumoniae serotype 3 (ST3). Glycan arrays containing synthetic ST3 repeating unit oligosaccharides were used to screen a human reference serum for antibodies and to define the recognition site of two ST3-specific protective monoclonal antibodies...
November 17, 2016: Cell Chemical Biology
https://www.readbyqxmd.com/read/27747768/prevnar-7-childhood-immunization-program-and-serotype-replacement-changes-in-pneumococcal-incidence-and-resulting-impact-on-health-care-costs-in-alberta-2003-2008
#18
Arianna Waye, Anderson W Chuck, Philip Jacobs, Gregory Tyrrell, James D Kellner
OBJECTIVE: Acute respiratory tract infections caused by Streptococcus pneumoniae are a leading cause of morbidity and mortality in young children and the elderly. In 2002, Alberta introduced a pneumococcal universal immunization program for children, using Pfizer's Prevnar 7, a 7-valent pneumococcal conjugate vaccine (PCV7). In this study, we explored the impact of the immunization program on the burden of disease and related health care costs in Alberta, in the context of serotype replacement...
June 2015: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/27747577/value-added-by-the-prevnar-13-childhood-immunization-program-in-alberta-canada-2010-2015
#19
Arianna Waye, Anderson W Chuck
BACKGROUND: Streptococcus pneumoniae is a pathogen causing acute respiratory infections, as well as meningitis and bacteremia. The province of Alberta, Canada, began vaccinating infants against seven S. pneumoniae serotypes in 2002 using Prevnar 7 (PCV7). However, a 13-valent conjugate vaccine (PCV13) was introduced in 2010 to address changes in the distribution of serotypes causing disease. PCV13 targets 13 serotypes including six additional serotypes to the previously adopted PCV7. OBJECTIVE: In this study, we estimate the impact of the new PCV13 immunization program on the burden of disease and related healthcare costs in Alberta...
September 2015: Drugs—Real World Outcomes
https://www.readbyqxmd.com/read/27610346/prevalence-of-recent-immunisation-in-children-with-febrile-convulsions
#20
Leya Motala, Guy D Eslick
AIM: To determine the prevalence of recent immunisation amongst children under 7 years of age presenting for febrile convulsions. METHODS: This is a retrospective study of all children under the age of seven presenting with febrile convulsions to a tertiary referral hospital in Sydney. A total of 78 cases occurred in the period January 2011 to July 2012 and were included in the study. Data was extracted from medical records to provide a retrospective review of the convulsions...
August 8, 2016: World Journal of Clinical Pediatrics
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