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RNA-Based Adjuvant CV8102 Enhances the Immunogenicity of a Licensed Rabies Vaccine in a first-In-Human Trial
Vaccine 37 (2019) 1819–1826 Contents lists available at ScienceDirect Vaccine journal homepage: www.elsevier.com/locate/vaccine RNA-based adjuvant CV8102 enhances the immunogenicity of a licensed rabies vaccine in a first-in-human trial Fatma Doener a,1, Henoch S. Hong a,1, Ingo Meyer b,1, Keyvan Tadjalli-Mehr c, Angelika Daehling c, ⇑ Regina Heidenreich a, Sven D. Koch a, Mariola Fotin-Mleczek a, Ulrike Gnad-Vogt c, a Curevac AG, Paul-Ehrlich-Strasse 15, 72076 Tübingen, Germany b CRS Clinical Research Services Mönchengladbach GmbH, 41061 Mönchengladbach, Germany c Curevac AG, Schumannstrasse 27, 60325 Frankfurt, Germany article info abstract Article history: Background: We report the first-in-concept human trial of the safety, tolerability and immunogenicity Received 27 September 2018 when a novel TLR 7/8/RIG I agonist RNA-based adjuvant, CV8102, was administered alone or mixed with Received in revised form 30 January 2019 fractional doses of a licensed rabies vaccine (RabipurÒ) as model antigen. Accepted 3 February 2019 Methods: The primary objective was to assess the safety and reactogenicity of various dose levels of Available online 21 February 2019 CV8102 alone or mixed with RabipurÒ in healthy 18–40 year-old male volunteers. A secondary objective was to assess the immune-enhancing potential of bedside-mixes of CV8102 with fractional doses of Keywords: Ò Rabipur by measuring induction of rabies virus neutralising titres (VNTs). Adjuvant Results: Fifty-six volunteers received 50–100 lg CV8102 alone (n = 11), bedside-mixed CV8102 and RNA Ò Ò Ò Rabies Rabipur (n = 20), or Rabipur alone (n = 25; control). -
Safety of Immunization During Pregnancy a Review of the Evidence
Safety of Immunization during Pregnancy A review of the evidence Global Advisory Committee on Vaccine Safety © World Health Organization 2014 All rights reserved. Publications of the World Health Organization are available on the WHO website (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications –whether for sale or for non-commercial distribution– should be addressed to WHO Press through the WHO website (www.who.int/about/licensing/copyright_form/en/index.html). The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. -
Pneumococcal Vaccine
Vaccines for Primary Care Pneumococcal, Shingles, Pertussis Devang Patel, M.D. Assistant Professor Chief of Service, MICU ID Service University of Maryland School of Medicine Pneumococcal Vaccine Pneumococcal Disease • 2nd most common cause of vaccine preventable death in the US • Major Syndromes – Pneumonia – Bacteremia – Meningitis Active Bacterial Core Surveillance (ABCs) Report Emerging Infections Program Network Streptococcus pneumoniae, 2010 (ORIG) Vaccine Target • Polysaccharide capsule allows bacteria to resist phagocytosis • Antibodies to capsule facilitate phagocytosis • >90 different pneumococcal capsular serotypes • Vaccines contain most common serotypes causing disease Pneumococcal Vaccines Pneumococcal Vaccines • Pneumococcal polysaccharide vaccine (PPSV23; Pneumovax) – Contains capsular polysaccharides – 23 most commonly infecting serotypes • Cause 60% of all pneumococcal infections in adults – Not recommended for children <2 due to poor immunogenicity of polysaccharides Pneumococcal Vaccines • Pneumococcal conjugate vaccine (PCV13, Prevnar) – Polysaccharides linked to nontoxic protein • higher antigenicity – Stimulates mucosal antibody • Eliminates nasal carriage in young children • Herd effect in adults – Reduction in PCV7 serotype disease >90% Prevnar 13 • 2000 - PCV7 approved for infants toddlers • 2010 - PCV13 recommended for infants and toddlers • 2012 – ACIP recommended PCV13 for high- risk adults • 2014 – recommended for adults >65 • 2018 – ACIP will revisit PCV13 use in adults – Childhood vaccines may eliminate -
Summary Guide to Tetanus Prophylaxis in Routine Wound Management
Summary Guide to Tetanus Prophylaxis in Routine Wound Management ASSESS WOUND A clean, minor wound All other wounds (contaminated with dirt, feces, saliva, soil; puncture wounds; avulsions; wounds resulting from flying or crushing objects, animal bites, burns, frostbite) Has patient completed a primary Has patient completed a primary tetanus diphtheria series?1, 7 tetanus diphtheria series?1, 7 No/Unknown Yes No/Unknown Yes Administer vaccine today.2,3,4 Was the most recent Administer vaccine and Was the most Instruct patient to complete dose within the past tetanus immune gobulin recent dose within series per age-appropriate 10 years? (TIG) now.2,4,5,6,7 the past 5 years?7 vaccine schedule. No Yes No Yes Vaccine not needed today. Vaccine not needed today. Administer vaccine today.2,4 2,4 Patient should receive next Administer vaccine today. Patient should receive next Patient should receive next dose Patient should receive next dose dose at 10-year interval after dose at 10-year interval after per age-appropriate schedule. per age-appropriate schedule. last dose. last dose. 1 A primary series consists of a minimum of 3 doses of tetanus- and diphtheria- 4 Tdap* is preferred for persons 11 through 64 years of age if using Adacel* or 10 years of containing vaccine (DTaP/DTP/Tdap/DT/Td). age and older if using Boostrix* who have never received Tdap. Td is preferred to tetanus 2 Age-appropriate vaccine: toxoid (TT) for persons 7 through 9 years, 65 years and older, or who have received a • DTaP for infants and children 6 weeks up to 7 years of age (or DT pediatric if Tdap previously. -
USDA-Approved Animal Rabies Vaccines
United States Department of Agriculture (USDA) Approved Animal Rabies Vaccines Table 1. Rabies Vaccines Licensed and Marketed in the United States, 2016 Age at For use Route of Product Name Produced by Marketed by Dose primary Booster vaccination in inoculation vaccination* A) MONOVALENT (Inactivated) RAB RABVAC 1 Boehringer Boehringer Dogs 1 ml 3 months Annually IM or SC Ingelheim Ingelheim Vetmedica Cats 1 ml 3 months Annually IM or SC Vetmedica Inc Inc License No. 124 RABVAC 3 Boehringer Boehringer Dogs 1 ml 3 months 1 year later & triennially IM or SC Ingelheim Ingelheim Vetmedica Cats 1 ml 3 months 1 year later & triennially IM or SC Vetmedica Inc Inc Horses 2 ml 3 months Annually IM License No. 124 EQUIRAB with Merck Animal Merck Animal Health Horses 1 ml 4 months Annually IM Havlogen Health License No. 165A DEFENSOR 1 Zoetis Zoetis Dogs 1 ml 3 months Annually IM or SC License No. 190 Cats 1 ml 3 months Annually SC DEFENSOR 3 Zoetis Zoetis Dogs 1 ml 3 months 1 year later & triennially IM or SC License No. 190 Cats 1 ml 3 months 1 year later & triennially SC Sheep 2 ml 3 months Annually IM Cattle 2 ml 3 months Annually IM NOBIVAC: 1- Zoetis Merck Animal Health Dogs 1 ml 3 months Annually IM or SC Rabies License No. 190 Cats 1 ml 3 months Annually SC NOBIVAC: 3- Zoetis Merck Animal Health Dogs 1 ml 3 months 1 year later & triennially IM or SC Rabies and 3- License No. 190 Cats 1 ml 3 months 1 year later & triennially SC Rabies CA Sheep 2 ml 3 months Annually IM Cattle 2 ml 3 months Annually IM IMRAB 1 Merial, Inc Merial, Inc Dogs 1 ml 3 months Annually SC License No. -
YF-VAX® Rx Only AHFS Category
YF-VAX® Rx Only Laboratory Personnel AHFS Category: 80:12 Laboratory personnel who handle virulent yellow fever virus or concentrated preparations Rx only of the yellow fever vaccine virus strains may be at risk of exposure by direct or indirect Yellow Fever Vaccine contact or by aerosols. (14) DESCRIPTION CONTRAINDICATIONS ® Hypersensitivity YF-VAX , Yellow Fever Vaccine, for subcutaneous use, is prepared by culturing the YF-VAX is contraindicated in anyone with a history of acute hypersensitivity reaction to any 17D-204 strain of yellow fever virus in living avian leukosis virus-free (ALV-free) chicken component of the vaccine. (See DESCRIPTION section.) Because the yellow fever virus embryos. The vaccine contains sorbitol and gelatin as a stabilizer, is lyophilized, and is used in the production of this vaccine is propagated in chicken embryos, do not administer hermetically sealed under nitrogen. No preservative is added. Each vial of vaccine is YF-VAX to anyone with a history of acute hypersensitivity to eggs or egg products due to supplied with a separate vial of sterile diluent, which contains Sodium Chloride Injection a risk of anaphylaxis. Less severe or localized manifestations of allergy to eggs or to USP – without a preservative. YF-VAX is formulated to contain not less than 4.74 log10 feathers are not contraindications to vaccine administration and do not usually warrant plaque forming units (PFU) per 0.5 mL dose throughout the life of the product. Before vaccine skin testing. (See PRECAUTIONS section, Testing for Hypersensitivity Re- reconstitution, YF-VAX is a pinkish color. After reconstitution, YF-VAX is a slight pink-brown actions subsection.) Generally, persons who are able to eat eggs or egg products may suspension. -
A Guide to Vaccinations for Parents
A GUIDE TO VACCINATIONS FOR PARENTS What are vaccines? When should my child be vaccinated? Why does my child need the HPV vaccine? HISTORY OF VACCINATIONS Smallpox is a serious infectious disease that causes fever and a distinctive, progressive 600 1796 skin rash. years ago Edward Jenner developed Variolation, intentionally a vaccine against smallpox. Cases of paralysis from polio in the U.S. exposing an individual to Almost 200 years later, in 1980, in the early 1950s: smallpox material, traces back the World Health Organization more than to 16th-century China. This declared that smallpox process resulted in a milder had been eradicated, 15,000 form of the disease. or wiped out. In the year 2017: Childhood vaccines can prevent 14 potentially serious 0 diseases or conditions throughout your child’s lifetime. 1955 1940s 1885 Jonas Salk’s polio vaccine The routine immunization Louis Pasteur developed a was proven safe and effective. schedule included vaccines vaccine against rabies. The Polio has now been eliminated against four potentially serious rabies vaccine series, which in the U.S., and organizations diseases (smallpox, diphtheria, can be given to people who are currently working tetanus, and pertussis). may have been exposed to to eradicate polio Now the schedule includes the virus, has made rabies worldwide. vaccines to prevent a total infection very rare in the of 14 conditions. United States. In the U.S., vaccines go through three phases of clinical trials to make sure they are safe and effective before they are licensed. 2006 Today The HPV vaccine was Vaccine research licensed in the U.S. -
Vaccine Information for PARENTS and CAREGIVERS
NATIONAL INSTITUTE FOR COMMUNICABLE DISEASES Division of the National Health Laboratory Service VACCINE INFOR MATION FOR PARENTS & CAREGIVERS First Edition November 2016 Editors-in-Chief Nkengafac Villyen Motaze (MD, MSc, PhD fellow), Melinda Suchard (MBBCh, FCPath (SA), MMed) Edited by: Cheryl Cohen, (MBBCh, FCPath (SA) Micro, DTM&H, MSc (Epi), Phd) Lee Baker, (Dip Pharm) Lucille Blumberg, (MBBCh, MMed (Micro) ID (SA) FFTM (RCPS, Glasgow) DTM&H DOH DCH) Published by: Ideas Wise and Wonderful (IWW) for National Institute for Communicable Diseases (NICD) First Edition: Copyright © 2016 Contributions by: Clement Adu-Gyamfi (BSc Hons, MSc), Jayendrie Thaver (BSc), Kerrigan McCarthy, (MBBCh, FCPath (SA), DTM&H, MPhil (Theol) Kirsten Redman (BSc Hons), Nishi Prabdial-Sing (PhD), Nonhlanhla Mbenenge (MBBCh, MMED) Philippa Hime (midwife), Vania Duxbury (BSc Hons), Wayne Howard (BSc Hons) Acknowledgments: Amayeza, Vaccine Information Centre (http://www.amayeza-info.co.za/) Centre for Communicable Diseases Fact Sheets (http://www.cdc.gov/vaccines/hcp/vis/) World Health Organization Fact Sheets (http://www.who.int/mediacentre/factsheets/en/) National Department of Health, South Africa (http://www.health.gov.za/) Disclaimer This book is intended as an educational tool only. Information may be subject to change as schedules or formulations are updated. Summarized and simplified information is presented in this booklet. For full prescribing information and contraindications for vaccinations, please consult individual package inserts. There has been -
Immunization-Form.Pdf
James Madison University Immunization Form COMMONWEALTH OF VIRGINIA LAW REQUIRES THAT THE CERTIFICATE OF IMMUNIZATION AND TB SCREENING BE COMPLETED AND SUBMITTED TO THE UNIVERSITY HEALTH CENTER. Instructions for new students: 1) Download (if .pdf does not display correctly, open the file in Adobe Reader) and print the Immunization Form and have it completed and signed by a health care professional. An official immunization record from your doctor or another school will be accepted. 2) Log into your MyJMUChart account to upload the completed and signed immunization form (or official record), as well as a copy of your health insurance card (front and back.) All uploaded forms must be in .pdf format. Immunizations must be up to date. 3) Complete the required TB Assessment and Health History for NEW students located under the “forms” tab in MyJMUChart. Due dates for undergraduate students: July 8, 2021 for Fall 2021 semester start and December 10, 2021 for Spring 2022 start. Due date for graduate students: No later than the third Friday of the first semester attending JMU. An enrollment hold and a $50 fine will be placed on your account if your immunization form and TB Screening are not deemed complete by the Health Center staff. CERTIFICATE OF IMMUNIZATION* This MUST be signed by a health care provider Name (print): _______________________________________________ Date of Birth: ______/_______/_______________ Date completed: _______/_______/_______ STUDENT ID NUMBER: __________________________ REQUIRED IMMUNIZATIONS COVID-19 (indicate which -
Measles, Mumps and Rubella Gone but Not Forgotten
Measles, mumps and rubella Gone but not forgotten David Isaacs Measles z Highly infectious human disease z 1 in 15 cases develop complications – otitis me dia, pneumoni a, encephalitis, SSPE z Pre vaccine epidemiology – 2 - 5 year cycle of epidemics – most common in 5 - 9 year olds – world wide 7 - 8 million deaths annually Measles z 99.9% of unimmunised children get measles z 1 in 5,000 to 10,000 cases die z Mortality : 888,000 deaths in 1998 (more than breast cancer, violence) z Morbidity : encephalitis (0.1%), convulsions ((%),p0.5%), pneumonia (1-7%), otitis media (5-9%) Measles: a global perspective z Vaccine available for over 40 years z Still caused 197,000 estimated deaths in 2007 – leading vaccine preventable killer of children z Highest disease incidence in Africa z Most deaths (98%) are in poorest countries – low vaccination coverage, high case fatality ratio Measles in Australia 1200 Notifications 60 Hospitalisations 50 1000 40 2001 – young 30 adults program Number 20 800 10 rr 0 Jan Jan Jan Jan Jan Jan Jan Jan Jan 600 2000 2001 2002 2003 2004 2005 2006 2007 2008 Month Numbe 400 200 0 Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan Jan 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 Month Nov 1993 – 2nd dose Jul 1998 – 2nd dose moved to 4-5 yo introduced for 10-16 yo Measles Control Campaign conducted Measles elimination in Australia: 1 The Meas les Con tro l campa ign (MCC) – July-December 1998 – mass vaccination 1.7 million primary school children (96% vaccinated) – reminder letter -
AAMC Standardized Immunization Form
AAMC Standardized Immunization Form Middle Last Name: First Name: Initial: DOB: Street Address: Medical School: City: Cell Phone: State: Primary Email: ZIP Code: AAMC ID: MMR (Measles, Mumps, Rubella) – 2 doses of MMR vaccine or two (2) doses of Measles, two (2) doses of Mumps and (1) dose of Rubella; or serologic proof of immunity for Measles, Mumps and/or Rubella. Choose only one option. Copy Note: a 3rd dose of MMR vaccine may be advised during regional outbreaks of measles or mumps if original MMR vaccination was received in childhood. Attached Option1 Vaccine Date MMR Dose #1 MMR -2 doses of MMR vaccine MMR Dose #2 Option 2 Vaccine or Test Date Measles Vaccine Dose #1 Serology Results Measles Qualitative -2 doses of vaccine or Measles Vaccine Dose #2 Titer Results: Positive Negative positive serology Quantitative Serologic Immunity (IgG antibody titer) Titer Results: _____ IU/ml Mumps Vaccine Dose #1 Serology Results Mumps Qualitative -2 doses of vaccine or Mumps Vaccine Dose #2 Titer Results: Positive Negative positive serology Quantitative Serologic Immunity (IgG antibody titer) Titer Results: _____ IU/ml Serology Results Rubella Qualitative Positive Negative -1 dose of vaccine or Rubella Vaccine Titer Results: positive serology Quantitative Serologic Immunity (IgG antibody titer) Titer Results: _____ IU/ml Tetanus-diphtheria-pertussis – 1 dose of adult Tdap; if last Tdap is more than 10 years old, provide date of last Td or Tdap booster Tdap Vaccine (Adacel, Boostrix, etc) Td Vaccine or Tdap Vaccine booster (if more than 10 years since last Tdap) Varicella (Chicken Pox) - 2 doses of varicella vaccine or positive serology Varicella Vaccine #1 Serology Results Qualitative Varicella Vaccine #2 Titer Results: Positive Negative Serologic Immunity (IgG antibody titer) Quantitative Titer Results: _____ IU/ml Influenza Vaccine --1 dose annually each fall Date Flu Vaccine © 2020 AAMC. -
Typhoid Vaccine W H a T Y O U N E E D T O K N O W
TYPHOID VACCINE W H A T Y O U N E E D T O K N O W Many Vaccine Information Statements are available in Spanish and other languages. See www.immunize.org/vis. What is typhoid? •Travelers to parts of the world where typhoid is 1 common. (NOTE: typhoid vaccine is not 100% Typhoid (typhoid fever) is a serious disease. It is effective and is not a substitute for being caused by bacteria called Salmonella Typhi. careful about what you eat or drink.) Typhoid causes a high fever, weakness, stomach •People in close contact with a typhoid carrier. pains, headache, loss of appetite, and sometimes a •Laboratory workers who work with Salmonella rash. If it is not treated, it can kill up to 30% of Typhi bacteria. people who get it. Some people who get typhoid become “carriers,” Inactivated Typhoid Vaccine (Shot) who can spread the •Should not be given to children younger than 2 disease to years of age. others. •One dose provides protection. It should be given Generally, at least 2 weeks before travel to allow the vaccine people get time to work. typhoid from contaminated •A booster dose is needed every 2 years for people food or water. Typhoid is not common in the U.S., who remain at risk. and most U.S. citizens who get the disease get it Live Typhoid Vaccine (Oral) while traveling. Typhoid strikes about 21 million people a year around the world and kills about •Should not be given to children younger than 6 200,000. years of age.