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Predictive markers of safety and immunogenicity of adjuvanted vaccines
Authors:Beatris Mastelic  Nathalie Garçon  Giuseppe Del Giudice  Hana Golding  Marion Gruber  Pieter Neels  Bernard Fritzell
Institution:1. WHO Center for Vaccinology and Neonatal Immunology, University of Geneva, CMU, 1 rue Michel-Servet, 1211 Geneva 4, Switzerland;2. GlaxoSmithKline Vaccines, Rixensart, Belgium;3. Novartis Vaccines and Diagnostics, Via Fiorentina 1, 53100 Siena, Italy;4. Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, 8800 Rockville Pike, Bethesda, MD 20892-0001, USA;5. Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD, USA;6. Federal Agency for Medicines and Health Products, EMA – CHMP, Belgium;7. IABS Human Vaccines Committee, France
Abstract:Vaccination represents one of the greatest public health triumphs; in part due to the effect of adjuvants that have been included in vaccine preparations to boost the immune responses through different mechanisms. Although a variety of novel adjuvants have been under development, only a limited number have been approved by regulatory authorities for human vaccines. This report reflects the conclusions of a group of scientists from academia, regulatory agencies and industry who attended a conference on the current state of the art in the adjuvant field. Held at the U.S. Pharmacopeial Convention (USP) in Rockville, Maryland, USA, from 18 to 19 April 2013 and organized by the International Association for Biologicals (IABS), the conference focused particularly on the future development of effective adjuvants and adjuvanted vaccines and on overcoming major hurdles, such as safety and immunogenicity assessment, as well as regulatory scrutiny. More information on the conference output can be found on the IABS website, http://www.iabs.org/.
Keywords:Vaccine  Adjuvant  Vaccine safety  AEs"}  {"#name":"keyword"  "$":{"id":"kwrd0030"}  "$$":[{"#name":"text"  "_":"adverse events  APCs"}  {"#name":"keyword"  "$":{"id":"kwrd0040"}  "$$":[{"#name":"text"  "_":"antigen presenting cells  AS"}  {"#name":"keyword"  "$":{"id":"kwrd0050"}  "$$":[{"#name":"text"  "_":"adjuvant systems  BNP"}  {"#name":"keyword"  "$":{"id":"kwrd0060"}  "$$":[{"#name":"text"  "_":"induced bovine neonatal pancytopenia  BM"}  {"#name":"keyword"  "$":{"id":"kwrd0070"}  "$$":[{"#name":"text"  "_":"bone marrow  BVD"}  {"#name":"keyword"  "$":{"id":"kwrd0080"}  "$$":[{"#name":"text"  "_":"bovine virus diarrhea  CRP"}  {"#name":"keyword"  "$":{"id":"kwrd0090"}  "$$":[{"#name":"text"  "_":"C-reactive protein  DDCs"}  {"#name":"keyword"  "$":{"id":"kwrd0100"}  "$$":[{"#name":"text"  "_":"dermal dendritic cells  Env"}  {"#name":"keyword"  "$":{"id":"kwrd0110"}  "$$":[{"#name":"text"  "_":"envelope glycoprotein  FDA"}  {"#name":"keyword"  "$":{"id":"kwrd0120"}  "$$":[{"#name":"text"  "_":"Food and Drug Administration  GFPDL"}  {"#name":"keyword"  "$":{"id":"kwrd0130"}  "$$":[{"#name":"text"  "_":"genome-fragment phage display libraries  HA"}  {"#name":"keyword"  "$":{"id":"kwrd0140"}  "$$":[{"#name":"text"  "_":"hemagglutinin  HAI"}  {"#name":"keyword"  "$":{"id":"kwrd0150"}  "$$":[{"#name":"text"  "_":"hemagglutination-inhibition  HBsAg"}  {"#name":"keyword"  "$":{"id":"kwrd0160"}  "$$":[{"#name":"text"  "_":"Hepatitis B surface antigen  HBV"}  {"#name":"keyword"  "$":{"id":"kwrd0170"}  "$$":[{"#name":"text"  "_":"Hepatitis B virus  HIV-1"}  {"#name":"keyword"  "$":{"id":"kwrd0180"}  "$$":[{"#name":"text"  "_":"human immunodeficiency virus type 1  ID"}  {"#name":"keyword"  "$":{"id":"kwrd0190"}  "$$":[{"#name":"text"  "_":"intradermal  IM"}  {"#name":"keyword"  "$":{"id":"kwrd0200"}  "$$":[{"#name":"text"  "_":"intramuscular  IFN"}  {"#name":"keyword"  "$":{"id":"kwrd0210"}  "$$":[{"#name":"text"  "_":"interferon  ISCOM"}  {"#name":"keyword"  "$":{"id":"kwrd0220"}  "$$":[{"#name":"text"  "_":"immune stimulating complexes  LAIV"}  {"#name":"keyword"  "$":{"id":"kwrd0230"}  "$$":[{"#name":"text"  "_":"Live Attenuated Influenza Vaccine  LC"}  {"#name":"keyword"  "$":{"id":"kwrd0240"}  "$$":[{"#name":"text"  "_":"Langerhans cells  LPS"}  {"#name":"keyword"  "$":{"id":"kwrd0250"}  "$$":[{"#name":"text"  "_":"lipopolysaccharide  MIV"}  {"#name":"keyword"  "$":{"id":"kwrd0260"}  "$$":[{"#name":"text"  "_":"monovalent inactivated vaccine  Mo"}  {"#name":"keyword"  "$":{"id":"kwrd0270"}  "$$":[{"#name":"text"  "_":"human primary monocytes  MoA"}  {"#name":"keyword"  "$":{"id":"kwrd0280"}  "$$":[{"#name":"text"  "_":"mode of action  MM6"}  {"#name":"keyword"  "$":{"id":"kwrd0290"}  "$$":[{"#name":"text"  "_":"Mono Mac 6  MPL"}  {"#name":"keyword"  "$":{"id":"kwrd0300"}  "$$":[{"#name":"text"  "$$":[{"#name":"__text__"  "_":"3-"}  {"#name":"italic"  "_":"O"}  {"#name":"__text__"  "_":"-desacyl-4′-monophosphoryl lipid A  MVA"}  {"#name":"keyword"  "$":{"id":"kwrd0310"}  "$$":[{"#name":"text"  "_":"modified vaccinia ankara  mPGES1"}  {"#name":"keyword"  "$":{"id":"kwrd0320"}  "$$":[{"#name":"text"  "_":"microsomal PGE synthase-1  nAbs"}  {"#name":"keyword"  "$":{"id":"kwrd0330"}  "$$":[{"#name":"text"  "_":"neutralizing antibody  NA"}  {"#name":"keyword"  "$":{"id":"kwrd0340"}  "$$":[{"#name":"text"  "_":"neuraminidase  NHP"}  {"#name":"keyword"  "$":{"id":"kwrd0350"}  "$$":[{"#name":"text"  "_":"non-human primates  PBMC"}  {"#name":"keyword"  "$":{"id":"kwrd0360"}  "$$":[{"#name":"text"  "_":"peripheral blood mononuclear cells  PGE2"}  {"#name":"keyword"  "$":{"id":"kwrd0370"}  "$$":[{"#name":"text"  "_":"prostaglandin E2  PLA"}  {"#name":"keyword"  "$":{"id":"kwrd0380"}  "$$":[{"#name":"text"  "_":"poly-lactic  rAd5"}  {"#name":"keyword"  "$":{"id":"kwrd0390"}  "$$":[{"#name":"text"  "_":"replication-defective adenovirus 5  SC"}  {"#name":"keyword"  "$":{"id":"kwrd0400"}  "$$":[{"#name":"text"  "_":"subcutaneous  SPADE"}  {"#name":"keyword"  "$":{"id":"kwrd0410"}  "$$":[{"#name":"text"  "_":"spanning-tree progression analysis of density normalized events  SPR"}  {"#name":"keyword"  "$":{"id":"kwrd0420"}  "$$":[{"#name":"text"  "_":"surface plasmon resonance  TC"}  {"#name":"keyword"  "$":{"id":"kwrd0430"}  "$$":[{"#name":"text"  "_":"transcutaneous  T follicular helper cells  TIV"}  {"#name":"keyword"  "$":{"id":"kwrd0450"}  "$$":[{"#name":"text"  "_":"trivalent inactivated vaccine  TLR"}  {"#name":"keyword"  "$":{"id":"kwrd0460"}  "$$":[{"#name":"text"  "_":"toll-like receptors  WHO"}  {"#name":"keyword"  "$":{"id":"kwrd0470"}  "$$":[{"#name":"text"  "_":"World Health Organization
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