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Randomized,double-blind,placebo-controlled,safety and immunogenicity study of 4 formulations of Anthrax Vaccine Adsorbed plus CPG 7909 (AV7909) in healthy adult volunteers
Authors:Robert J Hopkins  Nancy F Daczkowski  Paulina E Kaptur  Derek Muse  Eric Sheldon  Craig LaForce  Suha Sari  Thomas L Rudge  Edward Bernton
Institution:1. Emergent BioSolutions Inc., Gaithersburg, MD, USA;2. Jean Brown Research, Salt Lake City, UT, USA;3. Miami Research Associates, South Miami, FL, USA;4. North Carolina Clinical Research, Raleigh, NC, USA;5. Battelle Memorial Institute, Columbus, OH, USA
Abstract:A new anthrax vaccine that could accelerate the immune response and possibly reduce the number of injections needed for protection would be desirable in a post-exposure setting.
Keywords:ACIP  Advisory Committee on Immunization Practices  AE  adverse event  ALC  absolute lymphocyte count  ANOVA  analysis of variance  AVA  Anthrax Vaccine Adsorbed  AV7909  AVA plus CPG 7909  CI  confidence interval  CPG  cytosine-phosphate-guanine oligonucleotide  CRP  C-reactive protein  EBS  Emergent BioSolutions Inc    ELISA  enzyme-linked Immunosorbent assay  GI  gastrointestinal  GMT  geometric mean titer  HLA  human leukocyte antigen  IFN  interferon  IL  interleukin  IM  intramuscular  IP  interferon-inducible protein  NF50  50% neutralization factor  ODN  oligodeoxynucleotide  PA  protective antigen  PBMC  peripheral blood mononuclear cells  PEP  post-exposure prophylaxis  rPA  recombinant protective antigen  SAE  serious adverse event  SC  subcutaneous  SD  standard deviation  SEM  standard error of the mean  Th1  type of T helper cell  TNA  toxin neutralizing antibody  TRL  toll-like receptor
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