研究称人类基于DNA的流感疫苗具有积极作用

PowderMed,  Ltd.  today  announced  the  publication  of  positive  results  from  a  Phase  I  study  evaluating  its  proprietary  prophylactic  DNA  influenza  vaccine  in  the  latest  issue  (volume  24,  issue  21)  of  the  journal  VACCINE.  Based  on  these  results,  PowderMed  will  start  phase  II  studies  using  both  annual  and  bird  flu  strains  later  this  year.

Authored  by  lead  researcher  Dr.  Hansi  Dean,  the  report  in  VACCINE  documents  the  safety  and  immunogenicity  of  PowderMed’s  monovalent  influenza  DNA  vaccine  delivered  with  the  company’s  Particle  Medicated  Epidermal  Delivery  (PMED)  needle-free  injection  system.  The  trial  examined  three  doses  of  a  DNA  plasmid  encoding  the  H3  haemagglutinin  (HA)  gene  for  Panama  flu  (1,  2  and  4  micrograms)  administered  as  a  single  dose  to  36  healthy  adult  volunteers.  Immune  response  was  assessed  according  to  criteria  set  by  the  Committee  for  Proprietary  Medicinal  Products  (CPMP)  for  the  approval  of  annual  flu  vaccines  in  the  European  Union.  Key  findings  include:

-At  the  maximum  dose  tested  (4  micrograms),  all  subjects  achieved  a  seroprotective  level  of  antibodies  demonstrating  that  this  DNA  vaccine  is  a  viable  candidate  for  expanded  clinical  evaluation  as  a  potentially  powerful  defense  against  influenza  and  pandemic  flu.

-The  maximum  dose  (4  micrograms)  passed  the  CPMP  criteria  at  21  days  and  was  well  tolerated.  All  three  doses  passed  the  CPMP  criteria  at  56  days.

“Recent  years  have  seen  a  number  of  new  influenza  vaccine  approaches  tested  in  animal  model  systems  and  in  the  clinic.  However,  this  study  is  the  first  successful  demonstration  of  immunogenicity  of  an  influenza  DNA  vaccine  in  humans,”  said  Dr.  Hansi  Dean,  now  with  the  International  AIDS  Vaccine  Initiative.  “The  relative  immunogenicity  of  PowderMed’s  DNA  vaccine  compared  to  intramuscular  DNA  vaccination  is  likely  attributable  to  the  efficiency  of  intracellular  DNA  delivery  by  PMED.”

“The  publication  of  this  study  in  the  prestigious  journal  VACCINE  adds  to  the  growing  body  of  scientific  evidence  that  PowderMed’s  DNA  vaccine  and  the  PMED  platform  show  promise  to  address  the  major  healthcare  challenge  posed  by  influenza,  particularly  in  the  event  of  an  avian  flu  or  other  pandemic  outbreak,”  said  Dr.  Clive  Dix,  CEO  of  PowderMed.  “DNA  vaccines  have  the  potential  to  significantly  limit  the  burden  of  disease.  The  advantage  of  a  DNA-based  approach  is  that  the  vaccines  can  be  manufactured  very  rapidly  and  in  large  quantities,  while  yielding  an  efficacious  immune  response  at  low  doses.” (责任编辑：泉水)

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研究称人类基于DNA的流感疫苗具有积极作用