Safety of a GM-CSF adjuvant-plasmid DNA malaria vaccine

Gene Ther. 2001 Jul;8(13):1011-23. doi: 10.1038/


MuStDO 5 is a multivalent plasmid DNA vaccine for malaria comprised of five plasmid DNAs encoding five proteins from Plasmodium falciparum and one plasmid DNA encoding human GM-CSF. To evaluate the safety of MuStDO 5, a series of pre-clinical studies were conducted in mice and rabbits. In pharmacology studies in mice, GM-CSF could not be detected in the serum following either intramuscular or a combined intramuscular/intradermal administration of the vaccine, but was readily detected in the muscle following intramuscular administration. In a tissue distribution study in mice, MuStDO 5 plasmid DNA was detected by PCR initially in highly vascularized tissues, while at later time-points the plasmid DNA was detected primarily at the site(s) of injection. In GLP safety studies in mice and rabbits, repeated intramuscular/intradermal administration of the MuStDO 5 vaccine was found to be safe and well tolerated without any evidence of autoimmune pathology.

Publication types

  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Adjuvants, Immunologic / pharmacokinetics
  • Adjuvants, Immunologic / toxicity*
  • Animals
  • Antibodies, Antinuclear / blood
  • Female
  • Granulocyte-Macrophage Colony-Stimulating Factor / genetics
  • Granulocyte-Macrophage Colony-Stimulating Factor / pharmacokinetics
  • Granulocyte-Macrophage Colony-Stimulating Factor / toxicity*
  • Injections, Intradermal
  • Injections, Intramuscular
  • Malaria Vaccines / immunology
  • Malaria Vaccines / pharmacokinetics
  • Malaria Vaccines / toxicity*
  • Male
  • Mice
  • Mice, Inbred Strains
  • Muscle, Skeletal / metabolism
  • Plasmids
  • Polymerase Chain Reaction
  • Rabbits
  • Tissue Distribution
  • Vaccines, DNA / immunology
  • Vaccines, DNA / pharmacokinetics
  • Vaccines, DNA / toxicity*


  • Adjuvants, Immunologic
  • Antibodies, Antinuclear
  • Malaria Vaccines
  • Vaccines, DNA
  • Granulocyte-Macrophage Colony-Stimulating Factor