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

Autor: Parker, S E, Monteith, D, Horton, H, Hof, R, Hernandez, P, Vilalta, A, Hartikka, J, Hobart, P, Bentley, C E, Chang, A, Hedstrom, R, Rogers, W O, Kumar, S, Hoffman, S L, Norman, J A
Předmět:
Zdroj: Gene Therapy; Jul2001, Vol. 8 Issue 13, p1011, 13p
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index