Description
Genome HIV-1 (consensus sequence HIV-1 subtype A-EE
Vaccine DNA-4 contains equimolar amounts of four plasmid DNA in saline NaCl with the total concentration of 1 mg / ml
Scheme of purifying DNA vaccine
|
Parameter |
Method |
Criteria for DNA vaccines |
|
supercoiled DNA |
Agarose gel electrophoresis |
>90% |
|
RNA admixture |
Agarose gel electrophoresis |
- |
|
DNA E.coli admixture |
Southern blotting |
<10 ng / ml (5,7±3,6 ng / ml) |
|
Purity |
spectrophotometric analysis, λ=210-300 ng |
A260/A280>1.8 A260/A230>1.9
|
|
Protein admixture |
BCA test |
<10 ng / ml (6±4 ng / ml) |
|
Endotoxin content |
LAL test |
<0.1 EU / mg (0.04±0.03 EU / mg) |
|
Аuthenticity of plasmids |
PCR sequencing |
|
Preclinical studies
Security Rating:
• "DNA 4" is not toxic for laboratory animals in acute and chronic toxicity tests
• "DNA 4" refers to a class of 5 practically nontoxic substances
• Lethal doses of LD50, LF16 and LD84 are impossible to be reached
• "DNA 4" is not allergenic
• "DNA 4"does not have pyrogenic effects