Table 1 Quality control of candidate S-OIV H1N1 and NIBRG-14 H5N1 vaccines
Test items | Summary of results | Notes |
|---|---|---|
Abnormal toxicity | S-OIV pass, H5N1 not done | Body weight of tested mice increased |
Antigenicity | HAI titer: S-OIV 128 ~ 256 | Also interacted with NIBSC sntisera |
H5N1 1024 | ||
Endotoxin | S-OIV Between 28 ~ 51, | International criteria: ≤ 200 EU/ml |
H5N1 31.4 EU/ml, | ||
Ovalbumin | S-OIV ≈ 4 μg/ml, | Europe: ≤ 2 μg/ml; WHO: ≤ 5 μg/ml |
H5N1 55 μg/ml | ||
Formaldehyde | S-OIV 0.373 ~ 0.548 μg/ml, | WHO: ≤ 0.02% ~0.01% (≈1 mg/ml) |
H5N1 not done |