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Table 1 Study design and methodology

From: Immunogenicity of adenovirus-vector vaccine targeting hepatitis B virus: non-clinical safety assessment in non-human primates

Characteristic

Schedule

No. of animals

25 males/25 females

Groups

low-dose, mid-dose, high-dose, Ad5-null, and vehicle control group

Subcutaneous injection

Weekly × 7

Day killed

Days 46 and 71

Clinical signs

Twice daily

Body weight and temperature

Twice before injection, weekly after dosing

ECG

Pre-injection, day 44, and day 67

Clinical pathology (hematology, serum chemistry)

Pre-injection, day 21, day 44, and day 67

Serum IFN-γ

Pre-injection, day 7, day 35, day 45, and day 68

Lymphocyte subsets

Pre-injection, day 3, day 10, day 45, and day 68

Serum anti-Ad antibody, neutralizing antibody

Pre-injection, day 7, day 21, day 45, and day 68

Systemic autopsy, organ weight, histopathology

Day 46 and day 71

Hepatic IFN-γ, TNF-α, and IL-2