Safety Profile:

• 7 days after injection, 15% of participants reported adverse reactions (6 or 25% in the high dose in phase 1, and 16 or 19% in medium dose at days 0-21 in phase 2 had the most adverse reactions)
• Most common adverse reaction was injection site pain, then fever
• All reactions were mild and did not require treatment

Method:

• Randomized and placebo-controlled; adults aged 18-59 (with no positive COVID-19 result)
• Phase 1: 96 healthy adults were assigned to aluminum hydroxide only or low, medium, and high doses of the vaccine
• Phase 2: 224 healthy adults were given either aluminum hydroxide only, or 5 microgram/dose of the vaccine in two groups (days 1-14 or 1-21)

Performance:

• Geometric mean titer of phase 1 at 14 days post-injection: 316 in low-dose, 206 in medium-dose, and 297 in high-dose
• GMT of phase 2 using medium dose: 121 (injections received on days 0 and 14) and 247 (injections received on days 0 and 21)
• Seroconversion: 95.8% in medium-dose group in phase 1; 97.6% in two phase two groups; none in aluminum hydroxide only group