In this Phase 1 trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed upon by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. The observation was performed for 1.0 hour after the second dose.k The researchers conducted a safety evaluation and agreed to follow-up after discharge.

In this trial, all adverse events (AE), all AEs from 0-7 days, and all AEs from 8-30 days will be collected 30 minutes after each dose, and all AEs will be collected from the first dose to 30 days after the entire vaccination, and the first dose will be inoculated to the full course All serious adverse events (SAE) 6 months after vaccination.

Results

The Lancet Reported results on March 24, 2021 regarding this clinical study.

In the phase 1 trial, six (60%) of ten participants in the placebo group, 14 (70%) of 20 in the 25 μg group, and 18 (90%) of 20 in the 50 μg group reported at least one adverse event within 30 days after vaccination, with no significant between-group differences. Within 7 days after vaccination, most of the local and systemic reactogenicity was mild or moderate (grade 1 or 2 adverse events). The most common solicited local adverse events were injection-site pain, redness, and itch. The most common solicited systemic adverse events were cough, fever, and headache.

Two (10%) grade 3 or worse adverse events were reported in the 50 μg group.

One was vaccine-related (swelling and redness) and the other was a serious adverse event (rhabdomyolysis) but was assessed by the investigators as being unrelated to the vaccine. No vaccine-related serious adverse events were reported.