A phase 1 study of VLPCOV-01 in COVID-19 vaccinated healthy subjects

INTERVENTION: Intramuscular injection of VLPCOV‐01, placebo or BNT162b2, in the upper arm CONDITION: Prevention of infectious disease caused by SARS‐CoV‐2 PRIMARY OUTCOME: 1. Frequency and severity of solicited local and systemic reactogenicity AEs for 7 days following vaccination.; 2. Frequency and severity of unsolicited AEs until 28 days after vaccination.; 3. GMT of neutralizing antibodies against SARS‐CoV‐2 up to 4 weeks after vaccination.; 4. SRR of neutralizing antibodies against SARS‐CoV‐2 at 4 weeks after vaccination. INCLUSION CRITERIA: 1.Participants who are within 6‐12 months from the second vaccination of BNT162b2. 2. Healthy Japanese male and female subjects who are 20 to 65 years of age. 3. Participants who understand and agree to comply with the study procedures and provide written informed consent. 4. Participants whose BMI is 18‐35 kg/m^2. 5. Participants whose body temperature is below 37.5 degree Celsius at screening. 6. Participants who have negative results of SARS‐CoV‐2 PCR test at screening and SARS‐CoV‐2 antigen test on Day 1 before vaccination. 7. Participants who is willing and able to keep diary by himself/herself.