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

JRCT ID: jRCT2051210164

Registered date:01/02/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of infectious disease caused by SARS-CoV-2
• Date of first enrollment: 16/02/2022
• Target sample size: 92
• Study type: Interventional
• Intervention(s): Intramuscular injection of VLPCOV-01, placebo or BNT162b2, in the upper arm

Outcome(s)

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.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude criteria

1. Participants who have history of COVID-19.
2. Female participants who are confirmed or suspected pregnant, planned to be pregnant within 90 days of the investigational agent administration or who are breast-feeding.
3. Participants who have history of significant diseases of cardiac, vascular system (including thrombosis), blood, respiratory, hepatic, renal, GI, psychiatric diseases or disorders.
4. Participants who have history of allergy such as systemic skin rash.
5. Participants who have history of convulsion (including febrile convulsions), Guillain-Barre syndrome, acute disseminated encephalomyelitis.
6. Participants who were diagnosed immune system disorder.
7. Participants who are receiving or scheduling any medicine and/or therapy that could interfere with immunogenicity assessment of test medications.
8. Participants who have history of anaphylaxis caused by food or medicines.
9. Participants who have history or risk of allergy or anaphylaxis caused by any components of study medications.
10. Participants who received any investigational product or vaccine 28 days prior to screening of this study, or who are planning to join any other investigation study during this study.
11. Participants who are bleeding tendency and considered a contraindication to intramuscular injection by Principal investigator or Sub-investigator.
12. Participants who are judged inappropriate in their health condition by Principal investigator or Sub-investigator.

Related Information

• Primary Sponsor: Nobuaki Sato
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development