A phase 1 study of self-amplifying mRNA vaccine VLPCOV-01 Randomized, placebo-controlled, parallel group, first-in-human study (FIH Study)(COVID-19)

JRCT ID: jRCT2071210067

Registered date:28/09/2021

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: 28/09/2021
• Target sample size: 45
• Study type: Interventional
• Intervention(s): VLPCOV-01 0.5 mL or VLPCOV-01 Matching Placebo, intramuscular injection in the upper arm

Outcome(s)

Primary Outcome

Frequency and severity of solicited local and systemic reactogenicity AEs for 7 days following each vaccination.
Frequency and severity of unsolicited AEs until 28 days after last vaccination.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

1. Healthy Japanese male and female subjects who are 20 to 65 years of age.
2. Participants who understand and agree to comply with the study procedures and provide written informed consent.
3. Participants whose BMI is 18-35 kg/m^2.
4. Participants whose body temperature is below 37.5 degree Celsius at screening.
5. Participants who have negative PCR test results SARS-CoV-2 at screening.
6. Participants who is willing and able to keep diary by himself/herself.

Exclude criteria

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

Related Information

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