Prevention of infectious disease caused by SARS-CoV-2
Conditions
Interventions
Drug: VLPCOV-02
Administered IM
Drug: COMIRNATY RTU intramuscular injection (Bivalent: Original/Omicron BA.4-5)
Administered IM
Study Arms
-Experimental:VLPCOV-02 Dose 1
VLPCOV-02 given IM injectio
Sponsors
Aboshi Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged 18 years or older at the time of obtaining consent (2) Aged 75 years or younger at the time of obtaining consent (Part 1 only) (3) Signed written informed consent for participation in this study (4) Able to comply with the rules during participating in the study, receive tests and physical examinations prespecified in the study protocol, complete the electronic diary (e-Diary) themselves, and report such as their symptoms (5) Received the 2-dose primary vaccination series with the same SARS-CoV-2 uridine modified RNA vaccine ('mRNA vaccine,' thereafter), or received a booster inoculation with mRNA vaccine (any kind of mRNA vaccine and number of booster inoculations, including bivalent mRNA vaccine) following receiving the 2-dose primary vaccination series with the same mRNA vaccine (6) Six months or more elapsed from previous SARS-CoV-2 vaccination on the scheduled day of study drug inoculation (7) The body mass index (BMI) is 18.0 kg/m2 or more and 35 kg/m2 or less at Visit 00 (Part 1 only)
Exclusion criteria
Exclusion criteria: (1) Any flulike symptom (findings suggestive of infection, such as fever at axillary body temperature of 37.5 degrees or more, chill, cough, nasal discharge, headache, myalgia) within 72 hours before study drug inoculation (2) Positive SARS-CoV-2 antigen test result prior to study drug inoculation on Visit 01 (Day 1) (3) History of SARS-CoV-2 infection (including asymptomatic and deemed positive) within 6 months prior to Visit 01 (Day 1) (4) Complication or known history of serious cardiovascular (including thrombosis), hematological, respiratory, hepatic, renal, gastrointestinal, and/or psychoneurological disease (Part 1 only) (5) Complication of unstable serious cardiovascular (including thrombosis), hematologic, respiratory, hepatic, renal, gastrointestinal, and/or psychoneurological disease (Part 2 only) ' Unstable' is defined as: having undergone surgery or invasive procedures within 3 months prior to screening for this study, having required a change in therapeutic agent, etc. associated with a worsening of disease status, or having any of the above planned during the study period. (6) Complication of an active infection (7) Disease or status, or a known history deemed to interfere with the evaluation of the immunogenicity of the study drug, such as immunodeficiency and autoimmune disease (8) Received an agent or therapy deemed to interfere with the evaluation of the immunogenicity of the study drug, or having a schedule to receive the above during participating in the study (9) History of anaphylaxis or severe allergy in the past by food or pharmaceutical agents (including vaccine), etc. (10) History of convulsion (excluding febrile seizure), Guillain-Barre syndrome, or acute disseminated encephalomyelitis (11) Experienced a long-lasting (approximately 2 weeks as a guide) symptom of any kind from vaccination against SARS-CoV-2 or SARS-CoV-2 infection in the past (12) Females who do not agree to use appropriate contraception methods through 90 days after study drug inoculation (13) Pregnant or lactating females or those who intend to become pregnant through 90 days after study drug inoculation (14) Participation in other clinical study within 3 months prior to screening of this study, or are scheduled to be participated in other clinical study, etc. during participating in this study (15) Bleeding tendency, and for whom the principal investigator or sub-investigator determined intramuscular inoculation to be a contraindication (16) Ineligible by the principal investigator or sub-investigator for participating in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (Part 1) Safety 1. Incidence and severity of the following adverse events: (1) Solicited local adverse events which occurred through 7 days after study drug inoculation (2) Solicited systemic adverse events which occurred through 7 days after study drug inoculation (3) Adverse events which occurred through 4 weeks after study drug inoculation Immunogenicity 1. At Week 4 after study drug inoculation: (1) GMT of serum IgG titers against SARS-CoV-2 RBD protein (2) SRR of serum IgG titers against SARS-CoV-2 RBD protein (Part 2) Immunogenicity 1. At Week 4 after study drug inoculation: (1) GMT of serum neutralizing antibody titers against live virus (Omicron BA.5) (2) SRR of serum neutralizing antibody titers against live virus (Omicron BA.5) Safety 1. Incidence and severity of the following adverse events: (1) Solicited local adverse events which occurred through 7 days after study drug inoculation (2) Solicited systemic adverse events which occurred through 7 days after study drug inoculation (3) Adverse events which occurred through 4 weeks after study drug inoculation | — |
Contacts
Public ContactMasayuki Aboshi
VLP Therapeutics Japan, Inc.
Outcome results
None listed