A phase 1/2 trial of booster dose of VLPCOV-02 vaccine

JRCT ID: jRCT2051230005

Registered date:10/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of infectious disease caused by SARS-CoV-2
• Date of first enrollment: 10/04/2023
• Target sample size: 396
• Study type: Interventional

Intervention(s)

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 injections
Intervention: Drug: VLPCOV-02

-Experimental:VLPCOV-02 Dose 2
VLPCOV-02 given IM injections
Intervention: Drug: VLPCOV-02

-Active Comparator: COMIRNATY RTU intramuscular injection
COMIRNATY RTU intramuscular injection given IM injections
Intervention: Drug: COMIRNATY RTU intramuscular injection

Outcome(s)

Primary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old
• Gender: Both

Include 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)

Exclude 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

Related Information

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