A phase 3 confirmatory study of booster dose of VLPCOV-04 vaccine

JRCT ID: jRCT2051230141

Registered date:04/12/2023

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: 20/12/2023
• Target sample size: 2000
• Study type: Interventional
• Intervention(s): Administer 0.5 mL (3 micro g) VLPCOV-04 or 0.3mL Comirnaty RTU IMA (Monovalent: Omicron XBB.1.5) as a single intramuscular injection into the deltoid muscle of the upper arm

Outcome(s)

Primary Outcome

Immunogenicity
1. At Week 4 after vaccination with the drugs used in this study,
(1) Geometric mean titer (GMT) and seroresponse rate (SRR) of serum neutralizing antibody titers against the virus (Omicron XBB.1.5)

Secondary Outcome

Immunogenicity
1. At Weeks 26 and 52 after vaccination with the drugs used in the study,
(1) GMT and SRR of serum neutralizing antibody titers against the virus (Omicron XBB.1.5)
2. At Week 4 after vaccination with the drugs used in the study,
(1) GMT and SRR of serum immunoglobulin G titers against SARS-CoV-2 receptor binding domain protein (anti-RBD-IgG)

Efficacy against infection
1. During the study period at or after 7 days (Day 8) of vaccination with the drugs used in the study,
(1) SARS-CoV-2 infection rate
(2) COVID-19 incidence rate

Safety
1. Incidences and severity of the following adverse events:
(1) Solicited local adverse events occurring within 6 days (until Day 7) after vaccination with the drugs used in the study
(2) Solicited systemic adverse events occurring within 6 days (until Day 7) after vaccination with the drugs used in the study
(3) Adverse events occurring within 4 weeks (until Day 29) after vaccination with the drugs used in the study

2. Incidences of the following adverse events until Week 52 after vaccination with the drugs used in the study:
(1) Serious adverse events
(2) Adverse events leading to study discontinuation

Key inclusion & exclusion criteria

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

Include criteria

(1) Aged 18 years or older at the time of informed consent
(2) Signed written informed consent to participation in this study
(3) Able to comply with the requirements during participation in the study, receive physical examinations and testing prespecified
in the study protocol, complete the electronic diary (e-Diary) themselves, and report their symptoms and other information
(4) Have received the 2-dose primary vaccination series with the same SARS-CoV-2 RNA vaccines (hereinafter referred to as "mRNA vaccine"), or have received the 2-dose primary vaccination series with the same mRNA vaccines, followed by booster inoculation (irrespective of vaccine type and number of booster doses), with the latest vaccination performed using an mRNA vaccine
(5) At least 6 months between the last SARS-CoV-2 vaccination and the scheduled day of vaccination with the drugs used in the study

Exclude criteria

(1) Any flu-like symptom (findings suggestive of infection, such as pyrexia with an axillary body temperature of 37.5 degrees or higher, chills, cough, nasal discharge, headache, and myalgia) within 72 hours before vaccination with the drugs used in the study
(2) A positive SARS-CoV-2 antigen test result before vaccination with the drugs used in the study at Visit 01 (Day 1)
(3) A history of SARS-CoV-2 infection (including asymptomatic infection and deemed positivity) in or after March 2023
(4) Previous vaccination targeting Omicron XBB.1.5
(5) Any concomitant unstable serious cardiovascular (including thrombosis), hematologic, respiratory, hepatic, renal, gastrointestinal, and/or psychoneurological disease
"Unstable" is defined as: having undergone surgery or invasive procedures within 90 days before screening of this study, having required any measure such as change in the therapeutic agent in associated with worsening of disease status, or having any of the above planned during the study period.
(6) Any concomitant active infection
(7) Any concomitant or previous disease or condition deemed to affect evaluation of the drugs used in the study, such as immunodeficiency and autoimmune disease
(8) Receiving an agent or therapy deemed to affect evaluation of the drugs used in the study, or scheduled to receive such an agent or therapy during participation in the study
(9) Previous anaphylaxis or known severe allergy to any food or pharmaceutical agent (including vaccines), etc.
(10) A history of convulsion (excluding febrile seizure), Guillain-Barre syndrome, or acute disseminated encephalomyelitis
(11) Any long-lasting (approximately 2 weeks as a guide) symptom from previous vaccination against SARS-CoV-2 or SARS-CoV-2 infection
(12) Women who do not agree to use appropriate contraception methods throughout 90 days after vaccination with the drugs used in the study
(13) Pregnant or lactating women or those who intend to become pregnant during 90 days after vaccination with the drugs used in the study
(14) Have participated in any other clinical study or clinical research etc. and received any intervention such as an investigational drug within 90 days before screening of this study, or scheduled to participate in any other clinical study or clinical research etc. while in this study
(15) Bleeding tendency which is a contraindication to intramuscular vaccination in the opinion of the principal investigator or sub-investigator
(16) Ineligible for participating in this study in the opinion of the principal investigator or sub-investigator

Related Information

• Primary Sponsor: Masayuki Aboshi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development / Ministry of Health, Labour and Welfare