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A phase 3, Placebo-controlled, Randomized, Observer-blinded Trial to Evaluate the Efficacy of SARS-CoV-2 Vaccine VLPCOV-05 with a Booster Dose in Preventing COVID-19 in Healthy Adult Subjects

A phase 3 Trial to Evaluate the Efficacy of VLPCOV-05 Vaccine with a Booster Dose in Preventing COVID-19

Aboshi Masayuki

VLP Therapeutics Japan, Inc.

Hilton Plaza West Office Tower, 2-2-2 Umeda Kita-ku, Osaka city, Osaka

clinical@vlptherapeutics.com

Aboshi Masayuki

VLP Therapeutics Japan, Inc.

Hilton Plaza West Office Tower, 2-2-2 Umeda Kita-ku, Osaka city, Osaka

+81-70-8336-6345

clinical@vlptherapeutics.com

Not Recruiting

April. 10, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

prevention purpose

(1) Aged 18 years or older at the time of obtaining consent
(2) Signed written informed consent for participation in this study
(3) Able to comply with the rules during study participation, receive tests and physical examinations prespecified in the study protocol, complete the e-Diary themselves, and report their symptoms, etc.
(4) Received the 2-dose primary vaccination series with the same SARS-CoV-2 RNA vaccine (hereinafter referred to as "mRNA vaccine"), followed by booster doses (irrespective of the type of vaccine and the number of doses). The most recent vaccine inoculated must have been COMIRNATY intramuscular injection or RTU intramuscular injection (monovalent and bivalent: Omicron-adapted).
(5) Able to receive an antigen/nucleic acid detection test performed by the study site or any other medical institution at the onset of suspected COVID-19
(6) Able to contact via telephone, email, etc. themselves

(1) Any flulike symptom (findings suggestive of infection, such as fever at axillary body temperature of 37.5 degrees or higher [or intraoral temperature of 38.0degrees or higher], chill, cough, nasal discharge, headache, and myalgia) within 72 hours before study drug inoculation
(2) Positive SARS-CoV-2 antigen test or qualitative anti-N-IgG antibody test result prior to study drug inoculation on Visit 01 (Day 1)
(3) History of SARS-CoV-2 infection (including asymptomatic and deemed positive) in and after January 2024
(4) History of inoculation with Omicron JN.1-adapted vaccines or with VLPCOV-04
(5) History of myocarditis or pericarditis, or 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 prior to screening for this study, having required a change in therapeutic agent, etc. due to a worsening of disease status, or having any of the above planned during the study period.
(6) Any concomitant active infection
"Active infection" is defined as: being diagnosed as having a bacterial, viral, mycotic, or parasitic infection and requiring treatment, or having a chronic infection with ongoing activity, such as chronic hepatitis (e.g., hepatitis B or hepatitis C) and active tuberculosis.
(7) Disease or status, or a known history deemed to interfere with the evaluation of the study drug, such as immunodeficiency and autoimmune disease
(8) Received an agent or therapy deemed to interfere with the evaluation of the study drug, or are scheduled to receive the above during study participation
(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) Participated in any other clinical study or clinical research etc. and received any intervention such as an investigational drug or invasive procedures (e.g., blood collection exceeding 200 mL in total) within 90 days prior to screening of this study, or are scheduled to participate in any other clinical study or clinical research etc. (except observational studies involving no procedures such as blood sampling) during participation in this study
(15) Bleeding tendency, and for which the principal investigator or sub-investigator determined intramuscular inoculation to be a contraindication
(16) Determined ineligible by the principal investigator or sub-investigator for participation in this study

Both

Prevention of infectious disease caused by SARS-CoV-2

[Evaluation of immunogenicity]
Administer 0.5 mL (3 micro g) VLPCOV-05 or 0.3 mL COMIRNATY Injection Syringe for individuals aged 12 and above (Monovalent: Omicron JN.1) or placebo as a single intramuscular injection into the deltoid muscle of the upper arm.

[Evaluation of efficacy in preventing COVID-19]
Administer 0.5 mL (3 micro g) VLPCOV-05 or placebo as a single intramuscular injection into the deltoid muscle of the upper arm.

COVID-19 incidence rate during the evaluation period

[Definition of the evaluation period]
The evaluation period starts from Day 8 (7 days after vaccination with the drugs used in the study) and continues until one of the following conditions is met:
(1) All visits up to Week 26 after vaccination with the drugs used in the study are completed for all subjects, and case report forms for at least 399 cases of COVID-19 have been completed.
(2) If the number of COVID-19 cases does not reach 399, the evaluation period continues until all visits up to Week 52 after vaccination with the drugs used in the study are completed for all subjects.

[Efficacy against infection]
(1) Incidence rate of moderate I to severe COVID-19 during the evaluation period
(2) SARS-CoV-2 infection rate during the evaluation period

[Immunogenicity]
1. At 4 and 26 weeks after study drug inoculation:
(1) Serum neutralizing antibody titers against live viruses (Omicron JN.1 and other variants)

[Safety]
1. Incidences 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
2. Incidences of the following adverse events through 26 weeks after study drug inoculation:
(1) Serious adverse events
(2) Adverse events leading to study discontinuation

+81-3-5050-4268

Mar. 26, 2025

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