Coronavirus Disease (COVID-19)
Conditions
Interventions
Intervention group: WSK-V101K, administered as a single 1.0 mL dose via intramuscular injection into both deltoid muscles.
Control group: Recombinant coronavirus (SARS-CoV-2) vaccine, administered as
Sponsors
Nishimura Hideo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Japanese nationals residing in Japan who are between 18 and 85 years of age at the time of consent. In this context, Japanese refers to people who were born in Japan and whose four (biological) grandparents are Japanese (self-reported). 2) Participants who have provided written consent to participate in the clinical trial. 3) Participants who have completed the primary and booster immunizations of the COVID-19 vaccine and for whom at least three months have passed since their most recent booster immunization. 4) Participants who comply with the clinical trial guidelines undergo medical examinations and tests as specified in the clinical trial protocol and are able to report any symptoms. 5) Participants who have a negative HIV test result at screening. 6) Participants whose axillary temperature is 37.0 degree C or less before administration of the investigational drug (Visit 1). 7) Participants whose chest X-ray at screening reveals no clinically significant abnormalities. 8) Participants whose BMI at screening is 18.5 kg/m2 or greater and 30.0 kg/m2 or less. 9) Participants whose clinical test values at screening are within the reference range for the population or measurement institution, or who, if deviations from the reference range are observed, are deemed clinically unrelated by the investigator or sub-investigator. 10) Women who are surgically unable to conceive (those who lack ovaries and / or uterus, or who have received pelvic radiation therapy) and postmenopausal women (those who have been amenorrhea for 12 months or more). Women of childbearing potential must have negative pregnancy test results throughout the clinical trial period and agree to abstain from sex or use a contraceptive method with an annual contraceptive failure rate of less than 1% (progestin-containing IUD, copper-containing IUD, or male partner who has undergone vasectomy and is azoospermia) excluding hormonal contraception until 6 months after the final administration of the investigational drug. 11) Participants who the investigator or sub-investigator determines to be appropriate for inclusion in the clinical trial based on medical history, physical findings, and clinical test results.
Exclusion criteria
Exclusion criteria: 1)Participants who have received a formulation containing the antigenic composition of the 2025/2026 season COVID-19 vaccine after the start of routine vaccination in fiscal year 2025. 2)Participants who have been infected with COVID-19 within three months of screening. 3)Participants with serious cardiovascular, respiratory, renal, liver, hematological, neuropsychiatric, gastrointestinal, or endocrine disorders, thrombocytopenia, or coagulation disorders. 4)Participants with a history of convulsions or epilepsy due to vaccination. 5)Participants with an underlying disease or history of myocarditis or pericarditis. 6)Participants who are allergic to any of the components contained in the investigational drug or NUVAXOVID. 7)Participants with a history of a severe allergic reaction to the vaccine. 8)Participants who have previously tested positive for SARS-CoV-2 infection (within three months prior to consent) or who have been diagnosed with COVID-19 by a doctor at screening or before administration. 9)Participants with a history of immunodeficiency or close relatives with congenital immunodeficiency. 10)Participants with symptoms suspected to be SARS-CoV-2 infection (respiratory symptoms, headache, malaise, loss of smell, loss of taste, sore throat, etc.) at the time of consent. 11)Participants who have received immunosuppressive therapy, antiallergic therapy, cytotoxic therapy, or oral or inhaled corticosteroids within 6 months prior to investigational drug administration (excluding intranasal corticosteroid sprays and topical corticosteroids). 12)Participants who have received blood products within 4 months prior to sub-investigational drug administration. 13)Participants who have received other investigational/test drugs within 1 month prior to investigational drug administration. 14)Participants who have received attenuated vaccines within 1 month prior to investigational drug administration. 15)Participants who have received subunit or inactivated vaccines within 14 days prior to investigational drug administration. 16)Participants receiving anti-tuberculosis treatment. 17)Females with a positive pregnancy test. Women who are pregnant, breastfeeding, or planning to become pregnant within 6 months of receiving the investigational drug. 18)Participants deemed inappropriate for inclusion in the clinical trial by the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)To verify the non-inferiority of GMT of serum anti-LP.8.1 neutralizing activity 28 days after the WSK-V101K booster immunization compared to NUVAXOVID intramuscular Injection 1mL (hereinafter referred to as "NUVAXOVID") in participants aged 18 to 85 years. 2)To verify the non-inferiority of serum anti-LP.8.1 neutralizing activity immune response rate 28 days after the WSK-V101K booster immunization compared to NUVAXOVID in participants aged 18 to 85 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)To verify the non-inferiority of GMT of serum anti-XEC neutralizing activity 28 days after the WSK-V101K booster immunization compared to NUVAXOVID in participants aged 18 to 85 years. 2)To verify the non-inferiority of WSK-V101K compared to NUVAXOVID in the serum anti-XEC neutralizing activity immune response rate 28 days after the booster immunization in participants aged 18 to 85 years. 3)To investigate the safety of the WSK-V101K booster immunization (7 days, 28 days, 3 months, 6 months, and 12 months after administration). 4)To exploratory analyze the immunogenicity of the WSK-V101K booster immunization by stratifying the adult/elderly population and prior COVID-19 vaccine vaccination, the immunogenicity 6 months after the vaccine booster immunization, and the history of coadministration with influenza vaccine. | — |
Contacts
Public ContactWang
International Cooperation for Medical Innovation, Inc. (InCoMI)
Outcome results
None listed