A Phase 1, Placebo-controlled, Randomized, Observer-blinded Trial to Evaluate the Safety and Tolerability of SARS-CoV-2 Vaccine VLPCOV-U-01 in Healthy Adult Subjects (First-in-Human Study)
A Phase 1, Placebo-controlled, Randomized, Observer-blinded Trial to Evaluate the Safety and Tolerability of SARS-CoV-2 Vaccine VLPCOV-U-01 in Healthy Adult Subjects (First-in-Human Study)
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
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
Recruiting
Mar. 09, 2026
Mar. 09, 2026
80
Interventional
randomized controlled trial
double blind
placebo control
parallel assignment
prevention purpose
1.Aged >=18 years at the time of obtaining consent
2.Aged <75 years at the time of obtaining consent
3.Signed written informed consent for participation in this study
4.HLA genotyping result at Visit 00 showing any of the following alleles: A asterisk 24:02, A asterisk 02:01, A asterisk 02:06, A asterisk 26:01, A asterisk 11:01, or A asterisk 02:07
5.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.
6.Received the 2-dose primary vaccination series with the same SARS-CoV-2 RNA vaccine (hereinafter referred to as "mRNA vaccine"), followed by booster dose(s) immunization with an Omicron adapted vaccine (irrespective of the type of vaccine and the number of doses), with at least 6 months having elapsed since the most recent SARS-CoV-2 vaccination.
7.Body mass index (BMI) of 18.0 to 35.0 kg/m2 at Visit 00
1.Any flu-like symptom (findings suggestive of infection, such as fever at axillary body temperature of 37.5 degrees or higher (or intraoral temperature of 38.0 degrees or higher), chill, cough, nasal discharge, headache, and myalgia) within 72 hours before study drug inoculation
2.Positive SARS-CoV-2 antigen test before study drug inoculation at Visit 00 or Visit 01 (Day 1) or positive SARS-CoV-2 antigen test/nucleic acid detection test during screening (Visit 00 to Visit 01)
3.History of SARS-CoV-2 infection (including asymptomatic and deemed positive) within 6 months before obtaining consent
4.Systolic blood pressure of >160 mmHg or diastolic blood pressure of >100 mmHg
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 (e.g., common variable immunodeficiency, severe combined immunodeficiency) and autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) (including use of immunosuppressive agents [e.g., high-dose steroids, anti-TNF-alpha])
8.Receiving or scheduled to receive medications or therapies that may interfere with the evaluation of the study drug
"Medications or therapies that may interfere with the evaluation of the study drug" refer to biological products (e.g., anti-TNF-alpha agents [infliximab, adalimumab, etc.], anti-IL-6, anti-IL-5, etc.), JAK inhibitors (e.g., tofacitinib, baricitinib, etc.), and cell/cytokine therapies (e.g., CAR-T therapy, IL-2 therapy, etc.). Other medications or therapies that may clearly interfere with immune assessment will be determined through discussion between the principal investigator or sub-investigator and the sponsor. This criterion will also apply to medications approved overseas but not approved in Japan (e.g., oral minoxidil, medications administered at doses exceeding those approved in Japan) if they are judged to potentially interfere with the evaluation of the study drug based on their characteristics and overseas safety information (warnings, etc.).
9.History of anaphylaxis or severe allergy caused by food or pharmaceutical products (including vaccines), etc.
10.History of convulsion (excluding febrile seizure), Guillain-Barre syndrome, or acute disseminated encephalomyelitis
11.Positive for hepatitis B surface (HBs) antigen, hepatitis C virus (HCV) antibodies, human immunodeficiency virus (HIV) antibodies, serologic test for syphilis, or human T-cell leukemia virus type 1 (HTLV-1) antibodies
12.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
13.Females who do not agree to use appropriate contraception methods through 90 days after study drug inoculation
14.Pregnant or lactating females or those who intend to become pregnant through 90 days after the last dose of study drug inoculation
15.Received any investigational drug or invasive procedure (e.g., blood sampling in a total volume exceeding 200 mL) in any other clinical study or clinical research, etc. 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
16.Bleeding tendency, and for which the principal investigator or sub-investigator determined intramuscular inoculation to be a contraindication
17.Donated blood within the following periods prior to screening for this study:
- Whole blood donation (400 mL): Within 12 weeks (males) /within 16 weeks (females)
- Whole blood donation (200 mL): Within 4 weeks
- Apheresis donation (plasma/platelets): Within 2 weeks
18.Potential risk of worsening anemia (including latent iron deficiency) associated with the blood sampling schedule of this study, which is deemed clinically unacceptable based on screening test results. The following parameters shall apply in making the assessment, with due consideration given to subject safety:
- Hemoglobin: Those with a hemoglobin level of <10.0 g?/dL shall be excluded.
- Ferritin: For those with a ferritin level of <12ng/mL, the principal investigator or sub-investigator shall individually determine the eligibility based on a comprehensive assessment, taking the hemoglobin level into consideration.
19.Determined ineligible by the principal investigator or sub-investigator for participation in this study
18age old over
75age old not
Both
Prevention of infectious disease caused by SARS-CoV-2
The study drug will be administered intramuscularly into the upper arm deltoid muscle of the subjects at the specified dose twice in total, with a four-week interval between doses.
Subjects will be inoculated with VLPCOV-U-01 sequentially.
Inoculation will be performed in the order of dose groups : (Group 1:3 micro g), (Group 2:5 micro g), (Group 3:7.5 micro g), and (Group 4:15 micro g).
If it is not deemed feasible to progress to Dose Group 3, inoculation of Dose Group 5 (6 micro g) will be performed in place of Dose Group 3.
If it is not deemed feasible to progress to Dose Group 4, inoculation of Dose Group 6 (10 micro g) will be performed in place of Dose Group 4.
Incidence and severity of the following adverse events:
- Solicited local adverse events which occurred through 7 days after study drug inoculation
- Solicited systemic adverse events which occurred through 7 days after study drug inoculation
- Adverse events which occurred from the first dose of study drug inoculation through 4 weeks after the last dose of study drug inoculation
[Immunogenicity]
Frequency of interferon-gamma (IFN-gamma)-producing T cells following antigen stimulation with HLA-restricted peptide pools (ELISpot assay) through 4 weeks after the second dose of study drug inoculation
[Safety]
- Incidence of the following events through 52 weeks after the last dose of study drug inoculation:
- Serious adverse events
- COVID-19 which occurred on or after the 7th day (Day 8) following the first dose of study drug inoculation
-Incidence of the following events up to 17 weeks after the first dose of study drug inoculation
- Medically Attended unsolicited Adverse Event (MAAE)
VLP Therapeutics Japan, Inc.
Strategic Center of Biomedical Advanced Vaccine Research and Development for Preparedness and Response(SCARDA), Japan Agency for Medical Research and Development(AMED)
