COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2051200092

Corporate Communications Department

shionogiclintrials-admin@shionogi.co.jp

2020-12-09

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

Phase 1 Part-A:-A person with Japanese nationality.-Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF).-Apparently healthy as determined by medical assessment.-Body mass index (BMI) within the range 18.5 to 25.0 (inclusive) at Screening.Phase 1 Part-B:-A person with Japanese nationality.-Participant must be 65 years of age or above, at the time of signing the ICF.-BMI within the range 18.5 to 30.0 (inclusive) at Screening.Phase 1 Part-C:-A person with Japanese nationality.-Participant must be 20 to 64 years of age inclusive, at the time of signing the informed consent form (ICF).-Apparently healthy as determined by medical assessment.-BMI within the range 18.5 to 30.0 (inclusive) at Screening.Phase 2 Part:-A person with Japanese nationality.-Participant must be 20 to 64 years of age inclusive, at the time of signing the ICF.-BMI within the range 18.5 to 30.0 (inclusive) at Screening. et, al.

Common to Phase 1 Part-A, Phase 1 Part-B, Phase 1 Part-C, and Phase 2 Part:-Positive SARS-CoV-2 antigen test result at Screening.-Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders that, in the opinion of the investigator/subinvestigator, will lead to a safety issue or interfere with the assessment of efficacy-Body temperature higher than 37.5 degree Celsius on Day 1 before the vaccination.-Past use of vaccines related to SARS-CoV-2 prior to the first vaccination.-Hypersensitivity to any of the study drugs, or components thereof, or drug or other allergy that, in the opinion of the investigator/subinvestigator, contraindicates participation in the study (except pollinosis and atopic dermatitis).Phase 1 Part-A and Phase 1 Part-C:-Positive SARS-CoV-2 antibody test result at Screening or a known history of SARS-CoV-2 infection by medical consultation on Day 1 before the vaccination.-Past use of immunosuppressive drug within 6 months prior to the first vaccination.The following applies to Phase 1 Part-B and Phase 2 Part:-Immunosuppressed state [immunocompromised, with acquired immunodeficiency syndrome (AIDS), receiving systemic steroid or immunosuppressive drugs, being treated for malignancy or receiving other immunosuppressive therapy]. et, al.

2

Nagata Tsutae

20

64

Japan

Healthy volunteers

N/A

300

Phase 1 Part-A; Phase 1 Part-B; and Phase 1 Part-C:-The incidence of adverse events (AEs); adverse reactions; serious AEs (SAEs); solicited local reactogenicity AEs; and solicited systemic reactogenicity AEsPhase 2 Part:-Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody titer

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "2;day0-21;IM", "treatment_id": 1139, "treatment_name": "S-268019", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]