COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2051210057

Tetsuo Seki

seki@tri-kobe.org

2021-07-29

Not recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

1) Subjects aged between >18 and <85 years at the time of informed consent2) Subjects who provided written informed consent. For underage subjects, written consent must be obtained from the subject and the subjects legally acceptable representative3) Subjects who will be available for the study schedule and able to comply with subject requirements of the study and at the study center4) Subjects who are HIV-negative at screening5) Subjects with an axillary body temperature of <37.0 digrees on the day of enrollment6) Subjects with negative real-time polymerase chain reaction (PCR) for SARS-CoV-2 in saliva at screening7) Subjects with negative serum anti-SARS-CoV-2 antibodies (IgG and IgM) at screening8) Subjects without clinically relevant abnormal findings on chest X-ray at screening9) Subjects with a body mass index (BMI) of >18.5 to <30.0 kg/m^2 at screening10) Subjects without clinically relevant abnormal findings on 12-lead electrocardiogram (ECG) at screening11) Subjects with all laboratory test values at screening being within the reference ranges for the population or laboratory, or subjects with values outside the reference ranges judged by the investigator/sub-investigator to be clinically insignificant12) Female subjects of childbearing potential, who have a negative serum or urine pregnancy test and agree to use an adequate method of contraception during the study period13)Subjects judged by the investigator/sub-investigator to be appropriate for inclusion in the study on the basis of the medical history, physical findings, and laboratory data

1) Subjects who previously received a vaccine against SARS-CoV-2 2) Subjects with close contact with a COVID-19 patient within 30 days prior to immunization of the investigational product (according to the definition of close contacts by the National Institute of Infectious Diseases3) Subjects with a personal or family history of seizures, epilepsy, encephalopathy, or psychiatric disease4) Subjects allergic to any of the ingredients of the test product or placebo5) Subjects with a history of serious allergic reactions to vaccines6) Subjects with any acute febrile disease or infectious disease7) Subjects with a history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) or COVID-198) Subjects with a history of serious cardiovascular, respiratory, hematological, digestive, endocrine, neuropsychiatric, hepatic, or renal disease9) Subjects with hereditary or acquired vascular/neurogenic edema10) Subjects who had urticaria within 1 year prior to immunization of the investigational product11) Subjects with asplenism, post-splenectomy or functional asplenism12) Subjects with thrombocytopenia or any other coagulation disorder (possible contraindication to intramuscular injection)13) Subjects with vasovagal reactions to needle insertion14) Subjects who received immunosuppressive therapy, antiallergic therapy, cytotoxic therapy, or oral or inhaled corticosteroids (but not nasal corticosteroid sprays or topical corticosteroids) within 6 months prior to immunization of the investigational product15) Subjects who received any blood product within 4 months prior to immunization of the investigational product16) Subjects who participated in any other clinical trial or received any other study drug within 1 month prior to immunization of the investigational product in this study17) Subjects who received an attenuated vaccine within 1 month prior to immunization of the investigational product18) Subjects who received a subunit vaccine or inactivated vaccine within 14 days prior to immunization of the investigational product19) Subjects receiving anti-tuberculosis therapy20) Females with a positive pregnancy test. Females who are pregnant or breastfeeding or who plan to become pregnant within 6 months after immunization of the investigational product21) Subjects judged by the investigator or sub-investigator to be inappropriate for participation in this study

2

Fujita Yasuyuki

18

85

Japan

Healthy volunteers

N/A

240

Incidence of adverse reactions (ARs) during the 7 days following the start of each dosing in each cohort

Phase 1/Phase 2

[{"arm_notes": "3 doses, 1.0 mL each, 0, 22 and 43 days", "treatment_id": 1089, "treatment_name": "Recombinant sars-cov-2 vaccine (sf9 cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]