COVID-19 trials registries data warehouse

https://jrct.niph.go.jp/latest-detail/jRCT2071210106

Contact for Clinical Trial Information

dsclinicaltrial@daiichisankyo.co.jp

2021-12-28

Recruiting

RCT

Randomized

Parallel

Blind label

unclear

Prevention

1)Adults aged 18 to 64 years at the time of consent, or elderly subjects aged 65 years or older at the time of consent. 2)Subjects who had received the 2nd dose of the initial series of SARS-CoV-2 vaccines (either Comirnaty or Spikevax[previously Moderna]) at least 6 months prior to signing consent.

1)Subjects who have a history of seizure or epilepsy after vaccination. 2)Subjects who have had symptoms of SARS-CoV-2 infection and been diagnosed with SARS-CoV-2 infection by reverse transcription polymerase chain reaction (RT-PCR) test, SARS-CoV-2 antigen test, or SARS-CoV-2 antibody test in the past. 3)Subjects who have suggestive symptoms of SARS-CoV-2 infection (respiratory symptoms, headache, malaise, olfactory dysfunction, or taste disorder, etc.) at the time of consent. 4)Subjects who have a positive SARS-CoV-2 antigen test or SARSCoV-2 antibody test at the time of eligibility assessment. 5)Subjects who have a history of anaphylaxis or severe allergy to food, pharmaceuticals, cosmetics, vaccination, etc.

6

Inoguchi Akihiro

18

100

Japan

Healthy volunteers

N/A

5028

Efficasy: Geometric mean fold rise (GMFR) of neutralizing antibody titer against SARS-CoV-2 in blood after 4 weeks (Day 29) of treatment with the study drugSafety: Specific adverse events (injection site and systemic) and adverse reactions; unspecified adverse events and adverse reactions; serious adverse events and adverse reactions; laboratory data; 12-lead ECG (dose escalation part only)

Phase 2/Phase 3

[{"arm_notes": " booster 10 ug", "treatment_id": 422, "treatment_name": "Ds-5670a", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " booster 30 ug", "treatment_id": 422, "treatment_name": "Ds-5670a", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": " booster 60 ug", "treatment_id": 422, "treatment_name": "Ds-5670a", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 222, "treatment_name": "Bnt162b2", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]