Prevention of infectious disease by SARS-CoV-2
Conditions
Interventions
A intramuscular injection of DS-5670a (10, 30 or 60 ug) , placebo, Comirnaty, or Spikevax once in total
Sponsors
Inoguchi Akihiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 drug Safety: 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: - GMT and seroconversion rate of serum neutralizing activities against SARS-CoV-2 after 4 weeks from the administration of study drug - GMT of serum anti-RBD IgG titers after 4 weeks from the administration of study drug - The incidence of SARS-CoV-2 infection within 52 weeks from the administration of study drug Safety: - Serious adverse events - Solicited adverse events (injection site and systemic) - Unsolicited adverse events | — |
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed