A Randomized, Active-comparator, Observer-blind, Phase I/II/III Study to Demonstrate the Immunogenicity of a Single Booster Dose of DS-5670a in Adults and Elderly Received a Primary Series of Approved COVID-19 Vaccine

JRCT ID: jRCT2071210106

Registered date:28/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of infectious disease by SARS-CoV-2
• Date of first enrollment: 31/01/2022
• Target sample size: 5028
• Study type: Interventional
• Intervention(s): A intramuscular injection of DS-5670a (10, 30 or 60 ug) , placebo, Comirnaty, or Spikevax once in total

Outcome(s)

Primary Outcome

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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Inoguchi Akihiro
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare