ARCT-2301 Phase III Study

JRCT ID: jRCT2031230340

Registered date:12/09/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Prevention of SARS-CoV-2 infection
• Date of first enrollment: 30/09/2023
• Target sample size: 850
• Study type: Interventional

Intervention(s)

ARCT-2301: Administer 0.5 mL (5 micro g) as a single intramuscular injection.
COMIRNATY (BA.4-5) : Administer 0.3 mL (30 micro g) as a single intramuscular injection.

Outcome(s)

• Primary Outcome: Geometric mean titer (GMT) and Seroresponse rate (SRR) of neutralizing antibodies against SARS-CoV-2 (Omicron strain BA.4-5) on Day 29

Key inclusion & exclusion criteria

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

Include criteria

1) Individuals are participant (irrespective of gender) >=18 years of age at Informed consent.
2) Participant or legally authorized representatives must freely provide documented informed consent prior to study procedures being performed.
3) Individuals must have been previously vaccinated with mRNA COVID-19 vaccine and satisfy the following criteria.
- Received 2~4 doses with authorized mRNA COVID-19 vaccine (monovalent COMIRNATY or monovalent SPIKEVAX)
- Received the last booster dose of COMIRNATY RTU intramuscular injection ([bivalent: Wuhan strain/Omicron BA.1] or [bivalent: Wuhan strain/Omicron BA.4/5])
- At least 3 months have passed since the last vaccination at the time of screening
- Receipt of these vaccines is supported by any documents and application software

Exclude criteria

1) Individuals with acute medical illness or febrile illness, including oral temperature >= 37.5 degree Celsius within 1 day prior to Screening. These individuals may be offered the opportunity to enter the study after fever and illness has stabilized. Participants with suspected or confirmed COVID-19 should be excluded and referred for medical care. Rescreening will be permitted for individuals who presented with suspected COVID-19 if another cause is confirmed.
2) Individuals with a positive SARS-CoV-2 rapid antigen test at Screening
3) Individuals with a history of COVID-19 with ongoing sequelae of COVID-19 infection within 6 months
sequelae.

Related Information

• Primary Sponsor: Yusuke Okada
• Source(s) of Monetary Support: MHLW