ARCT-154 Phase III Study

JRCT ID: jRCT2071220080

Registered date:16/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of SARS-CoV-2 infection
• Date of first enrollment: 13/12/2022
• Target sample size: 780
• Study type: Interventional

Intervention(s)

ARCT-154: Administer 0.5 mL (5 micro g) as a single intramuscular injection.
COMIRNATY: Administer 0.3 mL (30 micro g) as a single intramuscular injection.

Outcome(s)

Primary Outcome

Primary Endpoint
To verify the non-inferiority of the geometric mean of neutralizing antibodies against SARS-CoV-2 (Wuhan strain) on Day 29 to COMIRNATY
Validate that the Seroresponse rate (SRR) neutralizing antibody response rate to SARS-CoV-2 (Wuhan strain) on Day 29 is non-inferior to COMIRNATY

Key inclusion & exclusion criteria

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

Include criteria

1) Individuals are male, female, or transgender participant >= 18 years of age at Screening.
2) Participant must freely provide documented informed consent prior to study procedures being performed.
3) Individuals must have been previously vaccinated with mRNA vaccine as follows:
- Received 3 complete doses of mRNA vaccine and the last dose received with COMIRNATY occurred >= 3 months prior to Screening
- Receipt of these vaccines is supported by any documents and application software
4) Individuals must agree to comply with all study visits and procedures (including blood tests, nasopharyngeal swabs and/or saliva sampling, diary completion, receipt of telephone calls from the site, willingness to be available for Unscheduled Clinic Visits).
5) Individuals who are able to cooperate with contraception for 28 days prior to vaccination with investigational product and for the duration of the study.

Exclude criteria

1) Individuals with acute medical illness or febrile illness, including oral temperature > 37.5 degree Celcius 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 (RT-PCR test may be performed according to institutional policy in addition to rapid antigen testing but will not be considered a screening requirement and should not delay vaccine administration).
3) Individuals with a history of COVID-19 or virologically confirmed SARS-CoV-2 infection within the past 4 months or history of COVID-19 with ongoing sequelae.
4) Individuals with a demonstrated inability to comply with the study procedures.
5) Individuals with any medical, neurological, or psychiatric condition that, in the opinion of the investigator, could place the participant at an unacceptable risk of injury or render the participant unable to comply with all study procedures and achieve successful completion of the trial.

Related Information

• Primary Sponsor: Fushimi Hideki
• Source(s) of Monetary Support: MHLW