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A randomized, multicenter, phase 3, observer-blind, active-controlled comparative study to evaluate the safety and immunogenicity of a booster shot of ARCT-154 (a self-amplifying mRNA COVID-19 vaccine) in healthy subjects

ARCT-154 Phase III Study

828

Of 825 subjects in the FAS, 805 (97.6%) subjects were >=18 to <65 years and 20 (2.4%) subjects were >=65 years of age, and 340 (41.2%) subjects were male and 485 (58.8%) subjects were female.

After signing informed consent form, subjects were interviewed (to determine medical history, SARS-CoV-2 exposure, concomitant medications/vaccination). Subjects were randomly assigned at a 1:1 ratio to receive single intramuscular dose of ARCT-154 or COMIRNATY being stratified based on the study site, time since the last vaccination, gender, and age. Solicited adverse events (AEs) and featured symptoms occurring after administration were collected up to Day 7, unsolicited AEs were collected up to Day 29, and death from AEs, serious AEs (SAEs) other than death, medically significant AEs, and AEs of special interest were collected up to Day 361. To assess immunogenicity, blood was collected on Day 1, 29, 91, 181, and 361 to measure antibody responses. Follow-up was done up to 12 months after administration.

Solicited local AEs (>=Grade 1) were reported in 397 subjects (94.5%) in the ARCT-154 group and 395 subjects (96.8%) in the COMIRNATY group. Solicited systemic AEs (>=Grade 1) were reported in 270 subjects ( 64.3%) in the ARCT-154 group and 254 subjects (62.3%) in the COMIRNATY group.

-The GMT ratio of neutralizing antibodies against SARS-CoV-2 (Wuhan strain) of ARCT-154 compared with COMIRNATY was 1.43 (95% CI: 1.26, 1.63) on Day 29. Since the lower limit of the 95% CI exceeded the predefined non-inferiority margin of 0.67, non-inferiority of ARCT-154 to COMIRNATY was confirmed. -The difference in SRR of neutralizing antibodies against SARS-CoV-2 (Wuhan strain) of ARCT-154 and COMIRNATY was 13.6% (95% CI: 6.8, 20.5) on Day 29. Since the lower limit of the 95% CI exceeded the predefined non-inferiority margin of -10%, non-inferiority of ARCT-154 to COMIRNATY was confirmed.

When ARCT-154 was administered intramuscularly as a booster dose in subjects who had received 3 doses of approved mRNA COVID-19 vaccine at least 3 months prior, the immunogenicity against SARS-CoV-2 (Wuhan strain) of ARCT-154 was non-inferior to that of COMIRNATY .

Jan. 14, 2025

Feb. 01, 2024

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(24)00060-4/fulltext

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2071220080

Fushimi Hideki

Meiji Seika Pharma Co.,Ltd.

2-4-16, Kyobashi, Chuo-ku, Tokyo

clinical-trials@meiji.com

Clinical Development Dept.

Meiji Seika Pharma Co.,Ltd.

2-4-16, Kyobashi, Chuo-ku, Tokyo

+81-3-3273-3746

clinical-trials@meiji.com

Complete

Dec. 13, 2022

Interventional

randomized controlled trial

double blind

active control

parallel assignment

treatment purpose

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.

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.

Both

Prevention of SARS-CoV-2 infection

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.

SARS-COV-2, COVID-19

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

+81-92-283-7701

Dec. 15, 2022

+81-3-5366-3006

Dec. 15, 2022

+81-6-6395-9000

Dec. 15, 2022

+81-42-625-5216

Dec. 15, 2022

+81-3-6779-8166

Dec. 15, 2022

+81-24-547-1111

Dec. 15, 2022

+81-3-3813-3111

Dec. 15, 2022

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