A study to investigate the safety, immunogenicity, and relative vaccine efficacy of mRNA-1283.222 injection compared with mRNA-1273.222 injection in participants >=12 years of age to prevent COVID-19

JRCT ID: jRCT2031230699

Registered date:13/03/2024

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: COVID-19
• Date of first enrollment: 15/03/2024
• Target sample size: 692
• Countries of recruitment: Canada,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

mRNA-1283.815 and mRNA-1273.815 are used in Japan.
Participants will be randomized in a 1:1 ratio to mRNA-1283.815 or mRNA-1273.815.
mRNA 1283.815 will be administered at a 10 micro-g dose level as an IM injection into the deltoid muscle or thigh on Day 1.
Or, mRNA-1273.815 will be administered at a 50 micro-g dose level as an IM injection into the deltoid muscle or thigh on Day 1.

Outcome(s)

Primary Outcome

- GMR of Omicron XBB.1.5 GMT in the Japan cohort who received mRNA-1283.815 10 micro-g over the Omicron XBB.1.5 GMT in the Japan cohort who received mRNA-1273.815 50 micro-g at Day 29 after the booster dose.
- Solicited local and systemic reactogenicity ARs during a 7-day follow-up period after the booster dose.
- Unsolicited AEs during the 28-day follow-up period after the booster dose.
- SAEs, MAAEs, AEs leading to withdrawal, AESIs from Day 1 to EoS.

Secondary Outcome

- Omicron XBB.1.5 and ancestral SARS-CoV-2 D614G GMTs at all planned timepoints (Day 91, Day 181, and Day 365).
- SRR against Omicron XBB.1.5 and ancestral SARS-CoV-2 D614G at all planned timepoints.

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Participants are eligible to be included in the study only if all of the following criteria apply during the screening period and at Day 1, unless noted otherwise:
1. Japanese male or female, at least 12 years of age at the time of consent (Screening Visit).
2. Investigators assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
3. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as postmenopausal or permanently sterilized. An FSH level should be measured at the discretion of the investigator to confirm postmenopausal status, if necessary.
Men who have undergone a sterilization procedure are eligible to participate in the study. Men who produce sperm are eligible to participate if they agree to refrain from the donation of sperm, be abstinent from reproductive sexual intercourse, and agree to remain abstinent OR agree to use an external condom when having sexual intercourse with females of childbearing potential through 90 days following vaccine administration.
4. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
- Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.
- Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1). Adequate female contraception is defined as consistent and correct use of a local health authority approved contraceptive method in accordance with the product label.
- Has agreed to continue adequate contraception through 90 days following vaccine administration.
5. Participant has provided written informed consent for participation in this study, including all evaluations and procedures as specified in this protocol.
6. Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants >=18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable.

Exclude criteria

Participants are excluded from the study if any of the following criteria apply:
1. Has had close contact, as defined by the CDC, with someone who had a SARS-CoV-2 infection in the past 14 days, or COVID-19 in the past 10 days. Participants may be rescreened after 14 days provided that they remain asymptomatic.
2. Participant is acutely ill or febrile (temperature >=38.0 degree celsius/100.4 degree fahrenheit) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day screening window and will retain their initially assigned participant number.
3. Has tested positive for SARS-CoV-2 using an authorized/approved lateral flow/rapid antigen or PCR test within 90 days of Screening.
4. Has received a COVID-19 vaccine within 90 days of the Screening Visit.
5. Has history of myocarditis, pericarditis, or myopericarditis that has not fully resolved within 3 months prior to Screening.
6. Has received a total of 6 doses or more of COVID-19 vaccine or received an XBB-containing COVID-19 vaccine.
7. Has received a COVID-19 vaccine at a dose different from the authorized/approved dose.
8. History of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to Screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
9. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease requiring immunosuppressive treatment or other immunosuppressive condition.
10. Dermatologic conditions that could affect local solicited AR assessments (eg, psoriasis patches affecting skin over the deltoid areas).
11. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any components of mRNA vaccine.
12. Reported history of bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
13. Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
14. Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 181 days prior to Screening (for corticosteroids >=10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
15. Has received or plans to receive any licensed vaccine =<60 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 60 days after the study injection.
16. Has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study.
17. Diagnosis of malignancy within the previous 5 years (excluding nonmelanoma skin cancer).
18. Has donated >=450 mL of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
19. Has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.
20. Is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel.
21. Participants are pregnant or breastfeeding.

Related Information

• Primary Sponsor: Chalkias Spyros
• Secondary ID(s): NCT05815498