A trial to evaluate the ability to provoke an immune response and the safety of mRNA-1273.529 (Omicron Variant) in comparison with mRNA-1273 (prototype) booster vaccine
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and InfestationsCoronavirus disease
- Registration Number
- ISRCTN99890480
- Lead Sponsor
- ModernaTX, Inc. (USA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 2924
1. Male or female, at least 16 years of age at the time of consent (Screening Visit)
2. Investigator’s assessment that participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures
3. Participant has provided written informed consent for participation in this study, including all evaluations and procedures as specified in this protocol
4. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as bilateral tubal ligation > 1 year prior to the Screening Visit, bilateral oophorectomy, hysterectomy, or postmenopausal (defined as amenorrhea for = 12 consecutive months prior to the Screening Visit without an alternative medical cause). A follicle stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status
5. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria:
5.1 Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.
5.2 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.
5.3 Has agreed to continue adequate contraception through 90 days following vaccine administration
6. Has received 2 prior doses of one of the following approved/authorized COVID-19 vaccines: Moderna, Pfizer/BioNTech, Oxford/AstraZeneca, Janssen. A heterologous vaccine regimen is acceptable
7. Participants who will receive the 4th dose as part of the study must have previously received a mRNA vaccine (Moderna or Pfizer/BioNTech) as the 3rd dose of a COVID-19 vaccine. Participants who will receive the 3rd dose as part of the study may have previously received 2 doses of an approved/authorized mRNA or a non-mRNA COVID-19 vaccine (a heterologous vaccine regimen is acceptable).
1. Had significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, as defined by the CDC as a close contact (without PPE) of someone who has had COVID 19.
2. Participant is acutely ill or febrile (temperature = 38.0°C/100.4°F) 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. Had tested positive for SARS-CoV-2 by approved/authorized lateral flow/rapid antigen or PCR test on 08 November 2021 or later.
4. Has received a COVID-19 vaccine within 3 months of the Screening Visit.
5. Has received a total of 4 doses or more of COVID-19 vaccine.
6. Has received a COVID-19 vaccine at a dose different from the authorized/approved dose.
7. 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.
8. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease requiring immunosuppressive treatment or other immunosuppressive condition.
9. Dermatologic conditions that could affect local solicited AR assessments (eg, tattoos, psoriasis patches affecting skin over the deltoid areas).
10. Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any components of mRNA vaccine.
11. Reported history of bleeding disorder that is considered a contraindication to intramuscular (IM) injection or phlebotomy.
12. 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. Asymptomatic conditions and conditions with no evidence of end organ involvement (eg, mild hypertension, dyslipidemia) are not exclusionary, provided that they are being appropriately managed and are clinically stable (ie, unlikely to result in symptomatic illness within the time course of this study). Illnesses or conditions may be exclusionary, even if otherwise stable, due to therapies used to treat them (eg, immune modifying treatments), at the discretion of the Investigator.
13. 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.
14. Has received or plans to receive any licensed vaccine = 28 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 28 days after the study injection (with the exception that approved seasonal influenza vaccine may be received by at least 7 and preferably 14 days apart from the stud
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method