A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05249829 |
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Recruitment Status :
Recruiting
First Posted : February 22, 2022
Last Update Posted : October 28, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| SARS-CoV-2 | Biological: mRNA-1273.529 Biological: mRNA-1273 Biological: mRNA-1273.214 | Phase 2 Phase 3 |
In Part 1, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.529 or mRNA-1273.
In Part 2, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.214 or mRNA-1273.
All participants will have previously received 2 or 3 doses of an authorized/approved COVID-19 vaccine. Participants who previously received 2 doses of a COVID-19 vaccine as a primary series will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 3rd dose, and participants who have previously received a primary series and 1 booster dose will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 4th dose (a mixed approach is acceptable). Each part will include Phase A (randomized, blinded) and Phase B (open-label, observational).
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 3924 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Phase A of this study will be observer-blinded. Phase B of the study will be open-label and blinding is not applicable |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | A Phase 2/3, Randomized, Observer-blind, Active-controlled, Multicenter Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 (Prototype) Booster Vaccine |
| Actual Study Start Date : | February 16, 2022 |
| Estimated Primary Completion Date : | April 7, 2023 |
| Estimated Study Completion Date : | April 7, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Part 1: mRNA-1273.529
Phase A: Participants will receive 1 intramuscular (IM) dose of mRNA-1273.529 on Day 1. Phase B: After Day 179, eligible participants may choose to be unblinded and to receive an additional booster outside of the study. |
Biological: mRNA-1273.529
Sterile liquid for injection |
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Active Comparator: Part 1: mRNA-1273
Phase A: Participants will receive 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 179, eligible participants may choose to be unblinded and to receive an additional booster outside of the study. |
Biological: mRNA-1273
Sterile liquid for injection |
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Experimental: Part 2: mRNA-1273.214
Phase A: Participants will receive 1 IM dose of mRNA-1273.214 on Day 1. Phase B: After Day 85, eligible participants may choose to be unblinded and to receive an additional booster outside of the study. |
Biological: mRNA-1273.214
Sterile liquid for injection |
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Active Comparator: Part 2: mRNA-1273
Phase A: Participants will receive 1 IM dose of mRNA-1273 on Day 1. Phase B: After Day 85, eligible participants may choose to be unblinded and to receive an additional booster outside of the study. |
Biological: mRNA-1273
Sterile liquid for injection |
- Geometric Mean Titer (GMT) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [ Time Frame: Up to Day 85 post-vaccination ]
- Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days post-vaccination) ]
- Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 29 (28 days post-vaccination) ]
- Number of Participants with Serious AEs (SAEs) [ Time Frame: Day 1 to end of study (Day 359) ]
- Number of Participants with Medically Attended AEs (MAAEs) [ Time Frame: Day 1 to end of study (Day 359) ]
- Number of Participants with AEs Leading to Withdrawal [ Time Frame: Day 1 to end of study (Day 359) ]
- Number of Participants with AEs of Special Interest (AESIs) [ Time Frame: Day 1 to end of study (Day 359) ]
- GMT of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain [ Time Frame: Up to Day 85 post-vaccination ]
- GMT of mRNA-1273.214 and mRNA-1273 Against the Prototype Strain [ Time Frame: Up to Day 85 post-vaccination ]
- GMT of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
- GMT of mRNA-1273.529 and mRNA-1273 Against the Prototype Strain [ Time Frame: Days 1, 29, 85, 179, and 359 ]
- Seroresponse Rate of Vaccine Recipients [ Time Frame: Days 1, 29, 85, 179, and 359 ]
- GMT of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains [ Time Frame: Days 29 and 85 ]
- Number of Participants with Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase-chain Reaction (RT-PCR) [ Time Frame: Day 1 through the end of study (Day 359) ]
- Number of Participants with Symptomatic SARS-CoV-2 Infection Measured by RT-PCR [ Time Frame: Day 1 through the end of study (Day 359) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Female participants of childbearing potential may be enrolled in the study if the participant 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); and has agreed to continue adequate contraception through 90 days following vaccine administration.
- Participant 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.
- 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).
Exclusion Criteria:
- Participant had close contact (without personal protective equipment [PPE]) as defined by the Centers for Disease Control and Prevention (CDC) in the past 14 days to someone diagnosed with SARS-CoV-2 infection or COVID-19 within 10 days of the close contact. Participants may be rescreened after 14 days provided that they remain asymptomatic.
- 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.
- Participant has tested positive for SARS-CoV-2 by an authorized/approved lateral flow/rapid antigen or polymerase chain reaction (PCR) test within 90 days of Screening.
- Participant has received a COVID-19 vaccine within 90 days of the Screening Visit.
- Participant has received a total of 4 doses or more of COVID-19 vaccine.
- Participant has received a COVID-19 vaccine at a dose different from the authorized/approved dose.
- 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.
- Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 181 days prior to screening (for corticosteroids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
- Participant 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 days and preferably 14 days apart from the study injection).
- Participant has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study.
- Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
- Participant 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.
Note: Other inclusion and exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05249829
| Contact: Moderna Clinical Trials Support Center | 1-877-777-7187 | clinicaltrials@modernatx.com |
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| Responsible Party: | ModernaTX, Inc. |
| ClinicalTrials.gov Identifier: | NCT05249829 |
| Other Study ID Numbers: |
mRNA-1273-P305 2022-000063-51 ( EudraCT Number ) |
| First Posted: | February 22, 2022 Key Record Dates |
| Last Update Posted: | October 28, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | Yes |
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