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CompletedNCT07089706Updated Jul 7, 2026

A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Formulations

A Phase 4 interventional study of mRNA-1283.251 Variant-containing Formulation in COVID-19, sponsored by ModernaTX, Inc.. Completed at 5 sites in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by ModernaTX, Inc. · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
832
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.

Read the detailed description

This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity of variant-containing formulations of the mRNA-1283 COVID-19 vaccine. As different variant-containing vaccine formulations will be evaluated, each study intervention (for example, updated mRNA-1283 COVID-19 vaccine) will be described in the subprotocol. For each evaluation of an updated variant vaccine, a new subprotocol will be generated.

Subprotocol 01 is a single arm study to evaluate immunogenicity and safety of mRNA-1283 (COVID-19 vaccine) 2025-2026 formula in individuals aged ≥65 years and ≥12 to \<65 years with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19.

The study included Parts A and B. Part A enrollment was discontinued due to addition of Part B to evaluate the safety and immunogenicity of variant-containing mRNA-1283 using a hypothesis driven study endpoint with reactogenicity data collection and longer safety follow up in Part B.

02

Conditions studied

  • COVID-19

Keywords

  • mRNA-1283
  • mRNA-1283 vaccine
  • SARS-CoV-2
  • SARS-CoV-2 Vaccine
  • Coronavirus
  • Coronavirus Infections
  • Virus Diseases
  • mNEXSPIKE®
  • COVID-19
  • COVID-19 vaccine
  • Moderna
03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 832 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

ModernaTX, Inc. is the lead sponsor of 112 studies on the registry; 14 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 32 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Subprotocol 1:

  • ≥65 years of age at the time of signing the informed consent or ≥12 to \<65 years of age at the time of signing the informed consent with at least 1 risk factor for severe outcomes from COVID-19.
  • Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
  • Participants who are assigned female at birth or could become pregnant:

    i) Has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1.

ii) 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).

iii) Has agreed to continue adequate contraception through 28 days following vaccine administration.

Exclusion criteria

Exclusion Criteria:

Subprotocol 1:

  • History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months prior to enrollment.
  • Acutely ill or febrile (temperature ≥38.0°Celsius/≥100.4°Fahrenheit) within 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the Screening window and will retain their initially assigned participant number.
  • History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
  • Receipt of the COVID-19 vaccine within 6 months prior to enrollment.
  • Receipt of any licensed non-COVID-19 vaccine within 28 days before or planned receipt within 28 days after the study intervention, except an influenza vaccine, which may be given 14 days before or after receipt of the study intervention.
  • Receipt of systemic immunosuppressants for >14 days in total, within 180 days prior to Screening Visit (for corticosteroids ≥10 milligrams [mg]/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
  • Receipt of systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.
  • History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic.
  • Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days after the study injection.

Note: Other protocol-specified inclusion and exclusion criteria may apply.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
832 participants (actual)

Study arms

  • Experimental
    mRNA-1283.251 Variant-containing Formulation

    Participants will receive an intramuscular (IM) injection of a mRNA-1283.251 variant-containing formulation.

    Biological: mRNA-1283.251 Variant-containing Formulation

Interventions

  • BiologicalmRNA-1283.251 Variant-containing Formulation

    Sterile liquid for injection

    Also known as: mNEXSPIKE®

06

What researchers measure

Primary outcomes

  1. Subprotocol 1: Part A - Geometric Mean (GM) Value of Neutralizing Antibody (nAb) Against Vaccine-matched COVID-19 Variants

    Time frame: Day 29

  2. Subprotocol 1: Part A - Geometric Mean Fold Rise (GMFR) of nAb Against Vaccine-matched COVID-19 Variants

    Time frame: Baseline to Day 29

  3. Subprotocol 1: Part B - GMFR of nAb Against Vaccine-matched COVID-19 Variants

    Time frame: Baseline to Day 29

  4. Subprotocol 1: Part A - Seroresponse Rate (SRR) of nAb Against Vaccine-matched COVID-19 Variants

    Time frame: Baseline to Day 29

Secondary outcomes

  1. Subprotocol 1: Part A - Number of Participants with Unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interests (AESIs), and AEs Leading to Study Withdrawal

    Time frame: Day 1 through Day 29

  2. Subprotocol 1: Part B - Number of Participants with Unsolicited AEs

    Time frame: Day 1 through Day 29

  3. Subprotocol 1: Part B - Number of Participants with SAEs, AESIs, and AEs Leading to Study Withdrawal

    Time frame: Day 1 through Day 181

  4. Subprotocol 1: Part B - Geometric Mean Ratio (GMR) of nAb Against Vaccine-matched COVID-19 Variants Between Participants Aged ≥12 to <65 Years and Those Aged ≥65 Years

    Time frame: Day 29

  5. Subprotocol 1: Part B - Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)

    Time frame: 7 days post vaccination

07

Study locations

5 sites
  • DelRicht Research-Atlanta
    Atlanta, Georgia 30329, United States
  • DelRicht Research-Baton Rouge
    Baton Rouge, Louisiana 70769, United States
  • DelRicht Research-New Orleans
    New Orleans, Louisiana 70115, United States
  • DelRicht Research-Gulfport
    Gulfport, Mississippi 39503, United States
  • DelRicht Research-Tulsa
    Tulsa, Oklahoma 74133, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07089706
Lead sponsor
ModernaTX, Inc.
Responsible party
Sponsor
First posted
Jul 28, 2025
Start date
Jul 21, 2025
Primary completion
Jun 16, 2026
Completion
Jun 16, 2026
Last update
Jul 7, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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