Official Title
A Phase 3b/4, Open-label Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Variant-containing Vaccine Formulations
Brief Summary

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

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 (eg, 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.

Active, not recruiting
COVID-19

Biological: mRNA-1283 Variant-containing Formulation

Sterile liquid for injection
Other Name: mNEXSPIKE®

Eligibility Criteria

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:

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.

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: N/A
Countries
United States
Locations

DelRicht Research-Atlanta
Atlanta, Georgia, United States

DelRicht Research-Baton Rouge
Baton Rouge, Louisiana, United States

DelRicht Research-New Orleans
New Orleans, Louisiana, United States

DelRicht Research-Gulfport
Gulfport, Mississippi, United States

DelRicht Research-Tulsa
Tulsa, Oklahoma, United States

Not Provided

ModernaTX, Inc.
NCT Number
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
MeSH Terms
COVID-19