SARS-CoV-2Phase 4NCT07863635
A Study to Investigate the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Formulations
A Phase 4 study testing mRNA-1273 and mRNA-1283 in people with SARS-CoV-2, run by ModernaTX, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- mRNA-1273 and mRNA-1283
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Oct 2026to 11 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥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.
- Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.
Who cannot join
- History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.
- Acutely ill or febrile within 72 hours prior to or at Day 1.
- History of a diagnosis or conditions that in the Investigator's opinion could affect participant's safety, assessment of endpoints, assessment of immune response, or adherence to study procedures.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
- History of coagulopathy or bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
- Receipt of any of the following:
Show all 11Show fewer
- COVID-19 vaccine within 3 months prior to enrollment,
- 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,
- Systemic immunosuppressive treatment within 180 days prior to the Screening or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study,
- Systemic immunoglobulins, long-acting biological therapies that affect immune responses, or blood products within 90 days prior to the Day 1 Visit or plans for receipt during the study.
- Note: Additional protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Delricht Research @ Charlotte
Charlotte, North Carolina, 28210
- Recruiting
Delricht Research @ Magnolia Family Medicine
Hendersonville, Tennessee, 37075
- Recruiting
Delricht Research @ Louisville
Louisville, Kentucky, 40205
- Recruiting
Delricht Research @ Overland
Overland Park, Kansas, 66209
- Recruiting
Delricht Research @ Zomnir Family Medicine
Prosper, Texas, 75078
About this study
Official title: A Phase 3b/4, Open-label Study to Assess the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment
- Conditions
- SARS-CoV-2
- Being tested
- mRNA-1273, mRNA-1283
- Keywords
- mRNA-1273, mRNA-1283, SARS-CoV-2, mRNA vaccine, Coronavirus, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna, SPIKEVAX®, mNEXSPIKE®
- Medical subject headings
- Coronavirus Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1273Biological
Also called SPIKEVAX®
Sterile liquid for injection
mRNA-1283Biological
Also called mNEXSPIKE®
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1273 (Variant Formulation) | Experimental | Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1. Receives: Biological: mRNA-1273 |
| mRNA-1283 (Variant Formulation) | Experimental | Participants will receive a single IM injection of mRNA-1283 on Day 1. Receives: Biological: mRNA-1283 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation
Measured: Day 29
Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation
Measured: Day 29
Secondary outcomes (3)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Day 1 through Day 29
Number of Participants with Serious AEs (SAEs), AEs Leading to Study Withdrawal, and AEs of Special Interest (AESIs)
Measured: Day 1 through Day 29/End of Study (EOS)
Seroresponse Rate (SRR) of Neutralizing Antibody (nAb)
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start9 Oct 2026
- Primary completion11 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863635
- Sponsor's protocol ID
- mRNA-1273_1283-P402
- Status last verified
- Nov 2026
- First submitted
- 2 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b/4, Open-label Study to Assess the Immunogenicity and Safety of mRNA COVID-19 Variant-containing Vaccine Formulations
- ClinicalTrials.gov ID
- NCT07863635
- Acronym / sponsor ID
- mRNA-1273_1283-P402
- Conditions
- SARS-CoV-2
- Keywords
- mRNA-1273, mRNA-1283, SARS-CoV-2, mRNA vaccine, Coronavirus, Messenger RNA, COVID-19, COVID-19 Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2026 (actual)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1283 and mRNA-1273 (variant formulations) within the current epidemiological environment
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mRNA-1273 (Variant Formulation) | Experimental | Biological: mRNA-1273Participants will receive a single intramuscular (IM) injection of mRNA-1273 on Day 1. |
| mRNA-1283 (Variant Formulation) | Experimental | Biological: mRNA-1283Participants will receive a single IM injection of mRNA-1283 on Day 1. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ≥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.
- Female participants of childbearing potential may be enrolled in the study if not pregnant or breastfeeding, subject to other criteria specified in the study protocol.
Key exclusion criteria (11 listed)
- History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 3 months prior to enrollment.
- Acutely ill or febrile within 72 hours prior to or at Day 1.
- History of a diagnosis or conditions that in the Investigator's opinion could affect participant's safety, assessment of endpoints, assessment of immune response, or adherence to study procedures.
- Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
- History of coagulopathy or bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1273Also: SPIKEVAX®Sterile liquid for injection | Biological | mRNA-1273 (Variant Formulation) |
| mRNA-1283Also: mNEXSPIKE®Sterile liquid for injection | Biological | mRNA-1283 (Variant Formulation) |
Primary outcome
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation
Time frame: Day 29
Geometric Mean Fold Rise (GMFR) of Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation
Time frame: Day 29
3 secondary outcomes
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Day 1 through Day 29
Number of Participants with Serious AEs (SAEs), AEs Leading to Study Withdrawal, and AEs of Special Interest (AESIs)
Time frame: Day 1 through Day 29/End of Study (EOS)
Seroresponse Rate (SRR) of Neutralizing Antibody (nAb)
Time frame: Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
Related trials for SARS-CoV-2
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing mRNA-1273 and mRNA-1283 in people with SARS-CoV-2, run by ModernaTX, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moderna WeCareTeam (+1-866-663-3762, WeCareClinicalTrials@modernatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Titer (GMT) of Neutralizing Antibody (nAb) Against Vaccine-matched Variant Formulation (time frame: Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.