A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters

NCT05137236 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: mRNA-1283-P201
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 17

Brief Summary

The main goal of Part A of this study is to assess the safety, reactogenicity, and immunogenicity of the study vaccine candidates. The main goal of Part B of this study is to assess the safety, reactogenicity, and immunogenicity of the mRNA-1283.529 booster vaccine candidate.

Conditions

SARS-CoV-2

Keywords

mRNA-1273; mRNA-1273 vaccine; SARS-CoV-2; SARS-CoV-2 Vaccine; Coronavirus; Virus Diseases; Messenger RNA; COVID-19; COVID-19 Vaccine; Moderna

Outcome Measures

Primary Outcomes (9)

• Parts A and B: Number of Participants With Solicited Local and Solicited Systemic Reactogenicity Adverse Reactions (ARs)

  An AR is any adverse event (AE) related to the IP injection. Solicited local ARs included pain at injection site, erythema (redness) at injection site, swelling (hardness) at injection site, localized axillary swelling or tenderness ipsilateral to the injection arm, and groin or underarm swelling or tenderness ipsilateral to the side of injection. Solicited systemic ARs included headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, fever, chills, irritability/crying, sleepiness, and loss of appetite. Note, not all solicited ARs were considered AEs. The Investigator determined if solicited AR was also to be recorded as an AE. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Up to Day 7

• Parts A and B: Number of Participants With Unsolicited AEs

  An unsolicited AE was defined as any AE reported by the participant that was not specified as a solicited AR in the protocol or was specified as a solicited AR but started outside the protocol-defined period for reporting solicited ARs. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Up to Day 28

• Parts A and B: Number of Participants With Serious Adverse Events (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study Participation and AEs of Special Interest (AESIs)

  SAEs were AEs that resulted in death, were life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly or birth defect, or was a medically important event. MAAEs were AEs that lead to an unscheduled visit to a healthcare provider. AESIs were AEs (serious or nonserious) of scientific and medical concern specific to the Sponsor's product or program for which ongoing monitoring and immediate notification by the investigator to the Sponsor was required. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Day 1 to Day 366

• Part A: Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Neutralizing Antibody (nAb) Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

  The GMT (50% inhibitory dose \[ID50\]) of nAb against ancestral SARS-CoV-2 and against SARS-CoV-2 variant B.1.351 are reported.

  Day 29

• Part A: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

  The GMFR measures the changes in immunogenicity titers or levels within participants.

  Day 29

• Part A: Number of Participants With Seroresponse Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

  Seroresponse was defined as an increase of SARS-CoV-2 specific binding antibody (bAb) level or nAb titer to at least 4x lower limit of quantification (LLOQ) if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.

  Day 29

• Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

  The GMT (ID50) of nAb against SARS-CoV-2 omicron variant (B.1.1.529) are reported.

  Day 29

• Part B: GMFR of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

  The GMFR measures the changes in immunogenicity titers or levels within participants.

  Day 29

• Part B: Number of Participants With Seroresponse Against SARS-CoV-2 Omicron Variant (B.1.1.529)

  Seroresponse was defined as an increase of SARS-CoV-2 specific bAb level or nAb titer to at least 4x LLOQ if the baseline is below the LLOQ, or a 4-fold or greater rise if pre-booster ≥ LLOQ.

  Day 29

Secondary Outcomes (10)

• Part A: GMT of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

  Days 1, 29, 91, 181, and 366

• Part A: GMT of SARS-CoV-2 Specific bAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

  Days 1, 29, 91, 181, and 366

• Part B: GMT of SARS-CoV-2 Specific nAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

  Days 1, 29, 91, 181, and 366

• Part B: GMT of SARS-CoV-2 Specific bAb Against SARS-CoV-2 Omicron Variant (B.1.1.529)

  Days 1, 29, 91, 181, and 366

• Part A: GMFR of SARS-CoV-2 Specific nAb Against Ancestral SARS-CoV-2 and Against SARS-CoV-2 Variant B.1.351

  Days 29, 91, 181, and 366

Other Outcomes (1)

• Number of Deaths Related to Study Drug

  Day 1 to Day 366

Study Arms (8)

Part A: mRNA-1283 Dose Level 1

EXPERIMENTAL

Participants will receive single intramuscular (IM) injection of mRNA-1283 at Dose Level 1 on Day 1.

Biological: mRNA-1283

Part A: mRNA-1283 Dose Level 2

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1283 at Dose Level 2 on Day 1.

Biological: mRNA-1283

Part A: mRNA-1283 Dose Level 3

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1283 at Dose Level 3 on Day 1.

Biological: mRNA-1283

Part A: mRNA-1283.211 Dose Level 1

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1283.211 at Dose Level 1 on Day 1.

Biological: mRNA-1283.211

Part A: mRNA-1283.211 Dose Level 2

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1283.211 at Dose Level 2 on Day 1.

Biological: mRNA-1283.211

Part A: mRNA-1273

ACTIVE COMPARATOR

Participants will receive single IM injection of mRNA-1273 on Day 1.

Biological: mRNA-1273

Part B: mRNA-1283.529 Dose Level 1

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1283.529 as a second booster at Dose Level 1 on Day 1.

Biological: mRNA-1283.529

Part B: mRNA-1283.529 Dose Level 2

EXPERIMENTAL

Participants will receive single IM injection of mRNA-1283.529 as a second booster at Dose Level 2 on Day 1.

Biological: mRNA-1283.529

Interventions

mRNA-1283 BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1283 Dose Level 1; Part A: mRNA-1283 Dose Level 2; Part A: mRNA-1283 Dose Level 3

mRNA-1283.211 BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1283.211 Dose Level 1; Part A: mRNA-1283.211 Dose Level 2

mRNA-1273 BIOLOGICAL

Sterile liquid for injection

Part A: mRNA-1273

mRNA-1283.529 BIOLOGICAL

Sterile liquid for injection

Part B: mRNA-1283.529 Dose Level 1; Part B: mRNA-1283.529 Dose Level 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as bilateral tubal ligation \>1 year prior to screening, bilateral oophorectomy, hysterectomy, or menopause.
• Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test on the day of vaccination (Day 1), practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreed to continue adequate contraception through 3 months following the last vaccine administration, and not currently breastfeeding.
• Participant must have received their second dose of the mRNA-1273 primary series at least 6 months prior to screening and enrollment (Part A) or have received the mRNA-1273 series and an mRNA-1273 booster dose at least 3 months prior to screening and enrollment (Part B).

You may not qualify if:

• Had significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, defined by the US Centers for Disease Control and Prevention (CDC) as a close contact of someone who has COVID-19.
• Is acutely ill or febrile (temperature ≥38.0 degree Celsius \[°C\]/100.4 degree Fahrenheit \[°F\]) less than 72 hours prior to or at the screening visit or Day 1.
• Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
• Has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to screening (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.
• Has received or plans to receive any licensed vaccine ≤28 days prior to the injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after the study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine.
• Has received systemic immunoglobulins or blood products within 3 months prior to the screening visit, or plans to receive these during the study.
• 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.
• Plans to participate in an interventional clinical trial of an investigational vaccine or drug while participating in this study.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (17)

MedPharmics, LLC

Phoenix, Arizona, 85015-1105, United States

Location

Research Centers of America

Hollywood, Florida, 33024-2709, United States

Location

Precision Clinical Research

Sunrise, Florida, 33351-7311, United States

Location

Tekton Research

Chamblee, Georgia, 30341, United States

Location

MedPharmics

Metairie, Louisiana, 70006, United States

Location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655-0002, United States

Location

Clinical Research Institute, Inc - CRN

Minneapolis, Minnesota, 55402-2700, United States

Location

Meridian Clinical Research (Nebraska)

Lincoln, Nebraska, 68510, United States

Location

MedPharmics, LLC. - Albuquerque

Albuquerque, New Mexico, 87102-3876, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

CTI Clinical Research Center

Cincinnati, Ohio, 45212, United States

Location

Meridian Clinical Research (Cincinnati)

Cincinnati, Ohio, 45246-2316, United States

Location

Aventiv Research Inc

Columbus, Ohio, 43213-6517, United States

Location

Coastal Carolina Research Center

North Charleston, South Carolina, 29405-4986, United States

Location

ACRC Trials

Frisco, Texas, 75033-4135, United States

Location

Ventavia Research Group

Houston, Texas, 77008, United States

Location

Health Research of Hampton Roads Inc.

Newport News, Virginia, 23606-4537, United States

Location

Related Publications (3)

• Chalkias S, Pragalos A, Akinsola A, Berman G, Ampajwala M, Meyer J, Schoch L, Zhou W, Paila YD, Deng W, Feng J, de Windt E, Edwards D, Miller J, Das R. Safety and Immunogenicity of SARS-CoV-2 Spike Receptor-Binding Domain and N-Terminal Domain mRNA Vaccine. J Infect Dis. 2025 Apr 15;231(4):e754-e763. doi: 10.1093/infdis/jiaf022.

  PMID: 39792478 DERIVED

• Stewart-Jones GBE, Elbashir SM, Wu K, Lee D, Renzi I, Ying B, Koch M, Sein CE, Choi A, Whitener B, Garcia-Dominguez D, Henry C, Woods A, Ma L, Montes Berrueta D, Avena LE, Quinones J, Falcone S, Hsiao CJ, Scheaffer SM, Thackray LB, White P, Diamond MS, Edwards DK, Carfi A. Domain-based mRNA vaccines encoding spike protein N-terminal and receptor binding domains confer protection against SARS-CoV-2. Sci Transl Med. 2023 Sep 13;15(713):eadf4100. doi: 10.1126/scitranslmed.adf4100. Epub 2023 Sep 13.

  PMID: 37703353 DERIVED

• Stewart-Jones GBE, Elbashir SM, Wu K, Lee D, Renzi I, Ying B, Koch M, Sein CE, Choi A, Whitener B, Garcia-Dominguez D, Henry C, Woods A, Ma L, Montes Berrueta D, Avena LE, Quinones J, Falcone S, Hsiao CJ, Scheaffer SM, Thackray LB, White P, Diamond MS, Edwards DK, Carfi A. Development of SARS-CoV-2 mRNA vaccines encoding spike N-terminal and receptor binding domains. bioRxiv [Preprint]. 2022 Oct 7:2022.10.07.511319. doi: 10.1101/2022.10.07.511319.

  PMID: 36238717 DERIVED

MeSH Terms

Conditions

Coronavirus Infections; Virus Diseases; COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Results Point of Contact

• Title: Moderna Clinical Trials Support Center
• Organization: ModernaTX, Inc.

clinicaltrials@modernatx.com

1-877-777-7187

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A of this study is designed as an observer-blind study. Part B of the study is designed as an open-label study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: November 30, 2021
• Study Start: December 6, 2021
• Primary Completion: March 23, 2023
• Study Completion: March 23, 2023
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-06

Locations

US (17)