A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old

NCT05375838 | Completed Phase 1 Results FDA Drug

• 1 other identifier: mRNA-1073-P101
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 14

Brief Summary

The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.

Conditions

SARS-CoV-2; Influenza

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Solicited Local and Systemic Adverse Reaction (ARs)

  Solicited ARs (local and systemic) were collected in the electronic diary (eDiary). Local ARs included: pain at injection site, erythema (redness) at injection site, swelling/induration (hardness) at injection site, and localized axillary swelling or tenderness ipsilateral to the injection arm. Systemic ARs included: headache, fatigue, myalgia (muscle aches all over the body), arthralgia (aching in several joints), nausea/vomiting, rash, body temperature (potentially fever), and chills. Note, that not all solicited ARs were considered adverse events (AEs). The Investigator reviewed whether the solicited AR was also to be recorded as an AE. A Summary of all serious AEs (SAEs) and all nonserious AEs ("Other"), regardless of causality, is in Reported "Adverse Events" section.

  Up to Day 8 (7 days post vaccination)

• Number of Participants With Unsolicited Adverse Events (AEs)

  An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A treatment-emergent AE (TEAE) was defined as any event not present before exposure to vaccine or any event already present that worsens in intensity or frequency after exposure. Any abnormal laboratory test result (hematology, clinical chemistry, or prothrombin time \[PT\]/partial thromboplastin time \[PTT\]) or other safety assessment (for example, electrocardiogram, radiological scan, vital sign measurement), including one that worsens from baseline and is considered clinically significant in the medical and scientific judgment of the Investigator. A summary of SAEs and all nonserious AEs ("Other") reported up to the end of the study, regardless of causality, is located in the Reported "Adverse Events" section.

  Up to Day 29 (28 days post vaccination)

• Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically-Attended AEs (MAAEs) and AEs Leading to Discontinuation

  An SAE was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. AESIs included thrombocytopenia, new onset of or worsening of the protocol specified neurologic diseases, anaphylaxis, and myocarditis/pericarditis. An MAAE is an AE that leads to an unscheduled visit to a healthcare practitioner. This would include visits to a study site for unscheduled assessments (for example, abnormal laboratory follow-up, and/or COVID-19 and visits to healthcare practitioners external to the study site (for example, urgent care, primary care physician). A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.

  Up to Day 181

Secondary Outcomes (6)

• Geometric Mean Titer of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains

  Day 29

• Geometric Mean Titer of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)

  Day 29

• Geometric Mean Fold Rise of Anti-Hemagglutinin Antibodies at Day 29, as Measured by Hemagglutination Inhibition Assay (HAI) For Vaccine-Matched Seasonal Influenza A and B Strains

  Day 29

• Geometric Mean Fold Rise of VAC62 Neutralizing Antibody at Day 29, as Measured by Pseudovirus Neutralization Assay (or Binding Antibody Assay) For SARS-CoV-2

  Day 29

• Percentage of Participants With Seroconversion as Measured by HAI Assay For Vaccine-Matched Seasonal Influenza A and B Strains

  Day 29

Study Arms (6)

mRNA-1273 Plus Placebo

EXPERIMENTAL

Participants will receive 2 intramuscular (IM) injections, one in each arm, of mRNA-1273 plus placebo at the specified dose level on Day 1.

Biological: mRNA-1273; Biological: Placebo

mRNA-1010 Plus Placebo

EXPERIMENTAL

Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus placebo at the specified dose level on Day 1.

Biological: mRNA-1010; Biological: Placebo

mRNA-1010 Plus mRNA-1273

EXPERIMENTAL

Participants will receive 2 IM injections, one in each arm, of mRNA-1010 plus mRNA-1273 at the specified dose level on Day 1.

Biological: mRNA-1010

Dose A: mRNA-1073 Plus Placebo

EXPERIMENTAL

Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.

Biological: mRNA-1073; Biological: Placebo

Dose B: mRNA-1073 Plus Placebo

EXPERIMENTAL

Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.

Biological: mRNA-1073; Biological: Placebo

Dose C: mRNA-1073 Plus Placebo

EXPERIMENTAL

Participants will receive 2 IM injections, one in each arm, of mRNA-1073 plus placebo at the specified dose level on Day 1.

Biological: mRNA-1073; Biological: Placebo

Interventions

mRNA-1073 BIOLOGICAL

Sterile liquid for injection

Dose A: mRNA-1073 Plus Placebo; Dose B: mRNA-1073 Plus Placebo; Dose C: mRNA-1073 Plus Placebo

mRNA-1010 BIOLOGICAL

Sterile liquid for injection

mRNA-1010 Plus Placebo; mRNA-1010 Plus mRNA-1273

mRNA-1273 BIOLOGICAL

Sterile liquid for injection

mRNA-1273 Plus Placebo

Placebo BIOLOGICAL

0.9% sodium chloride (normal saline) injection

Dose A: mRNA-1073 Plus Placebo; Dose B: mRNA-1073 Plus Placebo; Dose C: mRNA-1073 Plus Placebo; mRNA-1010 Plus Placebo; mRNA-1273 Plus Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI) of 18 kilograms per meter squared (kg/m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit.
• Participants must have been fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥ 120 days prior to the randomization visit (or less per local guidance).

You may not qualify if:

• Participant is acutely ill or febrile (temperature ≥ 38.0℃ \[100.4°F\]) 72 hours prior to or at the Screening Visit or Day 1. Participants meeting this criterion may be rescheduled within the 28-day Screening window and will retain their initially assigned participant number.
• Participant has a reported history of congenital or acquired immunodeficiency, immunosuppressive condition, or immune-mediated disease.
• Participant has dermatologic conditions that could affect local solicited adverse reaction (AR) assessments (for example, tattoos, psoriasis patches affecting skin over the deltoid areas).
• Participant has a reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines.
• Participant has a reported history of bleeding disorder that is considered a contraindication to IM injection or phlebotomy.
• Participant has a diagnosis of malignancy within previous 10 years (excluding nonmelanoma skin cancer).
• Participant has any medical, psychiatric, or occupational condition, including reported history of drug or alcohol 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 or plans to receive any vaccine authorized or approved by a local health agency ≤ 28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days before or after the study injections.
• Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤ 180 days prior to the randomization visit.
• Participant has tested positive for influenza by local health authority approved testing methods ≤ 180 days prior to the Screening Visit.
• Participant has had close contact to someone with SARS-CoV-2 infection or COVID-19 as defined by the US CDC in the past 10 days prior to the Screening Visit.
• Participant has known history of SARS-CoV-2 infection within ≤ 90 days.
• Participant has received systemic immunoglobulins or blood products ≤ 90 days prior to the Screening Visit or plans to receive systemic immunoglobulins or blood products during the study.
• Participant has a history of myocarditis, pericarditis, or myopericarditis.
• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (14)

Research Centers of America

Hollywood, Florida, 33024, United States

Location

AES - DRS - Optimal Research Illinois - Peoria

Peoria, Illinois, 61614, United States

Location

Meridian

Sioux City, Iowa, 51106, United States

Location

Benchmark Research

Metairie, Louisiana, 70006, United States

Location

Meridian

Norfolk, Nebraska, 68701, United States

Location

Meridian

Binghamton, New York, 13901, United States

Location

Rochester Clinical Research Inc

Rochester, New York, 14609, United States

Location

Meridian

Cincinnati, Ohio, 45219, United States

Location

Meridian

Cincinnati, Ohio, 45246, United States

Location

Benchmark Research

Austin, Texas, 78705, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

DM Clinical Research - CyFair

Houston, Texas, 77065, United States

Location

DM Clinical Research - TCDD

Houston, Texas, 77081, United States

Location

J Lewis Research

Salt Lake City, Utah, 84121, United States

Location

Related Publications (2)

• Rudman Spergel AK, Henry C, Nachbagauer R, Kaplonek P, Astley E, Avanesov A, Bertera H, Carmona L, Cizmeci D, Collins A, Embry A, Guo R, Mao X, Pucci A, Shao S, Shih-Lu-Lee J, Yu WH, Brune D, Chu L, Irfan M, Alter G, Ananworanich J, Shaw CA. Phase 1/2 randomized, observer-blind clinical trial of a first-generation, mRNA-based vaccine against seasonal influenza and COVID-19 in healthy adults. Hum Vaccin Immunother. 2026 Dec;22(1):2589644. doi: 10.1080/21645515.2025.2589644. Epub 2026 Feb 2.

  PMID: 41627968 DERIVED

• Sanchez-Martinez ZV, Alpuche-Lazcano SP, Stuible M, Akache B, Renner TM, Deschatelets L, Dudani R, Harrison BA, McCluskie MJ, Hrapovic S, Blouin J, Wang X, Schuller M, Cui K, Cho JY, Durocher Y. SARS-CoV-2 spike-based virus-like particles incorporate influenza H1/N1 antigens and induce dual immunity in mice. Vaccine. 2024 Dec 2;42(26):126463. doi: 10.1016/j.vaccine.2024.126463. Epub 2024 Oct 30.

  PMID: 39481241 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

mRNA-1073 COVID-19 and influenza combined vaccine; mRNA-1010 influenza vaccine; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus 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 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 17, 2022
• Study Start: May 13, 2022
• Primary Completion: December 29, 2022
• Study Completion: December 29, 2022
• Last Updated: February 28, 2024
• Results First Posted: February 28, 2024

Record last verified: 2024-01

Locations

US (14)