Clinical trial NCT05827926: A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults
Official title: A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: SARS-CoV-2
Influenza
Keywords: mRNA-1083
mRNA-1083 Vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
Influenza Vaccine
Moderna
Influenza
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-25
Enrollment: 1763
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults.

The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \<50 years of age.

Detailed description: Part 1: Participants will be enrolled into 1 of 2 age cohorts: Cohort A for adults ≥65 to \<80 years of age or Cohort B for adults ≥18 to \<65 year of age. In Cohort A, approximately 600 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since September 2022). In Cohort B, approximately 624 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by 2 age groups: ≥18 to \<50 years and ≥50 to \<65 years of age and by influenza vaccine status in the most recent influenza season (received or not received since September 2022).

Part 2: Approximately, 520 participants between ≥18 to \<50 years of age will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since Sept 2023).

Eligibility criteria: Key Inclusion Criteria:

Part 1 (Phase 1/2)

* Adults ≥18 to \<80 years of age at the time of consent.
* Body mass index (BMI) of 18 kilograms (kg)/square meter (m\^2) to 35 kg/m\^2 (inclusive) at the Screening Visit.
* Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
* 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 Day 1.

Part 2 (Phase 2 Extension)

* Adults ≥18 to \<50 years of age at the time of consent.
* BMI of 18 kg/m\^2 to 35 kg/m\^2 (inclusive) at the Screening Visit.
* Healthy as determined by medical evaluation, including medical history, and physical examination.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception through 90 days following vaccine administration, and not currently breastfeeding.
* Have received at least 2 doses of locally authorized or approved COVID-19 vaccines and last dose was ≥90 days prior to Day 1.

Key Exclusion Criteria:

Part 1 (Phase 1/2) and Part 2 (Phase 2 Extension)

* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* 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 clinical trial or could interfere with the interpretation of study results.
* Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration.
* Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1.
* Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
* Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
* 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 clinical trial.
* Working or has worked as study personnel, is an immediate family member or household member of study personnel, study site staff, or Sponsor personnel, or resides in a nursing home.

Part 2 (Phase 2 Extension) Only

* Participants who enrolled in Part 1 of the mRNA-1083-P101 (Phase 1/2) study.

Note: Other inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to Day 7 (7 days after vaccination)
measure: Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs
timeFrame: Up to Day 28 (28 days after vaccination)
measure: Parts 1 and 2: Number of Participants With Unsolicited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study
timeFrame: Day 1 through Day 181
measure: Part 2: Change From Baseline in Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
timeFrame: Baseline (Day 1), Day 29
measure: Part 2: Change From Baseline in GMT of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA)
timeFrame: Baseline (Day 1), Day 29
measure: Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29 Compared to Baseline (Day 1), as Measured by HAI Assay
timeFrame: Baseline (Day 1), Day 29
measure: Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29 Compared to Baseline (Day 1), as Measured by PsVNA
timeFrame: Baseline (Day 1), Day 29
measure: Part 2: Influenza: Percentage of Participants with Seroconversion at Day 29, as Measured by HAI Assay
timeFrame: Baseline (Day 1) to Day 29
measure: Part 2: SARS-CoV-2: Percentage of Participants with Seroresponse at Day 29, as Measured by PsVNA
timeFrame: Baseline (Day 1) to Day 29
Secondary outcomes:
measure: Part 1: Change From Baseline in GMT of Antibodies for Influenza, as Measured by HAI Assay
timeFrame: Baseline (Day 1), Day 29, and Day 181
measure: Part 1: Change From Baseline in GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA
timeFrame: Baseline (Day 1), Day 29, and Day 181
measure: Part 1: GMFR of Antibodies for Influenza at Days 29 and 181 Compared to Baseline (Day 1), as Measured by HAI Assay
timeFrame: Baseline (Day 1), Day 29, and Day 181
measure: Part 1: GMFR of Antibodies for SARS-CoV-2 at Days 29 and 181 Compared to Baseline (Day 1), as Measured by PsVNA
timeFrame: Baseline (Day 1), Day 29, and Day 181
measure: Part 1: Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay
timeFrame: Baseline (Day 1) to Day 29, and Day 181
measure: Part 1: SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA
timeFrame: Baseline (Day 1) to Day 29, and Day 181
measure: Part 2: Change From Baseline in GMT of Antibodies for Influenza at Day 181, as Measured by HAI Assay
timeFrame: Baseline (Day 1), Day 181
measure: Part 2: Change From Baseline in GMT of Antibodies for SARS-CoV-2 at Day 181, as Measured by PsVNA
timeFrame: Baseline (Day 1), Day 181
measure: Part 2: GMFR of Antibodies for Influenza at Day 181 Compared to Baseline (Day 1), as Measured by HAI Assay
timeFrame: Baseline (Day 1), Day 181
measure: Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 181 Compared to Baseline (Day 1), as Measured by PsVNA
timeFrame: Baseline (Day 1), Day 181
measure: Part 2: Influenza: Percentage of Participants with Seroconversion at Day 181, as Measured by HAI Assay
timeFrame: Baseline (Day 1) to Day 181
measure: Part 2: SARS-CoV-2: Percentage of Participants with Seroresponse at Day 181, as Measured by PsVNA
timeFrame: Baseline (Day 1) to Day 181
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Clinical Trials
state: Arizona
city: Colton
country: United States
facility: Benchmark Research
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Modesto
country: United States
facility: Central Valley Research
state: California
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: Longmont
country: United States
facility: Tekton Research
state: Colorado
city: DeLand
country: United States
facility: Accel Research Sites
state: Florida
city: Hollywood
country: United States
facility: CenExel
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Columbus
country: United States
facility: Centricity Research
state: Georgia
city: Decatur
country: United States
facility: Accel Research Site
state: Georgia
city: Decatur
country: United States
facility: CenExel iResearch
state: Georgia
city: Lilburn
country: United States
facility: Lifeline Primary Care
state: Georgia
city: Morton
country: United States
facility: Koch Family Medicine
state: Illinois
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: River Forest
country: United States
facility: DM Clinical Research
state: Illinois
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Wichita
country: United States
facility: Tekton Research
state: Kansas
city: Versailles
country: United States
facility: Versailles Family Medicine
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical research
state: Louisiana
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Prairieville
country: United States
facility: DelRicht Research
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Internal Medicine
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research
state: Maryland
city: Brookline
country: United States
facility: DM Clinical Research
state: Massachusetts
city: Dearborn Heights
country: United States
facility: Vida Clinical Studies
state: Michigan
city: Gulfport
country: United States
facility: DelRicht Research
state: Mississippi
city: Kansas City
country: United States
facility: Clay Platte Family Medicine
state: Missouri
city: Lincoln
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research
state: Nevada
city: Las Vegas
country: United States
facility: CCT Research
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Charlotte
country: United States
facility: Tryon Medical Partners
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Columbus
country: United States
facility: Centricity Research
state: Ohio
city: Dayton
country: United States
facility: WellNow Urgent Care & Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Institute of East Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: DelRicht Research
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research Inc
state: Oklahoma
city: Philadelphia
country: United States
facility: DM Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mercado Medical Practice
state: Pennsylvania
city: Charleston
country: United States
facility: DelRicht Research
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates
state: South Carolina
city: Elizabethton
country: United States
facility: Medical Care
state: Tennessee
city: Hendersonville
country: United States
facility: DelRicht Research
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Beaumont
country: United States
facility: Tekton Research
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Houston
country: United States
facility: Cyfair Clinical Research
state: Texas
city: Houston
country: United States
facility: Texas Center for Drug Development
state: Texas
city: McKinney
country: United States
facility: DelRicht Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: Tekton Research
state: Texas
city: Pleasant View
country: United States
facility: CCT Research
state: Utah
city: Roy
country: United States
facility: Ogden Clinic
state: Utah
city: Salt Lake City
country: United States
facility: JBR Clinical Research
state: Utah
city: Hampton
country: United States
facility: Meridian Clinical Research
state: Virginia
city: Portsmouth
country: United States
facility: Velocity Clinical Research
state: Virginia
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics Campus
state: Washington
Study officials:
References: