A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults

Influenza Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05827926
• Other study ID #: mRNA-1083-P101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: April 14, 2023
• Est. completion date: December 2, 2024

Study information

• Verified date: May 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1763
• Est. completion date: December 2, 2024
• Est. primary completion date: December 2, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• SARS-CoV-2

Intervention

Biological:
• Influenza Vaccine 1
quadrivalent seasonal influenza vaccine
• mRNA-1083.1
Sterile liquid for injection
• mRNA-1083.2
Sterile liquid for injection
• mRNA-1083.3
Sterile liquid for injection
• Investigational Influenza Vaccine 1
Sterile liquid for injection
• Investigational COVID-19 Vaccine 1
Sterile liquid for injection
• COVID-19 Vaccine 1
Sterile liquid for injection
• Investigational Influenza Vaccine 2
Sterile liquid for injection
• Influenza Vaccine 2
quadrivalent seasonal influenza vaccine
• mRNA-1083
Sterile liquid for injection
• Investigational COVID-19 Vaccine 2
Sterile liquid for injection
• COVID-19 Vaccine 2
Sterile liquid for injection

Locations

Country	Name	City	State
United States	Annapolis Internal Medicine	Annapolis	Maryland
United States	Benchmark Research	Austin	Texas
United States	Tekton Research	Austin	Texas
United States	Velocity Clinical research	Baton Rouge	Louisiana
United States	Tekton Research	Beaumont	Texas
United States	DM Clinical Research	Brookline	Massachusetts
United States	Chandler Clinical Trials	Chandler	Arizona
United States	DelRicht Research	Charleston	South Carolina
United States	Tryon Medical Partners	Charlotte	North Carolina
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Velocity Clinical Research	Cincinnati	Ohio
United States	Velocity Clinical Research	Cincinnati	Ohio
United States	Benchmark Research	Colton	California
United States	Centricity Research	Columbus	Georgia
United States	Centricity Research	Columbus	Ohio
United States	WellNow Urgent Care & Research	Dayton	Ohio
United States	Vida Clinical Studies	Dearborn Heights	Michigan
United States	Accel Research Site	Decatur	Georgia
United States	CenExel iResearch	Decatur	Georgia
United States	Accel Research Sites	DeLand	Florida
United States	Medical Care	Elizabethton	Tennessee
United States	Benchmark Research	Fort Worth	Texas
United States	DelRicht Research	Gulfport	Mississippi
United States	Meridian Clinical Research	Hampton	Virginia
United States	DelRicht Research	Hendersonville	Tennessee
United States	CenExel	Hollywood	Florida
United States	Cyfair Clinical Research	Houston	Texas
United States	Texas Center for Drug Development	Houston	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	Clay Platte Family Medicine	Kansas City	Missouri
United States	CCT Research	Las Vegas	Nevada
United States	Excel Clinical Research	Las Vegas	Nevada
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Lifeline Primary Care	Lilburn	Georgia
United States	Velocity Clinical Research	Lincoln	Nebraska
United States	Tekton Research	Longmont	Colorado
United States	Accel Research Sites	Maitland	Florida
United States	DelRicht Research	McKinney	Texas
United States	Benchmark Research	Metairie	Louisiana
United States	Suncoast Research Group	Miami	Florida
United States	Central Valley Research	Modesto	California
United States	Koch Family Medicine	Morton	Illinois
United States	Trial Management Associates	Myrtle Beach	South Carolina
United States	DelRicht Research	New Orleans	Louisiana
United States	Velocity Clinical Research	Norfolk	Nebraska
United States	Las Vegas Clinical Trials	North Las Vegas	Nevada
United States	Lynn Institute of East Oklahoma	Oklahoma City	Oklahoma
United States	Optimal Research	Peoria	Illinois
United States	DM Clinical Research	Philadelphia	Pennsylvania
United States	Mercado Medical Practice	Philadelphia	Pennsylvania
United States	CCT Research	Pleasant View	Utah
United States	Velocity Clinical Research	Portsmouth	Virginia
United States	DelRicht Research	Prairieville	Louisiana
United States	DM Clinical Research	River Forest	Illinois
United States	Rochester Clinical Research	Rochester	New York
United States	Velocity Clinical Research	Rockville	Maryland
United States	Ogden Clinic	Roy	Utah
United States	Benchmark Research	Sacramento	California
United States	JBR Clinical Research	Salt Lake City	Utah
United States	Benchmark Research	San Angelo	Texas
United States	Tekton Research	San Antonio	Texas
United States	DelRicht Research	Tulsa	Oklahoma
United States	Versailles Family Medicine	Versailles	Kentucky
United States	Wenatchee Valley Hospital & Clinics Campus	Wenatchee	Washington
United States	Tekton Research	Wichita	Kansas
United States	Trial Management Associates	Wilmington	North Carolina
United States	Tekton Research Inc	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parts 1 and 2: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)		Up to Day 7 (7 days after vaccination)
Primary	Parts 1 and 2: Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs		Up to Day 28 (28 days after vaccination)
Primary	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		Day 1 through Day 181
Primary	Part 2: Change From Baseline in Geometric Mean Titer (GMT) of Antibodies for Influenza at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay		Baseline (Day 1), Day 29
Primary	Part 2: Change From Baseline in GMT of Antibodies for SARS-CoV-2 at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA)		Baseline (Day 1), Day 29
Primary	Part 2: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza at Day 29 Compared to Baseline (Day 1), as Measured by HAI Assay		Baseline (Day 1), Day 29
Primary	Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 29 Compared to Baseline (Day 1), as Measured by PsVNA		Baseline (Day 1), Day 29
Primary	Part 2: Influenza: Percentage of Participants with Seroconversion at Day 29, as Measured by HAI Assay	Seroconversion is defined as a Day 29 titer =1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is =1:10 in anti-HA antibodies measured by HAI assay.	Baseline (Day 1) to Day 29
Primary	Part 2: SARS-CoV-2: Percentage of Participants with Seroresponse at Day 29, as Measured by PsVNA	Seroresponse is defined as a Day 29 titer =4-fold if baseline is =lower limit of quantification (LLOQ) or =4*LLOQ if baseline titer is	Baseline (Day 1) to Day 29
Secondary	Part 1: Change From Baseline in GMT of Antibodies for Influenza, as Measured by HAI Assay		Baseline (Day 1), Day 29, and Day 181
Secondary	Part 1: Change From Baseline in GMT of Antibodies for SARS-CoV-2, as Measured by PsVNA		Baseline (Day 1), Day 29, and Day 181
Secondary	Part 1: GMFR of Antibodies for Influenza at Days 29 and 181 Compared to Baseline (Day 1), as Measured by HAI Assay		Baseline (Day 1), Day 29, and Day 181
Secondary	Part 1: GMFR of Antibodies for SARS-CoV-2 at Days 29 and 181 Compared to Baseline (Day 1), as Measured by PsVNA		Baseline (Day 1), Day 29, and Day 181
Secondary	Part 1: Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay	Seroconversion is defined as a Day 29 and Day 181 titer =1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is =1:10 in anti-HA antibodies measured by HAI assay.	Baseline (Day 1) to Day 29, and Day 181
Secondary	Part 1: SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA	Seroresponse is defined as a Day 29 and Day 181 titer =4-fold if baseline is =LLOQ or =4*LLOQ if baseline titer is	Baseline (Day 1) to Day 29, and Day 181
Secondary	Part 2: Change From Baseline in GMT of Antibodies for Influenza at Day 181, as Measured by HAI Assay		Baseline (Day 1), Day 181
Secondary	Part 2: Change From Baseline in GMT of Antibodies for SARS-CoV-2 at Day 181, as Measured by PsVNA		Baseline (Day 1), Day 181
Secondary	Part 2: GMFR of Antibodies for Influenza at Day 181 Compared to Baseline (Day 1), as Measured by HAI Assay		Baseline (Day 1), Day 181
Secondary	Part 2: GMFR of Antibodies for SARS-CoV-2 at Day 181 Compared to Baseline (Day 1), as Measured by PsVNA		Baseline (Day 1), Day 181
Secondary	Part 2: Influenza: Percentage of Participants with Seroconversion at Day 181, as Measured by HAI Assay	Seroconversion is defined as a Day 181 titer =1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is =1:10 in anti-HA antibodies measured by HAI assay.	Baseline (Day 1) to Day 181
Secondary	Part 2: SARS-CoV-2: Percentage of Participants with Seroresponse at Day 181, as Measured by PsVNA	Seroresponse is defined as a Day 181 titer =4-fold if baseline is =LLOQ or =4*LLOQ if baseline titer is	Baseline (Day 1) to Day 181