A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults

January 30, 2024 updated by: ModernaTX, Inc.

Phase 1/2, Randomized, Observer-Blind, Parallel, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults ≥18 Years of Age

The purpose of this Phase 1/2 study is to generate sufficient safety and immunogenicity data of mRNA-1018 pandemic influenza candidate vaccines in healthy adults ≥18 years of age to enable the initiation of a large Phase 3 trial with one selected vaccine candidate. The study will be conducted in 2 Parts (Part A and Part B) that will enroll and run concurrently. Part A of the study will evaluate 4 vaccine candidates (H5N8, H7N9, H5 only, and H7 only). Part B of the study will evaluate a single vaccine candidate (H5 only-CG).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1504

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • South Jordan, Utah, United States, 84095
        • J. Lewis Research, Inc/Jordan River Family Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Key Inclusion Criteria:

  • Healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and results of electrocardiogram testing.
  • Body mass index of 18 kilograms (kg)/square meter (m^2) to 39 kg/m^2 (inclusive) at the Screening visit.
  • For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.

Key Exclusion Criteria:

  • Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
  • History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
  • Any medical, psychiatric, or occupational condition, including reported history of substance 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 systemic immunosuppressants or immune-modifying drugs for >14 days in total within 180 days prior to Screening Visit (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.
  • Participant has received any vaccine authorized or approved by local health agency including mRNA vaccine ≤28 days prior to study intervention (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after the study intervention.
  • Participant has participated in an interventional clinical study within 28 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.

Other inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1
Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22.
Biological: mRNA-1018 for H5N8
Sterile liquid for injection
Experimental: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2
Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H5N8
Sterile liquid for injection
Experimental: Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3
Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H5N8
Sterile liquid for injection
Experimental: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1
Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H5 Only
Sterile liquid for injection
Experimental: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2
Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H5 Only
Sterile liquid for injection
Experimental: Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3
Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H5 Only
Sterile liquid for injection
Experimental: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1
Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H7N9
Sterile liquid for injection
Experimental: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2
Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H7N9
Sterile liquid for injection
Experimental: Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3
Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H7N9
Sterile liquid for injection
Experimental: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1
Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H7 Only
Sterile liquid for injection
Experimental: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2
Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H7 Only
Sterile liquid for injection
Experimental: Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3
Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H7 Only
Sterile liquid for injection
Experimental: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1
Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H5 Only-CG
Sterile liquid for injection
Experimental: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2
Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H5 Only-CG
Sterile liquid for injection
Experimental: Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3
Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22.
Biological: mRNA-1018 for H5 Only-CG
Sterile liquid for injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame: Up to Day 29 (7 days after each injection)
Up to Day 29 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame: Up to Day 43 (21 days after each injection)
Up to Day 43 (21 days after each injection)
Number of Participants with AEs Leading to Discontinuation From Study
Time Frame: Day 1 to Day 205 (end of study [EoS])
Day 1 to Day 205 (end of study [EoS])
Number of Participants with Medically-Attended AEs (MAAEs)
Time Frame: Day 1 to Day 205 (EoS)
Day 1 to Day 205 (EoS)
Number of Participants with Serious Adverse Events (SAEs)
Time Frame: Day 1 to Day 205 (EoS)
Day 1 to Day 205 (EoS)
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame: Day 1 to Day 205 (EoS)
Day 1 to Day 205 (EoS)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay
Time Frame: Days 22, 29, and 43
Days 22, 29, and 43
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay
Time Frame: Baseline (Day 1), Days 22, 29, and 43
Baseline (Day 1), Days 22, 29, and 43
Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay
Time Frame: Baseline (Day 1) to Days 22, 29, and 43
Seroconversion is defined as a Day 22, 29, or 43 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 Days 22, 29, and 43
Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43
Time Frame: Days 22, 29, and 43
Days 22, 29, and 43
GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay
Time Frame: Days 22, 29, and 43
Days 22, 29, and 43
GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay
Time Frame: Baseline (Day 1), Days 22, 29, and 43
Baseline (Day 1), Days 22, 29, and 43
Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise
Time Frame: Baseline (Day 1) to Days 22, 29, and 43
Number of participants with a change in the Days 22, 29, or 43 NAI titer of at least 2-/3-/4-fold rise, defined as ≥2-/3-/4-fold of the lower level of quantitation (LLOQ) if the Day 1 titer is <LLOQ; or ≥2-/3-/4-fold of the Day 1 titer if the Day 1 titer is ≥LLOQ.
Baseline (Day 1) to Days 22, 29, and 43

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2023

Primary Completion (Estimated)

July 26, 2024

Study Completion (Estimated)

July 26, 2024

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1018-P101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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