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

NCT ID: NCT05972174

Last Updated: 2025-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

1504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-10

Study Completion Date

2024-07-16

Brief Summary

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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).

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Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

mRNA-1018 for H5N8

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H5N8

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H5N8

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H5 Only

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H5 Only

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H5 Only

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H7N9

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H7N9

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H7N9

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H7 Only

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H7 Only

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H7 Only

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H5 Only-CG

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H5 Only-CG

Intervention Type BIOLOGICAL

Sterile liquid for injection

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.

Group Type EXPERIMENTAL

mRNA-1018 for H5 Only-CG

Intervention Type BIOLOGICAL

Sterile liquid for injection

Interventions

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mRNA-1018 for H5N8

Sterile liquid for injection

Intervention Type BIOLOGICAL

mRNA-1018 for H7N9

Sterile liquid for injection

Intervention Type BIOLOGICAL

mRNA-1018 for H5 Only

Sterile liquid for injection

Intervention Type BIOLOGICAL

mRNA-1018 for H7 Only

Sterile liquid for injection

Intervention Type BIOLOGICAL

mRNA-1018 for H5 Only-CG

Sterile liquid for injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ModernaTX, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CenExel RCA

Hollywood, Florida, United States

Site Status

Velocity Clinical Research

Savannah, Georgia, United States

Site Status

Johnson County Clin-Trials

Lenexa, Kansas, United States

Site Status

DM Clinical Research

Southfield, Michigan, United States

Site Status

Velocity Clinical Research

Lincoln, Nebraska, United States

Site Status

Velocity Clinical Research Providence

East Greenwich, Rhode Island, United States

Site Status

DM Clinical Research

Sugar Land, Texas, United States

Site Status

DM Clinical Research

Tomball, Texas, United States

Site Status

J. Lewis Research, Inc/Jordan River Family Medicine

South Jordan, Utah, United States

Site Status

Royal Victoria Infirmary

Newcastle upon Tyne, England, United Kingdom

Site Status

Southampton General Hospital

Southampton, England, United Kingdom

Site Status

University Hospitals Birmingham

Birmingham, London, United Kingdom

Site Status

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, London, United Kingdom

Site Status

University Hospitals

Bristol, London, United Kingdom

Site Status

Cardiff and Vale University

Cardiff, London, United Kingdom

Site Status

Northern Care Alliance

Salford, London, United Kingdom

Site Status

Royal Cornwall Hospital

Truro, London, United Kingdom

Site Status

North Wales Clinical Research Centre

Wrexham, London, United Kingdom

Site Status

Quadram Institute NNUH CRF

Norwich, Norfolk, United Kingdom

Site Status

Lakeside Healthcare Research Unit

Corby, Northamptonshire, United Kingdom

Site Status

Western Hospital Edinburgh

Edinburgh, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Guy's and St Thomas' NHS Foundation Trust - St Thomas' Hospital

London, , United Kingdom

Site Status

Chelsea and Westminster Hospital

London, , United Kingdom

Site Status

St Georges Vaccine Institute Cranmer Terrace

London, , United Kingdom

Site Status

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status

Velocity Clinical Research

North Finchley, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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mRNA-1018-P101

Identifier Type: -

Identifier Source: org_study_id

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