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

NCT05972174 | Completed Phase 1 FDA Drug

• 1 other identifier: mRNA-1018-P101
• Study Type: interventional
• Target: 1,504
• Locations: 2 countries
• Sites: 27

Brief Summary

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).

Conditions

Influenza

Keywords

Influenza vaccine; Moderna; mRNA-1018; Virus Diseases; Vaccines; Pandemic influenza

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

  Up to Day 29 (7 days after each injection)

• Number of Participants with Unsolicited Adverse Events (AEs)

  Up to Day 43 (21 days after each injection)

• Number of Participants with AEs Leading to Discontinuation From Study

  Day 1 to Day 205 (end of study [EoS])

• Number of Participants with Medically-Attended AEs (MAAEs)

  Day 1 to Day 205 (EoS)

• Number of Participants with Serious Adverse Events (SAEs)

  Day 1 to Day 205 (EoS)

• Number of Participants with Adverse Events of Special Interest (AESIs)

  Day 1 to Day 205 (EoS)

Secondary Outcomes (7)

• Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay

  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

  Baseline (Day 1), Days 22, 29, and 43

• Number of Participants With Seroconversion at Days 22, 29, and 43, as 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

  Days 22, 29, and 43

• GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay

  Days 22, 29, and 43

Study Arms (15)

Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1

EXPERIMENTAL

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

Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2

EXPERIMENTAL

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

Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3

EXPERIMENTAL

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

Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1

EXPERIMENTAL

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

Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2

EXPERIMENTAL

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

Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3

EXPERIMENTAL

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

Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1

EXPERIMENTAL

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

Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2

EXPERIMENTAL

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

Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3

EXPERIMENTAL

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

Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1

EXPERIMENTAL

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

Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2

EXPERIMENTAL

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

Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3

EXPERIMENTAL

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

Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1

EXPERIMENTAL

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

Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2

EXPERIMENTAL

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

Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3

EXPERIMENTAL

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

Interventions

mRNA-1018 for H5N8 BIOLOGICAL

Sterile liquid for injection

Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1; Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2; Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3

mRNA-1018 for H7N9 BIOLOGICAL

Sterile liquid for injection

Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1; Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2; Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3

mRNA-1018 for H5 Only BIOLOGICAL

Sterile liquid for injection

Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1; Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2; Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3

mRNA-1018 for H7 Only BIOLOGICAL

Sterile liquid for injection

Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1; Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2; Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3

mRNA-1018 for H5 Only-CG BIOLOGICAL

Sterile liquid for injection

Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1; Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2; Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (27)

CenExel RCA

Hollywood, Florida, 33024, United States

Location

Velocity Clinical Research

Savannah, Georgia, 31406, United States

Location

Johnson County Clin-Trials

Lenexa, Kansas, 66219, United States

Location

DM Clinical Research

Southfield, Michigan, 48076, United States

Location

Velocity Clinical Research

Lincoln, Nebraska, 68510, United States

Location

Velocity Clinical Research Providence

East Greenwich, Rhode Island, 02818, United States

Location

DM Clinical Research

Sugar Land, Texas, 77478, United States

Location

DM Clinical Research

Tomball, Texas, 77375, United States

Location

J. Lewis Research, Inc/Jordan River Family Medicine

South Jordan, Utah, 84095, United States

Location

Royal Victoria Infirmary

Newcastle upon Tyne, England, NE1 4LP, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

University Hospitals Birmingham

Birmingham, London, B15 2TH, United Kingdom

Location

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, London, BD9 6RL, United Kingdom

Location

University Hospitals

Bristol, London, Bs2 8DX, United Kingdom

Location

Cardiff and Vale University

Cardiff, London, CF14 4XW, United Kingdom

Location

Northern Care Alliance

Salford, London, M6 8HD, United Kingdom

Location

Royal Cornwall Hospital

Truro, London, TR1 3LJ, United Kingdom

Location

North Wales Clinical Research Centre

Wrexham, London, LL13 7YP, United Kingdom

Location

Quadram Institute NNUH CRF

Norwich, Norfolk, NR4 7UQ, United Kingdom

Location

Lakeside Healthcare Research Unit

Corby, Northamptonshire, NN17 2UR, United Kingdom

Location

Western Hospital Edinburgh

Edinburgh, EH4 CXU, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

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

London, SE1 7EH, United Kingdom

Location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

St Georges Vaccine Institute Cranmer Terrace

London, SW17 ORE, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, W1T 7HA, United Kingdom

Location

Velocity Clinical Research

North Finchley, N12 8BU, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human; Virus Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: July 10, 2023
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-06

Locations

US (9); GB (18)