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

Primary Purpose

Influenza

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1018 for H5N8
mRNA-1018 for H7N9
mRNA-1018 for H5 Only
mRNA-1018 for H7 Only
mRNA-1018 for H5 Only-CG
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza vaccine, Moderna, mRNA-1018, Virus Diseases, Vaccines, Pandemic influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • J. Lewis Research, Inc/Jordan River Family MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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

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

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

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

Arm Description

Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22.

Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22.

Outcomes

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants with AEs Leading to Discontinuation From Study
Number of Participants with Medically-Attended AEs (MAAEs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Adverse Events of Special Interest (AESIs)

Secondary Outcome Measures

Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay
Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies From Baseline to Days 22, 29, and 43, as Measured by HAI Assay
Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay
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.
Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43
GMT of Anti-Neuraminidase (NA) Antibodies at Days 22, 29, and 43, as Measured by Neuraminidase Inhibition (NAI) Assay
GMFR of Anti-NA Antibodies From Baseline to Days 22, 29, and 43, as Measured by NAI Assay
Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise
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.

Full Information

First Posted
July 25, 2023
Last Updated
July 25, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05972174
Brief Title
A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
May 22, 2024 (Anticipated)
Study Completion Date
May 22, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza vaccine, Moderna, mRNA-1018, Virus Diseases, Vaccines, Pandemic influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22.
Arm Title
Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22.
Arm Title
Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22.
Arm Title
Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22.
Arm Title
Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22.
Arm Title
Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22.
Intervention Type
Biological
Intervention Name(s)
mRNA-1018 for H5N8
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1018 for H7N9
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1018 for H5 Only
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1018 for H7 Only
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1018 for H5 Only-CG
Intervention Description
Sterile liquid for injection
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time Frame
Up to Day 29 (7 days after each injection)
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 43 (21 days after each injection)
Title
Number of Participants with AEs Leading to Discontinuation From Study
Time Frame
Day 1 to Day 205 (end of study [EoS])
Title
Number of Participants with Medically-Attended AEs (MAAEs)
Time Frame
Day 1 to Day 205 (EoS)
Title
Number of Participants with Serious Adverse Events (SAEs)
Time Frame
Day 1 to Day 205 (EoS)
Title
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame
Day 1 to Day 205 (EoS)
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay
Description
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.
Time Frame
Baseline (Day 1) to Days 22, 29, and 43
Title
Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43
Time Frame
Days 22, 29, and 43
Title
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
Title
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
Title
Number of Participants with a Change in the Days 22, 29, and 43 NAI Titer of at Least 2-/3-/4-Fold Rise
Description
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.
Time Frame
Baseline (Day 1) to Days 22, 29, and 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moderna Clinical Trials Support Center
Phone
1-877-777-7187
Email
clinicaltrials@modernatx.com
Facility Information:
Facility Name
J. Lewis Research, Inc/Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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