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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05972174
Recruitment Status : Active, not recruiting
First Posted : August 2, 2023
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Influenza Biological: mRNA-1018 for H5N8 Biological: mRNA-1018 for H7N9 Biological: mRNA-1018 for H5 Only Biological: mRNA-1018 for H7 Only Biological: mRNA-1018 for H5 Only-CG Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : July 10, 2023
Estimated Primary Completion Date : July 26, 2024
Estimated Study Completion Date : July 26, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot Vaccines

Arms and Interventions
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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


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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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.

  4. Number of Participants With HAI Titer ≥ 1:40 at Days 22, 29, and 43 [ Time Frame: Days 22, 29, and 43 ]
  5. 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 ]
  6. 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 ]
  7. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05972174


Locations
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United States, Utah
J. Lewis Research, Inc/Jordan River Family Medicine
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05972174    
Other Study ID Numbers: mRNA-1018-P101
First Posted: August 2, 2023    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
Influenza vaccine
Moderna
mRNA-1018
 Virus Diseases
Vaccines
Pandemic influenza
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases