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

• ClinicalTrials.gov Identifier: NCT05972174
• Recruitment Status: Active, not recruiting
• First Posted: August 2, 2023
• Last Update Posted: January 31, 2024
• Sponsor: ModernaTX, Inc.
• Information provided by (Responsible Party): ModernaTX, Inc.

Tracking Information

• First Submitted Date: July 25, 2023
• First Posted Date: August 2, 2023
• Last Update Posted Date: January 31, 2024
• Actual Study Start Date: July 10, 2023
• Estimated Primary Completion Date: July 26, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 25, 2023)

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: 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) ]
• Number of Participants with AEs Leading to Discontinuation From Study [ Time Frame: 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) ]
• Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Day 1 to Day 205 (EoS) ]
• Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Day 1 to Day 205 (EoS) ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 25, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Influenza

Intervention

• Biological: mRNA-1018 for H5N8
  Sterile liquid for injection
• Biological: mRNA-1018 for H7N9
  Sterile liquid for injection
• Biological: mRNA-1018 for H5 Only
  Sterile liquid for injection
• Biological: mRNA-1018 for H7 Only
  Sterile liquid for injection
• Biological: mRNA-1018 for H5 Only-CG
  Sterile liquid for injection

Study Arms

• 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.
  Intervention: Biological: mRNA-1018 for H5N8
• 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.
  Intervention: Biological: mRNA-1018 for H5N8
• 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.
  Intervention: Biological: mRNA-1018 for H5N8
• 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.
  Intervention: Biological: mRNA-1018 for H5 Only
• 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.
  Intervention: Biological: mRNA-1018 for H5 Only
• 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.
  Intervention: Biological: mRNA-1018 for H5 Only
• 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.
  Intervention: Biological: mRNA-1018 for H7N9
• 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.
  Intervention: Biological: mRNA-1018 for H7N9
• 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.
  Intervention: Biological: mRNA-1018 for H7N9
• 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.
  Intervention: Biological: mRNA-1018 for H7 Only
• 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.
  Intervention: Biological: mRNA-1018 for H7 Only
• 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.
  Intervention: Biological: mRNA-1018 for H7 Only
• 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.
  Intervention: Biological: mRNA-1018 for H5 Only-CG
• 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.
  Intervention: Biological: mRNA-1018 for H5 Only-CG
• 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.
  Intervention: Biological: mRNA-1018 for H5 Only-CG

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 30, 2024): 1504
• Original Estimated Enrollment (submitted: July 25, 2023): 1500
• Estimated Study Completion Date: July 26, 2024
• Estimated Primary Completion Date: July 26, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05972174
• Other Study ID Numbers: mRNA-1018-P101
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: ModernaTX, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: ModernaTX, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: ModernaTX, Inc.
• Verification Date: January 2024