A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults

Official title

A Phase 3, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Immunogenicity, Safety, and Reactogenicity of mRNA-1018-H5 Pandemic Influenza Vaccine in Adults ≥18 Years of Age

Overview

The purpose of this study is to evaluate humoral immunogenicity after 2 doses of mRNA-1018-H5, and to evaluate the safety and reactogenicity of mRNA-1018-H5 in adults ≥18 years of age.

Interventions

• Biological mRNA-1018-H5
  Sterile liquid for injection.
• Biological Placebo
  Sterile liquid for injection.

Primary outcome measures

• Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43 [Time frame: Day 43]
• Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay [Time frame: Day 43]
• 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 50 (28 days after each injection)]
• Number of Participants with AEs Leading to Discontinuation, Medically-attended AEs (MAAEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs) [Time frame: Day 1 to Day 205]

Secondary outcome measures (4)

• Geometric Mean Titer (GMT) of Anti-H5N1 Antibodies at Day 43, as Measured by Microneutralization (MN) Assay [Time frame: Day 43]
• GMT of HAI Antibodies at Days 22 and 205, as Measured by HAI Assay [Time frame: Days 22 and 205]
• GMT of HAI Antibodies at Days 22 and 205, as Measured by MN Assay [Time frame: Days 22 and 205]
• Percentage of Participants with HAI Titers at Different Cut-Offs [Time frame: Up to Day 205]

Eligibility criteria

Inclusion criteria

• Healthy as determined by medical evaluation including medical history; and physical examination. Participants with clinically stable chronic medical conditions are permitted.
• Participants who are assigned female at birth or could become pregnant are eligible to participate if the participant is not pregnant or breast/chest feeding, and one of the following conditions applies:

• Is a person of nonchildbearing potential (PONCBP) OR
• Is a person of childbearing potential (POCBP)
• A POCBP must have a negative highly sensitive pregnancy test at Screening and on the day of the first dose of study intervention.

Exclusion criteria

• Participant is acutely ill or febrile (body temperature ≥ 38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) within 72 hours prior to or at the Screening Visit or Day 1.
• History of myocarditis, pericarditis, or myopericarditis.
• History of Guillain-Barre syndrome.
• Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
• Treated with antiviral therapies for influenza (eg, Tamiflu, Xofluza) within 28 days prior to Day 1.
• Prior receipt of a pandemic influenza vaccine or participation in any pandemic influenza vaccine clinical study, including the mRNA-1018-P101 study.
• Any medical, psychiatric, or occupational condition, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with adherence to study procedures or the interpretation of study results.
• Participant has received systemic immunosuppressants including long-acting biological therapies that affect immune responses (eg, infliximab, methotrexate, omalizumab, etc.), within 180 days prior to Screening or plans to do so at any time during participation in the study.
• Participant has received corticosteroids at ≥10 mg/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
• Participants has received any licensed 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 21 days after the study intervention.
• Participant has participated in an interventional clinical study within 90 days prior to the Screening visit based on the medical history interview or plans to do so while participating in this study.

Note: Other inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

United Kingdom · 26 centers

• Velocity Clinical Research-Bristol — Bristol
• Velocity Clinical Research - High Wycombe — High Wycombe
• Wansford Research Ltd — Peterborough
• Futuremeds Teesside Middlefield Centre University Hospital of North Tees — Stockton-on-Tees
• NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Fou — Bournemouth
• NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Founda — Weymouth
• Panthera Glasgow — Glasgow
• Panthera Enfield — Enfield
• … and 18 more centers

United States · 10 centers

• Velocity Clinical Research, San Bernardino — San Bernardino
• Velocity Clinical Research, Savannah — Savannah
• Velocity Clinical Research, Boise — Meridian
• Velocity Clinical Research, Rockville — Rockville
• Velocity Clinical Research, Omaha — Omaha
• Velocity Clinical Research, Cleveland — Beachwood
• Velocity Clinical Research, Providence — East Greenwich
• Velocity Clinical Research, Anderson — Anderson
• … and 2 more centers

Identifiers

NCT: NCT07496450 · mRNA-1018-P301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗