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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Key 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.
Key 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.
Primary outcome measure(s)
Percentage of Participants With Hemagglutination Inhibition (HAI) Titer ≥ 1:40 at Day 43 — Day 43 HAI Titer \>=1:40.
Percentage of Participants With Seroconversion at Day 43, as Measured by HAI Assay — Day 43 Seroconversion is defined as a Day 43 titer ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in HAI titer measured by HAI assay.
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 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) — Day 1 to Day 205
Trial sites (35)
Facility
City
Region
Status
Velocity Clinical Research, San Bernardino
San Bernardino
California
Velocity Clinical Research, Savannah
Savannah
Georgia
Velocity Clinical Research, Boise
Meridian
Idaho
Velocity Clinical Research, Rockville
Rockville
Maryland
Velocity Clinical Research, Omaha
Omaha
Nebraska
Velocity Clinical Research, Cleveland
Beachwood
Ohio
Velocity Clinical Research, Providence
East Greenwich
Rhode Island
Velocity Clinical Research, Anderson
Anderson
South Carolina
Velocity Clinical Research, Dallas
Dallas
Texas
Velocity Clinical Research, Suffolk
Suffolk
Virginia
Velocity Clinical Research-Bristol
Bristol
Bristol (Unitary Authority)
Velocity Clinical Research - High Wycombe
High Wycombe
Buckinghamshire
Wansford Research Ltd
Peterborough
Cambridgeshire
Futuremeds Teesside Middlefield Centre University Hospital of North Tees
Stockton-on-Tees
County Durham
NIHR Wessex CRDC - Bournemouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
Bournemouth
Dorset
NIHR Wessex CRDC - Weymouth Research Hub (Under University Hospital Southampton NHS Foundation Trust)
Weymouth
Dorset
Panthera Glasgow
Glasgow
Glasgow City (Scotland)
Panthera Enfield
Enfield
Greater London
Hounslow Medical Centre
Hounslow
Greater London
hVIVO Services Limited
London
Greater London
Velocity Clinical Research-North London
London
Greater London
Accellacare North London
Northwood
Greater London
Accellacare South London
Orpington
Greater London
Velocity Clinical Research-Romford
Romford
Greater London
Panthera Rochdale
Rochdale
Greater Manchester
NIHR Wessex CRDC - Southampton Research Hub (Under University Hospital Southampton NHS FT)
Southampton
Hampshire
Fylde Coast Clinical Research at Layton Medical Centre
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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