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mRNA-1018 for H5N8

Phase 1

Influenza | Vaccine | Infectious Disease |Moderna, Inc.|Trials Updated: Jul 16, 2025

mRNA-1018 for H5N8 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment1,504

FDA Designations

No designations recorded

mRNA-1018 for H5N8 clinical trials

mRNA-1018 for H5N8 · 1 trial · 1 indication

Phase 1 1
NCT05972174A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy AdultsInfluenza
COMPLETED1,504 Analytics
PHASE1COMPLETED
A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults
InfluenzaUnlock trial analytics

Study Endpoints

Primary Endpoints

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 43 (21 days after each injection)
Number of Participants with AEs Leading to Discontinuation From Study
Day 1 to Day 205 (end of study [EoS])
Number of Participants with Medically-Attended AEs (MAAEs)
Day 1 to Day 205 (EoS)
Number of Participants with Serious Adverse Events (SAEs)
Day 1 to Day 205 (EoS)
Number of Participants with Adverse Events of Special Interest (AESIs)
Day 1 to Day 205 (EoS)

Secondary Endpoints

Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Days 22, 29, and 43, as Measured by Hemagglutination Inhibition (HAI) Assay
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
Baseline (Day 1), Days 22, 29, and 43
Number of Participants With Seroconversion at Days 22, 29, and 43, as Measured by HAI Assay
Baseline (Day 1) to Days 22, 29, and 43
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 1EXPERIMENTALParticipants will receive mRNA-1018 for H5N8 at dose level 1 by intramuscular (IM) injection on Day 1 and Day 22.
Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 2EXPERIMENTALParticipants will receive mRNA-1018 for H5N8 at dose level 2 by IM injection on Day 1 and Day 22.
Part A Group 1 Vaccine: mRNA-1018 for H5N8 Dose Level 3EXPERIMENTALParticipants will receive mRNA-1018 for H5N8 at dose level 3 by IM injection on Day 1 and Day 22.
Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 1EXPERIMENTALParticipants will receive mRNA-1018 for H5 only at dose level 1 by IM injection on Day 1 and Day 22.
Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 2EXPERIMENTALParticipants will receive mRNA-1018 for H5 only at dose level 2 by IM injection on Day 1 and Day 22.
Part A Group 1 Vaccine: mRNA-1018 for H5 Only Dose Level 3EXPERIMENTALParticipants will receive mRNA-1018 for H5 only at dose level 3 by IM injection on Day 1 and Day 22.
Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 1EXPERIMENTALParticipants will receive mRNA-1018 for H7N9 at dose level 1 by IM injection on Day 1 and Day 22.
Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 2EXPERIMENTALParticipants will receive mRNA-1018 for H7N9 at dose level 2 by IM injection on Day 1 and Day 22.
Part A Group 2 Vaccine: mRNA-1018 for H7N9 Dose Level 3EXPERIMENTALParticipants will receive mRNA-1018 for H7N9 at dose level 3 by IM injection on Day 1 and Day 22.
Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 1EXPERIMENTALParticipants will receive mRNA-1018 for H7 only at dose level 1 by IM injection on Day 1 and Day 22.
Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 2EXPERIMENTALParticipants will receive mRNA-1018 for H7 only at dose level 2 by IM injection on Day 1 and Day 22.
Part A Group 2 Vaccine: mRNA-1018 for H7 Only Dose Level 3EXPERIMENTALParticipants will receive mRNA-1018 for H7 only at dose level 3 by IM injection on Day 1 and Day 22.
Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 1EXPERIMENTALParticipants will receive mRNA-1018 for H5 Only-CG at dose level 1 by IM injection on Day 1 and Day 22.
Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 2EXPERIMENTALParticipants will receive mRNA-1018 for H5 Only-CG at dose level 2 by IM injection on Day 1 and Day 22.
Part B Group 1 Vaccine: mRNA-1018 for H5 Only-CG Dose Level 3EXPERIMENTALParticipants will receive mRNA-1018 for H5 Only-CG at dose level 3 by IM injection on Day 1 and Day 22.

Interventions

NameTypeDescription
mRNA-1018 for H5N8BIOLOGICALSterile liquid for injection
mRNA-1018 for H7N9BIOLOGICALSterile liquid for injection
mRNA-1018 for H5 OnlyBIOLOGICALSterile liquid for injection
mRNA-1018 for H7 OnlyBIOLOGICALSterile liquid for injection
mRNA-1018 for H5 Only-CGBIOLOGICALSterile liquid for injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites27

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 femal...

Countries:United StatesUnited Kingdom
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Frequently asked questions about mRNA-1018 for H5N8

What is mRNA-1018 for H5N8?

mRNA-1018 for H5N8 is an investigational mRNA vaccine developed by Moderna, Inc. for pandemic influenza. It is designed to protect against the H5N8 avian influenza strain and is in Phase 1 clinical development. The vaccine is being studied in healthy adults.

Who is developing mRNA-1018 for H5N8?

mRNA-1018 for H5N8 is being developed by Moderna, Inc., which trades on the Nasdaq under the ticker MRNA. Moderna is the sponsor of the clinical program evaluating this pandemic influenza vaccine candidate.

What phase is mRNA-1018 for H5N8 in?

mRNA-1018 for H5N8 is in Phase 1 clinical development. The Phase 1 trial has been completed, and the vaccine remains investigational. It has not been approved by the FDA or any other regulatory agency for use in humans.

What clinical trials is mRNA-1018 for H5N8 in?

mRNA-1018 for H5N8 has been evaluated in one clinical trial: NCT05972174, titled "A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults." This Phase 1 trial enrolled 1,504 participants across the United States and the United Kingdom and is now completed.

What is mRNA-1018 for H5N8 used for?

mRNA-1018 for H5N8 is being developed for the prevention of influenza caused by the H5N8 avian influenza strain. It is a pandemic influenza vaccine candidate intended for use in healthy adults and is currently investigational.