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mRNA-1018 for H5N8

Phase 1

Influenza | Monoclonal antibody | Infectious Disease |Moderna, Inc.|Last Updated: Jul 16, 2025

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

Clinical trial landscape

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
Influenza
NCT059721741,504
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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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Competitive Landscape -Influenza 14 trials

CompanyTickerTrialsLead PhaseDrugs
Sinovac Biotech Ltd.SVA1PHASE3Participants will receive one dose of vaccine of Sinovac QIV, Vaxigrip QIV
GSK plc Sponsored ADRGSK2PHASE2Flu mRNA, Comparator 1, Comparator 2, Comparator 3
Moderna, Inc.MRNA1PHASE3mRNA-1018-H5
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)CDTX1PHASE3CD388
Traws Pharma, Inc.TRAW2PHASE2TRX-100
AstraZeneca PLCAZN1PHASE1AZD4117, AZD5315
Sanofi SA Sponsored ADRSNY2 - Efluelda Tetra Pre-filled syringe
Pfizer Inc.PFE1 - COVID-19 Vaccine
Abbott LaboratoriesABT1N/AUndisclosed
Grace Therapeutics, Inc.GRCE1N/AUndisclosed
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Frequently asked questions about mRNA-1018 for H5N8

What is mRNA-1018 used for?

mRNA-1018 is an investigational messenger RNA (mRNA) vaccine being developed for influenza, specifically targeting the H5N8 strain. It is designed to prevent infection caused by this influenza virus. The vaccine is currently in clinical development and has not been approved for public use.

Who is developing mRNA-1018?

mRNA-1018 is being developed by Moderna, Inc., a biotechnology company traded on the NASDAQ under the ticker symbol MRNA. Moderna is conducting clinical trials to evaluate the safety and immunogenicity of this pandemic influenza candidate vaccine in healthy adults.

What phase is mRNA-1018 in?

mRNA-1018 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the vaccine remains investigational. It has not received regulatory approval and is still undergoing evaluation to determine its safety and immune response in humans.

What clinical trials is mRNA-1018 in?

mRNA-1018 was studied in a Phase 1 clinical trial identified as NCT05972174, titled "A Study of mRNA-1018 Pandemic Influenza Candidate Vaccines in Healthy Adults." The trial enrolled 1,504 participants in the United States and the United Kingdom and has been completed.

How does mRNA-1018 work?

mRNA-1018 is an mRNA-based vaccine that works by instructing cells to produce a viral protein, which triggers an immune response against the H5N8 influenza virus. This approach aims to generate protective antibodies without using a live virus, potentially offering a rapid response to pandemic threats.