NCT07019883View on ClinicalTrials.gov

A Study to Evaluate the Safety and Immunogenicity of Two Doses of a Novel H5 Central Antigen mRNA-LNP in Healthy Adults

PHASE1RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

June 12, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Avian Influenza
Interventions
BIOLOGICAL

H5 AC-Anhui RNA Vaccine

A nucleoside-modified mRNA vaccine encoding a stabilized, antigenically central hemagglutinin (HA) from influenza A(H5), based on A/Anhui/1/2005 (clade 2.3.4) with substitutions 222QL, 224GS, 156TA, and 134TA. The 2119-nt mRNA is encapsulated in lipid nanoparticles (LNPs) for intramuscular delivery.

BIOLOGICAL

H5 Astrakhan RNA Vaccine

The vaccine product consists of a monovalent nucleoside-modified mRNA that encodes a traditionally selected avian influenza HA. The H5 Astrakhan RNA encodes the HA from the clade 2.3.4.4b A/Astrakhan/3212/2020 virus.

OTHER

Sodium Chloride, 0.9%

0.9% Sodium Chloride Injection

Trial Locations (3)

27703

RECRUITING

Duke Vaccine and Trials Unit, Durham

37232-0011

RECRUITING

Vanderbilt University Medical Center, Nashville

77030-3411

RECRUITING

Baylor College of Medicine, Houston

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH