Drug intelligence / Profile preview

H5N1 pandemic influenza virus-like particle vaccine

Development stage
Phase 1
Lead developer
Novavax
Modality
Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics, Recombinant Protein Vaccines → Recombinant Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

The **H5N1 pandemic influenza virus-like particle vaccine** is an investigational vaccine comprised of virus-like particles (VLPs) containing hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins from the influenza A/Indonesia/05/2005 (H5N1) strain (clade 2.1), produced in Sf9 insect cells. It elicits humoral immune responses, including hemagglutination inhibition (HAI) and microneutralization (MN) antibodies, with cross-reactivity against other clade 2 subtypes, as demonstrated in dose-ranging studies using 15, 45, or 90 μg HA/dose. Developed under a BARDA contract, it advanced to an FDA-approved phase I/II clinical trial involving 230 healthy adults, showing seroconversion rates up to 100% with adjuvants and good tolerability, positioning it as a promising platform for pandemic preparedness due to its economical production and potent immunogenicity.[7]

Other names
A/Indonesia/05/2005 (H5N1) VLP vaccine
02

Targets

H5 HA (Influenza A hemagglutinin H5)HA (Hemagglutinin)

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