Drug intelligence / Profile preview

2009 H1N1 influenza VLP vaccine

Development stage
Phase 2
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 **2009 H1N1 influenza VLP vaccine** is a recombinant virus-like particle (VLP) vaccine developed by **Novavax** targeting the 2009 pandemic H1N1 influenza virus (A/California/04/2009 or similar strains). VLPs mimic the structure of the influenza virus, incorporating hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins produced via baculovirus expression in insect cells, without genetic material to prevent replication. It induces protective humoral immunity, including high hemagglutination inhibition (HAI) antibody titers, IgG2a responses, and mucosal IgA, providing complete protection against lethal homologous challenge in preclinical ferret and mouse models even at low doses (e.g., 3.75 mcg). Developed rapidly (in weeks) using genetic sequences from CDC, it advanced to Phase II trials for safety and immunogenicity but was not FDA-approved as a monovalent product, unlike egg-based inactivated vaccines[5][9][13][17].

Other names
2009 H1N1 VLP vaccineH1N1 VLP vaccineH-1N1 VLP vaccineH 1N1 VLP vaccine
02

Targets

HA (Hemagglutinin)Neuraminidase

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