H5N1 VLP vaccine: Interim Phase I data

Interim data from a single-blind, U.S. Phase I trial in 100 healthy volunteers aged 18-49 years showed that a 20 µg dose of the H5N1 VLP vaccine plus 2.5 µg intradermal Glucopyranosyl Lipid A (GLA-AF) adjuvant led to a hemagglutination inhibition (HAI) seroconversion rate defined as a 4-fold increase from baseline in HAI titer of 65%, a seroprotection rate of 70% and a 10.3-fold increase in geometric mean titer (GMT). A 20 µg dose of the H5N1 VLP vaccine plus 2.5 µg intramuscular GLA-AF adjuvant led to a seroconversion rate of 80%, a seroprotection rate of 85% and an 8.7-fold increase in GMT. A 20 µg dose of the H5N1 VLP vaccine plus a 0.5 µg intramuscular alum adjuvant led to a seroconversion rate of 83.3%, a seroprotection rate of 89.9% and an 11.4-fold increase in GMT. The vaccine was well tolerated. Subjects in each treatment group received 2 injections given 3 weeks apart. Data were presented at the World Vaccine meeting in Washington, D.C.

Medicago said all 3 configurations of adjuvant and route of administration for the 20 µg dose of the H5N1 VLP vaccine induced an immune response against the H5N1 viral strain that exceeded the 3 immunogenicity criteria from EMA's CHMP for licensure of influenza vaccines - 40% seroconversion, 70% seroprotection and a 2.5-fold increase in GMT. The trial was conducted by not-for-profit Infectious Disease Research Institute (IDRI) (Seattle, Wash.). The intradermal injections were administered using the MicronJet600 microneedle device from NanoPass Technologies Ltd. (Ness Ziona, Israel). ...