title: Evaluation of a virosomal H5N1 vaccine formulated with Matrix M™ adjuvant in a phase I clinical trial.
abstract: The avian influenza H5 virus epizootic continues to cause zoonosis with human fatalities, highlighting the continued need for pandemic preparedness against this subtype. This study evaluated the tolerability and immunogenicity of a Matrix M™ adjuvanted virosomal H5N1 vaccine in a phase I clinical trial. Sixty healthy adults were vaccinated intramuscularly with two doses of influenza H5N1 (NIBRG-14) virosomal vaccine alone (30 μg haemagglutinin (HA)) or 1.5, 7.5 or 30 μg HA formulated with 50 μg Matrix M™ adjuvant. The antibody response was analysed by haemagglutination inhibition (HI), microneutralisation (MN) and single radial haemolysis (SRH) assays. The vaccine was well tolerated in all groups but injection site pain was more frequently observed in the Matrix M™ adjuvanted groups. The vaccine elicited homologous and heterologous H5N1-specific antibody responses and the Matrix M™ adjuvanted formulations met all the EU regulatory criteria. In conclusion, Matrix M™ adjuvant was well tolerated and augmented the antibody response allowing considerable dose sparing down to 1.5 μg HA.
authors.affiliation: Influenza Centre, The Gade Institute, University of Bergen, N-5021 Bergen, Norway. rebecca.cox@gades.uib.no
authors.forename: Rebecca J
authors.initials: RJ
authors.lastname: Cox
authors.forename: Gabriel
authors.initials: G
authors.lastname: Pedersen
authors.forename: Abdullah S
authors.initials: AS
authors.lastname: Madhun
authors.forename: Signe
authors.initials: S
authors.lastname: Svindland
authors.forename: Marianne
authors.initials: M
authors.lastname: Sævik
authors.forename: Lucy
authors.initials: L
authors.lastname: Breakwell
authors.forename: Katja
authors.initials: K
authors.lastname: Hoschler
authors.forename: Marieke
authors.initials: M
authors.lastname: Willemsen
authors.forename: Laura
authors.initials: L
authors.lastname: Campitelli
authors.forename: Jane Kristin
authors.initials: JK
authors.lastname: Nøstbakken
authors.forename: Gerrit Jan
authors.initials: GJ
authors.lastname: Weverling
authors.forename: Jaco
authors.initials: J
authors.lastname: Klap
authors.forename: Kenneth C
authors.initials: KC
authors.lastname: McCullough
authors.forename: Maria
authors.initials: M
authors.lastname: Zambon
authors.forename: Ronald
authors.initials: R
authors.lastname: Kompier
authors.forename: Haakon
authors.initials: H
authors.lastname: Sjursen
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects*; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002626:Chemistry, Pharmaceutical; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006461:Hemolysis; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009500:Neutralization Tests; D010146:Pain / Q000453:epidemiology; D014611:Vaccination / Q000379:methods; D022721:Vaccines, Virosome / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D007252:Influenza Vaccines; D022721:Vaccines, Virosome