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Vaccine
Article in Press, Uncorrected Proof - Note to users
doi:10.1016/j.vaccine.2011.08.042 | How to Cite or Link Using DOI
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Evaluation of a virosomal H5N1 vaccine formulated with Matrix M? adjuvant in a phase I clinical trial
Rebecca J. Coxa, b, Corresponding Author Contact Information, E-mail The Corresponding Author, Gabriel Pedersena, Abdullah S. Madhuna, Signe Svindlanda, Marianne S?vikc, Lucy Breakwelld, Katja Hoschlerd, Marieke Willemsene, Laura Campitellif, Jane Kristin N?stbakkena, Gerrit Jan Weverlinge, Jaco Klape, Kenneth C. McCulloughg, Maria Zambond, Ronald Kompiere and Haakon Sjursenc, h
a Influenza Centre, The Gade Institute, University of Bergen, N-5021 Bergen, Norway
b Department of Research & Development, Haukeland University Hospital, Bergen, Norway
c Infectious Diseases Unit, Haukeland University Hospital, Bergen, Norway
d Respiratory Unit, Health Protection Agency (HPA) Colindale, London, UK
e Crucell, the Netherlands
f National Influenza Centre, Department of Infectious, Parasitic and Immune-mediated diseases, Istituto Superiore di Sanit? (ISS), Rome, Italy
g Institute of Virology and Immunoprophylaxis (IVI), Sensemattstrasse 293, CH-3147 Mittelh?usern, Switzerland
h Institute of Medicine, University of Bergen, Bergen, Norway
Received 27 June 2011;
revised 28 July 2011;
accepted 8 August 2011.
Available online 22 August 2011.
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 (NIBRG14) 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.
Highlights
► Phase I clinical trial evaluating the tolerability and immunogenicity of a Matrix M? adjuvanted virosomal H5N1 vaccine. ► Vaccination elicited homologous and heterologous H5N1-specific antibody responses. ► Two doses of Matrix M? adjuvanted 1.5 μg HA virosomal met all the EU regulatory criteria. ► Matrix M? adjuvant was well tolerated and augmented the antibody response allowing considerable dose sparing down to 1.5 μg HA. ► Comparison of the antibody responses by haemagglutination inhibition (HI), microneutralisation (MN) and single radial haemolysis (SRH) serological assays.
http://www.sciencedirect.com/science/article/pii/S0264410X11012837
Article in Press, Uncorrected Proof - Note to users
doi:10.1016/j.vaccine.2011.08.042 | How to Cite or Link Using DOI
Permissions & Reprints
Evaluation of a virosomal H5N1 vaccine formulated with Matrix M? adjuvant in a phase I clinical trial
Rebecca J. Coxa, b, Corresponding Author Contact Information, E-mail The Corresponding Author, Gabriel Pedersena, Abdullah S. Madhuna, Signe Svindlanda, Marianne S?vikc, Lucy Breakwelld, Katja Hoschlerd, Marieke Willemsene, Laura Campitellif, Jane Kristin N?stbakkena, Gerrit Jan Weverlinge, Jaco Klape, Kenneth C. McCulloughg, Maria Zambond, Ronald Kompiere and Haakon Sjursenc, h
a Influenza Centre, The Gade Institute, University of Bergen, N-5021 Bergen, Norway
b Department of Research & Development, Haukeland University Hospital, Bergen, Norway
c Infectious Diseases Unit, Haukeland University Hospital, Bergen, Norway
d Respiratory Unit, Health Protection Agency (HPA) Colindale, London, UK
e Crucell, the Netherlands
f National Influenza Centre, Department of Infectious, Parasitic and Immune-mediated diseases, Istituto Superiore di Sanit? (ISS), Rome, Italy
g Institute of Virology and Immunoprophylaxis (IVI), Sensemattstrasse 293, CH-3147 Mittelh?usern, Switzerland
h Institute of Medicine, University of Bergen, Bergen, Norway
Received 27 June 2011;
revised 28 July 2011;
accepted 8 August 2011.
Available online 22 August 2011.
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 (NIBRG14) 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.
Highlights
► Phase I clinical trial evaluating the tolerability and immunogenicity of a Matrix M? adjuvanted virosomal H5N1 vaccine. ► Vaccination elicited homologous and heterologous H5N1-specific antibody responses. ► Two doses of Matrix M? adjuvanted 1.5 μg HA virosomal met all the EU regulatory criteria. ► Matrix M? adjuvant was well tolerated and augmented the antibody response allowing considerable dose sparing down to 1.5 μg HA. ► Comparison of the antibody responses by haemagglutination inhibition (HI), microneutralisation (MN) and single radial haemolysis (SRH) serological assays.
http://www.sciencedirect.com/science/article/pii/S0264410X11012837