Evaluation of a virosomal H5N1 vaccine formulated with Matrix M™ adjuvant in a phase I clinical trial

Rebecca J. Cox; Gabriel Pedersen; Abdullah S. Madhun; Signe Svindland; Marianne Sævik; Lucy Breakwell; Katja Hoschler; Marieke Willemsen; Laura Campitelli; Jane Kristin Nøstbakken; Gerrit Jan Weverling; Jaco Klap; Kenneth C. McCullough; Maria Zambon; Ronald Kompier; Haakon Sjursen

doi:10.1016/j.vaccine.2011.08.042

Evaluation of a virosomal H5N1 vaccine formulated with Matrix M™ adjuvant in a phase I clinical trial

Rebecca J. Cox^*, Gabriel Pedersen, Abdullah S. Madhun, Signe Svindland, Marianne Sævik, Lucy Breakwell, Katja Hoschler, Marieke Willemsen, Laura Campitelli, Jane Kristin Nøstbakken, Gerrit Jan Weverling, Jaco Klap, Kenneth C. McCullough, Maria Zambon, Ronald Kompier, Haakon Sjursen

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Pages (from-to)	8049-8059
Number of pages	11
Journal	Vaccine
Volume	29
Issue number	45
DOIs	https://doi.org/10.1016/j.vaccine.2011.08.042
Publication status	Published - 19 Oct 2011

Bibliographical note

Funding Information:
This study was funded by the European Union FP6 PANFLUVAC (044115) and intramurally by the Influenza Centre, University of Bergen and the Bergen Clinical Vaccine Consortium. We thank Dr. Kjell Rørvik, Steinar Sørnes, Wenke Trovik, Solveig Andersen, Hanne Bjorhovde (Haukeland University Hospital and the University of Bergen, Norway), Dr. Isabella Donatelli (ISS), Italy and Centre for Clinical Research, Haukeland University Hospital for assistance with the study.

Keywords

Antibody response
Cross-reactivity
HI
Influenza H5N1
MN
Matrix M
SRH

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.vaccine.2011.08.042

Cite this

Cox, R. J., Pedersen, G., Madhun, A. S., Svindland, S., Sævik, M., Breakwell, L., Hoschler, K., Willemsen, M., Campitelli, L., Nøstbakken, J. K., Weverling, G. J., Klap, J., McCullough, K. C., Zambon, M., Kompier, R., & Sjursen, H. (2011). Evaluation of a virosomal H5N1 vaccine formulated with Matrix M™ adjuvant in a phase I clinical trial. Vaccine, 29(45), 8049-8059. https://doi.org/10.1016/j.vaccine.2011.08.042

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title = "Evaluation of a virosomal H5N1 vaccine formulated with Matrix M{\texttrademark} 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{\texttrademark} 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{\texttrademark} 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{\texttrademark} adjuvanted groups. The vaccine elicited homologous and heterologous H5N1-specific antibody responses and the Matrix M{\texttrademark} adjuvanted formulations met all the EU regulatory criteria. In conclusion, Matrix M{\texttrademark} adjuvant was well tolerated and augmented the antibody response allowing considerable dose sparing down to 1.5. μg HA.",

keywords = "Antibody response, Cross-reactivity, HI, Influenza H5N1, MN, Matrix M, SRH",

author = "Cox, \{Rebecca J.\} and Gabriel Pedersen and Madhun, \{Abdullah S.\} and Signe Svindland and Marianne S{\ae}vik and Lucy Breakwell and Katja Hoschler and Marieke Willemsen and Laura Campitelli and N{\o}stbakken, \{Jane Kristin\} and Weverling, \{Gerrit Jan\} and Jaco Klap and McCullough, \{Kenneth C.\} and Maria Zambon and Ronald Kompier and Haakon Sjursen",

note = "Funding Information: This study was funded by the European Union FP6 PANFLUVAC (044115) and intramurally by the Influenza Centre, University of Bergen and the Bergen Clinical Vaccine Consortium. We thank Dr. Kjell R{\o}rvik, Steinar S{\o}rnes, Wenke Trovik, Solveig Andersen, Hanne Bjorhovde (Haukeland University Hospital and the University of Bergen, Norway), Dr. Isabella Donatelli (ISS), Italy and Centre for Clinical Research, Haukeland University Hospital for assistance with the study. ",

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Cox, RJ, Pedersen, G, Madhun, AS, Svindland, S, Sævik, M, Breakwell, L, Hoschler, K, Willemsen, M, Campitelli, L, Nøstbakken, JK, Weverling, GJ, Klap, J, McCullough, KC, Zambon, M, Kompier, R & Sjursen, H 2011, 'Evaluation of a virosomal H5N1 vaccine formulated with Matrix M™ adjuvant in a phase I clinical trial', Vaccine, vol. 29, no. 45, pp. 8049-8059. https://doi.org/10.1016/j.vaccine.2011.08.042

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AU - Cox, Rebecca J.

AU - Pedersen, Gabriel

AU - Madhun, Abdullah S.

AU - Svindland, Signe

AU - Sævik, Marianne

AU - Breakwell, Lucy

AU - Hoschler, Katja

AU - Willemsen, Marieke

AU - Campitelli, Laura

AU - Nøstbakken, Jane Kristin

AU - Weverling, Gerrit Jan

AU - Klap, Jaco

AU - McCullough, Kenneth C.

AU - Zambon, Maria

AU - Kompier, Ronald

AU - Sjursen, Haakon

N1 - Funding Information: This study was funded by the European Union FP6 PANFLUVAC (044115) and intramurally by the Influenza Centre, University of Bergen and the Bergen Clinical Vaccine Consortium. We thank Dr. Kjell Rørvik, Steinar Sørnes, Wenke Trovik, Solveig Andersen, Hanne Bjorhovde (Haukeland University Hospital and the University of Bergen, Norway), Dr. Isabella Donatelli (ISS), Italy and Centre for Clinical Research, Haukeland University Hospital for assistance with the study.

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N2 - 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.

AB - 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.

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KW - Cross-reactivity

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KW - Influenza H5N1

KW - MN

KW - Matrix M

KW - SRH

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Evaluation of a virosomal H5N1 vaccine formulated with Matrix M™ adjuvant in a phase I clinical trial

Abstract

Bibliographical note

Keywords

UN SDGs

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