tetano
Editor, Senior Moderator
Christoph Hatza, b,
Jakob P. Cramerc,
Andr? Vertruyend,
Tino F. Schwarze,
Frank von Sonnenburgf,
Astrid Borkowskig, Corresponding author contact information, E-mail the corresponding author,
Maria Lattanzig,
Anne Katrin Hilbertg,
Giovanni Della Cioppag,
Geert Leroux-Roelsh
a Division of Communicable Diseases, Institute for Social and Preventive Medicine, University of Zurich, Zurich, Switzerland
b Swiss Tropical and Public Health Institute, Basel, Switzerland
c Section Tropical Medicine, University Medical Center Hamburg-Eppendorf, Germany
d St.Vincentius Hospital, Antwerp, Belgium
e Central Laboratory and Vaccine Centre, Stiftung Juliusspital, Wuerzburg, Germany
f Department of Infectious Diseases and Tropical Medicine, University of Munich, Germany
g Novartis Vaccines and Diagnostics, Siena, Italy
h Centre for Vaccinology, Ghent University and Hospital, Belgium
Received 21 November 2011. Revised 4 May 2012. Accepted 9 May 2012. Available online 21 May 2012.
http://dx.doi.org/10.1016/j.vaccine.2012.05.013, How to Cite or Link Using DOI
Background
Modern cell-culture production techniques and the use of adjuvants helps to ensure that the global demand for pandemic influenza vaccine can be met. This study aimed to assess the immunogenicty and safety profiles of various cell-culture-derived A/H1N1 pandemic vaccine formulations in healthy adult and elderly subjects.
Methods
Adult (18?60 years) subjects (n = 544) received vaccine either containing 3.75 μg of antigen with half the standard dose of MF59? (Novartis Vaccines and Diagnostics) adjuvant, 7.5 μg antigen with a full dose of MF59, or a non-adjuvanted vaccine containing 15 μg of antigen. Elderly (≥61 years) subjects (n = 268) received either the 3.75 μg or 7.5 μg adjuvanted formulations. Two priming vaccine doses were administered 3 weeks apart, followed by a single booster dose of seasonal influenza vaccine 1 year later. Immunogenicity was assessed 3 weeks after each vaccination. The safety profile of each formulation was evaluated throughout the study.
Results
A single primary dose of each A/H1N1 vaccine formulation was sufficient to meet all three European (CHMP) licensure criteria for pandemic influenza vaccines in adult subjects. Two licensure criteria were met after one vaccine dose in elderly subjects; two primary doses were required to meet all three criteria in this age group. The highest antibody titres were observed in response to the 7.5 μg vaccine containing a full dose of MF59 adjuvant. All subjects rapidly generated seroprotective antibody titres in response to booster vaccination.
Conclusion
This study identified one 3.75 μg vaccine dose containing half the standard dose of MF59 adjuvant as optimal for adults, two doses were optimal for elderly subjects. The antigen-sparing properties of MF59, and rapid, modern, cell-culture production techniques represent significant steps towards meeting the global demand for influenza vaccine.
Highlights
► One dose of cell-culture-derived, pandemic influenza vaccine adequate for adults. ► Two doses required for the elderly. Adjuvanted vaccine well tolerated in all subjects. ► Rapid production by cell-culture helps to meet global demand for pandemic vaccines.
http://www.sciencedirect.com/science/article/pii/S0264410X12007050
Jakob P. Cramerc,
Andr? Vertruyend,
Tino F. Schwarze,
Frank von Sonnenburgf,
Astrid Borkowskig, Corresponding author contact information, E-mail the corresponding author,
Maria Lattanzig,
Anne Katrin Hilbertg,
Giovanni Della Cioppag,
Geert Leroux-Roelsh
a Division of Communicable Diseases, Institute for Social and Preventive Medicine, University of Zurich, Zurich, Switzerland
b Swiss Tropical and Public Health Institute, Basel, Switzerland
c Section Tropical Medicine, University Medical Center Hamburg-Eppendorf, Germany
d St.Vincentius Hospital, Antwerp, Belgium
e Central Laboratory and Vaccine Centre, Stiftung Juliusspital, Wuerzburg, Germany
f Department of Infectious Diseases and Tropical Medicine, University of Munich, Germany
g Novartis Vaccines and Diagnostics, Siena, Italy
h Centre for Vaccinology, Ghent University and Hospital, Belgium
Received 21 November 2011. Revised 4 May 2012. Accepted 9 May 2012. Available online 21 May 2012.
http://dx.doi.org/10.1016/j.vaccine.2012.05.013, How to Cite or Link Using DOI
Background
Modern cell-culture production techniques and the use of adjuvants helps to ensure that the global demand for pandemic influenza vaccine can be met. This study aimed to assess the immunogenicty and safety profiles of various cell-culture-derived A/H1N1 pandemic vaccine formulations in healthy adult and elderly subjects.
Methods
Adult (18?60 years) subjects (n = 544) received vaccine either containing 3.75 μg of antigen with half the standard dose of MF59? (Novartis Vaccines and Diagnostics) adjuvant, 7.5 μg antigen with a full dose of MF59, or a non-adjuvanted vaccine containing 15 μg of antigen. Elderly (≥61 years) subjects (n = 268) received either the 3.75 μg or 7.5 μg adjuvanted formulations. Two priming vaccine doses were administered 3 weeks apart, followed by a single booster dose of seasonal influenza vaccine 1 year later. Immunogenicity was assessed 3 weeks after each vaccination. The safety profile of each formulation was evaluated throughout the study.
Results
A single primary dose of each A/H1N1 vaccine formulation was sufficient to meet all three European (CHMP) licensure criteria for pandemic influenza vaccines in adult subjects. Two licensure criteria were met after one vaccine dose in elderly subjects; two primary doses were required to meet all three criteria in this age group. The highest antibody titres were observed in response to the 7.5 μg vaccine containing a full dose of MF59 adjuvant. All subjects rapidly generated seroprotective antibody titres in response to booster vaccination.
Conclusion
This study identified one 3.75 μg vaccine dose containing half the standard dose of MF59 adjuvant as optimal for adults, two doses were optimal for elderly subjects. The antigen-sparing properties of MF59, and rapid, modern, cell-culture production techniques represent significant steps towards meeting the global demand for influenza vaccine.
Highlights
► One dose of cell-culture-derived, pandemic influenza vaccine adequate for adults. ► Two doses required for the elderly. Adjuvanted vaccine well tolerated in all subjects. ► Rapid production by cell-culture helps to meet global demand for pandemic vaccines.
http://www.sciencedirect.com/science/article/pii/S0264410X12007050