tetano
Editor, Senior Moderator
Vaccine
Available online 31 March 2012
Assessment of the immunogenicity and safety of varying doses of an MF59?-adjuvanted cell culture-derived A/H1N1 pandemic influenza vaccine in Japanese paediatric, adult and elderly subjects
Hiroyuki Fukasea,
Hidetoshi Furuieb,
Yuji Yasudac,
Ryoya Komatsud,
Kenji Matsushitae,
Taketsugu Minamif,
Yutaka Suehirog,
Hiroshi Yotsuyanagih,
Haruko Kusadokoroi,
Hiroshi Sawatai,
Noriko Nakurai,
Maria Lattanzij, Corresponding author contact information, E-mail the corresponding author
a CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan
b Heishinkai Medical Group Incorporated, Osaka Pharmacology Clinical Research Hospital, Osaka, Japan
c Yasuda Clinic, Kyoto, Japan
d Ryoya Komatsu Clinic, Osaka, Japan
e Kamoike Seikyou Clinic, Kagoshima, Japan
f Minami Clinic, Kagoshima, Japan
g Saiseikai Nakatsu Hospital, Osaka, Japan
h The University of Tokyo, Faculty of Medicine, University Hospital Infectious Diseases, Tokyo, Japan
i Novartis Pharma, Tokyo, Japan
j Novartis Vaccines and Diagnostics, Siena, Italy
Received 9 June 2011. Revised 10 March 2012. Accepted 21 March 2012. Available online 31 March 2012.
http://dx.doi.org/10.1016/j.vaccine.2012.03.053,
Abstract
Introduction
Effective vaccination strategies are required to combat future influenza pandemics. Here we report the results of three independent clinical trials performed in Japan to assess the immunogenicity, tolerability and safety of varying doses of a cell culture-derived MF59?-adjuvanted A/H1N1 pandemic vaccine in healthy Japanese paediatric, adult and elderly subjects.
Methods
One hundred and twenty-three children (6 months?18 years), and 200 adults (19?60 years) were randomly assigned in a 1:1 ratio to receive two doses of vaccine containing either 7.5 μg antigen with a full (9.75 mg) adjuvant dose, or 3.75 μg antigen with a half (4.875 mg) adjuvant dose. One hundred elderly (≥61 years) subjects received only the low antigen/adjuvant vaccine formulation. Immunogenicity was assessed by haemagglutination inhibition assay at baseline and three weeks after the first and second vaccine doses on Days 22 and 43, respectively. Solicited and unsolicited adverse reactions were recorded for seven and 21 days post-immunization, respectively.
Results
In adult and elderly subjects, a single low antigen/adjuvant dose vaccination was sufficient to meet all of the three European licensure criteria established for influenza vaccines. One high, or two low antigen/adjuvant dose vaccinations were required to meet the licensure criteria in paediatric subjects. Both vaccine formulations were well tolerated, with the majority of adverse reactions mild to moderate in severity. None of the five serious adverse events reported throughout the three trials were considered to be vaccine-related by the investigators.
Conclusion
The use of MF59 adjuvant allows for much reduced vaccine antigen content, and a single dose administration schedule in adults and the elderly. The production of pandemic vaccine using modern cell culture techniques is highly advantageous in terms of the quantity, quality, and rapidity of antigen production; these benefits, in combination with the use of MF59, maximize manufacturing capacity and global vaccine supply. These data support the suitability of the investigational vaccine for use in the Japanese paediatric, adult, and elderly populations.
Highlights
► Immunogenicity and safety of a novel cell culture-derived A/H1N1 influenza vaccine. ► Antigen/adjuvant dose range study in Japanese infants, children, adults, and elderly subjects. ► One low-dose required in adults and the elderly. One high-dose required for children.
http://www.sciencedirect.com/science/article/pii/S0264410X12004458
Available online 31 March 2012
Assessment of the immunogenicity and safety of varying doses of an MF59?-adjuvanted cell culture-derived A/H1N1 pandemic influenza vaccine in Japanese paediatric, adult and elderly subjects
Hiroyuki Fukasea,
Hidetoshi Furuieb,
Yuji Yasudac,
Ryoya Komatsud,
Kenji Matsushitae,
Taketsugu Minamif,
Yutaka Suehirog,
Hiroshi Yotsuyanagih,
Haruko Kusadokoroi,
Hiroshi Sawatai,
Noriko Nakurai,
Maria Lattanzij, Corresponding author contact information, E-mail the corresponding author
a CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan
b Heishinkai Medical Group Incorporated, Osaka Pharmacology Clinical Research Hospital, Osaka, Japan
c Yasuda Clinic, Kyoto, Japan
d Ryoya Komatsu Clinic, Osaka, Japan
e Kamoike Seikyou Clinic, Kagoshima, Japan
f Minami Clinic, Kagoshima, Japan
g Saiseikai Nakatsu Hospital, Osaka, Japan
h The University of Tokyo, Faculty of Medicine, University Hospital Infectious Diseases, Tokyo, Japan
i Novartis Pharma, Tokyo, Japan
j Novartis Vaccines and Diagnostics, Siena, Italy
Received 9 June 2011. Revised 10 March 2012. Accepted 21 March 2012. Available online 31 March 2012.
http://dx.doi.org/10.1016/j.vaccine.2012.03.053,
Abstract
Introduction
Effective vaccination strategies are required to combat future influenza pandemics. Here we report the results of three independent clinical trials performed in Japan to assess the immunogenicity, tolerability and safety of varying doses of a cell culture-derived MF59?-adjuvanted A/H1N1 pandemic vaccine in healthy Japanese paediatric, adult and elderly subjects.
Methods
One hundred and twenty-three children (6 months?18 years), and 200 adults (19?60 years) were randomly assigned in a 1:1 ratio to receive two doses of vaccine containing either 7.5 μg antigen with a full (9.75 mg) adjuvant dose, or 3.75 μg antigen with a half (4.875 mg) adjuvant dose. One hundred elderly (≥61 years) subjects received only the low antigen/adjuvant vaccine formulation. Immunogenicity was assessed by haemagglutination inhibition assay at baseline and three weeks after the first and second vaccine doses on Days 22 and 43, respectively. Solicited and unsolicited adverse reactions were recorded for seven and 21 days post-immunization, respectively.
Results
In adult and elderly subjects, a single low antigen/adjuvant dose vaccination was sufficient to meet all of the three European licensure criteria established for influenza vaccines. One high, or two low antigen/adjuvant dose vaccinations were required to meet the licensure criteria in paediatric subjects. Both vaccine formulations were well tolerated, with the majority of adverse reactions mild to moderate in severity. None of the five serious adverse events reported throughout the three trials were considered to be vaccine-related by the investigators.
Conclusion
The use of MF59 adjuvant allows for much reduced vaccine antigen content, and a single dose administration schedule in adults and the elderly. The production of pandemic vaccine using modern cell culture techniques is highly advantageous in terms of the quantity, quality, and rapidity of antigen production; these benefits, in combination with the use of MF59, maximize manufacturing capacity and global vaccine supply. These data support the suitability of the investigational vaccine for use in the Japanese paediatric, adult, and elderly populations.
Highlights
► Immunogenicity and safety of a novel cell culture-derived A/H1N1 influenza vaccine. ► Antigen/adjuvant dose range study in Japanese infants, children, adults, and elderly subjects. ► One low-dose required in adults and the elderly. One high-dose required for children.
http://www.sciencedirect.com/science/article/pii/S0264410X12004458