Tags

Type your tag names separated by a space and hit enter

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.
Vaccine. 2012 Jul 13; 30(33):5030-7.V

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.

Authors+Show Affiliations

CPC Clinic, Medipolis Medical Research Institute, Kagoshima, Japan.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22472791

Citation

Fukase, Hiroyuki, et al. "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." Vaccine, vol. 30, no. 33, 2012, pp. 5030-7.
Fukase H, Furuie H, Yasuda Y, et al. 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. Vaccine. 2012;30(33):5030-7.
Fukase, H., Furuie, H., Yasuda, Y., Komatsu, R., Matsushita, K., Minami, T., Suehiro, Y., Yotsuyanagi, H., Kusadokoro, H., Sawata, H., Nakura, N., & Lattanzi, M. (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. Vaccine, 30(33), 5030-7. https://doi.org/10.1016/j.vaccine.2012.03.053
Fukase H, et al. 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. Vaccine. 2012 Jul 13;30(33):5030-7. PubMed PMID: 22472791.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Fukase,Hiroyuki, AU - Furuie,Hidetoshi, AU - Yasuda,Yuji, AU - Komatsu,Ryoya, AU - Matsushita,Kenji, AU - Minami,Taketsugu, AU - Suehiro,Yutaka, AU - Yotsuyanagi,Hiroshi, AU - Kusadokoro,Haruko, AU - Sawata,Hiroshi, AU - Nakura,Noriko, AU - Lattanzi,Maria, Y1 - 2012/04/01/ PY - 2011/06/09/received PY - 2012/03/10/revised PY - 2012/03/21/accepted PY - 2012/4/5/entrez PY - 2012/4/5/pubmed PY - 2012/10/18/medline SP - 5030 EP - 7 JF - Vaccine JO - Vaccine VL - 30 IS - 33 N2 - 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22472791/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)00445-8 DB - PRIME DP - Unbound Medicine ER -