Application of DNA microarray technology to influenza A/Vietnam/1194/2004 (H5N1) vaccine safety evaluation.
We propose that DNA microarray analysis can be used in the quality control of pandemic and endemic influenza vaccine. Based on the expression profiles of 76 genes in the rat lung one day after inoculation of influenza vaccine, we can distinguish whole-virion influenza vaccine (PDv: pandemic influenza vaccine and WPv: whole virion-particle vaccine) and sub-virion vaccine (HA vaccine) from saline. Among these 76 genes, we found genes up-regulated by influenza infection, as well as genes involved in the immune response, and interferon. Hierarchical clustering of each influenza vaccine by the expression profiles of these 76 genes matched data from current quality control tests in Japan, such as the abnormal toxicity test (ATT) and the leukopenic toxicity test (LTT). Thus, it can be concluded that DNA microarray technology is an informative, rapid and highly sensitive method with which to evaluate the quality of influenza vaccines. Using DNA microarray system, consistent with the results of the ATT and LTT, it was clarified that there was no difference in vaccine quality between PDv and WPv.
Mizukami
Takuo
T
Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama, Tokyo 208-0011, Japan.
Imai
Jun-ichi
J
Hamaguchi
Isao
I
Kawamura
Mika
M
Momose
Haruka
H
Naito
Seishiro
S
Maeyama
Jun-ichi
J
Masumi
Atsuko
A
Kuramitsu
Madoka
M
Takizawa
Kazuya
K
Nomura
Nobuo
N
Watanabe
Shinya
S
Yamaguchi
Kazunari
K
D000818:Animals; D001835:Body Weight; D053124:Influenza A Virus, H5N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology; D007564:Japan; D007958:Leukocyte Count; D008168:Lung / Q000276:immunology; D008297:Male; D020411:Oligonucleotide Array Sequence Analysis / Q000379:methods*; D011786:Quality Control; D051381:Rats; D011916:Rats, Inbred F344; D022223:Vaccines, Subunit / Q000009:adverse effects / Q000276:immunology
D007252:Influenza Vaccines; D022223:Vaccines, Subunit