Immunogenicity and safety of influenza A (H1N1) 2009 monovalent inactivated split vaccine in Korea.
In a pandemic, the development of an effective influenza vaccine is the most important subject from the view of public health. This study was performed to evaluate the immunogenicity and safety of inactivated, monovalent H1N1 2009 vaccine (Green Cross Corporation, Yongin, Korea) among healthy adults aged 19-64 years (Group 1) and the elderly aged ≥ 65 years (Group 2) in a two-dose regimen, 21 days apart. At baseline, 28 of 454 participants (6.1%) had hemagglutination-inhibition titers of ≥ 1:40 with no significant difference between age groups (p=0.27). There was an apparent dose-dependent antibody response; participants receiving the dose of 30 μg hemagglutinin (HA) showed higher geometric mean titers (GMTs) than the 15 μg HA group in both age groups. Despite the rates of seroprotection and seroconversion were significantly higher with 30 μg HA formulation than 15 μg HA formula in Group 2, there was no definite difference in Group 1 irrespective of vaccine formula. Significant GMT elevation after the second dose was not noted in either age group, regardless vaccine formulations. No deaths, vaccine-related serious adverse events, or immediate unsolicited adverse reactions occurred during the study periods.
Division of Infectious Diseases, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea.
Hee Jin
HJ
Cheong
Joon Young
JY
Song
Jung Yeon
JY
Heo
Ji Yun
JY
Noh
Won Suk
WS
Choi
Dae Won
DW
Park
Seong-Heon
SH
Wie
Woo Joo
WJ
Kim
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000914:Antibodies, Viral / Q000097:blood; D004306:Dose-Response Relationship, Immunologic; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006805:Human Experimentation; D006801:Humans; D007117:Immunization, Secondary / Q000379:methods; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D056910:Republic of Korea; D014611:Vaccination / Q000379:methods; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D022223:Vaccines, Subunit / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D007252:Influenza Vaccines; D015164:Vaccines, Inactivated; D022223:Vaccines, Subunit