To evaluate the efficacy of a non-adjuvant A/H1N1/2009 influenza
A vaccine (GC1115), we demonstrated the immunogenicity
and protective efficacy of GC1115 in mouse and
ferret models. The immunogenicity of GC1115 was confirmed
after intramuscular administration of 1.875, 3.75, 7.5, and
15 μg hemagglutinin antigen (HA) in mice and 7.5, 15, and
30 μg HA in ferrets at 3-week intervals. A single immunization
with GC1115 at HA doses > 7.5 μg induced detectable
seroconversion in most mice, and all mice given a second
dose exhibited high antibody responses in a dose-dependent
manner. The mice in the mock (PBS) and 1.875 μg HA immunized
groups succumbed by 13 days following A/California/
04/09 infection, while all mice in groups given more
than 3.75 μg HA were protected from lethal challenge with
the A/California/04/09 virus. In ferrets, although immunization
with even a single dose of 15 or 30 μg of HA induced
detectable HI antibodies, all ferrets given two doses of vaccine
seroconverted and exhibited HI titers greater than 80
units. Following challenge with A/California/04/09, the mock
(PBS) immunized ferrets showed influenza-like clinical symptoms,
such as increased numbers of coughs, elevated body
temperature, and body weight loss, for 7 days, while GC1115-
immunized ferrets showed attenuated clinical symptoms only
for short time period (3–4 days). Further, GC1115-immunized
ferrets displayed significantly lower viral titers in the upper
respiratory tract (nasal cavity) than the mock vaccinated group
in a dose-dependent manner. Taken together, this study demonstrates
the immunogenicity and protective efficacy of
GC1115 as a non-adjuvanted vaccine.
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