Title Efficacy of A/H1N1/2009 split inactivated influenza A vaccine (GC1115) in mice and ferrets
Author Hae Jung Han1,2, Min-Suk Song1, Su-Jin Park1, Han Yeul Byun2, Norbert John C. Robles1, Suk-Hoon Ha2, and Young Ki Choi1*
Address 1College of Medicine and Medical Research Institute, Chungbuk National University, Cheongju 28644, Republic of Korea, 2Research & Development Center, GC Pharma., Yongin 16924, Republic of Korea
Bibliography Journal of Microbiology, 57(2),163–169, 2019,
DOI 10.1007/s12275-019-8504-1
Key Words H1N1 pandemic, influenza, vaccination, immunogenicity, protective efficacy
Abstract 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.