Jialei Hu1, Lei Jiao2, Yuemei Hu1, Kai Chu1, Jingxin Li1, Fengcai Zhu1, Taishun Li3, Zhiyuan Wu2, Dong Wei4, Fanyue Meng1, Bingxiang Wang2. 1. a Jiangsu Provincial Center for Diseases Control and Prevention , Nanjing , China. 2. b Lanzhou Institute of Biological Products Co.,Ltd. , Lanzhou , China. 3. c Department of Public Health , Southeast University , Nanjing , China. 4. d National Institute for Food and Drug Control , Beijing , China.
Abstract
BACKGROUND: To evaluate the one-year immunogenicity and safety of a subunit plague vaccine. METHODS: In the initial study, 240 healthy adults aged 18-55 years were administrated with 2 doses of 15 or 30 µg plague vaccines at day 0 and 28, respectively. In this extended follow-up study, we evaluated the immunogenicity and safety of the plague vaccine up to one year. RESULTS: For antibody to envelope antigen faction 1 (F1) antigen, titers were up to new peaks at month 6, then declined slowly to month 12, but remained at higher levels than those at day 56. Geometric mean titers (GMTs) of F1 were significantly higher in 30 µg group than those in 15 µg group at month 6 and 12 (P < 0.0001 and P < 0.001). However, approximate 100% seroconversion rates of F1 antibodies were found in both 15 and 30 µg groups at the both time points. For antibody to recombinant virulence (rV) antigen, titers and seroconversion rates were decreased sharply at month 6 and continue to decrease at month 12. GMTs and seroconversion rates were not significantly different between the 15 and 30 µg groups, respectively. No serious adverse events (SAEs) related to vaccine occurred. CONCLUSION: The new plague vaccine (F1+rV) induced a robust immune response up to 12 months and showed a good safety profile in adults aged 18-55 years.
BACKGROUND: To evaluate the one-year immunogenicity and safety of a subunit plague vaccine. METHODS: In the initial study, 240 healthy adults aged 18-55 years were administrated with 2 doses of 15 or 30 µg plague vaccines at day 0 and 28, respectively. In this extended follow-up study, we evaluated the immunogenicity and safety of the plague vaccine up to one year. RESULTS: For antibody to envelope antigen faction 1 (F1) antigen, titers were up to new peaks at month 6, then declined slowly to month 12, but remained at higher levels than those at day 56. Geometric mean titers (GMTs) of F1 were significantly higher in 30 µg group than those in 15 µg group at month 6 and 12 (P < 0.0001 and P < 0.001). However, approximate 100% seroconversion rates of F1 antibodies were found in both 15 and 30 µg groups at the both time points. For antibody to recombinant virulence (rV) antigen, titers and seroconversion rates were decreased sharply at month 6 and continue to decrease at month 12. GMTs and seroconversion rates were not significantly different between the 15 and 30 µg groups, respectively. No serious adverse events (SAEs) related to vaccine occurred. CONCLUSION: The new plague vaccine (F1+rV) induced a robust immune response up to 12 months and showed a good safety profile in adults aged 18-55 years.
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