Journal
VACCINE
Volume 33, Issue 33, Pages 4124-4129Publisher
ELSEVIER SCI LTD
DOI: 10.1016/j.vaccine.2015.06.050
Keywords
Hepatitis E vaccine; Antibody persistence; Mathematical models; Immunogenicity
Categories
Funding
- Fujian Major Scientific and Technological Special Project [2014Y2101]
- Xiamen Scientific and Technological Plan Project [3502Z201410045]
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Background: The first commercialized hepatitis E vaccine, HEV 239, has been shown to be safe and highly immunogenic, the protection as well as the vaccine-induced anti-HEV maintained for at least 4.5 years. However, the longer term persistence of the vaccine-induced anti-HEV responses is unknown. Methods: Two statistical models, the power-law model and the modified power-law model, were applied to predict the long-term antibody response of the HEV 239 vaccine. The models were fit using the anti-HEV IgG data from a modeling subpopulation of 1278 baseline seronegative vaccinees who seroconverted within one month after finishing the whole vaccination course in the phase 3 trial of HEV 239. In addition, antibody data from a validation subpopulation were used to validate the robustness of the derived models. Results: In the vaccinees without pre-vaccination immunity, the power-law model and the modified power-law model estimated that the median duration of the detectable antibody (>= 0.077 WU/ml) was 8 years and 13 years, respectively. The power-law model and the modified power-law model estimated that 50% of these vaccinees will maintain detectable levels of anti-HEV IgG for 8 years and >30 years, respectively. Conclusions: The recombinant hepatitis E vaccine HEV 239 is predicted to provide from 8 years to nearly life-long persistence of anti-HEV IgG above detectable levels. Model predictions are based on conservative mathematical assumptions. (NCT01014845). (C) 2015 Elsevier Ltd. All rights reserved.
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