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Medline ® Abstract for Reference 38

of 'Hepatitis A virus infection: Prevention'

Model based estimates of long-term persistence of inactivated hepatitis A vaccine-induced antibodies in adults.
Hens N, Habteab Ghebretinsae A, Hardt K, Van Damme P, Van Herck K
Vaccine. 2014 Mar;32(13):1507-13. Epub 2014 Feb 7.
BACKGROUND: In this paper, we review the results of existing statistical models of the long-term persistence of hepatitis A vaccine-induced antibodies in light of recently available immunogenicity data from 2 clinical trials (up to 17 years of follow-up).
METHODS: Healthy adult volunteers monitored annually for 17 years after the administration of the first vaccine dose in 2 double-blind, randomized clinical trials were included in this analysis. Vaccination in these studies was administered according to a 2-dose vaccination schedule: 0, 12 months in study A and 0, 6 months in study B (NCT00289757/NCT00291876). Antibodies were measured using an in-house ELISA during the first 11 years of follow-up; a commercially available ELISA was then used up to Year 17 of follow-up. Long-term antibody persistence from studies A and B was estimated using statistical models for longitudinal data. Data from studies A and B were modeled separately.
RESULTS: A total of 173 participants in study A and 108 participants in study B were included in the analysis. A linear mixed model with 2 changepoints allowed all available results to be accounted for. Predictions based on this model indicated that 98% (95%CI: 94-100%) of participants in study A and 97% (95%CI: 94-100%) of participants in study B will remain seropositive 25 years after receiving the first vaccine dose. Other models using part of the data provided consistent results:≥95% of the participants was projected to remain seropositive for≥25 years.
CONCLUSION: This analysis, using previously used and newly selected model structures, was consistent with former estimates of seropositivity rates≥95% for at least 25 years.
Centre for Health Economic Research and Modeling Infectious Diseases (CHERMID), Vaccine&Infectious Disease Institute (WHO Collaborating Centre), University of Antwerp, Wilrijk, Belgium; Center for Statistics (CenStat), Interuniversity Institute of Biostatistics and statistical Bioinformatics (I-BioStat), Hasselt University, Diepenbeek, Belgium.