Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial.

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Immunogenicity and Safety of Trivalent Split Influenza Vaccine in Healthy Korean Adults with Low Pre-Existing Antibody Levels: An Open Phase I Trial.

Yonsei Med J. 2016 Nov;57(6):1354-60

Authors: Kang K, Han S, Hong T, Jeon S, Paek J, Kang JH, Yim DS

Abstract
PURPOSE: A phase I clinical trial was conducted to evaluate the immunogenicity and safety of newly developed egg-cultivated trivalent inactivated split influenza vaccine (TIV) in Korea.
MATERIALS AND METHODS: The TIV was administered to 43 healthy male adults. Subjects with high pre-existing titers were excluded in a screening step. Immune response was measured by a hemagglutination inhibition (HI) assay.
RESULTS: The seroprotection rates against A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2009 were 74.42% [95% confidence interval (CI): 61.38-87.46], 72.09% (95% CI: 58.69-85.50), and 86.05% (95% CI: 75.69-96.40), respectively. Calculated seroconversion rates were 74.42% (95% CI: 61.38-87.46), 74.42% (95% CI: 61.38-87.46), and 79.07% (95% CI: 66.91-91.23), respectively. There were 25 episodes of solicited local adverse events in 21 subjects (47.73%), 21 episodes of solicited general adverse events in 16 subjects (36.36%) and 5 episodes of unsolicited adverse events in 5 subjects (11.36%). All adverse events were grade 1 or 2 and disappeared within three days.
CONCLUSION: The immunogenicity and safety of TIV established in this phase I trial are sufficient to plan a larger scale clinical trial.

PMID: 27593862 [PubMed - indexed for MEDLINE]

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