SYFa89f2bd280ee4e3eb63de83505bf38bfRegistry ID: 2023-509178-44-00|RecruitingPhase 4
Avian influenza vaccine immunity
Avian and seasonal influenza vaccine induced immune responses
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interventional
N/A
1 country
1
The main objective of this study is to evaluate the humoral and cell-mediated immune responses induced by the customized avian influenza vaccine, specifically against the H5N1 2.3.4.4b clade.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
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December 21, 2023
Actual (reported)Primary outcome measure: Seroconversion proportion in all study subjects 3 weeks after the second dose given at least 21 days after the first dose, as assessed by the microneutralization test
Rate of seroconversion defined as the percentage of subjects with either a pre-vaccination MNT titer < 1:10 and a post vaccination MNT titer ≥ 1:80 or a pre-vaccination MNT titer ≥ 1:10 and a minimum four-fold rise in post-vaccination HI antibody titer.
Geometric mean titers at pre- and post-vaccination
Detectable increase in T cell (CD4+ and CD8+) responses against H5N1 virus specific antigens in avian influenza virus vaccinated individuals
Finnish Institute For Health And Welfare
Helsinki, 00300, Finland
Hanna Nohynek
First Submitted
December 21, 2023
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