The objectives of this study were to assess the safety and tolerability of DCB07010 when given intranasally at escalating dose levels of 7.5μg, 15μg, 30μg and 45μg, in combination with 22.5μg of influenza HA antigen (7.5μg HA of each of three strains) and to generate sufficient immunogenicity data to enable dose selection for larger and more definitive Phase 2 studies. This was a single center, double-blind, randomized (2:1), dose-escalation study to assess the safety, tolerability and immunogenicity of 4 different vaccine-adjuvant doses in comparison to influenza HA alone. The 4 treatment cohorts were given DCB07010 in a dose- escalating manner.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
36
A protein based adjuvant originated from prokaryotic organism.
HA antigens from three strains of influenza virus ( 7.5 μg of HA each strain).
National Taiwan Univserity Hospital
Taipei, Taiwan
Geometric Mean Titers (GMT) against all three strains of viral antigen
Geometric Mean Titers (GMT) against all three strains of viral antigen after 2 doses of DCB07010 adjuvanted egg-derived vaccines or egg-derived vaccine. The geometric mean titers against all three-vaccine strains were assessed by egg-derived antigen haemagglutination inhibition (HI) assay. Statistic tests were two-sided and were set for alpha = 0.05. The purpose of this study was exploratory in safety and the formal statistical analysis was not necessary.
Time frame: Day=0, 28
Geometric Mean Ratio (GMR) after 2 dose of vaccines
Geometric Mean Ratio (GMR) after 2 dose of egg-based vaccine and DCB07010-adjuvanted vaccines. Statistic tests were two-sided and were set for alpha = 0.05. The purpose of this study was exploratory in safety and the formal statistical analysis was not necessary.
Time frame: Day=0, 28
Seroconversion Rates (SCR) measurements
Seroconversion Rates (SCR) is defined the percentage of subjects with pre-vaccination HI titers \< 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer to each of the three vaccine components on Day 28.
Time frame: Day=0, 28
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