Flu, Human Clinical Trial
Official title:
A Randomized, Double-blind Phase I Trial to Evaluate the Safety, Tolerability, and Immunogenicity of DCB07010 Adjuvant Given Intranasally at Ascending Dose Levels and Co-administered With Trivalent Inactivated Influenza Virus Antigen
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.
n/a
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