Trials / Completed
CompletedNCT03293732
Study of the Safety, Tolerability and Immunogenicity of an Intranasal Influenza Vaccine Administered to Healthy Adults
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- Advagene Biopharma Co. Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | DCB07010 | A protein based adjuvant originated from prokaryotic organism. |
| BIOLOGICAL | HA antigens | HA antigens from three strains of influenza virus ( 7.5 μg of HA each strain). |
Timeline
- Start date
- 2012-11-28
- Primary completion
- 2013-03-30
- Completion
- 2013-09-30
- First posted
- 2017-09-26
- Last updated
- 2020-01-07
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT03293732. Inclusion in this directory is not an endorsement.