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Study of the Safety, Tolerability and Immunogenicity of an Intranasal Influenza Vaccine Administered to Healthy Adults

NCT03293732 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-01-07

No results posted yet for this study

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

  • Flu, Human

Interventions

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).

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER

  • Advagene Biopharma Co. Ltd.

    lead INDUSTRY

Principal Investigators

  • Shaun-Chwen Chang, Ph.D. · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-28
Primary Completion
2013-03-30
Completion
2013-09-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03293732 on ClinicalTrials.gov