NCT03293732

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2013

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
Last Updated

January 7, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

September 19, 2017

Last Update Submit

January 6, 2020

Conditions

Flu, Human

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day=0, 28

Secondary Outcomes (2)

  • Geometric Mean Ratio (GMR) after 2 dose of vaccines

    Day=0, 28

  • Seroconversion Rates (SCR) measurements

    Day=0, 28

Study Arms (5)

HA antigen only

ACTIVE COMPARATOR

All subjects in this group received 2 doses of 22.2 μg HA antigens

Biological: HA antigens

7.5 μg of DCB07010

EXPERIMENTAL

All subjects in this group received 7.5 μg of DCB07010 in 22.2 μg HA antigens twice.

Biological: DCB07010Biological: HA antigens

15 μg of DCB07010

EXPERIMENTAL

All subjects in this group received 15 μg of DCB07010 in 22.2 μg HA antigens twice.

Biological: DCB07010Biological: HA antigens

30 μg of DCB07010

EXPERIMENTAL

All subjects in this group received 30 μg of DCB07010 in 22.2 μg HA antigens twice.

Biological: DCB07010Biological: HA antigens

45 μg of DCB07010

EXPERIMENTAL

All subjects in this group received 45 μg of DCB07010 in 22.2 μg HA antigens twice.

Biological: DCB07010Biological: HA antigens

Interventions

DCB07010BIOLOGICAL

A protein based adjuvant originated from prokaryotic organism.

15 μg of DCB0701030 μg of DCB0701045 μg of DCB070107.5 μg of DCB07010
HA antigensBIOLOGICAL

HA antigens from three strains of influenza virus ( 7.5 μg of HA each strain).

15 μg of DCB0701030 μg of DCB0701045 μg of DCB070107.5 μg of DCB07010HA antigen only

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Non-smoking adult aged between 20-40 years old;
  • Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, chest X-rays, ophthalmoscopy, cardiac echo, and electrocardiogram;
  • Body Mass Index (BMI) between 18.5 and 25, inclusive, (BMI will be calculated as weight in kilogram \[kg\]/height in meters2 \[m2\]);
  • Normal hematology, biochemistry and urinalysis determinations;
  • Subject is willing and able to comply with study procedures and sign informed consent

You may not qualify if:

  • Subject with serious underlying chronic illness;
  • Documented evidence of allergic rhinitis;
  • Subject with acute sinusitis or chronic sinusitis accompanying acute symptoms within 3 days prior to enrollment;
  • Immunosuppressed subjects as result of illness or treatment;
  • Female subject of childbearing potential who:
  • is lactating; or
  • has positive urine pregnancy test at Visit 2 or Visit 3; or
  • refuse to adopt reliable method of contraception during the study;
  • Subject received blood products or immunoglobulin within 3 months prior enrollment;
  • Subjects with long-term use of steroids, including parenteral steroids or high dose inhaled steroids within 28 days prior to enrollment;
  • Subject has received any intranasal medication or nasal topical treatment within 7 days prior to enrollment;
  • Subject has received any investigational agent within 28 days or 5 half- lives, whichever is longer, prior to the first dose of investigational product;
  • Subject has previously experienced anaphylaxis;
  • Subject has allergy to eggs or prior influenza vaccine;
  • Subject with laboratory-confirmed influenza or has been vaccinated against influenza within 6 months prior to enrollment;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univserity Hospital

Taipei, 10002, Taiwan

Location

Related Publications (1)

  • Pan SC, Hsieh SM, Lin CF, Hsu YS, Chang M, Chang SC. A randomized, double-blind, controlled clinical trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with adjuvant LTh(alphaK): A phase I study. Vaccine. 2019 Mar 28;37(14):1994-2003. doi: 10.1016/j.vaccine.2019.02.006. Epub 2019 Mar 2.

    PMID: 30837170DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Shaun-Chwen Chang, Ph.D.

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 26, 2017

Study Start

November 28, 2012

Primary Completion

March 30, 2013

Study Completion

September 30, 2013

Last Updated

January 7, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)