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

Sponsor

Advagene Biopharma Co. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03293732

Collaborator

National Taiwan University Hospital (Other)

Enrollment

Location

Arms

10.1

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Flu, Human	Biological: DCB07010 Biological: HA antigens	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Nov 28, 2012

Actual Primary Completion Date :

Mar 30, 2013

Actual Study Completion Date :

Sep 30, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: HA antigen only All subjects in this group received 2 doses of 22.2 μg HA antigens	Biological: HA antigens HA antigens from three strains of influenza virus ( 7.5 μg of HA each strain).
Experimental: 7.5 μg of DCB07010 All subjects in this group received 7.5 μg of DCB07010 in 22.2 μg HA antigens twice.	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).
Experimental: 15 μg of DCB07010 All subjects in this group received 15 μg of DCB07010 in 22.2 μg HA antigens twice.	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).
Experimental: 30 μg of DCB07010 All subjects in this group received 30 μg of DCB07010 in 22.2 μg HA antigens twice.	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).
Experimental: 45 μg of DCB07010 All subjects in this group received 45 μg of DCB07010 in 22.2 μg HA antigens twice.	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).

Outcome Measures

Primary Outcome Measures

Geometric Mean Titers (GMT) against all three strains of viral antigen [Day=0, 28]
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.

Secondary Outcome Measures

Geometric Mean Ratio (GMR) after 2 dose of vaccines [Day=0, 28]
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.
Seroconversion Rates (SCR) measurements [Day=0, 28]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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;
Subject with acute respiratory illness or administered antibiotics or antivirals within 7 days prior to enrollment;
Subject with body temperature high than 38°C within 3 days prior to enrollment;
Subject with documented history of Bell's palsy or neurological disorder.
Subject with documented history of diarrhea within one month prior to study enrollment
A positive test for HIV antibody.
Subject has received Chinese medication or herbal medication within 28 days prior to enrollment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan Univserity Hospital	Taipei		Taiwan	10002

Sponsors and Collaborators

Advagene Biopharma Co. Ltd.
National Taiwan University Hospital

Investigators

Study Chair: Shaun-Chwen Chang, Ph.D., National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Advagene Biopharma Co. Ltd.

ClinicalTrials.gov Identifier:

NCT03293732

Other Study ID Numbers:

DCB07030-CT-01

First Posted:

Sep 26, 2017

Last Update Posted:

Jan 7, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Influenza, Human

Study Results

No Results Posted as of Jan 7, 2020