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

Primary Purpose

Flu, Human

Status

Completed

Phase

Phase 1

Locations

Taiwan

Study Type

Interventional

Intervention

DCB07010

HA antigens

About this trial

This is an interventional prevention trial for Flu, Human

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

National Taiwan Univserity Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Arm Label

HA antigen only

7.5 μg of DCB07010

15 μg of DCB07010

30 μg of DCB07010

45 μg of DCB07010

Arm Description

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

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Geometric Mean Ratio (GMR) after 2 dose of vaccines

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

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.

Full Information

NCT ID

NCT03293732

First Posted

September 19, 2017

Last Updated

January 6, 2020

Sponsor

Advagene Biopharma Co. Ltd.

Collaborators

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03293732

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

November 28, 2012 (Actual)

Primary Completion Date

March 30, 2013 (Actual)

Study Completion Date

September 30, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Advagene Biopharma Co. Ltd.

Collaborators

National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Flu, Human

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HA antigen only

Arm Type

Active Comparator

Arm Description

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

Arm Title

7.5 μg of DCB07010

Arm Type

Experimental

Arm Description

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

Arm Title

15 μg of DCB07010

Arm Type

Experimental

Arm Description

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

Arm Title

30 μg of DCB07010

Arm Type

Experimental

Arm Description

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

Arm Title

45 μg of DCB07010

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

DCB07010

Intervention Description

A protein based adjuvant originated from prokaryotic organism.

Intervention Type

Biological

Intervention Name(s)

HA antigens

Intervention Description

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

Primary Outcome Measure Information:

Title

Geometric Mean Titers (GMT) against all three strains of viral antigen

Description

Time Frame

Day=0, 28

Secondary Outcome Measure Information:

Title

Geometric Mean Ratio (GMR) after 2 dose of vaccines

Description

Time Frame

Day=0, 28

Title

Seroconversion Rates (SCR) measurements

Description

Time Frame

Day=0, 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaun-Chwen Chang, Ph.D.

Organizational Affiliation

National Taiwan University Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

National Taiwan Univserity Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30837170

Citation

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.

Results Reference

derived

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

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