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DNA-based Influenza Vaccine in the Elderly

Primary Purpose

Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

FVH1 - a DNA-based influenza vaccine

About this trial

This is an interventional prevention trial for Influenza, Human focused on measuring Universal Influenza, Intradermal DNA-Based Vaccine, Senior, Electroporation, H1, Influenza, FVH1

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Written informed consent in accordance with institutional guidelines;
Adults of either gender ≥ 65 years of age at entry;
Healthy subjects, as judged by the Qualified Investigator based on medical history, physical examination, and normal results of an electrocardiogram (ECG), complete blood count (CBC), serum chemistries, and urinalysis done up to 4 weeks prior to enrollment and administration of vaccine or placebo by ID/EP;
Current non-smoker (for 3 months prior to vaccine study);
Willing to forego any other influenza vaccination during the study;
Able and willing to comply with all study procedures.

Exclusion Criteria:

Any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site (excluding inhaled and eye drop-containing corticosteroids) or the use of other immunosuppressive agents. All other corticosteroids must be discontinued ≥ 4 weeks prior to Day 1 of study vaccine administration;
Administration of any blood product within 3 months of enrollment;
Subjects with contraindications to influenza vaccination other than egg allergy (such as a history of Guillain-Barre Syndrome after receiving influenza vaccine);
Administration of any vaccine within 6 weeks of enrollment; subjects may not receive any licensed seasonal influenza vaccine during the study unless they have been assigned to a study group receiving the seasonal vaccine;
Participation in a study with an investigational compound or device within 4 weeks of signing informed consent;
Subjects with cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
Subjects with a history of seizures (unless seizure free for 5 years);
Subjects with tattoos, scars, or active lesions/rashes within 2 cm of the site of vaccination + EP;
Subjects with any implanted heart leads;
Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements;
Prisoner subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study;
Any other conditions judged by the investigator that would limit the evaluation of a subject.

Sites / Locations

MS Building Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Group 1- DNA prime DNA boost

Group 2 - DNA prime Seasonal Vaccine boost

Group 3 - sWFI prime Seasonal Vaccine boost

Arm Description

0.9 mg of FVH1 vaccine delivered ID followed by electroporation on Day 0, Week 15 and Week 27

0.9 mg FVH1 vaccine delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15

100 microliters of sterile water for injection delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15

Outcomes

Primary Outcome Measures

Safety and tolerability of a DNA-based influenza vaccine composed of a combination of two different H1 HA plasmids administered ID followed by electroporation in healthy elderly adult subjects

Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events

Secondary Outcome Measures

Humoral and cellular immune responses

Magnitude and frequency of antibody and cell mediated immune response to influenza proteins

Full Information

NCT ID

NCT01587131

First Posted

April 25, 2012

Last Updated

April 16, 2015

Sponsor

University of Manitoba

Collaborators

Inovio Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01587131

Brief Title

DNA-based Influenza Vaccine in the Elderly

Official Title

Phase I, Open Label Study of a DNA Vaccine's Ability to Increase the Immune Response to the Trivalent Seasonal Influenza Vaccine in the Elderly

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Manitoba

Collaborators

Inovio Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether FVH1, a DNA-based influenza vaccine, will be safe and generally well tolerated in healthy elderly adult volunteers and will result in greater immunogenicity when used to prime the immune response to a dose of a trivalent inactivated seasonal vaccine.

Detailed Description

The use of DNA plasmids containing genes that express viral antigens may be a promising way to formulate a vaccine that can effectively prevent infection and disease caused by the H1N1 influenza virus. Plasmid vectors are simple to construct and are easy to manufacture at a relatively low cost. Vaccination with plasmids that express influenza proteins should induce the development of serum antibodies and might also induce significant quantities of secretory IgA antibodies and/or CMI. The DNA sequences included in the vaccine could also result in the proliferation of T lymphocytes that could broaden the effectiveness of the vaccine to include variant strains of H1N1 with antigenically modified HA (i.e., drifted strains). Electroporation (EP) is a technology in which a transmembrane electrical field is applied to increase the permeability of cell membranes to create microscopic pathways (pores) and thereby enhance the uptake of drugs, vaccines, or other agents into target cells. Their presence allows macromolecules, ions, and water to pass from one side of the membrane to the other. The presence of a constant field influences the kinetics of directional translocation of the macromolecular plasmid, such that the plasmid delivery in vivo has been sufficient to achieve physiological levels of secreted proteins. ID injection of a plasmid followed by EP has been used very successfully to deliver therapeutic genes that encode for a variety of hormones, cytokines, or enzymes in a variety of species. EP is currently being used in humans to deliver cancer vaccines and therapeutics as well as in gene therapy. The expression levels are increased by as much as 3 orders of magnitude over plasmid injection alone. The use of EP via the CELLECTRA® device should increase the expression of H1N1 influenza virus genes in the study vaccine.

6. Conditions and Keywords

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

Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases

Keywords

Universal Influenza, Intradermal DNA-Based Vaccine, Senior, Electroporation, H1, Influenza, FVH1

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1- DNA prime DNA boost

Arm Type

Experimental

Arm Description

0.9 mg of FVH1 vaccine delivered ID followed by electroporation on Day 0, Week 15 and Week 27

Arm Title

Group 2 - DNA prime Seasonal Vaccine boost

Arm Type

Experimental

Arm Description

0.9 mg FVH1 vaccine delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15

Arm Title

Group 3 - sWFI prime Seasonal Vaccine boost

Arm Type

Placebo Comparator

Arm Description

100 microliters of sterile water for injection delivered ID followed by electroporation on Day 0 and Trivalent Seasonal Influenza Vaccine delivered IM on Week 15

Intervention Type

Biological

Intervention Name(s)

FVH1 - a DNA-based influenza vaccine

Intervention Description

0.9 mg FVH1 vaccine

Primary Outcome Measure Information:

Title

Safety and tolerability of a DNA-based influenza vaccine composed of a combination of two different H1 HA plasmids administered ID followed by electroporation in healthy elderly adult subjects

Description

Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events

Time Frame

Day 0 through Month 12

Secondary Outcome Measure Information:

Title

Humoral and cellular immune responses

Description

Magnitude and frequency of antibody and cell mediated immune response to influenza proteins

Time Frame

Day 0 through Month 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent in accordance with institutional guidelines; Adults of either gender ≥ 65 years of age at entry; Healthy subjects, as judged by the Qualified Investigator based on medical history, physical examination, and normal results of an electrocardiogram (ECG), complete blood count (CBC), serum chemistries, and urinalysis done up to 4 weeks prior to enrollment and administration of vaccine or placebo by ID/EP; Current non-smoker (for 3 months prior to vaccine study); Willing to forego any other influenza vaccination during the study; Able and willing to comply with all study procedures. Exclusion Criteria: Any concurrent condition requiring the continued use of systemic or topical steroids at or near the injection site (excluding inhaled and eye drop-containing corticosteroids) or the use of other immunosuppressive agents. All other corticosteroids must be discontinued ≥ 4 weeks prior to Day 1 of study vaccine administration; Administration of any blood product within 3 months of enrollment; Subjects with contraindications to influenza vaccination other than egg allergy (such as a history of Guillain-Barre Syndrome after receiving influenza vaccine); Administration of any vaccine within 6 weeks of enrollment; subjects may not receive any licensed seasonal influenza vaccine during the study unless they have been assigned to a study group receiving the seasonal vaccine; Participation in a study with an investigational compound or device within 4 weeks of signing informed consent; Subjects with cardiac pre-excitation syndromes (such as Wolff-Parkinson-White); Subjects with a history of seizures (unless seizure free for 5 years); Subjects with tattoos, scars, or active lesions/rashes within 2 cm of the site of vaccination + EP; Subjects with any implanted heart leads; Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements; Prisoner subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (i.e. infections disease) illness must not be enrolled into this study; Any other conditions judged by the investigator that would limit the evaluation of a subject.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Kobinger, PhD

Organizational Affiliation

National Microbiology & University of Manitoba

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Trina Racine, PhD

Organizational Affiliation

National Microbiology Laboratory, Canada

Official's Role

Study Director

Facility Information:

Facility Name

MS Building Health Sciences Centre

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

DNA-based Influenza Vaccine in the Elderly

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