DNA-based Influenza Vaccine in the Elderly

NCT01587131 | Completed Phase 1 DMC

• 1 other identifier: B2011:131
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  Day 0 through Month 12

Secondary Outcomes (1)

• Humoral and cellular immune responses

  Day 0 through Month 12

Study Arms (3)

Group 1- DNA prime DNA boost

EXPERIMENTAL

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

Biological: FVH1 - a DNA-based influenza vaccine

Group 2 - DNA prime Seasonal Vaccine boost

EXPERIMENTAL

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

Biological: FVH1 - a DNA-based influenza vaccine

Group 3 - sWFI prime Seasonal Vaccine boost

PLACEBO COMPARATOR

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

Biological: FVH1 - a DNA-based influenza vaccine

Interventions

FVH1 - a DNA-based influenza vaccine BIOLOGICAL

0.9 mg FVH1 vaccine

Group 1- DNA prime DNA boost; Group 2 - DNA prime Seasonal Vaccine boost; Group 3 - sWFI prime Seasonal Vaccine boost

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead
• Inovio Pharmaceuticals: collaborator

Study Sites (1)

MS Building Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Infections

Study Officials

• Gary Kobinger, PhD

  National Microbiology & University of Manitoba

  PRINCIPAL INVESTIGATOR

• Trina Racine, PhD

  National Microbiology Laboratory, Canada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 27, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: March 1, 2015
• Last Updated: April 17, 2015

Record last verified: 2013-01

Locations

CA (1)