DNA-based Influenza Vaccine in the Elderly

Phase 1

Waitlist Available

Led By Gary Kobinger, PhD

Research Sponsored by University of Manitoba

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 0 through month 12

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.

Eligible Conditions

Central Nervous System Viral Infection
Flu-Related Pain
Congenital Upper Airway Disorders
Influenza (Flu)
Acute Viral Respiratory Infection
Viral Infections
Respiratory Diseases
Viral Diseases
Flu
Respiratory Infection
RNA Virus Infections

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 through month 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 through month 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 through month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Humoral and cellular immune responses

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Group 2 - DNA prime Seasonal Vaccine boostExperimental Treatment1 Intervention

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

Group II: Group 1- DNA prime DNA boostExperimental Treatment1 Intervention

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

Group III: Group 3 - sWFI prime Seasonal Vaccine boostPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

FVH1 - a DNA-based influenza vaccine

2012

Completed Phase 1

~50

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