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

NCT01587131 Phase 1 COMPLETED

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.

Details

Lead sponsor	University of Manitoba
Phase	Phase 1
Status	COMPLETED
Enrolment	50
Start date	2012-06
Completion	2015-03

Conditions

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

Interventions

• FVH1 - a DNA-based influenza vaccine

Primary outcomes

• 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 — Day 0 through Month 12
  Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events

Countries

Canada