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FVH1- a DNA-based influenza vaccine · 1 trial · 6 indications
Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| FVH1 - a DNA-based influenza vaccine | BIOLOGICAL | 0.9 mg FVH1 vaccine |
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 (E...
FVH1 is a DNA-based influenza vaccine being developed for the prevention of influenza in humans. It is designed to generate an immune response against influenza viruses. The vaccine is currently in clinical development and has been studied in a Phase 1 trial involving elderly participants.
FVH1 is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol INO. Inovio focuses on DNA-based immunotherapies and vaccines, and FVH1 is one of its investigational vaccine candidates for influenza.
FVH1 is in Phase 1 of clinical development. It is an investigational DNA-based influenza vaccine that has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the vaccine remains in early-stage clinical testing.
FVH1 has been studied in one clinical trial with the identifier NCT01587131, titled 'DNA-based Influenza Vaccine in the Elderly.' This Phase 1 trial was completed and enrolled 50 participants aged 65 years and older in Canada. The trial was randomized and placebo-controlled.
Yes, FVH1 is a DNA-based influenza vaccine. It is designed to deliver DNA encoding influenza antigens to stimulate an immune response. The vaccine is being evaluated for its safety and immunogenicity in elderly populations, as seen in the completed Phase 1 trial.