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FVH1- a DNA-based influenza vaccine · 1 trial · 6 indications
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| 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 an investigational DNA-based vaccine developed by Inovio Pharmaceuticals, Inc. (ticker INO) for the prevention of human influenza. It is designed to be given as a preventive immunization against influenza virus infection and was studied in an elderly population. It is not an approved product and remains in clinical development.
FVH1 is being developed for the prevention of influenza in humans, specifically human influenza and related respiratory viral infections. Its only recorded clinical study enrolled healthy volunteers aged 65 years and older, so the intended use studied to date is preventive immunization against influenza in the elderly.
FVH1 is developed by Inovio Pharmaceuticals, Inc., which trades under the ticker INO. Inovio is the sponsor of the clinical program for this DNA-based influenza vaccine candidate.
FVH1 is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials ongoing. It is an investigational vaccine and is not approved by the FDA or any other regulatory authority based on the development stage reached so far.
FVH1 has been studied in one completed Phase 1 trial, NCT01587131, titled "DNA-based Influenza Vaccine in the Elderly." The trial enrolled 50 participants aged 65 years and older in Canada, used a randomized, placebo-controlled design, and included healthy volunteers. No trials are currently active.
Yes. FVH1 and "FVH1, a DNA-based influenza vaccine" refer to the same Inovio Pharmaceuticals candidate. The longer form simply describes the vaccine platform, a DNA-based approach to influenza prevention, and both names point to the same Phase 1 program studied in NCT01587131.