drugset / Trial / NCT00647465
Effect of the Interferon Alpha Citizen by Sub-Lingual Way on the Humoral Immunizing Answer
Phase 3
Terminated
140 enrolled
Assistance Publique - Hôpitaux de Paris
Orakine Ltd, Dublin, Ireland · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
Influenza vaccination reduces the morbidity and mortality associated with influenza infection in at risk groups including the elderly and individuals with an impaired immune response, but is not totally protective in all recipient. Cytokines including type I interferons are known to play a key role in the innate immune response to virus infection and in the induction of the primary adaptive-immune response. Thus, we evaluated the safety of sublingual administration of IFNa and its effect on immune response to influenza vaccination in a randomized double-blind placebo controlled study in elderly institutionalized individuals.
Timeline
- Start
- 2005-10
- Primary completion
- 2006-05
- Completion
- 2008-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | interferon alfa-2b | Protein / enzyme biologic | 107 iu | Subcutaneous |