Effect of the Interferon Alpha Citizen by Sub-Lingual Way on the Humoral Immunizing Answer

• Status: Terminated
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Orakine Ltd, Dublin, Ireland
• Treatments: Interferons; Vaccines

Criteria

Inclusion Criteria:

• Subjects aged 75 or more, -institutionalized-

• Subjects who were informed of the objectives of the study and who have given their written consent.

• Subjects who have received at least one prior influenza vaccination in the previous 5 years.

• Subjects who should be vaccinated against influenza during the 2005 vaccination campaign.

Exclusion Criteria:

• Individuals with severe disease, including neoplasia, autoimmune disease, or type I diabetes

• concomitant treatment with glucocorticoid or immunosuppressive drugs splenectomy or tonsillectomy

• or incapacity to open the mouth