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

NCT00647465 | Terminated Phase 3 DMC

• 1 other identifier: P050601
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza Infection

Keywords

Influenza vaccine; interferon; adjuvant; the elderly

Outcome Measures

Primary Outcomes (1)

• Percentage of subjects presenting an increase > 4 fold of antiH1N1 or antiH3N2 or anti-B haemagglutination inhibition antibody titer, 3 weeks following influenza vaccination.

  21 days

Secondary Outcomes (8)

• geometric mean of haemagglutination antibody titer obtained at day 21 with or without IFNa

  21 days

• influenza virus strain-specific IgG total, IgG2a, IgG2a/IgG1 ratio, secretory IgA responses at day 21 in each group .

  21 days

• influenza virus strain-specific secretory IgA anti-influenza antibody titers in saliva 14 and 21 days following vaccination.

  21 days

• evaluation of individual response to IFNa treatment

  21 days

• levels of serologic alpha interferon and of anti- alpha -interferon at day 21.

  21 days

Study Arms (2)

1

ACTIVE COMPARATOR

IFNalpha 2b

Drug: vaccine

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

vaccine DRUG

IFNalpha 2b

Also known as: Influenza vaccination

1

Placebo DRUG

Placebo

2

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Orakine Ltd, Dublin, Ireland: collaborator

Study Sites (1)

Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Broca-La Rochefoucauld, Service de Gérontologie 1

Paris, 75005, France

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Vaccines; Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Viral Vaccines

Study Officials

• Frederic Bloch, MD, PhD

  Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Broca-La Rochefoucauld, Service de Gérontologie 1 AP-HP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2008
• First Posted: March 31, 2008
• Study Start: October 1, 2005
• Primary Completion: May 1, 2006
• Study Completion: March 1, 2008
• Last Updated: March 31, 2008

Record last verified: 2005-11

Locations

FR (1)