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Effect of the Interferon Alpha Citizen by Sub-Lingual Way on the Humoral Immunizing Answer (GP-INFA)

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ClinicalTrials.gov Identifier: NCT00647465
Recruitment Status : Terminated (End of the study)
First Posted : March 31, 2008
Last Update Posted : March 31, 2008
Orakine Ltd, Dublin, Ireland
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Influenza Infection Drug: vaccine Drug: Placebo Phase 3

Detailed Description:

The protection afforded by the commonly used influenza sub-unit vaccines is thought to be due principally to the production of antibodies to viral haemagglutinin. The haemagglutination inhibitory (HAI) antibody titer is generally used as a surrogate marker of protection and a HAI antibody titer of 1:40 or greater is considered to confer protection. This is attained, however, in only 50% of elderly subject. Thus, there is an unmet need for an effective non-toxic adjuvant capable of enhancing the antibody response to influenza and other vaccines. Type I IFNs have been shown to induce B-lymphocytes to differentiate into antibody producing plasma cells and to be necessary for the production of both specific and polyclonal IgGs in response to influenza infection. Furthermore, type I IFNs increase the primary antibody response to a soluble antigen in vivo, and increase the production of all IgG sub-classes. Type I IFNs play a key role in adjuvant-induced Th1 responses. Thus, we evaluated the safety of sublingual administration of IFNa and its effect on immune response to influenza vaccination.Institutionalized subjects, aged 75 or more, were randomly assigned to two groups to receive in a double-blind fashion either 107 IU of Intron ATM in 1 ml of isotonic saline or 1 ml of saline alone (placebo) administered sublingually. Interferon or placebo were retained in the mouth for at least 30 seconds prior to ejection. All subjects were then vaccinated, within 30 minutes, with a single intramuscular injection (im) of influenza vaccine (InfluvacTM, Solvay Pharma, France).

The primary objective of this study is to compare the immunogenicity percentage of subjects who increased up to 4 fold their HAI antibody titer at day 21) obtained in the IFN treated group relative to the placebo treated group.

The secondary objectives are to compare mean HAI antibodies titers obtained in the two groups at day 21 ; specific IgG, IgG2a, IgG2a/IgG1 ratio and secretory IgA titers in the 2 groups; specific secretory IgA titers in saliva; durability of protective HAI antibodies titers 3 and 6 months after the vaccination and the safety of sublingual administration of IFNa.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Randomized Double-Blind Placebo Controlled Study Evaluating the Effect of Sublingual Administration of IFNa on the Immune Response to Influenza Vaccination in Subjects Aged 75 or More.
Study Start Date : October 2005
Primary Completion Date : May 2006
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
IFNalpha 2b
Drug: vaccine
IFNalpha 2b
Other Name: Influenza vaccination
Placebo Comparator: 2
Drug: Placebo

Primary Outcome Measures :
  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. [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. geometric mean of haemagglutination antibody titer obtained at day 21 with or without IFNa [ Time Frame: 21 days ]
  2. influenza virus strain-specific IgG total, IgG2a, IgG2a/IgG1 ratio, secretory IgA responses at day 21 in each group . [ Time Frame: 21 days ]
  3. influenza virus strain-specific secretory IgA anti-influenza antibody titers in saliva 14 and 21 days following vaccination. [ Time Frame: 21 days ]
  4. evaluation of individual response to IFNa treatment [ Time Frame: 21 days ]
  5. levels of serologic alpha interferon and of anti- alpha -interferon at day 21. [ Time Frame: 21 days ]
  6. Percentage of patients maintaining protective antibody titers 3 and 6 months following vaccination. [ Time Frame: 3 months and 6 months after ]
  7. Predictive factors of vaccine response (age, total lymphocyte cell count, CD4 cell count…) [ Time Frame: 21 days ]
  8. Evaluation of cellular vaccine response in a subgroup of subjects. [ Time Frame: 21 days ]

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Ages Eligible for Study:   75 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647465

Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Broca-La Rochefoucauld, Service de Gérontologie 1
Paris, France, 75005
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Orakine Ltd, Dublin, Ireland
Principal Investigator: Frederic Bloch, MD, PhD Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Broca-La Rochefoucauld, Service de Gérontologie 1 AP-HP

Responsible Party: Mathieu QUINTIN, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00647465     History of Changes
Other Study ID Numbers: P050601
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: March 31, 2008
Last Verified: November 2005

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Influenza vaccine
the elderly

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents