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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00647465
Other study ID # P050601
Secondary ID
Status Terminated
Phase Phase 3
First received March 26, 2008
Last updated March 28, 2008
Start date October 2005
Est. completion date March 2008

Study information

Verified date November 2005
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 140
Est. completion date March 2008
Est. primary completion date May 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 75 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
vaccine
IFNalpha 2b
Placebo
Placebo

Locations

Country Name City State
France Assistance Publique-Hôpitaux de Paris, Groupe Hospitalier Broca-La Rochefoucauld, Service de Gérontologie 1 Paris

Sponsors (2)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris Orakine Ltd, Dublin, Ireland

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary geometric mean of haemagglutination antibody titer obtained at day 21 with or without IFNa 21 days No
Secondary influenza virus strain-specific IgG total, IgG2a, IgG2a/IgG1 ratio, secretory IgA responses at day 21 in each group . 21 days No
Secondary influenza virus strain-specific secretory IgA anti-influenza antibody titers in saliva 14 and 21 days following vaccination. 21 days No
Secondary evaluation of individual response to IFNa treatment 21 days No
Secondary levels of serologic alpha interferon and of anti- alpha -interferon at day 21. 21 days No
Secondary Percentage of patients maintaining protective antibody titers 3 and 6 months following vaccination. 3 months and 6 months after No
Secondary Predictive factors of vaccine response (age, total lymphocyte cell count, CD4 cell count…) 21 days No
Secondary Evaluation of cellular vaccine response in a subgroup of subjects. 21 days No
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