Vaccination Against Influenza in Autoimmune Diseases - Full Text View

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01065285

Purpose

The project is to evaluate immunogenicity, efficacy and tolerance of vaccination against influenza (seasonal and H1N1) in patients affected with systemic and autoimmune diseases.

Condition	Intervention	Phase
Autoimmune Diseases	Biological: Evaluation of vaccines against flu	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of Vaccination Against Influenza (Seasonal and H1N1) in Patients Presenting Systemic or Autoimmune Diseases Treated or Not With Steroids, and/or Immunosuppressant, and/or Biotherapy: an Open, Prospective Trial (MAIVAX)

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases Flu

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Protection against H1N1 influenza, defined by antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Mesure of antibody level of 1/40, measured by hemagglutination, 3 weeks after the first injection and after the second injection

Secondary Outcome Measures:

Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment (comparison of patients treated by immunosuppressants or not treated) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Antibody levels against H1N1 in the different groups of patients, defined according diseases and their treatment
Number of side effects related to vaccination [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Number of local side effects related to vaccination (erythema and/or pain at injection site) [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Number of patients who will develop influenza despite vaccination [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Number of patients who had antibodies against H1N1 before vaccination [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Number of hospitalisations and deaths related to influenza [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Number of flares of the autoimmune diseases that could be related to vaccination [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Determine if the induction of LT-CD4 to J21-28 anti-jams is correlated to the concentrations of antibody anti-vaccines measured in 6 months [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
Determine if the basal concentrations of LT-CD4 anti-jam to J21-J28 are correlated to the concentrations of antibody anti-vaccines measured in 6 months [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Enrollment:	234
Study Start Date:	October 2009
Estimated Study Completion Date:	February 2012
Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Evaluation of vaccines against flu Evaluation of vaccines against flu	Biological: Evaluation of vaccines against flu evaluate efficacy and tolerance Other Name: Evaluation of vaccines against flu in auto-imune diseases

Detailed Description:

This prospective study concentrates on patients with vasculitis, systemic sclerosis, Sjögren's syndrome, systemic lupus erythematosus and other connective tissue diseases.

Patients responding to the inclusion criteria, will receive vaccine against seasonal influenza then, 3 weeks later, vaccine against H1N1 influenza. According to the results of ongoing trials a second injection of H1N1 vaccine has been scheduled 3 weeks later. At each consultation a blood sample will be taken to evaluate immunogenicity of vaccination. Two additional consultations have been scheduled: one month after the last vaccine administration and at 6 month, in order to evaluate the occurrence of late side effects.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adult patients presenting autoimmune and systemic diseases,
treating or not with steroids, and/or immunosuppressants and/or biotherapies, especially vasculitis, scleroderma, Sjogren's syndrome and systemic lupus (main groups)

Exclusion Criteria:

Absence of informed consent
Disease which did not responded to the above criteria
Active infection at time of vaccination
HIV infection
History of Guillain-Barre syndrome
Allergy to one component of the vaccine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065285

Locations

France
Hopital Cochin
Paris, France, 75014

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Loïc GUILLEVIN, MD PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT01065285 History of Changes
Other Study ID Numbers:	P 090901
Study First Received:	October 21, 2009
Last Updated:	January 31, 2012
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Influenza
autoimmune diseases
vaccination
H1N1

Additional relevant MeSH terms:

Autoimmune Diseases
Influenza, Human
Immune System Diseases
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases

Respiratory Tract Infections
Respiratory Tract Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012