Efficacy and Safety of Influenza Vaccine During Sarcoidosis

• Register: ClinicalTrials.gov
• Last refreshed on: 4 May 2015
• Main ID: NCT01687517
• Date of registration: 14/09/2012
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Efficacy and Safety of Influenza Vaccine During Sarcoidosis SARCOVAC
• Scientific title: Determination of the Efficacy and Safety of the Seasonal Influenza Vaccine Among Patients Suffering From Sarcoidosis.
• Date of first enrolment: October 2012
• Target sample size: 190
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01687517
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Claire Le Jeunne, MD, PhD
• Affiliation: Hôtel Dieu Hospital

Key inclusion & exclusion criteria

Inclusion Criteria for patients:

- Age = 18 and = 65;

- Signature of informed consent

- Follow-up : six months following the influenza vaccination at D0

- Sarcoidosis diagnosed and histologically proven since at least 6 months

- unchanged treatment of Sarcoidosis for at least 3 months, except for the case of a
decrease in doses of corticosteroids and at a stable dose of immunosuppressive drugs

- Indication for a seasonal influenza vaccination.

Existence of one or more of these clinical situations:

- pulmonary location (dyspnea, radiological or stage IV pulmonary function tests (PFT)
altered with decreased forced vital capacity (FVC), forced expiratory volume average
(FEV) or the diffusion of carbon monoxide (TLCO) below 65% of predicted value;

- Cardiac impairment confirmed

- Central nervous system impairment and / or device and confirmed with clinical impact
and abnormal imaging and / or electromyogram- Renal impairment (histologically
confirmed) responsible for a decrease in creatinine clearance

- disabling Lupus pernio

- Sinuso-nasal and / or laryngeal impairment histologically confirmed

- Disseminated impairment, ie affecting more than four organs

- Dose of corticosteroids =to 10 mg per day of the equivalent of prednisone or the
necessity of an immunosuppressive therapy (with the exception of Rituximab) to
control sarcoidosis- Existence of an associated metabolic disorder

- Patients with sarcoidosis and living in a care house

- Sarcoidosis occurring in health/nursing staff

Inclusion criteria for healthy volunteers

- Age = 18 and = 65 years

- Signature of informed consent

- Lack of underlying disease, especially autoimmune diseases and / or sarcoidosis

- Follow-up possible during the six months following the influenza vaccination

Exclusion Criteria for all:

- Hypersensitivity to the active substances, eggs and one of the excipients of the
vaccine

- Acute febrile episode in the week prior to vaccination

- Count with a documented case of influenza within a week prior to vaccination

- Infection with HIV HBV or HCV known,

- Current pregnancy or positive urine pregnancy test

- Multiple Sclerosis

- History of Guillain-Barré

- Organ Transplantation

- Cancer in the last 3 years

- Other vaccination received within 3 weeks prior to the study vaccine injection

- Treatment with chemotherapy

- Transfusion or immunoglobulin administration during the last 3 months

- Co-morbidity requiring biological therapy that specifically targets B cells (eg
rituximab)

- Patient for which an increase of the treatment is planned in the month following
vaccination.

- Acute infection in the month prior to vaccination

- non affiliated to a health social security system

- Participation in another biomedical research for the duration of the study

- Individuals deprived of freedom by an administrative or court order



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza Vaccine

Sarcoidosis

Intervention(s)

Drug: Seasonal influenza vaccine available for the 2012-2013 vaccine campaign

Primary Outcome(s)

Humoral immunogenicity [Time Frame: 21 days post-vaccination]

Secondary Outcome(s)

Long term immune response [Time Frame: At 6 months post-vaccination]

Other immune response [Time Frame: Between Day 0 to 6 months post-vaccination]

Clinical phenotype [Time Frame: at Day 21 and Day 180]

Disease activity evolution [Time Frame: at Day 0, Day 21 and Day 180]

Effect of therapy on immunogenicity [Time Frame: at Day 21 and Day 180]

Lymphocytes subpopulations analysis [Time Frame: At Day 0 and at 21 days post-vaccination]

Regulatory T Lymphocytes [Time Frame: At Day 0 and Day 21]

Auto immunity activity [Time Frame: At Day 0, at Day 21 and at 6 months post-vaccination]

Immunogenicity [Time Frame: at Day 0, Day 21 and Day 180]

Immunogenicity between groups [Time Frame: at Day 0, Day 21 and Day 180]

Secondary ID(s)

P110115

Source(s) of Monetary Support

Please refer to primary and secondary sponsors