Efficacy and Safety of Influenza Vaccine During Sarcoidosis

NCT01687517 | Completed Phase 3 DMC

• 1 other identifier: P110115
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcoidosis is an inflammatory disease of unknown origin that can affect all organs, especially the lungs and mediastinum. Some location of sarcoidosis may require treatment with corticosteroids or immunosuppressors.Although seasonal influenza vaccination can be recommended in sarcoidosis in some subgroups at risk (respiratory failure, pulmonary fibrosis, age over 65, use of immunosuppressive therapy, etc ...), the investigators presently have no data on the efficacy and safety (absence of adverse reactions) of seasonal influenza vaccination in sarcoidosis.Especially it is not known whether the seasonal influenza vaccine provides the same rate and same type of vaccine response in sarcoidosis patients than in the general population. Similarly, it is unclear whether the vaccine response is modified by the severity of the disease and treatment with corticosteroids and immunosuppressors.Based on what is known in systemic lupus and rheumatoid arthritis, which are both inflammatory and autoimmune diseases, the investigators expect at best a 50% vaccine response in patients with sarcoidosis and a 85% vaccination response in healthy controls. The demonstration of a vaccine response could allow reconsidering new vaccine approaches in sarcoidosis.

Conditions

Sarcoidosis; Influenza Vaccine

Keywords

sarcoidosis; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Humoral immunogenicity

  Humoral immunogenicity of the vaccine will be measured 3 weeks after injection of influenza vaccine (day 21) by comparison of the seroconversion rates between patients with sarcoidosis and the control group of healthy subjects.

  21 days post-vaccination

Secondary Outcomes (10)

• Immunogenicity

  at Day 0, Day 21 and Day 180

• Clinical phenotype

  at Day 21 and Day 180

• Auto immunity activity

  At Day 0, at Day 21 and at 6 months post-vaccination

• Effect of therapy on immunogenicity

  at Day 21 and Day 180

• Immunogenicity between groups

  at Day 0, Day 21 and Day 180

Study Arms (2)

Patient

EXPERIMENTAL

90 patients suffering from sarcoidosis

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

Volunteer

ACTIVE COMPARATOR

100 volunteers

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

Interventions

Seasonal influenza vaccine available for the 2012-2013 vaccine campaign DRUG

Single injection of the vaccine at D0 (0.5mL intra-muscularly or subcutaneous for patient under anticoagulant treatment)

Patient; Volunteer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hotel-Dieu Hospital

Paris, 75004, France

Location

Related Publications (8)

• Mert A, Bilir M, Ozaras R, Tabak F, Karayel T, Senturk H. Results of hepatitis B vaccination in sarcoidosis. Respiration. 2000;67(5):543-5. doi: 10.1159/000067471.

  PMID: 11070460 BACKGROUND

• Recommendation for the composition of influenza virus vaccines for use in 1999. Wkly Epidemiol Rec. 1998 Oct 2;73(40):305-8. No abstract available. English, French.

  PMID: 9787645 BACKGROUND

• Statement on sarcoidosis. Joint Statement of the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) adopted by the ATS Board of Directors and by the ERS Executive Committee, February 1999. Am J Respir Crit Care Med. 1999 Aug;160(2):736-55. doi: 10.1164/ajrccm.160.2.ats4-99. No abstract available.

  PMID: 10430755 BACKGROUND

• Bouvry D, Naccache JM, Valeyre D. [Interstitial lung diseases in sarcoidosis]. Rev Prat. 2007 Dec 31;57(20):2258-65. French.

  PMID: 18320746 BACKGROUND

• Valeyre D, Duperron F. [Sarcoidosis: diagnosis and management of extra-pulmonary forms]. Rev Mal Respir. 2006 Dec;23(6):757-8. doi: 10.1016/s0761-8425(06)72092-7. No abstract available. French.

  PMID: 17886354 BACKGROUND

• Lofgren S. The concept of erythema nodosum revised. Scand J Respir Dis. 1967;48(3):348-53. No abstract available.

  PMID: 5183631 BACKGROUND

• James DG. Lupus pernio. Lupus. 1992 May;1(3):129-31. doi: 10.1177/096120339200100302.

  PMID: 1301972 BACKGROUND

• Asukata Y, Ishihara M, Hasumi Y, Nakamura S, Hayashi K, Ohno S, Mizuki N. Guidelines for the diagnosis of ocular sarcoidosis. Ocul Immunol Inflamm. 2008 May-Jun;16(3):77-81. doi: 10.1080/09273940802051100.

  PMID: 18569792 BACKGROUND

MeSH Terms

Conditions

Sarcoidosis; Influenza, Human

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Claire Le Jeunne, MD, PhD

  Hôtel Dieu Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2012
• First Posted: September 19, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2014
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)