<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01687517</url>
  </required_header>
  <id_info>
    <org_study_id>P110115</org_study_id>
    <nct_id>NCT01687517</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Influenza Vaccine During Sarcoidosis</brief_title>
  <acronym>SARCOVAC</acronym>
  <official_title>Determination of the Efficacy and Safety of the Seasonal Influenza Vaccine Among Patients Suffering From Sarcoidosis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sarcoidosis is an inflammatory disease of unknown origin that can affect all organs,&#xD;
      especially the lungs and mediastinum. Some location of sarcoidosis may require treatment with&#xD;
      corticosteroids or immunosuppressors.Although seasonal influenza vaccination can be&#xD;
      recommended in sarcoidosis in some subgroups at risk (respiratory failure, pulmonary&#xD;
      fibrosis, age over 65, use of immunosuppressive therapy, etc ...), the investigators&#xD;
      presently have no data on the efficacy and safety (absence of adverse reactions) of seasonal&#xD;
      influenza vaccination in sarcoidosis.Especially it is not known whether the seasonal&#xD;
      influenza vaccine provides the same rate and same type of vaccine response in sarcoidosis&#xD;
      patients than in the general population. Similarly, it is unclear whether the vaccine&#xD;
      response is modified by the severity of the disease and treatment with corticosteroids and&#xD;
      immunosuppressors.Based on what is known in systemic lupus and rheumatoid arthritis, which&#xD;
      are both inflammatory and autoimmune diseases, the investigators expect at best a 50% vaccine&#xD;
      response in patients with sarcoidosis and a 85% vaccination response in healthy controls. The&#xD;
      demonstration of a vaccine response could allow reconsidering new vaccine approaches in&#xD;
      sarcoidosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data on vaccination in sarcoidosis are largely insufficient. It is thus unclear whether the&#xD;
      vaccine response is modified according to the clinical phenotype of the disease and/or&#xD;
      treatment with corticosteroids and immunosuppressants. However, sarcoidosis is accompanied by&#xD;
      numerous disturbances of the immune system, including a tendency to anergy which may affect&#xD;
      the efficacy of the vaccine, especially when the disease is active and severe. In addition,&#xD;
      the tolerance of influenza vaccination in patients with sarcoidosis has not been studied&#xD;
      yet.The influenza vaccination in sarcoidosis is a common practice among medical specialists&#xD;
      who care for patients with sarcoidosis, either internists or lung specialists.. However, the&#xD;
      practice of this vaccination is not based on scientific evidence, because there are no data&#xD;
      establishing the efficacy and safety of influenza vaccination in sarcoidosis.Thus, it is&#xD;
      possible that the influenza vaccine is less immunogenic in patients with sarcoidosis than in&#xD;
      healthy adults, which may reduce the clinical effectiveness of vaccination. It therefore&#xD;
      seems essential to determine the efficacy and safety of this vaccine, which is widely&#xD;
      practiced. Poor efficiency could lead to the development of different vaccination strategies,&#xD;
      based in particular on the administration of adjuvanted vaccines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Humoral immunogenicity</measure>
    <time_frame>21 days post-vaccination</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity</measure>
    <time_frame>at Day 0, Day 21 and Day 180</time_frame>
    <description>Effect of the initial clinical phenotype (including disease activity score) on the seroconversion and seroprotection rates, and the seroconversion factor, at each visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical phenotype</measure>
    <time_frame>at Day 21 and Day 180</time_frame>
    <description>Descriptive study of the evolution of clinical phenotype (eg, severity of illness) after vaccination at D21 and D180</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Auto immunity activity</measure>
    <time_frame>At Day 0, at Day 21 and at 6 months post-vaccination</time_frame>
    <description>Comparison of autoantibody levels before and after vaccination (anti-nuclear total, rheumatoid factor, anti-GM1 measured at D0, D21 and D180) in all individuals included in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of therapy on immunogenicity</measure>
    <time_frame>at Day 21 and Day 180</time_frame>
    <description>Effect of the dose of corticosteroids and immunosuppressive therapy on the seroconversion and seroprotection rates and seroconversion factor at D21 and D180;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity between groups</measure>
    <time_frame>at Day 0, Day 21 and Day 180</time_frame>
    <description>Comparison of the seroprotection rate and the seroconversion factor between patients with sarcoidosis and the control group of healthy subjects at D21 and D180 post-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long term immune response</measure>
    <time_frame>At 6 months post-vaccination</time_frame>
    <description>Comparison of the persistence of the immune response between patients with sarcoidosis and control subjects at D180</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lymphocytes subpopulations analysis</measure>
    <time_frame>At Day 0 and at 21 days post-vaccination</time_frame>
    <description>Comparison between D0 and D21 of the distributions in absolute values and percentages of circulating lymphocyte subpopulations, in particular mucosal &quot;homing&quot; CD4+ lymphocytes, in all individuals included in the study;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Regulatory T Lymphocytes</measure>
    <time_frame>At Day 0 and Day 21</time_frame>
    <description>Effect of the regulatory T cells titers on the seroconversion and seroprotection rates, and the seroconversion factor at D0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease activity evolution</measure>
    <time_frame>at Day 0, Day 21 and Day 180</time_frame>
    <description>Effect of the CD4+-CD103+ T cells + at J0 and its evolution between J0 and J21 days based on the scalability of sarcoidosis evaluated by 1/changes in serum enzyme angiotensin converting, IgG, IgA IgM,; 2/ the comparative pulmonary radiological changes and 3/ the in pulmonary function changes between day 0 and day 180.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other immune response</measure>
    <time_frame>Between Day 0 to 6 months post-vaccination</time_frame>
    <description>Seroprevalence and comparison between D0 and D180 of anti-diphtheria toxin and anti-tetanus toxin in all individuals included.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">190</enrollment>
  <condition>Sarcoidosis</condition>
  <condition>Influenza Vaccine</condition>
  <arm_group>
    <arm_group_label>Patient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>90 patients suffering from sarcoidosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Volunteer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>100 volunteers</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Seasonal influenza vaccine available for the 2012-2013 vaccine campaign</intervention_name>
    <description>Single injection of the vaccine at D0 (0.5mL intra-muscularly or subcutaneous for patient under anticoagulant treatment)</description>
    <arm_group_label>Patient</arm_group_label>
    <arm_group_label>Volunteer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for patients:&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 65;&#xD;
&#xD;
          -  Signature of informed consent&#xD;
&#xD;
          -  Follow-up : six months following the influenza vaccination at D0&#xD;
&#xD;
          -  Sarcoidosis diagnosed and histologically proven since at least 6 months&#xD;
&#xD;
          -  unchanged treatment of Sarcoidosis for at least 3 months, except for the case of a&#xD;
             decrease in doses of corticosteroids and at a stable dose of immunosuppressive drugs&#xD;
&#xD;
          -  Indication for a seasonal influenza vaccination.&#xD;
&#xD;
        Existence of one or more of these clinical situations:&#xD;
&#xD;
          -  pulmonary location (dyspnea, radiological or stage IV pulmonary function tests (PFT)&#xD;
             altered with decreased forced vital capacity (FVC), forced expiratory volume average&#xD;
             (FEV) or the diffusion of carbon monoxide (TLCO) below 65% of predicted value;&#xD;
&#xD;
          -  Cardiac impairment confirmed&#xD;
&#xD;
          -  Central nervous system impairment and / or device and confirmed with clinical impact&#xD;
             and abnormal imaging and / or electromyogram- Renal impairment (histologically&#xD;
             confirmed) responsible for a decrease in creatinine clearance&#xD;
&#xD;
          -  disabling Lupus pernio&#xD;
&#xD;
          -  Sinuso-nasal and / or laryngeal impairment histologically confirmed&#xD;
&#xD;
          -  Disseminated impairment, ie affecting more than four organs&#xD;
&#xD;
          -  Dose of corticosteroids ≥to 10 mg per day of the equivalent of prednisone or the&#xD;
             necessity of an immunosuppressive therapy (with the exception of Rituximab) to control&#xD;
             sarcoidosis- Existence of an associated metabolic disorder&#xD;
&#xD;
          -  Patients with sarcoidosis and living in a care house&#xD;
&#xD;
          -  Sarcoidosis occurring in health/nursing staff&#xD;
&#xD;
        Inclusion criteria for healthy volunteers&#xD;
&#xD;
          -  Age ≥ 18 and ≤ 65 years&#xD;
&#xD;
          -  Signature of informed consent&#xD;
&#xD;
          -  Lack of underlying disease, especially autoimmune diseases and / or sarcoidosis&#xD;
&#xD;
          -  Follow-up possible during the six months following the influenza vaccination&#xD;
&#xD;
        Exclusion Criteria for all:&#xD;
&#xD;
          -  Hypersensitivity to the active substances, eggs and one of the excipients of the&#xD;
             vaccine&#xD;
&#xD;
          -  Acute febrile episode in the week prior to vaccination&#xD;
&#xD;
          -  Count with a documented case of influenza within a week prior to vaccination&#xD;
&#xD;
          -  Infection with HIV HBV or HCV known,&#xD;
&#xD;
          -  Current pregnancy or positive urine pregnancy test&#xD;
&#xD;
          -  Multiple Sclerosis&#xD;
&#xD;
          -  History of Guillain-Barré&#xD;
&#xD;
          -  Organ Transplantation&#xD;
&#xD;
          -  Cancer in the last 3 years&#xD;
&#xD;
          -  Other vaccination received within 3 weeks prior to the study vaccine injection&#xD;
&#xD;
          -  Treatment with chemotherapy&#xD;
&#xD;
          -  Transfusion or immunoglobulin administration during the last 3 months&#xD;
&#xD;
          -  Co-morbidity requiring biological therapy that specifically targets B cells (eg&#xD;
             rituximab)&#xD;
&#xD;
          -  Patient for which an increase of the treatment is planned in the month following&#xD;
             vaccination.&#xD;
&#xD;
          -  Acute infection in the month prior to vaccination&#xD;
&#xD;
          -  non affiliated to a health social security system&#xD;
&#xD;
          -  Participation in another biomedical research for the duration of the study&#xD;
&#xD;
          -  Individuals deprived of freedom by an administrative or court order&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Le Jeunne, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hôtel Dieu Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hotel-Dieu Hospital</name>
      <address>
        <city>Paris</city>
        <zip>75004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>11070460</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9787645</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10430755</PMID>
  </reference>
  <reference>
    <citation>Bouvry D, Naccache JM, Valeyre D. [Interstitial lung diseases in sarcoidosis]. Rev Prat. 2007 Dec 31;57(20):2258-65. French.</citation>
    <PMID>18320746</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17886354</PMID>
  </reference>
  <reference>
    <citation>Lofgren S. The concept of erythema nodosum revised. Scand J Respir Dis. 1967;48(3):348-53. No abstract available.</citation>
    <PMID>5183631</PMID>
  </reference>
  <reference>
    <citation>James DG. Lupus pernio. Lupus. 1992 May;1(3):129-31. doi: 10.1177/096120339200100302.</citation>
    <PMID>1301972</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18569792</PMID>
  </reference>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>April 20, 2015</last_update_submitted>
  <last_update_submitted_qc>April 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 21, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sarcoidosis</keyword>
  <keyword>healthy volunteers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Sarcoidosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01687517
org study id: P110115
nct id: NCT01687517
lead sponsor: 
has dmc: Yes
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.
Data on vaccination in sarcoidosis are largely insufficient. It is thus unclear whether the
      vaccine response is modified according to the clinical phenotype of the disease and/or
      treatment with corticosteroids and immunosuppressants. However, sarcoidosis is accompanied by
      numerous disturbances of the immune system, including a tendency to anergy which may affect
      the efficacy of the vaccine, especially when the disease is active and severe. In addition,
      the tolerance of influenza vaccination in patients with sarcoidosis has not been studied
      yet.The influenza vaccination in sarcoidosis is a common practice among medical specialists
      who care for patients with sarcoidosis, either internists or lung specialists.. However, the
      practice of this vaccination is not based on scientific evidence, because there are no data
      establishing the efficacy and safety of influenza vaccination in sarcoidosis.Thus, it is
      possible that the influenza vaccine is less immunogenic in patients with sarcoidosis than in
      healthy adults, which may reduce the clinical effectiveness of vaccination. It therefore
      seems essential to determine the efficacy and safety of this vaccine, which is widely
      practiced. Poor efficiency could lead to the development of different vaccination strategies,
      based in particular on the administration of adjuvanted vaccines.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Humoral immunogenicity
time frame: 21 days post-vaccination
description: 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.
measure: Immunogenicity
time frame: at Day 0, Day 21 and Day 180
description: Effect of the initial clinical phenotype (including disease activity score) on the seroconversion and seroprotection rates, and the seroconversion factor, at each visit
measure: Clinical phenotype
time frame: at Day 21 and Day 180
description: Descriptive study of the evolution of clinical phenotype (eg, severity of illness) after vaccination at D21 and D180
measure: Auto immunity activity
time frame: At Day 0, at Day 21 and at 6 months post-vaccination
description: Comparison of autoantibody levels before and after vaccination (anti-nuclear total, rheumatoid factor, anti-GM1 measured at D0, D21 and D180) in all individuals included in the study.
measure: Effect of therapy on immunogenicity
time frame: at Day 21 and Day 180
description: Effect of the dose of corticosteroids and immunosuppressive therapy on the seroconversion and seroprotection rates and seroconversion factor at D21 and D180;
measure: Immunogenicity between groups
time frame: at Day 0, Day 21 and Day 180
description: Comparison of the seroprotection rate and the seroconversion factor between patients with sarcoidosis and the control group of healthy subjects at D21 and D180 post-vaccination.
measure: Long term immune response
time frame: At 6 months post-vaccination
description: Comparison of the persistence of the immune response between patients with sarcoidosis and control subjects at D180
measure: Lymphocytes subpopulations analysis
time frame: At Day 0 and at 21 days post-vaccination
description: Comparison between D0 and D21 of the distributions in absolute values and percentages of circulating lymphocyte subpopulations, in particular mucosal "homing" CD4+ lymphocytes, in all individuals included in the study;
measure: Regulatory T Lymphocytes
time frame: At Day 0 and Day 21
description: Effect of the regulatory T cells titers on the seroconversion and seroprotection rates, and the seroconversion factor at D0
measure: Disease activity evolution
time frame: at Day 0, Day 21 and Day 180
description: Effect of the CD4+-CD103+ T cells + at J0 and its evolution between J0 and J21 days based on the scalability of sarcoidosis evaluated by 1/changes in serum enzyme angiotensin converting, IgG, IgA IgM,; 2/ the comparative pulmonary radiological changes and 3/ the in pulmonary function changes between day 0 and day 180.
measure: Other immune response
time frame: Between Day 0 to 6 months post-vaccination
description: Seroprevalence and comparison between D0 and D180 of anti-diphtheria toxin and anti-tetanus toxin in all individuals included.
arm group label: Patient
arm group type: Experimental
description: 90 patients suffering from sarcoidosis
arm group label: Volunteer
arm group type: Active Comparator
description: 100 volunteers
intervention type: Drug
intervention name: Seasonal influenza vaccine available for the 2012-2013 vaccine campaign
description: Single injection of the vaccine at D0 (0.5mL intra-muscularly or subcutaneous for patient under anticoagulant treatment)
arm group label: Patient
arm group label: Volunteer
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claire Le Jeunne, MD, PhD
role: Study Chair
affiliation: Hôtel Dieu Hospital
facility: 
country: France
citation: 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
citation: 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
citation: 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
citation: Bouvry D, Naccache JM, Valeyre D. [Interstitial lung diseases in sarcoidosis]. Rev Prat. 2007 Dec 31;57(20):2258-65. French.
PMID: 18320746
citation: 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
citation: Lofgren S. The concept of erythema nodosum revised. Scand J Respir Dis. 1967;48(3):348-53. No abstract available.
PMID: 5183631
citation: James DG. Lupus pernio. Lupus. 1992 May;1(3):129-31. doi: 10.1177/096120339200100302.
PMID: 1301972
citation: 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
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Sarcoidosis
mesh term: Vaccines