SarcoidosisPhase 3SARCOVACNCT01687517
Efficacy and Safety of Influenza Vaccine During Sarcoidosis
A Phase 3 study testing Seasonal influenza vaccine available for the 2012-2013 vaccine campaign in people with Sarcoidosis and Influenza Vaccine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcoidosis, Influenza Vaccine
- What is being tested?
- Seasonal influenza vaccine available for the 2012-2013 vaccine campaign
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination of the Efficacy and Safety of the Seasonal Influenza Vaccine Among Patients Suffering From Sarcoidosis.
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.
Read the detailed description
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.
- Conditions
- Sarcoidosis, Influenza Vaccine
- Being tested
- Seasonal influenza vaccine available for the 2012-2013 vaccine campaign
- Keywords
- sarcoidosis, healthy volunteers
- Medical subject headings
- Sarcoidosis, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seasonal influenza vaccine available for the 2012-2013 vaccine campaignDrug
Single injection of the vaccine at D0 (0.5mL intra-muscularly or subcutaneous for patient under anticoagulant treatment)
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | 90 patients suffering from sarcoidosis Receives: Drug: Seasonal influenza vaccine available for the 2012-2013 vaccine campaign |
| Volunteer | Active comparator | 100 volunteers Receives: Drug: Seasonal influenza vaccine available for the 2012-2013 vaccine campaign |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 21 days post-vaccination
Secondary outcomes (10)
Immunogenicity
Effect of the initial clinical phenotype (including disease activity score) on the seroconversion and seroprotection rates, and the seroconversion factor, at each visit
Measured: at Day 0, Day 21 and Day 180
Clinical phenotype
Descriptive study of the evolution of clinical phenotype (eg, severity of illness) after vaccination at D21 and D180
Measured: at Day 21 and Day 180
Auto immunity activity
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.
Measured: At Day 0, at Day 21 and at 6 months post-vaccination
Effect of therapy on immunogenicity
Effect of the dose of corticosteroids and immunosuppressive therapy on the seroconversion and seroprotection rates and seroconversion factor at D21 and D180;
Measured: at Day 21 and Day 180
Immunogenicity between groups
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.
Measured: at Day 0, Day 21 and Day 180
Long term immune response
Comparison of the persistence of the immune response between patients with sarcoidosis and control subjects at D180
Measured: At 6 months post-vaccination
Lymphocytes subpopulations analysis
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;
Measured: At Day 0 and at 21 days post-vaccination
Regulatory T Lymphocytes
Effect of the regulatory T cells titers on the seroconversion and seroprotection rates, and the seroconversion factor at D0
Measured: At Day 0 and Day 21
Disease activity evolution
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.
Measured: at Day 0, Day 21 and Day 180
Other immune response
Seroprevalence and comparison between D0 and D180 of anti-diphtheria toxin and anti-tetanus toxin in all individuals included.
Measured: Between Day 0 to 6 months post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startOct 2012
- Primary completionJun 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Claire Le Jeunne, MD, PhD, Study chair, Hôtel Dieu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687517
- Sponsor's protocol ID
- P110115
- Acronym
- SARCOVAC
- Status last verified
- Oct 2025
- First submitted
- 14 Sep 2012
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 11070460Recommendation 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.
PubMed 9787645Statement 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.
PubMed 10430755Bouvry D, Naccache JM, Valeyre D. [Interstitial lung diseases in sarcoidosis]. Rev Prat. 2007 Dec 31;57(20):2258-65. French.
PubMed 18320746Valeyre 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.
PubMed 17886354Lofgren S. The concept of erythema nodosum revised. Scand J Respir Dis. 1967;48(3):348-53. No abstract available.
PubMed 5183631James DG. Lupus pernio. Lupus. 1992 May;1(3):129-31. doi: 10.1177/096120339200100302.
PubMed 1301972Asukata 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.
PubMed 18569792
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Efficacy and Safety of the Seasonal Influenza Vaccine Among Patients Suffering From Sarcoidosis.
- ClinicalTrials.gov ID
- NCT01687517
- Acronym / sponsor ID
- SARCOVAC / P110115
- Conditions
- Sarcoidosis, Influenza Vaccine
- Keywords
- sarcoidosis, healthy volunteers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Drug: Seasonal influenza vaccine available for the 2012-2013 vaccine campaign90 patients suffering from sarcoidosis |
| Volunteer | Active comparator | Drug: Seasonal influenza vaccine available for the 2012-2013 vaccine campaign100 volunteers |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seasonal influenza vaccine available for the 2012-2013 vaccine campaignSingle injection of the vaccine at D0 (0.5mL intra-muscularly or subcutaneous for patient under anticoagulant treatment) | Drug | Patient, Volunteer |
Primary outcome
Humoral immunogenicity
Time frame: 21 days post-vaccination
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.
10 secondary outcomes
Immunogenicity
Time frame: at Day 0, Day 21 and Day 180
Clinical phenotype
Time frame: at Day 21 and Day 180
Auto immunity activity
Time frame: At Day 0, at Day 21 and at 6 months post-vaccination
Effect of therapy on immunogenicity
Time frame: at Day 21 and Day 180
Immunogenicity between groups
Time frame: at Day 0, Day 21 and Day 180
Long term immune response
Time frame: At 6 months post-vaccination
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
Disease activity evolution
Time frame: at Day 0, Day 21 and Day 180
Other immune response
Time frame: Between Day 0 to 6 months post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 11070460Mert 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.
- Background: PubMed 9787645Recommendation 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.
- Background: PubMed 10430755Statement 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.
- Background: PubMed 18320746Bouvry D, Naccache JM, Valeyre D. [Interstitial lung diseases in sarcoidosis]. Rev Prat. 2007 Dec 31;57(20):2258-65. French.
- Background: PubMed 17886354Valeyre 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.
- Background: PubMed 5183631Lofgren S. The concept of erythema nodosum revised. Scand J Respir Dis. 1967;48(3):348-53. No abstract available.
- Background: PubMed 1301972James DG. Lupus pernio. Lupus. 1992 May;1(3):129-31. doi: 10.1177/096120339200100302.
- Background: PubMed 18569792Asukata 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Le Jeunne, MD, PhD study chair
Hôtel Dieu Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Seasonal influenza vaccine available for the 2012-2013 vaccine campaign in people with Sarcoidosis and Influenza Vaccine, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Humoral immunogenicity (time frame: 21 days post-vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687517, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.