Does the flu shot work in sarcoidosis patients? new study aims to find out
NCT ID NCT01687517
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looked at whether the seasonal flu vaccine works as well in people with sarcoidosis as it does in healthy people. Researchers gave the flu shot to 190 adults with sarcoidosis and compared their immune response to a group of healthy volunteers. The goal was to see if the vaccine is effective and safe in this patient group, especially for those on steroids or immunosuppressants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- seasonal influenza vaccine
- What this could lead to
- If successful, this study could show that the flu vaccine is effective and safe for people with sarcoidosis, supporting current vaccination recommendations.
- What could go wrong
- This is a completed Phase 3 trial with only 190 participants, so results may not apply to all sarcoidosis patients. The vaccine response may be lower than expected, especially in those on immunosuppressants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
190 people
The number who actually took part.
- Start date
-
Oct 2012
- Finished
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Oct 2014
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hotel-Dieu Hospital
Paris, 75004, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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