Systemic LupusLUPCELLVAXNCT04894253
Immune Response to SARS-CoV-2 Vaccination in Systemic Lupus
An observational study of Systemic Lupus, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The main objective is to study the impact of vaccination against Covid-19 on the specific humoral and cellular immune response (against SARS-CoV-2) and non-specific (evolution of the pathological immune system of the disease), in a lupus population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus
- What is being tested?
- SRAS-CoV-2 vaccination immunological response
- Type of treatment
- Vaccines
- How many people
- 7 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jun 2021to 22 Dec 2023
- How long will I take part?
- 18 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic lupus, monitored and vaccinated at the national reference center for "rare systemic autoimmune diseases" of the University Hospitals of Strasbourg.
Who may be able to join
- Adult subject (≥ 18 years old), male or female
- Patient with systemic lupus according to ACR 1997 criteria
- Patient followed by the National Reference Center "Rare Systemic Autoimmune Diseases" of the University Hospitals of Strasbourg
- Patient who agreed to be vaccinated against SARS-CoV-2
- Subject having expressed his non-opposition to the research
- Subject affiliated to a social health insurance protection scheme
Who cannot join
- Patient treated by:
- Corticosteroids (> = 10mg / day)
- Immunosuppressant (azathioprine, mycophenolate mofetil, cyclophosphamide) to control lupus activity
- A biomedicine targeting B cells (rituximab, belumimab).
- Inability to provide informed information about the subject (subject in an emergency, difficulty in understanding the subject, etc.)
- Subject under safeguard of justice
- Subject under guardianship
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Immune Response to SARS-CoV-2 Vaccination in Patients With Systemic Lupus
The main objective is to study the impact of vaccination against Covid-19 on the specific humoral and cellular immune response (against SARS-CoV-2) and non-specific (evolution of the pathological immune system of the disease), in a lupus population.
The secondary objective is to study the impact of lupus disease activity on the humoral and cellular response of patients following vaccination against SARS-CoV-2.
The hypothesis is that disease activity and / or certain treatments used in lupus may interfere with the humoral and cellular immune response induced by vaccination against SARS-CoV-2.
- Conditions
- Systemic Lupus
- Being tested
- SRAS-CoV-2 vaccination immunological response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRAS-CoV-2 vaccination immunological responseBiological
Follow for 18 months a single group of 30 patients with systemic lupus after their SRAS-CoV-2 vaccination.
Intervention includes immunological analysis on additional volume of blood collected as part of routine care.
| Study group | Role | What they receive |
|---|---|---|
| Single group of 30 patients with systemic lupus | Not described Receives: Biological: SRAS-CoV-2 vaccination immunological response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of the immune response following vaccination against SARS-CoV-2
Collection of clinical data and correlation with immunological analyzes of the biological samples
Measured: 3 or 4 weeks
Investigation of the immune response following vaccination against SARS-CoV-2
Collection of clinical data and correlation with immunological analyzes of the biological samples
Measured: 3 months
Investigation of the immune response following vaccination against SARS-CoV-2
Collection of clinical data and correlation with immunological analyzes of the biological samples
Measured: 6 months
Investigation of the immune response following vaccination against SARS-CoV-2
Collection of clinical data and correlation with immunological analyzes of the biological samples
Measured: 12 months
Investigation of the immune response following vaccination against SARS-CoV-2
Collection of clinical data and correlation with immunological analyzes of the biological samples
Measured: 18 months
Secondary outcomes (5)
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.
Measured: 3 or 4 weeks
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.
Measured: 3 months
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.
Measured: 6 months
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.
Measured: 12 months
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Measurement of lupus disease activity by a validated score (SLEDAI) at the time of vaccination and follow-up.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start7 Jun 2021
- Primary completion7 Jun 2021
- Study completion22 Dec 2023
Why it stopped: inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic LupusStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894253
- Sponsor's protocol ID
- 8263
- Acronym
- LUPCELLVAX
- Status last verified
- Dec 2025
- First submitted
- 18 May 2021
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Immune Response to SARS-CoV-2 Vaccination in Patients With Systemic Lupus
- ClinicalTrials.gov ID
- NCT04894253
- Acronym / sponsor ID
- LUPCELLVAX / 8263
- Conditions
- Systemic Lupus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: inclusion difficulties
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 22 Dec 2023 (actual)
- First posted
- 20 May 2021 (actual)
- 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.
The main objective is to study the impact of vaccination against Covid-19 on the specific humoral and cellular immune response (against SARS-CoV-2) and non-specific (evolution of the pathological immune system of the disease), in a lupus population.
The secondary objective is to study the impact of lupus disease activity on the humoral and cellular response of patients following vaccination against SARS-CoV-2.
The hypothesis is that disease activity and / or certain treatments used in lupus may interfere with the humoral and cellular immune response induced by vaccination against SARS-CoV-2.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 18 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group of 30 patients with systemic lupus | – | Biological: SRAS-CoV-2 vaccination immunological response |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic lupus, monitored and vaccinated at the national reference center for "rare systemic autoimmune diseases" of the University Hospitals of Strasbourg.
Key inclusion criteria (6 listed)
- Adult subject (≥ 18 years old), male or female
- Patient with systemic lupus according to ACR 1997 criteria
- Patient followed by the National Reference Center "Rare Systemic Autoimmune Diseases" of the University Hospitals of Strasbourg
- Patient who agreed to be vaccinated against SARS-CoV-2
- Subject having expressed his non-opposition to the research
Key exclusion criteria (7 listed)
- Patient treated by:
- Inability to provide informed information about the subject (subject in an emergency, difficulty in understanding the subject, etc.)
- Subject under safeguard of justice
- Subject under guardianship
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 |
|---|---|---|
| SRAS-CoV-2 vaccination immunological responseFollow for 18 months a single group of 30 patients with systemic lupus after their SRAS-CoV-2 vaccination. Intervention includes immunological analysis on additional volume of blood collected as part of routine care. | Biological | Single group of 30 patients with systemic lupus |
Primary outcome
Investigation of the immune response following vaccination against SARS-CoV-2
Time frame: 3 or 4 weeks
Collection of clinical data and correlation with immunological analyzes of the biological samples
Investigation of the immune response following vaccination against SARS-CoV-2
Time frame: 3 months
Collection of clinical data and correlation with immunological analyzes of the biological samples
Investigation of the immune response following vaccination against SARS-CoV-2
Time frame: 6 months
Collection of clinical data and correlation with immunological analyzes of the biological samples
Investigation of the immune response following vaccination against SARS-CoV-2
Time frame: 12 months
Collection of clinical data and correlation with immunological analyzes of the biological samples
Investigation of the immune response following vaccination against SARS-CoV-2
Time frame: 18 months
Collection of clinical data and correlation with immunological analyzes of the biological samples
5 secondary outcomes
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Time frame: 3 or 4 weeks
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Time frame: 3 months
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Time frame: 6 months
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Time frame: 12 months
Study the impact of lupus disease activity on SARS-CoV-2 vaccine immune response
Time frame: 18 months
Results and safety
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus, run by University Hospital, Strasbourg, France 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 23 Dec 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.
Are results available for this study?
The study was stopped early (reason given: inclusion difficulties). Results are not available in the source record.
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?
Investigation of the immune response following vaccination against SARS-CoV-2 (time frame: 3 or 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2025.