InfluenzaSYS01NCT05787964
Immunity to Infection in Healthy Participants and Participants With Cancer
An observational study of Influenza and SARS-CoV-2, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Many cancer patients are highly susceptible to infection and respond poorly to vaccination. This observational study will determine molecular and cellular features of immunity to viral pathogens in participants with cancer and compare them to healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza, SARS-CoV-2, Hematologic Malignancy
- What is being tested?
- Biological sample collection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2022to 1 Sep 2024
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with cancer will be drawn from the local clinics at the University Hospital Tübingen. Healthy participants will be recruited from university and hospital employees not associated with the study.
Who may be able to join
- You are aged 18 years or older.
- You are able to understand and give informed consent.
- Participants with cancer: you are suffering from cancer
- Healthy participants: you are a healthy individual.
Who cannot join
- You are unable to give informed consent.
- You have been suffering from an acute infection with fever during the last three days.
- You have a Hb level of less than 9 g/dl.
- You have a human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hopsital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Systems Biology Analysis of Vaccine-induced Immunity to Infectious Diseases in Healthy Participants and Participants With Cancer
Many cancer patients are highly susceptible to infection and respond poorly to vaccination. This observational study will determine molecular and cellular features of immunity to viral pathogens in participants with cancer and compare them to healthy controls. The aim is to identify how antiviral immunity in participants with cancer differs from that in healthy participants to understand why cancer patients are more susceptible to infections. In this context, the investigators will also evaluate immunity to medically indicated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seasonal influenza vaccine received by study participants during standard care (vaccines are not part of the study).
Read the detailed description
Cancer and its treatments are associated with dysregulated immune systems, and cancer patients are highly susceptible to infections (e.g., influenza, SARS-CoV-2). Importantly, cancer patients often respond poorly to vaccination. The molecular and cellular mechanisms underlying immune dysregulation and poor immunity in cancer patients are manifold, variable among individual patients/conditions, and poorly understood. An in-depth understanding of these mechanisms is essential to identifying novel strategies to prevent infectious diseases and developing individualized therapies.
In this observational study, the investigators will collect blood samples from 200 participants with hematological and oncological malignancies and healthy participants and analyze the cellular and humoral immune status in the context of SARS-CoV-2 and influenza infection and vaccination within these samples using systems biological tools. Medically indicated vaccination against SARS-CoV-2 and influenza during study participation is allowed.
This study aims to (1) examine the fundamental innate, cellular, and humoral immune responses to pathogens that form the basis of immunological memory and (2) identify molecular and cellular mechanisms responsible for the reduced immune immunity to viral pathogens in participants with cancer.
- Conditions
- Influenza, SARS-CoV-2, Hematologic Malignancy, Solid Tumor
- Being tested
- Biological sample collection
- Medical subject headings
- Influenza, Human, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biological sample collectionProcedure or surgery
Whole blood (blood draw/phlebotomy) will be obtained to proceed with immunologic analysis of samples. Collection of biologic samples will occur up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | Healthy adults aged > 18 years Receives: Procedure: Biological sample collection | |
| Participants with haematological malignancies | Multiple myeloma patients receiving lenalidomide and smoldering multiple myeloma patients under observation. Receives: Procedure: Biological sample collection | |
| Participants with solid tumours | Stage IV non-small cell lung cancer patients treated with checkpoint inhibitor therapy +/- chemotherapy. Receives: Procedure: Biological sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in virus-specific antibody levels
Determination of differences in plasma and serum antibody levels between healthy participants and participants with cancer.
Measured: 12 months
Differences in cytokine levels
Determination of differences in plasma and serum cytokine levels between healthy participants and participants with cancer.
Measured: 12 months
Differences in immune cell composition
Determination of quantitative, phenotypical, and functional differences in immune cells from healthy participants and participants with cancer.
Measured: 12 months
Differences in molecular immune cell makeup
Determination of epigenetic, transcriptional, and proteomic makeup of immune cells from healthy participants and participants with cancer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Oct 2022
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Lengerke, Ph.D., Study director, University Hospital TuebingenFlorian Wimmers, Ph.D., Study director, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05787964
- Sponsor's protocol ID
- SYS01
- Acronym
- SYS01
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2023
- Last updated
- 9 May 2024
- 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 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biology Analysis of Vaccine-induced Immunity to Infectious Diseases in Healthy Participants and Participants With Cancer
- ClinicalTrials.gov ID
- NCT05787964
- Acronym / sponsor ID
- SYS01 / SYS01
- Conditions
- Influenza, SARS-CoV-2, Hematologic Malignancy, Solid Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 28 Mar 2023 (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.
Many cancer patients are highly susceptible to infection and respond poorly to vaccination. This observational study will determine molecular and cellular features of immunity to viral pathogens in participants with cancer and compare them to healthy controls. The aim is to identify how antiviral immunity in participants with cancer differs from that in healthy participants to understand why cancer patients are more susceptible to infections. In this context, the investigators will also evaluate immunity to medically indicated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and seasonal influenza vaccine received by study participants during standard care (vaccines are not part of the study).
Detailed description
Cancer and its treatments are associated with dysregulated immune systems, and cancer patients are highly susceptible to infections (e.g., influenza, SARS-CoV-2). Importantly, cancer patients often respond poorly to vaccination. The molecular and cellular mechanisms underlying immune dysregulation and poor immunity in cancer patients are manifold, variable among individual patients/conditions, and poorly understood. An in-depth understanding of these mechanisms is essential to identifying novel strategies to prevent infectious diseases and developing individualized therapies.
In this observational study, the investigators will collect blood samples from 200 participants with hematological and oncological malignancies and healthy participants and analyze the cellular and humoral immune status in the context of SARS-CoV-2 and influenza infection and vaccination within these samples using systems biological tools. Medically indicated vaccination against SARS-CoV-2 and influenza during study participation is allowed.
This study aims to (1) examine the fundamental innate, cellular, and humoral immune responses to pathogens that form the basis of immunological memory and (2) identify molecular and cellular mechanisms responsible for the reduced immune immunity to viral pathogens in participants with cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | Procedure: Biological sample collectionHealthy adults aged > 18 years |
| Participants with haematological malignancies | – | Procedure: Biological sample collectionMultiple myeloma patients receiving lenalidomide and smoldering multiple myeloma patients under observation. |
| Participants with solid tumours | – | Procedure: Biological sample collectionStage IV non-small cell lung cancer patients treated with checkpoint inhibitor therapy +/- chemotherapy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with cancer will be drawn from the local clinics at the University Hospital Tübingen. Healthy participants will be recruited from university and hospital employees not associated with the study.
Key inclusion criteria (4 listed)
- You are aged 18 years or older.
- You are able to understand and give informed consent.
- Participants with cancer: you are suffering from cancer
- Healthy participants: you are a healthy individual.
Key exclusion criteria (4 listed)
- You are unable to give informed consent.
- You have been suffering from an acute infection with fever during the last three days.
- You have a Hb level of less than 9 g/dl.
- You have a human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
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 |
|---|---|---|
| Biological sample collectionWhole blood (blood draw/phlebotomy) will be obtained to proceed with immunologic analysis of samples. Collection of biologic samples will occur up to 12 months. | Procedure or surgery | Healthy participants, Participants with haematological malignancies, Participants with solid tumours |
Primary outcome
Differences in virus-specific antibody levels
Time frame: 12 months
Determination of differences in plasma and serum antibody levels between healthy participants and participants with cancer.
Differences in cytokine levels
Time frame: 12 months
Determination of differences in plasma and serum cytokine levels between healthy participants and participants with cancer.
Differences in immune cell composition
Time frame: 12 months
Determination of quantitative, phenotypical, and functional differences in immune cells from healthy participants and participants with cancer.
Differences in molecular immune cell makeup
Time frame: 12 months
Determination of epigenetic, transcriptional, and proteomic makeup of immune cells from healthy participants and participants with cancer.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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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.
Claudia Lengerke, Ph.D. study director
University Hospital Tuebingen
Florian Wimmers, Ph.D. study director
University Hospital Tuebingen
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 Influenza and SARS-CoV-2, run by University Hospital Tuebingen at 1 site in Germany.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 May 2024. 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 Germany. 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?
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?
Differences in virus-specific antibody levels (time frame: 12 months). The study lists 4 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 9 May 2024.